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[null,"**NOTE: Information is subject to change"]
[null,"Application Number ","Date Application Submitted ","Applicant Organisation \n(Data Controller)","Applicant","Application Title","HRCDC Decision Date","HRCDC Decision  ","Appeal Panel Decision","*Status"]
[null,"19-001-AF3","14.02.2019","Royal College of Surgeons in Ireland","David Williams ","Irish National Adverse Events Study (INAES-2)","13.06.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-002-AF1","12.04.2019","Waterford Institute of Technology \nHealth Service Executive","Neil Crowhurst","A retrospective case analysis of serious untoward incidents in super catchment mental health services in the HSE South East.","16.12.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-003-AF2","24.04.2019","St Vincent’s University Hospital, Dublin\nMonash University, Melbourne","Alistair Nichol","Treatment of Invasively ventilated adults with Early Activity and  Mobilisation (TEAM) Trial  ","25.07.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-003-AF2/AMD1","03.12.2020","St Vincent’s University Hospital, Dublin\nMonash University, Melbourne","Alistair Nichol","Treatment of Invasively ventilated adults with Early Activity and  Mobilisation (TEAM) Trial  ","11.12.2020","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"19-004-AF2","24.04.2019","St Vincent’s University Hospital, Dublin\nUniversity Medical Centre Utrecht\nMonash University, Australia ","Alistair Nichol","Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP) ","25.07.2019","Conditional Declaration",null,"Declaration Live"]
[null,"19-004-AF2/AMD1/COV","01.04.2020","St. Vincent’s University Hospital, Dublin \nUniversity Medical Centre Utrecht\nMonash University, Australia ","Alistair Nichol","REMAP CAP: COVID-19 Domains and Consent Models","02.04.2020","Amendment Approved ",null,"Declaration Live"]
[null,"19-004-AF2/AMD2/COV","20.05.2020","St. Vincent’s University Hospital, Dublin \nUniversity Medical Centre Utrecht\nMonash University, Australia ","Alistair Nichol","REMAP CAP: COVID-19 Domains and Consent Models","04.06.2020","Amendment Approved ",null,"Declaration Live"]
[null,"19-004-AF2/AMD3/COV","18.09.2020","St. Vincent’s University Hospital, Dublin \nUniversity Medical Centre Utrecht\nMonash University, Australia ","Alistair Nichol","REMAP-CAP Trial: COVID-19 Domains - Vitamin C and Therapeutic Anticoagulation","23.09.2020","Amendment Approved ",null,"Declaration Live"]
[null,"19-004-AF2/AMD4","03.01.2024","St. Vincent’s University Hospital, Dublin \nUniversity Medical Centre Utrecht\nMonash University, Australia ","Alistair Nichol","REMAP-CAP Trial: COVID-19 Domains - Vitamin C and Therapeutic Anticoagulation","30.01.2024","Amendment Approved ",null,"Declaration Live"]
[null,"19-004-AF2/AMD5","05.09.2025","St. Vincent’s University Hospital, Dublin \nUniversity Medical Centre Utrecht\nMonash University, Australia ","Alistair Nichol","REMAP-CAP Trial: COVID-19 Domains - Vitamin C and Therapeutic Anticoagulation","07.10.2025","Amendment Approved ",null,"Declaration Live"]
[null,"19-005-AF2","26.04.2019","St. James's  Hospital Dublin","Richard Flavin","St. James's Hospital Cancer Biobank (SJHCB)","16.11.2021","Conditional Declaration",null,"Declaration Live"]
[null,"19-006-AF3","29.04.2019","Beaumont Hospital","Michael Farrell","The contribution of Whole Genome Sequencing to Brain Tumour Biology ","13.06.2019","No Declaration","Conditional Declaration","Declaration Live"]
[null,"19-006-AF3/AMD1","23.10.2023","Beaumont Hospital","Michael Farrell","The contribution of Whole Genome Sequencing to Brain Tumour Biology ","14.11.2023","Amendment Approved ",null,"Declaration Live"]
[null,"19-006-AF3/AMD2","26.11.2024","Beaumont Hospital","Michael Farrell","The contribution of Whole Genome Sequencing to Brain Tumour Biology ","08.12.2024","Amendment Approved ",null,"Declaration Live"]
[null,"19-007-AF2","03.05.2019","St Vincent’s University Hospital, Dublin\nUniversity College Dublin\nMonash University, Australia     \nLund University, Sweden    \nRegion Skane Skanevaard Sund Sweden  \n","Alistair Nichol","Targeted therapeutic mild hypercapnia after resusitated cardiac arrest  (TAME)","10.09.2019","Conditional Declaration",null,"Declaration Live"]
[null,"19-008-AF2","03.05.2019","St Vincent’s University Hospital, Dublin\nUniversity College Dublin\nMonash University, Australia     \nLund University, Sweden    \nRegion Skane Skanevaard Sund Sweden  \n","Alistair Nichol","Targeted Hypothermia versus targeted Normothermia after Out of Hospital Cardaic Arrest (TTM2)","10.09.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-009-AF3","03.05.2019","National Disability Authority","Aideen Hartney","Moving In Study ","13.06.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-010-AF3","04.06.2019","Beaumont Hospital, Dublin\nNational University of Ireland, Galway","Karen Doyle","Analysis of clots retrieved from stroke patients and correlation of the effect of thrombolytics and mechanical thrombectomy.","10.09.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-011-AF3","25.06.2019","Royal College of Surgeons in Ireland","Gianpiero Cavalleri ","Irish Traveller History Study "," 17.10.2019","Requested more information ",null,"Declaration No Longer Required or Expired"]
[null,"19-012-AF2","26.06.2019","Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin\nHealth Service Executive South","Leonie Young\nArnold Hill\nBryan Hennessy ","Breast Cancer Proteomics and Molecular Heterogeneity","25.11.2019","Conditional Declaration",null,"Declaration Live"]
[null,"19-013-AF2","02.07.2019","University College Cork","Maeve Rooney","Irish Omega 3 Study","10.09.2019","Conditional Declaration",null,"Declaration Live"]
[null,"19-014-AF2","05.07.2019","Royal College of Surgeons in Ireland","Jochen Prehn \nAnnette Byrne","Colossus Study","16.12.2019","Declaration Made",null,"Declaration No Longer Required or Expired"]
[null,"19-015-AF2","05.07.2019","Trinity College Dublin","Mary McCarron","IDS - TILDA ","17.10.2019","Conditional Declaration",null,"Declaration Live"]
[null,"19-015-AF2/AMD1","07.08.2020","Trinity College Dublin","Mary McCarron","IDS - TILDA ","04.09.2020","Amendment Approved ",null,"Declaration Live"]
[null,"19-015-AF2/AMD2","27.01.2023","Trinity College Dublin","Mary McCarron","IDS - TILDA (Wave 5)","28.02.2023","Amendment Approved ",null,"Declaration Live"]
[null,"19-015-AF2/AMD3","04.03.2025","Trinity College Dublin","Mary McCarron","IDS - TILDA (Wave 6)","25.03.2025","Amendment Approved ",null,"Declaration Live"]
[null,"19-016-AF2","05.07.2019","Trinity College Dublin\nHealth Service Executive (CervicalCheck)","Cara Martin\nJohn O’Leary","CERVIVA - HPV","04.09.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-016-AF2/AMD1","16.12.2024","Trinity College Dublin\nHealth Service Executive (CervicalCheck)","Cara Martin\nJohn O’Leary","CERVIVA - HPV","19.12.2024","Amendment Approved ",null,"Declaration Live"]
[null,"19-017-AF2","05.07.2019","Royal College of Surgeons in Ireland","Tom Fahey","Optimising prescribing in older community dwelling people","17.10.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-018-AF2","05.07.2019","University College Cork","Mairead Kiely","COMBINE Study","02.03.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-019-AF2","05.07.2019","University College Cork","Fergus McCarthy","IMPROvED Study","02.03.2020","Declaration Made",null,"Declaration No Longer Required or Expired"]
[null,"19-019-AF2/AMD1","07.09.2022","University College Cork","Fergus McCarthy","IMPROvED Study","04.10.2022","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"19-020-AF2","05.07.2019","University College Cork","Deirdre Murray ","BASELINE Study ","22.06.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-020-AF2/AMD1","13.07.2021","University College Cork","Elaine McCarthy\nDeirdre Murray\nFergus McCarthy ","BASELINE Study \n(The IDEA Study - a joint amendment to the BASELINE and SCOPE studies)","20.07.2021","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"19-021-AF3","05.07.2019","National Suicide Research Foundation","Paul Corcoran","National Self Harm Registry Ireland ","\n30.04.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-021-AF3/AMD1","28.04.2022","National Suicide Research Foundation","Paul Corcoran","National Self Harm Registry Ireland ","10.05.2022","Amendment Approved ",null,"Declaration Live"]
[null,"19-021-AF3/AMD2","25.04.2023","National Suicide Research Foundation","Paul Corcoran","National Self Harm Registry Ireland ","09.05.2023","Amendment Approved ",null,"Declaration Live"]
[null,"19-022-AF2","05.07.2019","Trinity College Dublin","Rose Anne Kenny ","The Irish Longitudinal Study on Ageing (TILDA)","25.11.2019 ","Conditional Declaration",null,"Declaration Live"]
[null,"19-022-AF2/AMD1","18.02.2025","Trinity College Dublin","Rose Anne Kenny ","The Irish Longitudinal Study on Ageing (TILDA)","26.02.2025","Amendment Approved ",null,"Declaration Live"]
[null,"19-023-AF2","05.07.2019","Beaumont Hospital \n","Ger Curley ","Effect of naïve and pre-activated MSCs on monocyte/macrophage function in patients with pulmonary and non pulmonary sepsis","02.04.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-023-AF2/AMD1","18.08.2020","Beaumont Hospital \n","Ger Curley ","Effect of naïve and pre-activated MSCs on monocyte/macrophage function in patients with pulmonary and non pulmonary sepsis","04.09.2020","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"19-023-AF2/AMD2","12.04.2023","Beaumont Hospital \n","Ger Curley ","Effect of naïve and pre-activated MSCs on monocyte/macrophage function in patients with pulmonary and non pulmonary sepsis","09.05.2023","Requested more information",null,"Declaration No Longer Required or Expired"]
[null,"19-024-AF2","05.07.2019","University College Cork","Geraldine Boylan ","Development of a real time seizure detection algorithm for neonates","12.11.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-025-AF2","05.07.2019","Alpha1 - Foundation Ireland","Gerry McElvaney","Irish National AATD Registry (Alpha-1)","26.05.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-026-AF2","05.07.2019","A. Trinity College Dublin\nB. The following collaborators are joint controllers with TCD for the respective academic sub-studies utilising MAMMI data:\n(i) University of Gothenburg, Sweden\n(ii) Murdoch Children’s Research Institute, Australia","Deirdre Daly ","MAMMI study (data processing for sub-studies with University of Gothenburg and Murdoch Children’s Research Institute)","14.06.2022","Conditional Declaration",null,"Declaration Live"]
[null,"19-027-AF3","05.07.2019","National University of Ireland Galway\nGalway University Hospitals","Sharon Glynn","Identification of predictive and prognostic biomarkers in triple negative breast cancer","26.01.2021","Conditional Declaration",null,"Declaration Live"]
[null,"19-031-AF2","05.07.2019","The Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin","Deborah McNamara\nJochen Prehn ","Bowel Disease Bio-resource Development: Identification of Potential Biomarkers for Bowel Disease","17.10.2019","Conditional Declaration",null,"Declaration Live"]
[null,"19-031-AF2/AMD1","13.09.2022","The Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin","Deborah McNamara\nJochen Prehn ","Bowel Disease Bio-resource Development: Identification of Potential Biomarkers for Bowel Disease","04.10.2022","Amendment Approved ",null,"Declaration Live"]
[null,"19-031-AF2/AMD2","27.09.2024","The Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin","Deborah McNamara\nJochen Prehn ","Bowel Disease Bio-resource Development: Identification of Potential Biomarkers for Bowel Disease","11.10.2024","Amendment Approved ",null,"Declaration Live"]
[null,"19-033-AF3","05.07.2019","University College Dublin","Gerard Bury ","The Medical Emergencies Responder - Integration and Training (MERIT) Programme Study (Cardiac Arrest and Pre-Hospital Thrombolysis in Irish General Practice)","26.01.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-038-AF1","05.07.2019","Genuity Science [Formerly Genomics Medicine Ireland Ltd]","Emer Fallon ","The Genomic Basis of Alzheimers disease in Ireland ","16.12.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-040-AF3","05.07.2019","Saolta Hospital – Galway University Hospital","John Laffey","The Interaction between Noradrenaline dosage, Troponin level and Mortality in Septic Shock","13.10.2020","Requested more information",null,"Declaration No Longer Required or Expired"]
[null,"19-041-AF3/COV","05.07.2019 ","Saolta Hospital - Galway University Hospital","John Laffey","The role of T-Regulatory and Mononuclear Phagocyte Cells causing Immune Dysfunction in Sepsis (A study on the role of immune dysfunction in sepsis and COVID-19)","06.05.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-043-AF3","06.07.2019","Trinity College Dublin","Rose Anne Kenny","The Irish Longitudinal Study on Ageing (TILDA) GRO Linkage","25.11.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-044-AF2","06.07.2019","Trinity College Dublin\nFiralis SAS","Mark Little","Rare Kidney Disease (RKD) Registry and Bioresource (collaborative\nstudy with Firalis SAS – the HELICAL Study)","20.07.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-045-AF2","06.07.2019","Trinity College Dublin\nSt. James's Hospital, Dublin","Sharon O Toole ","The Gynaecological Cancer Bioresource (DISCOVARY Bioresource) and ongoing studies.","14.12.2021","Conditional Declaration",null,"Declaration Live"]
[null,"19-045-AF2/AMD1","14.11.2023","Trinity College Dublin (TCD)\nSt James’s Hospital (SJH)\n","Sharon O Toole ","The Gynaecological Cancer Bioresource (DISCOVARY Bioresource) and ongoing studies.","30.01.2024","Amendment Approved ",null,"Declaration Live"]
[null,"19-045-AF2/AMD2","18.04.2024","Trinity College Dublin (TCD)\nSt James’s Hospital (SJH)\n","Sharon O Toole ","The Gynaecological Cancer Bioresource (DISCOVARY Bioresource) and ongoing studies.","28.05.2024","Amendment Approved ",null,"Declaration Live"]
[null,"19-052-AF1","06.07.2019","National Maternity Hospital\nTrinity College Dublin ","Susan Knowles\nStephen Smith ","GENESIS: the genomic landscape of neonatal Escherichia coli sepsis","16.12.2019","Requested more information ",null,"Declaration No Longer Required or Expired"]
[null,"19-060-AF3","07.07.2019","University of Limerick","Austin Stack ","National Kidney Disease Surveillance System (NKDSS) and Quality Assurance (QA) Programme","13.10.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-062-AF1","09.07.2019","Beaumont Hospital, Dublin\nRoyal College of Surgeons in Ireland","Zena Moore\nNatalie McEvoy","The relationship between Sub Epidermal Moisture (SEM) measurement and Inflammatory markers in the early identification of Pressure Ulcers. ","10.09.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-064-AF1","06.08.2019","National University of Ireland, Galway","Paul Buitelaar","Discussion Forum use for Public Health Surveillance","25.11.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-070-AF2","07.08.2019","University College Cork","Fergus McCarthy","Screening of Pregnancy Endpoints - SCOPE study","22.06.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-070-AF2/AMD1","13.07.2021","University College Cork","Elaine McCarthy\nDeirdre Murray\nFergus McCarthy","Screening of Pregnancy Endpoints - SCOPE study\n(The IDEA Study - a joint amendment to the BASELINE and SCOPE studies)","20.07.2021","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"19-072-AF2","07.08.2019","University College Cork","Eugene Dempsey","The Monitor Study: Multimodal assessment of newborns at risk of neonatal hypoxic ischaemic encephalopathy","12.11.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-073-AF3","07.08.2019","University College Cork","Daniel Costello","Incidences of new diagnosis of first seizures and epliepsey in Cork City and county over a one year period","30.04.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-075-AF2","07.08.2019","University of Galway\nGalway University Hospital - Saolta University Health Care Group","Michael Kerin","University of Galway-Saolta Cancer Biobank","28.02.2023","Conditional Declaration",null,"Declaration Live"]
[null,"19-077-AF3","07.08.2019","New Data Controller: University College Dublin (UCD)","David Galvin","Irish Prostate Cancer Outcomes Research (IPCOR Study)","25.06.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-077-AF3/AMD1","01.02.2021","New Data Controller: University College Dublin (UCD)","David Galvin","Irish Prostate Cancer Outcomes Research (IPCOR Study)","02.03.2021","Amendment Approved ",null,"Declaration Live"]
[null,"19-077-AF3/AMD2","17.07.2025","New Data Controller: University College Dublin (UCD)","David Galvin","Irish Prostate Cancer Outcomes Research (IPCOR Study)","17.07.2025","Amendment Approved ",null,"Declaration Live"]
[null,"19-084-AF1","11.10.2019","Health Service Executive","Karn Cliffe","Examine the impact and experiences of people 1 year post-sepsis diagnosis within an Irish healthcare context.","16.12.2019","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"19-085-AF1","13.12.2019","Royal College of Surgeons in Ireland\nBeaumont Hospital","Shona Pfeiffer","Validation of microRNAs as novel diagnostic and therapeutic targets in ischaemic brain injury (Blood biomarkers to predict recovery from ischaemic stroke)","02.03.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-085-AF1/AMD1","04.06.2021","Royal College of Surgeons in Ireland\n","Shona Pfeiffer","Validation of microRNAs as novel diagnostic and therapeutic targets in ischaemic brain injury (Blood biomarkers to predict recovery from ischaemic stroke)","20.07.2021","Amendment Approved ",null,"Declaration Live"]
[null,"19-086-AF1","23.12.2019","St James’s Hospital Dublin","Ignacio Martin-Loeches","Sepsis Immunosuppression in Critically Ill Patients","02.03.2020","Conditional Declaration",null,"Declaration Live"]
[null,"19-086-AF1/AMD1","25.02.2021","St James’s Hospital Dublin","Ignacio Martin-Loeches","Sepsis Immunosuppression in Critically Ill Patients","02.03.2021","Amendment Approved ",null,"Declaration Live"]
[null,"19-086-AF1/AMD2","06.09.2022","St James’s Hospital Dublin","Ignacio Martin-Loeches","Sepsis Immunosuppression in Critically Ill Patients","04.10.2022","Amendment Approved ",null,"Declaration Live"]
[null,"20-001-AF1","11.02.2020","Royal College of Surgeons in Ireland","Jack Laffan","A retrospective analysis of the Irish national Acute Coronary Syndrome (ACS) programme database","26.05.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-001-AF1/AMD1","01.06.2022","Royal College of Surgeons in Ireland","Jack Laffan","A retrospective analysis of the Irish national Acute Coronary Syndrome (ACS) programme database","12.07.2022","No Amendment made"]
[null,"20-003-AF1","27.02.2020","Beaumont Hospital","Gerard Curley","Blood Brain Barrier (BBB) Disruption And Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Changes In Severe Traumatic Brain Injury (TBI)","30.04.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-004-AF1","16.03.2020","Tallaght University Hospital","Sean Kennelly","Outcome for Older People with Cognitive Impairment Attending the Emergency Department","25.06.2020","Declaration Made",null,"Declaration No Longer Required or Expired"]
[null,"20-004-AF1/AMD1","31.08.2023","Tallaght University Hospital","Sean Kennelly","Outcome for Older People with Cognitive Impairment Attending the Emergency Department","19.09.2023","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"20-005-AF1/COV ","26.03.2020","University College Dublin\nSt. Vincent’s University Hospital Dublin\nMater Misericordiae University Hospital\nCork University Hospital\nBeaumont Hospital\nWexford General Hospital\nChildren’s Health Ireland","Patrick Mallon","The All-Ireland Infectious Diseases Cohort Project\n(AIID Cohort Project)","12.10.2021","Conditional Declaration",null,"Declaration Live"]
[null,"20-005-AF1/COV/AMD1","26.09.2025","University College Dublin \nSt Vincent’s University Hospital\nMater Misericordiae University Hospital\nCork University Hospital\nBeaumont Hospital\nWexford General Hospital\nChildren’s Health Ireland at Crumlin and Temple Street.\nSt. James’s Hospital \nNational Orthopaedic Hospital Cappagh \nOur Lady of Lourdes Hospital Drogheda","Patrick Mallon","The All-Ireland Infectious Diseases Cohort Project\n(AIID Cohort Project)","07.10.2025","Amendment Approved",null,"Declaration Live"]
[null,"20-006-AF1/COV","02.04.2020","The Royal College of Surgeons in Ireland","Gerard Curley","A randomized double-blind placebo-controlled trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness.","15.04.2020\n","Conditional Declaration",null,"Declaration Live"]
[null,"20-006-AF1/COV/AMD1","24.08.2020","The Royal College of Surgeons in Ireland","Gerard Curley","A randomized double-blind placebo-controlled trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness.","04.09.2020","Amendment Approved ",null,"Declaration Live"]
[null,"20-007-AF1/COV","03.04.2020","St. James's Hospital, Dublin","Ignacio Martin-Loeches","Integration of data analytics in critically ill patients with COVID-19 infection (INTEGRATOMICS)","15.04.2020\n","No Declaration"]
[null,"20-008-AF1/COV","07.04.2020","Tallaght University Hospital","Ana Rakovac","Clinical, laboratory and radiological characteristics as predictors of outcome in patients with COVID-19","13.05.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-010-AF1/COV","22.04.2020","University Hospital Limerick","Linda Coate","COVID-IYON Study.","30.04.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-012-AF1/COV","14.05.2020","St James’s Hospital Dublin","Cliona Ni Cheallaigh","COVID-19 Bioresource","20.05.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-013-AF1/COV","19.05.2020","Department of Health, Ireland\nUniversity College Cork","Joe Eustace","WHO Solidarity Trial","20.05.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-013-AF1/COV/AMD1","27.10.2022","Department of Health, Ireland\nUniversity College Cork","Joe Eustace","WHO Solidarity Trial","08.11.2022","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"20-015-AF1-COV","21.05.2020","European Society For Medical Oncology (ESMO)","Maccon Keane","The ESMO-CoCARE Registry for patients with a Malignancy who are diagnosed with COVID-19","26.05.2020","No Declaration"]
[null,"20-016-AF1-COV","21.05.2020","Trinity College Dublin","Julie Regan","Clinical Characteristics of Dysphagia and Communication Difficulties among Hospitalised Adults with COVID-19 in Ireland: An Observational Cohort Study","10.06.2020","No Declaration"]
[null,"20-020-AF1-COV","16.06.2020","Teagasc","Paul Cotter ","Irish Coronavirus Sequencing Consortium","25.06.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-021-AF1-COV","16.07.2020","University Hospital Waterford","Fiachra Cooke","ReCaP: Rectal cancer Management During the COVID-19 Pandemic","23.09.2020","No Declaration"]
[null,"20-022-AF1","20.07.2020","Queens University Belfast\nSt Vincent's University Hospital\nBelfast Health and Social Care Trust","Alistair Nichol","PHIND Study","04.09.2020","Conditional Declaration",null,"Declaration Live"]
[null,"20-022-AF1/AMD1","28.06.2021","Queens University Belfast\nSt Vincent's University Hospital\nBelfast Health and Social Care Trust","Alistair Nichol","PHIND Study","20.07.2021","Amendment Approved ",null,"Declaration Live"]
[null,"20-022-AF1/AMD2","29.03.2023","Queens University Belfast\nSt Vincent's University Hospital\nBelfast Health and Social Care Trust","Alistair Nichol","PHIND Study","13.06.2023","Amendment Approved ",null,"Declaration Live"]
[null,"20-023-AF1-COV","20.07.2020","Trinity College Dublin","Julie Regan","Dysphagia and Communication Difficulties amongst Adults Hospitalised with COVID-19 across Ireland (DISCOVER): A multi-site retrospective cohort study \n ","28.07.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-024-AF1-COV","29.07.2020","St Vincent's University Hospital\nUniversity of Edinburgh\nNHS Lothian Health Board.","Alistair Nichol","Genetics of Mortality in Critical Care (GenOMICC)","04.09.2020","Conditional Declaration",null,"Declaration Live"]
[null,"20-024-AF1-COV-AMD1","05.08.2022","St Vincent's University Hospital\nUniversity of Edinburgh\nNHS Lothian Health Board.","Alistair Nichol","Genetics of Mortality in Critical Care (GenOMICC)","04.10.2022","Amendment Approved",null,"Declaration Live"]
[null,"20-024-AF1-COV-AMD2","09.01.2025","St Vincent's University Hospital\nUniversity of Edinburgh\nNHS Lothian Health Board.","Alistair Nichol","Genetics of Mortality in Critical Care (GenOMICC)","25.02.2025","Amendment Approved",null,"Declaration Live"]
[null,"20-025-AF1-COV","10.08.2020","University College Dublin","Conor McAloon","Using contact tracing data to gain insights into the epidemiology of COVID-19 infection in Ireland","04.09.2020","Declaration Made",null,"Declaration No Longer Required or Expired"]
[null,"20-026-AF1-COV","12.08.2020","National University of Ireland Galway\n","John Laffey","CHARTER-Irl Study ","23.09.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-026-AF1-COV/AMD1","07.12.2021","National University of Ireland Galway","John Laffey","CHARTER-Irl Study ","14.12.2021","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"20-027-AF1","31.08.2020","Beaumont Hospital","Ger Curley ","Immune Dysfunction in Acute Brain Injury","13.10.2020","Conditional Declaration",null,"Declaration Live"]
[null,"20-029-AF1","04.09.2020","Trinity College Dublin\nNational Disability Authority","Fintan Sheerin","Models of Care for people Ageing with an Intellectual Disability","11.12.2020","No Declaration"]
[null,"20-030-AF1","29.09.2020","INOTREM S.A. ","INOTREM S.A. ","The ‘ASTONISH’ Study ","12.11.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-031-AF1","30.09.2020","St James’s Hospital, Dublin","Ignacio Martin-Loeches ","Fluid resuscitation with 20% albumin versus crystalloid Septic Shock","12.11.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-031-AF1/AMD1","25.11.2021","St James’s Hospital, Dublin","Ignacio Martin-Loeches ","Fluid resuscitation with 20% albumin versus crystalloid Septic Shock","25.01.2022","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"20-032-AF1","29.10.2020","St James’s Hospital, Dublin","Deirdre Broderick","Molecular Epidemiology of Mumps in Dublin Ireland","11.12.2020\n","Requested more information ",null,"Declaration No Longer Required or Expired"]
[null,"20-033-AF1","29.10.2020","St James’s Hospital, Dublin","Deirdre Broderick","Epidemiologic study of LGV","11.12.2020\n","No Declaration"]
[null,"20-034-AF1","12.11.2020","University College Cork","Ivan Perry ","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opiate Use in Ireland (2015 – 2019) ","11.12.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-035-AF1","19.11.2020","GlaxoSmithKline Research & Development Ltd","Ignacio Martin-Loeches  ","Effectiveness of treatment for infusion in ICU patients with complicated influenza (“IV Zanamivir Effectiveness Study”)"," 13.04.2021","Conditional Declaration",null,"Declaration Live"]
[null,"20-035-AF1/AMD1","16.12.2021","GlaxoSmithKline Research & Development Ltd","Ignacio Martin-Loeches  ","Effectiveness of treatment for infusion in ICU patients with complicated influenza (“IV Zanamivir Effectiveness Study”)","25.01.2022","Amendment Approved ",null,"Declaration Live"]
[null,"20-035-AF1/AMD2","30.01.2023","GlaxoSmithKline Research & Development Ltd","Ignacio Martin-Loeches  ","Effectiveness of treatment for infusion in ICU patients with complicated influenza (“IV Zanamivir Effectiveness Study”)","28.02.2023","Amendment Approved ",null,"Declaration Live"]
[null,"20-036-AF1","20.11.2020","Monash University\nUniversity College Dublin","Alistair Nichol","EPO-TRAUMA","11.12.2020","Conditional Declaration",null,"Declaration Live"]
[null,"20-036-AF1-AMD1","19.10.2021","Monash University\nUniversity College Dublin","Alistair Nichol","EPO-TRAUMA","16.11.2021","Amendment Approved ",null,"Declaration Live"]
[null,"20-036-AF1-AMD2","23.08.2023","Monash University\nUniversity College Dublin","Alistair Nichol","EPO-TRAUMA","19.09.2023","Amendment Approved ",null,"Declaration Live"]
[null,"20-037-AF1-COV","22.11.2020","University College Dublin\n","Emer Doheny","Home monitoring of respiration in COVID-19 patients using smartphone technology: analysis of retrospective data","11.12.2020","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-039-AF1","02.12.2020","Hunter New England Health Local Health District","Bairbre McNicholas ","A pilot multicentre randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock.","02.03.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"20-039-AF1/AMD1","23.11.2022","Hunter New England Health Local Health District","Bairbre McNicholas ","A pilot multicentre randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock.","13.12.2022","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"20-039-AF1/AMD2","24.05.2023","Hunter New England Local Health District","Bairbre McNicholas ","A pilot multicentre randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock.","22.08.2023","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"21-001-AF1","01.02.2021","South Infirmary Victoria University Hospital  (SIVUH) ","Patrick Sheahan","Determination of HPV status of Oropharynx cancer using p16 immunohistochemistry, morphology, and RNAscope (RNA ISH)","22.06.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-002-AF1","12.03.2021","Medical Reseach Institute of New Zealand (MRINZ)","Alistair Nichol","The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets (Mega-ROX)","13.04.2021","Conditional Declaration",null,"Declaration Live"]
[null,"21-002-AF1/AMD1","25.04.2023","Medical Reseach Institute of New Zealand (MRINZ)","Alistair Nichol","The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets (Mega-ROX)","13.06.2023","Amendment Approved ",null,"Declaration Live"]
[null,"21-002-AF1/AMD2","12.09.2024","Medical Reseach Institute of New Zealand (MRINZ)","Alistair Nichol","The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets (Mega-ROX)","08.10.2024","Amendment Approved ",null,"Declaration Live"]
[null,"21-003-AF1","12.03.2021","St James's Hospital, Dublin\nTrinity College Dublin","Tom Rogers","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans","18.05.2021","Conditional Declaration",null,"Declaration Live"]
[null,"21-003-AF1-AMD1","17.01.2022","St James's Hospital, Dublin\nTrinity College Dublin","Tom Rogers","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans","12.04.2022","Amendment Approved ",null,"Declaration Live"]
[null,"21-003-AF1-AMD2","11.05.2023","St James's Hospital, Dublin\nTrinity College Dublin","Tom Rogers","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans","13.06.2023","Amendment Approved ",null,"Declaration Live"]
[null,"21-003-AF1-AMD3","07.07.2024","St James's Hospital, Dublin\nTrinity College Dublin","Tom Rogers","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans","02.09.2024","Amendment Approved ",null,"Declaration Live"]
[null,"21-004-AF1","15.03.2021","AM-Pharma B.V.","Alistair Nichol","AP-recAP-AKI-03-01 (REVIVAL)","18.05.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-005-AF1","15.03.2021","National University of Ireland Galway","Akke Vellinga","Collaboration to reduce Antimicrobial use and Resistance and identify opportunities for improvement and Awareness  (CARA study)","18.05.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-006-AF1/CSO ","15.03.2021","University College Dublin","Carla Perrotta","SARS-CoV-2 clusters and superspreading events in workplaces in Ireland: a retrospective  analysis","22.06.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-007-AF1/COV","04.05.2021","University College Dublin","Alistair Nichol","Irish National Pandemic Biological Sampling in critically ill -COIVD-19 (INPBS-COIVD 19)","18.05.2021","Conditional Declaration",null,"Declaration Live"]
[null,"21-008-AF1","31.05.2021","The Royal College of Surgeons in Ireland","Norman Delanty","Evaluation of the 24/7 EEGTM SubQ system in subjects with uncontrolled epilepsy across \ntwo important common epilepsy syndromes","20.07.2021","Requested more information ",null,"Declaration No Longer Required or Expired"]
[null,"21-009-AF1","15.06.2021","Trinity College Dublin \n","Mary McCarron","Including best practices and the voices of experience in developing post-diagnostic dementia support guidelines for people with an intellectual disability","20.07.2021\n","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-009-AF1/AMD1","21.01.2022","Trinity College Dublin \n","Mary McCarron","Including best practices and the voices of experience in developing post-diagnostic dementia support guidelines for people with an intellectual disability","25.01.2022","Amendment Approved ",null,"Declaration No Longer Required or Expired"]
[null,"21-010-AF1","22.06.2021","The Florey Institute of Neuroscience and Mental Health, Australia","Edel Hennessy, Fiona Lucey","A Phase 3, Multi-Arm Multi-Stage Covariate-Adjusted Response-Adaptive Randomised Trial to Determine Optimal Early Mobility Training after Stroke (AVERT DOSE)","17.08.2021","Conditional Declaration",null,"Declaration Live"]
[null,"21-010-AF1/AMD1","30.01.2024","The Florey Institute of Neuroscience and Mental Health, Australia","Edel Hennessy, Fiona Lucey","A Phase 3, Multi-Arm Multi-Stage Covariate-Adjusted Response-Adaptive Randomised Trial to Determine Optimal Early Mobility Training after Stroke (AVERT DOSE)","20.05.2024","Amendment Approved",null,"Declaration Live"]
[null,"21-011-AF1/CSO","08.07.2021","Economic and Social Research Institute","Seamus McGuinness","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","17.08.2021","Conditional Declaration",null,"Declaration Live"]
[null,"21-011-AF1/CSO/AMD1","21.07.2022","Economic and Social Research Institute","Seamus McGuinness","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","17.08.2022","Amendment Approved",null,"Declaration Live"]
[null,"21-011-AF1/CSO/AMD2","18.07.2023","Economic and Social Research Institute","Seamus McGuinness","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","22.08.2023","Amendment Approved",null,"Declaration Live"]
[null,"21-011-AF1/CSO/AMD3","27.08.2024","Economic and Social Research Institute","Seamus McGuinness","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","02.09.2024","Amendment Approved",null,"Declaration Live"]
[null,"21-012-AF1","30.07.2021","Beaumont Hospital Dublin","Norman Delanty","Everolimus for drug-resistant seizures associated with GATOR1 complex epilepsies","07.09.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-013-AF1","05.08.2021","National Screening Service\nRoyal College of Surgeons in Ireland","Maeve Mullooly","Mammographic breast density and breast cancer outcomes in a population-based breast screening programme","07.09.2021","Conditional Declaration",null,"Declaration Live"]
[null,"21-015-AF1/CSO","03.09.2021","Dublin City University\nUniversity College Dublin","Andrew McCarren","UPCOM (Understanding and Preventing Covid-19 Outbreaks in Meat Processing Plants - Prepared for the Future)","14.12.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-016-AF1","13.09.2021","University College Cork","Elaine Walsh","Medication review for frail older adults in primary care: use of the STOPPFrail (version 2) tool in nursing home populations.","12.10.2021 /\n16.11.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-017-AF1/CSO","23.09.2021"," Irish College of General Practitioners","Michael O’Callaghan","COVID-19 in Ireland: A retrospective analysis of general practice’s contribution to assessment and testing","12.10.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"21-018-AF1/CSO","06.10.2021","National University of Ireland Galway","Alberto Alvarez-Iglesias","Quantifying the Effects of Public Health Interventions in Ireland","16.11.2021","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"22-001-AF1/CSO","23.03.2022","University College Dublin","Prof Patricia Fitzpatrick","Study of the impact of lifestyle factors on COVID-19 outcomes","12.04.2022","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"22-001-AF1/CSO/AMD1","07.11.2022","University College Dublin","Prof Patricia Fitzpatrick","Study of the impact of lifestyle factors on COVID-19 outcomes","13.12.2022","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"22-001-AF1/CSO/AMD2","03.10.2023","University College Dublin","Prof Patricia Fitzpatrick","Study of the impact of lifestyle factors on COVID-19 outcomes","17.10.2023","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"22-001-AF1/CSO/AMD3","06.08.2024","University College Dublin","Prof Patricia Fitzpatrick","Study of the impact of lifestyle factors on COVID-19 outcomes","07.08.2024","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"22-001-AF1/CSO/AMD4","07.04.2025","University College Dublin","Prof Patricia Fitzpatrick","Study of the impact of lifestyle factors on COVID-19 outcomes","11.04.2025","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"22-002-AF1","23.03.2022","Avista – St Anne’s\n(Formally the Daughters of Charity)","Michelle O’Brien","Understanding the wishes and support needs of people with\nintellectual disability as they grow older.","06.09.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-003-AF1","06.04.2022","Otsuka Pharmaceutical Development & Commercialization Inc. (OPDC) \n(Avanir Pharmaceuticals is no longer involved in this study).","Caroline Mason","A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type","10.05.2022","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"22-003-AF1/AMD1","06.04.2023","Otsuka Pharmaceutical Development & Commercialization Inc. (OPDC) \n(Avanir Pharmaceuticals is no longer involved in this study).","Caroline Mason","A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type","22.08.2023","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"22-005-AF1","12.05.2022","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Norman Delanty","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE \nPhase 2)","14.06.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-005-AF1/AMD1","17.11.2022","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Norman Delanty","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE \nPhase 2)","13.12.2022","Amendment Approved",null,"Declaration Live"]
[null,"22-005-AF1/AMD2","29.08.2023","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Norman Delanty","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE \nPhase 2)","19.09.2023","Amendment Approved",null,"Declaration Live"]
[null,"22-005-AF1/AMD3","01.07.2024","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Norman Delanty","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE \nPhase 2)","22.07.2024","Amendment Approved",null,"Declaration Live"]
[null,"22-006-AF1","13.05.2022","Royal College of Surgeons in Ireland \n","Gianpiero Cavalleri","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age","14.06.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-006-AF1/AMD1","31.02.2023","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Gianpiero Cavalleri","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age","28.02.2023","Amendment Approved",null,"Declaration Live"]
[null,"22-006-AF1/AMD2","24.07.2023","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Gianpiero Cavalleri","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age","22.08.2023","Amendment Approved",null,"Declaration Live"]
[null,"22-006-AF1/AMD3","27.06.2023","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Gianpiero Cavalleri","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age","10.07.2024","Amendment Approved",null,"Declaration Live"]
[null,"22-006-AF1/AMD4","08.07.2025","Royal College of Surgeons in Ireland (RCSI) – FutureNeuro Centre \nBeaumont Hospital\nSt James's Hospital","Gianpiero Cavalleri","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age","11.07.2025","Amendment Approved",null,"Declaration Live"]
[null,"22-007-AF1","16.05.2022","University College Cork","Denis O'Mahony","OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly \nHospitalized Patients (OPTIMATE).","12.07.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-008-AF1","16.05.2022","Royal College of Surgeons in Ireland ","Frank Moriarty","Evaluation of policies and practices to support safe and appropriate controlled drug \nprescribing","12.07.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-009-AF1","08.06.2022","University College Dublin","Tomás Barry","Linking and harnessing health and population data to improve outcomes in Out-of-Hospital Cardiac Arrest","12.07.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-009-AF1/AMD1","11.12.2023","University College Dublin","Tomás Barry","Linking and harnessing health and population data to improve outcomes in Out-of-Hospital Cardiac Arrest","12.01.2024","Amendment Approved",null,"Declaration Live"]
[null,"22-010-AF1","10.06.2022","Royal College of Surgeons in Ireland \nBeaumont Hospital\nSt James's Hospital","Gianpiero Cavalleri","Blockchain and AI Enabled Stratified Trials System (BESTS): A pilot study","04.10.2022","No Declaration"]
[null,"22-011-AF1","11.07.2022","Trinity College Dublin","Iracema Lero","SENSE-Cog Residential Care: A feasibility study of hearing and vision support to improve \nquality of life in care home residents with dementia","13.12.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-011-AF1/AMD1","28.04.2023","Trinity College Dublin","Iracema Lero","SENSE-Cog Residential Care: A feasibility study of hearing and vision support to improve \nquality of life in care home residents with dementia","13.06.2023","Amendment Approved",null,"Declaration Live"]
[null,"22-012-AF1","06.10.2022","National Office of Clinical Audit (NOCA) and Health Service Executive (HSE) National Ambulance Service (NAS)","Professor Frank Doyle","Targeted Review and Amalgamation of Unmapped Major Trauma and Ambulance Data in Ireland: TRAUMA Study","08.11.2022","Conditional Declaration",null,"Declaration Live"]
[null,"22-013-AF1","21.12.2022","Royal College of Surgeons in Ireland"," David Williams ","Maximising equity and accessibility of acute stroke care pathways in Ireland (Part C): Patient outcome and experience","25.01.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-001-AF1","03.01.2023","Daiichi Sankyo Europe GmbH","Prof Janice Walshe","EUROPA T-DXd - EUropean Real-world experience Of Previously treated advanced/metastatic HER2-positive breast cancer patients Accessing trastuzumab deruxtecan through a named patient program","28.02.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-002-AF1","18.02.2023","Royal College of Surgeons Ireland\nBeaumont Hospital","Norman Delanty","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","29.03.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-002-AF1/AMD1","04.07.2023","Royal College of Surgeons Ireland\nBeaumont Hospital","Norman Delanty","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","22.08.2023","Amendment Approved",null,"Declaration Live"]
[null,"23-002-AF1/AMD2","27.02.2024","Royal College of Surgeons Ireland\nBeaumont Hospital","Norman Delanty","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","03.04.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-002-AF1/AMD3","11.03.2025","Royal College of Surgeons Ireland\nBeaumont Hospital","Norman Delanty","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","31.03.2025","Amendment Approved",null,"Declaration Live"]
[null,"23-002-AF1/AMD4","02.09.2025","Royal College of Surgeons Ireland\nBeaumont Hospital","Norman Delanty","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","16.09.2025","Amendment Approved"]
[null,"23-003-AF1","27.02.2023","Cancer Trials Ireland (CTI)\nAbbott Laboratories","Ray McDermott","The CADY Sub-Study 1: Biomarker and Major Adverse Cardiovascular Events (MACE) data Analysis","29.03.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-003-AF1/AMD1","12.05.2025","Cancer Trials Ireland (CTI)\nAbbott Laboratories","Ray McDermott","The CADY Sub-Study 1: Biomarker and Major Adverse Cardiovascular Events (MACE) data Analysis","30.05.2025","Amendment Approved",null,"Declaration Live"]
[null,"23-004-AF1","26.04.2023","The University of Newcastle, Australia","Bairbre McNicholas","Individualised Blood Pressure Targets versus Standard Care among Critically Ill\npatients with Shock - A Multicentre Randomised Controlled Trial\n(REACT Shock RCT)","22.08.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-004-AF1/AMD1","20.11.2023","The University of Newcastle, Australia","Bairbre McNicholas","Individualised Blood Pressure Targets versus Standard Care among Critically Ill\npatients with Shock - A Multicentre Randomised Controlled Trial\n(REACT Shock RCT)","29.01.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-005-AF1","11.05.2023","National Disability Authority","Caroline O’Nolan","The journey from wardship to supported decision-making: An examination of the process and the experiences of people leaving wardship","22.08.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-006-AF1","12.05.2023","Dublin City University","Marcia Kirwan ","COST2CARE: Addressing the economic and human cost of hospital acquired and nursing\u0002sensitive adverse events in older patients through optimal use of routine discharge data and \nmeasurement of missed nursing care.","13.06.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-008-AF1","29.05.2023","Monash University ","Alistair Nichol","ARISE FLUIDS","22.08.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-009-AF1","29.05.2023","University of Edinburgh","Alistair Nichol","Anaemia management with red Blood Cell transfusion to improve post intensive care\ndisability- a randomised controlled trial – (The ABC post-intensive care trial)","19.09.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-010-AF1","19.06.2023","Biotest AG","Biotest AG","ESsCAPE","22.08.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-010-AF1/AMD1","31.10.2024","Biotest AG","Biotest AG","ESsCAPE","10.12.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-011-AF1","22.06.2023","Trinity College Dublin","Mary Mc Carron","Building Circles of Support for People with Intellectual Disabilities","22.08.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-012-AF1","04.07.2023","Beaumont Hospital\nRoyal College of Surgeons in Ireland","Norman Delanty","Research Use of Diagnostic Genomic Testing Data for Epilepsy","12.12.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-012-AF1/AMD1","19.05.2025","Beaumont Hospital\nRoyal College of Surgeons in Ireland","Norman Delanty","Research Use of Diagnostic Genomic Testing Data for Epilepsy","30.05.2025","Amendment Approved",null,"Declaration Live"]
[null,"23-013-AF1","24.07.2023","Tallaght University Hospital\nMater Misericordiae University Hospital","Sean O’Dowd","The Prevalence of Primary Tauopathies in Ireland; a Clinically-Defined Population Study in the Province of Leinster","12.12.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-014-AF1","27.07.2023","Trinity College Dublin","Owen Smith","Adolescent and Young Adult (AYA) Cancer Epidemiology in Ireland – a retrospective review of National Cancer Registry Ireland (NCRI) data from 2002 to 2018","19.09.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-015-AF1","28.07.2023","South/South West Hospital Group as part of the HSE.","Brendan Fitzgerald","Investigation into the use of IL-1β, I-CAM1 and/or E-Selectin in identifying the effects of infection in placental tissue.","19.09.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-015-AF1/AMD1","19.03.2024","South/South West Hospital Group as part of the HSE.","Brendan Fitzgerald","Investigation into the use of IL-1β, I-CAM1 and/or E-Selectin in identifying the effects of infection in placental tissue.","03.04.2024","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"23-016-AF1","31.07.2023","Amsterdam University Medical Centers","Lieuwe J. Bos","Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS).","17.10.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-016-AF1/AMD1","26.10.2023","Amsterdam University Medical Centers","Lieuwe J. Bos","Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS).","19.02.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-016-AF1/AMD2","11.06.2025","Amsterdam University Medical Centers","Lieuwe J. Bos","Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS).","09.07.2025","Amendment Approved",null,"Declaration Live"]
[null,"23-017-AF1 ","01.08.2023","University of Torino","University of Torino","Preventing caRdiovascular collapsE with VasoprEssors duriNg Tracheal IntubatiON: The PREVENTION Randomized Controlled Trial","17.10.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-017-AF1 /AMD1","14.04.2025","University of Torino","University of Torino","Preventing caRdiovascular collapsE with VasoprEssors duriNg Tracheal IntubatiON: The PREVENTION Randomized Controlled Trial","01.05.2025","Amendment Approved",null,"Declaration Live"]
[null,"23-019-AF1","20.09.2023","University of Nottingham","Ronan Collins","Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3)","17.10.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-019-AF1/AMD1","24.01.2024","University of Nottingham","Ronan Collins","Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3)","26.03.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-020-AF1","14.10.2023","University College Cork","Seán Millar","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opioid Use in Ireland (2020 – 2022)","14.11.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-020-AF1/AMD1","26.04.2024","University College Cork","Seán Millar","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opioid Use in Ireland (2020 – 2022)","20.05.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-020-AF1/AMD2","30.10.2024","University College Cork","Seán Millar","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opioid Use in Ireland (2020 – 2022)","18.11.2024","Amendment Approved",null,"Declaration Live"]
[null,"23-021-AF1","16.10.2023","National Orthopaedic Hospital Cappagh (NOHC)\nNational Office for Clinical Audit (NOCA) @ RCSI","James Cashman","Patient-Reported Outcomes in Cemented and Uncemented Total Hip Replacements","14.11.2023","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"23-023-AF1","15.11.2023","Helsingborg Hospital, Sweden","Alistair Nichol","Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation – the STEPCARE triaL","12.12.2023","Conditional Declaration",null,"Declaration Live"]
[null,"23-023-AF1/AMD1","21.10.2024","Helsingborg Hospital, Sweden","Alistair Nichol","Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation – the STEPCARE triaL","17.04.2025","Amendment Approved",null,"Declaration Live"]
[null,"23-024-AF1","13.12.2023","University Health Network, Canada","Alistair Nichol","Platform of Randomized Adaptive Clinical Trials in Critical Illness (PRACTICAL) Randomized Controlled Trial","30.01.2024","Conditional Declaration",null,"Declaration Live"]
[null,"23-024-AF1/AMD1","10.10.2024","University Health Network, Canada","Alistair Nichol","Platform of Randomized Adaptive Clinical Trials in Critical Illness (PRACTICAL) Randomized Controlled Trial","31.10.2024","Amendment Approved",null,"Declaration Live"]
[null,"24-001-AF1","19.02.2024","Cork University Hospital","Aaron Doherty","Exploring MALDI-TOF MS data to improve the diagnosis and treatment of Staphylococcus aureus bacteraemia.","26.03.2024","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"24-001-AF1/AMD1","04.07.2024","Cork University Hospital","Aaron Doherty","Exploring MALDI-TOF MS data to improve the diagnosis and treatment of Staphylococcus aureus bacteraemia.","10.07.2024","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"24-002-AF1","21.02.2024","Monash University","Ger Curley","Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment (The BONANZA Trial)","26.03.2024 / 30.04.2024","Requested more information , Conditional Declaration",null,"Declaration Live"]
[null,"24-002-AF1/AMD1","27.06.2025","Monash University","Ger Curley","Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment (The BONANZA Trial)","16.07.2025","Amendment Approved",null,"Declaration Live"]
[null,"24-003-AF1","23.02.2024","Monash University","Alistair Nichol","Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients (SPICE IV)","30.04.2024 / 25.06.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-004-AF1","06.03.2024","University Hospital Limerick","Maeve Herlihy","Acral Melanoma: Incidence, clinical course and survival patterns in Ireland from 1994 – 2022","30.04.2024","Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"24-004-AF1/AMD1","15.08.2024","University Hospital Limerick","Maeve Herlihy","Acral Melanoma: Incidence, clinical course and survival patterns in Ireland from 1994 – 2022","02.09.2024","Amendment Approved",null,"Declaration No Longer Required or Expired"]
[null,"24-005-AF1","27.03.2024","Royal College of Surgeons Ireland\nBeaumont Hospital\nCentric Health","Jarushka Naidoo","The ‘Lung Health Check’ Pilot","30.04.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-005-AF1/AMD1","17.11.2025","Royal College of Surgeons Ireland\nBeaumont Hospital\nCentric Health","Jarushka Naidoo","The ‘Lung Health Check’ Pilot","19.11.2025","Amendment Approved",null,"Declaration Live"]
[null,"24-006-AF1","19.04.2024","Rotunda Hospital","Fionnuala Ní Áinle","Determining the Impact of the “Thrombocalc” VTE Risk Assessment on the Incidence of postpartum VTE in the Rotunda Hospital, and derivation of a novel postpartum VTE risk prediction model.","13.08.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-007-AF1","09.05.2024","University of Torino","Vincenzo Russotto","International obServational sTudy on AiRway manaGement in operAting room and non‐operaTing room anaEsthesia (STARGATE)","28.05.2024 / 25.06.2024","Requested more information , Conditional Declaration",null,"Declaration No Longer Required or Expired"]
[null,"24-008-AF1","28.06.2024","Beaumont Hospital","David Williams","Development and Validation of a Risk Prediction Model of Adverse Drug Events in Older Adults Presenting to an Acute Tertiary Hospital","13.08.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-009-AF1","05.07.2024","Health Intelligence Unit, HSE\nSt James’s Hospital Dublin","Clíona Ní Cheallaigh","INCLUDE: Integrating National Repositories for the Cooperation Linkage and Understanding of a Data Driven approach to the needs of Excluded people","25.02.2025","Conditional Declaration",null,"Declaration Live"]
[null,"24-009-AF1/AMD1","04.04.2025","Health Intelligence Unit, HSE\nSt James’s Hospital Dublin","Clíona Ní Cheallaigh","INCLUDE: Integrating National Repositories for the Cooperation Linkage and Understanding of a Data Driven approach to the needs of Excluded people","11.04.2025","Amendment Approved",null,"Declaration Live"]
[null,"24-010-AF1","30.09.2024","Association AfterROSC","Pr Alain Cariou","Study about the various prognostic scores calculated upon admission to the intensive care unit for patients admitted after cardiac arrest.","12.11.2024 / 28.01.2025","Requested more information , Conditional Declaration",null,"Declaration Live"]
[null,"24-011-AF1","25.10.2024","Trinity College Dublin","Eilish Burke","A Feasibility Assessment of the Echolight Bone Screening Device for Individuals with Intellectual disabilities","12.11.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-012-AF1","01.11.2024","University of Oxford","Andrea Haren","Threshold for Platelets Study (T4P)","12.11.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-013-AF1","06.11.2024","Health Service Executive\nTrinity College Dublin","Lorraine Schwanberg","Learning from Incidents – a mixed-method study of incident reviews.","10.12.2024","Conditional Declaration",null,"Declaration Live"]
[null,"24-014-AF1","25.11.2024","University of Warwick\nUniversity Hospitals Bristol and Weston NHS Foundation Trust","Patrick O’Sullivian & Prof Alistair Nichol","AIRWAYS-3","28.01.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-001-AF1","22.01.2025","Ghent University Hospital ","Eric Hoste","Acute Kidney Injury – Epidemiology in ICU Patients 2 (AKI-EPI 2)","25.02.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-002-AF1/CSO","20.02.2025","Dublin City University","Ronan O’Toole","An epidemiological study of COVID-19 in the Irish Traveller population","25.03.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-003-AF1","19.03.2025","St. Vincent’s University Hospital ","Patrick Murray","Cirrhosis-Acute Kidney Injury Cohort Study","29.04.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-004-AF1/CSO","03.06.2025","Royal College of Surgeons In Ireland","Edward Gregg","Impact of diabetes and co-morbidities on health status, economic activity and morality","24.06.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-005-AF1","28.05.2025","HSE ","Katie McFaul","Cork University Hospital Beneficiaries of Temporary Protection Living with HIV Cross-Sectional Study","24.06.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-006-AF1","07.07.2025","University College Dublin","Patricia Maguire","The role of Extracellular Vesicles in disorders of haemostasis and organ injury following Acute Brain Injury (COALESCE-Brain)","12.08.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-007-AF1","09.07.2025","Novus Diagnostics","Ger Curley","Clinical Feasibility Study of a Prototype Device (SepTec) System for Early Detection of Sepsis in Critically Ill Patients.","12.08.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-007-AF1/AMD1","05.11.2025","Novus Diagnostics","Ger Curley","Clinical Feasibility Study of a Prototype Device (SepTec) System for Early Detection of Sepsis in Critically Ill Patients.","19.11.2025","Amendment Approved",null,"Declaration Live"]
[null,"25-008-AF1","09.07.2025","St. James’s Hospital","Donal Sexton","GENAKI: Generative AI for Acute Kidney Injury Prediction and Management at St. James’s Hospital","09.09.2025","Requested more information , Conditional Declaration",null,"Declaration Live"]
[null,"25-011-AF1","01.08.2025","University Health Network","Matteo Parotto","EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit (EXTUBE","09.09.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-011-AF1/AMD1","01.08.2025","University Health Network","Matteo Parotto","EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit (EXTUBE","18.11.2025","Amendment Approved",null,"Declaration Live"]
[null,"25-011-AF1/AMD1","28.11.2025","University Health Network","Matteo Parotto","EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit (EXTUBE","02.12.2025","Amendment Approved",null,"Declaration Live"]
[null,"25-012-AF1/CSO","05.08.2025","University College Cork","Patricia Kearney","RECONNECT: chRonic disEase: disCOvery, aNalysis aNd prEdiCTive modelling – Case study using PCRS dataset","09.09.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-013-AF1","06.08.2025","Trinity College Dublin","Caoimhin Mac Giolla Phadraig","Keep My Teeth: A Pragmatic Trial of a Co-Designed, Multicomponent Oral Health Promotion Intervention in Disability Services","09.09.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-014-AF1","02.09.2025","University College Cork","Suzanne Timmons","In-Touch: Implementation of a person-centered palliative care iNtervention To imprOve comfort, QUality of Life and social engagement of people with advanced dementia in Care Homes","07.10.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-015-AF1/CSO ","01.10.2025","Royal College of Surgeons in Ireland","Frank Moriarty","Prevalence and Trends of Polypharmacy and Medication-Related Issues in Primary Care: A Repeated Cross-Sectional Study of GMS Pharmacy Claims Data in Ireland (2013–2024).","11.11.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-016-AF1","06.10.2025","National Rehabilitation Hospital","Eimear Smith","Outcomes and Management of Sports-Related Spinal Cord Injuries in Ireland: A 10-Year Retrospective Analysis"]
[null,"25-017-AF1/CSO","21.10.2025","Dublin City University","Mary Hall","An investigation into the impact of smoking on Irish mortality 2022-2023","11.11.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-018-AF1","29.10.2025","University of Galway\nMonash University","Fidelma Dunne","MiPS: Metformin in Pregnancy Study","11.11.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-019-AF1","04.11.2025","Galway University Hospitals\nHealth Services Executive","John Laffey","Understanding the risk factors contributing to outcomes of older perioperative patients in Ireland: The Irish Perioperative OutcomeS (IPOS) Study","09.12.2025","Requested more information "]
[null,"25-020-AF1","05.11.2025","Renal Health Intelligence Subcommittee, HSE National Renal Office (NRO)","Conor Judge","Comprehensive analysis of traditional and novel risk factors for stroke in persons with kidney failure in Ireland."]
[null,"25-021-AF1","12.11.2025","Tallaght University Hospital","Antoinette O’Connor","Biomarkers in the identification of Alzheimer’s Disease in people with Down Syndrome (Bio-MinDS)","09.12.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-022-AF1/CSO","02.12.2025","University College Cork","Emma Wallace","Trends in Respiratory Medication Prescriptions in Ireland Before and After the Introduction of a Chronic Disease Management programme in General Practice: An Interrupted Time Series","09.12.2025","Conditional Declaration",null,"Declaration Live"]
[null,"25-023-AF1","01.12.2025","Galway University Hospital","Bairbre McNicholas","A Mixed Methods Study to Develop and Validate an ML-NLP Decision-Support Framework for ICU Fluid Management-SMART FLOW"]

{"sheet":"19-001-AF3","index":1,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref:","19-001-AF3"]
[null,"Application Title ","Irish National Adverse Events Study "]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland "]
[null,"Lead Applicant ","David Williams"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","This study (INAES-2) proposes to determine current rates of adverse events in Irish acute hospitals and to establish whether the implementation of the Clinical Programmes has influenced overall adverse event frequency. INAES-2 will also be able to compare adverse event rates with those reported in the recently updated National Incident Management System (NIMS). A key goal of INAES-2 is to provide the Irish healthcare sector with a data collection tool capable of being used by hospitals and frontline staff to determine local adverse event prevalence rates with a view to quality improvement. 3200 data subjects randomly selected from 8 hospital sites. 200 surgical and 200 medical from 8 hospitals. Collecting existing clinical data from hospital healthcare records. "]
[null,"Reason for seeking a Declaration","A Declaration is sought for the collection of data relating to adverse events from hospital healthcare records from randomly selected admissions across eight hospital sites by trained nurse and physican reviewers. No consent has been obtained for this processing. Data collected is pseudonymised at the point of collection. A master list linking patient identifiers to the data collected is held and will subsequently be destroyed by the host hospital - the research team do not have access to this list."]
[null,"HRCDC Meeting Date #1","29th April, 2019"]
[null,"HRCDC Meeting Date #2","13th June, 2019"]
[null,"HRCDC Decision Date ","13th June, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","1. The HRCDC require written confirmation that the Master list (including all hard and soft electronic copies) associated with source personal data, has been destroyed, as soon as this occurs.  (CONDITION MET)\n2. As part of the Annual Review report to the HRCDC, the Applicant is requested to provide specific information on the Patient and Public involvement (PPI) during the lifetime of the study and outline any issues considered and addressed as part of that involvement.  (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","Amended: Commencing August 8th, 2018 and shall be valid for until 31st October 2019 (Amended at 25th July, 2019 meeting) "]
[null,"Status of Declaration","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","1. No precedent set: Each application is considered on its individual merits. It should be noted that any future consent declaration being sought for next waves of ‘INAES’ studies, that application will be viewed on its own merits. Therefore, the Applicant should not view this decision for 19-001-AF3, as a precedent for future applications.\n2. For future applications, the HRCDC recommends the Applicant consider condition 2 when designing the future waves of ‘INAES’ studies."]

{"sheet":"19-002-AF1","index":2,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-002-AF1"]
[null,"Application Title ","Retrospective case analysis of serious untoward incidents in super catchment mental health services in the HSE South East"]
[null,"Applicant Organisation (Data Controller)","Waterford Institute of Technology\nHealth Service Executive "]
[null,"Lead Applicant ","Neil Crowhurst (HSE)"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Mental health services in the counties of Waterford and Wexford were amalgamated in 2011. Concern has been expressed about the level of serious incidents involving users of mental health services. This study proposes to look at the collective contextual issues which may contribute to serious incidents occurring which may include psychiatric morbidity, use of alcohol and drugs, the physical environment and external issues such as homelessness."]
[null,"Reason for seeking a Declaration","The project will involve the principal investigator reviewing personal data in the form of incident reports and from the patient’s notes without the explicit consent of the data subject. A pilot exercise to review 10 charts will also be undertaken within this study for reliability and research quality purposes."]
[null,"HRCDC Meeting Date","16th December 2019"]
[null,"HRCDC Decision Date ","16th December 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. In addition to the staff and patient information leaflets developed, to further enhance the data protection principle of ‘transparency’, the Applicant is requested to ensure more robust transparency arrangements are in place to inform staff and patients about this study and the data being used for the study. Transparency can be enhanced by way of providing public notices at the relevant mental health services sites involved in this study. These notices should include relevant contact information and practical steps for individuals who may wish to withdraw from the study, if they believe their personal data may be included. The notices should be clearly visible at each site and in place prior to data collection commencing at that location. Other means of making the information about the study publicly available, should be considered, as appropriate. (CONDITION MET)\n\nNOTE: Further information on providing transparent information can be found on the Data Protection Commission’s website; https://www.dataprotection.ie/en/organisations/know-your-obligations/transparency. It is advisable to consult with your Data Protection Officer as needed.\n\nCondition 2. As the Health Service Executive & Waterford Institute of Technology have now been confirmed as Joint-Data Controllers, an appropriate Joint Data Controller arrangement also should be in place between these parties. It is advisable to discuss this with your Institution’s legal office and Data Protection Officer, as appropriate. (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 16th December 2019 and shall be valid until 31st March, 2023"]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-003-AF2","index":3,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-003-AF2","19-003-AF2/AMD1"]
[null,"Application Title ","Treatment of Invasively ventilated adults with Early Activity and Mobilisation (TEAM) Trial  ","Treatment of Invasively ventilated adults with Early Activity and Mobilisation (TEAM) Trial  "]
[null,"Applicant Organisation (Data Controller)","St Vincent’s University Hospital, Dublin (Lead Data Controller)\nMonash University, Melbourne ","St Vincent’s University Hospital, Dublin (Lead Data Controller)\nMonash University, Melbourne "]
[null,"Lead Applicant ","Alistair Nichol ","Alistair Nichol "]
[null,"Research commenced prior to submission of application","Yes","No"]
[null,"Research Objective","The aim of the TEAM study is to evaluate the effect of early activity and mobilisation during prolonged invasive mechanical ventilation (IMV). Patients who are critically ill are treated in ICUs, and receive IMV to help with their breathing, which is a lifesaving intervention. However, this intervention, confines patients to their beds for long periods of time and is associated with poor recovery of physical function and severe muscle weakness. This is called intensive care unit acquired weakness (ICUAW). Though many patients recover, not all return to the same level of function as before their illness.","The Applicant requests an amendment to the existing consent declaration for the following reasons:\n•\tThe assent/consent protocol has been amended to include telephone consent/assent.\n•\tThe study wishes to include two additional research sites: Galway University Hospital and Beacon Hospital."]
[null,"Reason for seeking a Declaration","A consent declaration is requested as the model for obtaining consent from subjects in this study is initially based on a Relative’s Deferred Assent to collect and process the patient’s data, followed by obtaining deferred/delayed ‘Subject Consent to Continue’ to collect and process their data. The patient’s data will be processed for research purposes at the start of the study without specific explicit consent from the subject as the patient is sedated and is not able to give informed consent upon entry into the study.","Amendment: The amendment to the study is to reflect an amendment to the consent/assent model due to COVID-19 restrictions. In addition the amendment seeks to include the addition of two new hospital sites to the study. "]
[null,"HRCDC Meeting Date","25th July 2019","11th December 2020"]
[null,"HRCDC Decision Date ","25th July 2019","11th December 2020"]
[null,"HRCDC Decision","Conditional Declaration","Amendment  Approved"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC has requested that all appropriate contractual arrangements (legal agreements) must be in place with the relevant institutions, regarding the transfer of personal data for the purpose of the research study. This is a safeguard that the HRCDC has requested and therefore confirmation that these agreements must be provided to the HRCDC. Until this confirmation is received the Declaration will not cover the processing activity of transferring data. (CONDITION MET)\n\nCondition 2: Confirmation of Research Ethics approval from the Tallaght University Hospital site must be provided to the HRCDC, once granted. No data processing can commence at this site until such written confirmation is provided to the HRCDC. (CONDITION MET)\n\nCondition 3: The HRCDC has requested that, where a patient continues to lack capacity for a prolonged period of time and where the next-of-kin assent remains in place, the following action should be taken as an additional safeguard:  The researcher should seek confirmation from the next-of-kin (or individuals) who provided assent,  that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. (CONDITION MET)","Condition 1: The Applicant is requested to consult with Data Protection Officers at St. Vincent’s University Hospital and Galway University Hospital in relation to any data protection matters that may have arisen since the commencement date of processing personal data for the study, until the date that this amendment to the declaration has been made and to provide any relevant feedback to the HRCDC. (CONDITION MET)\n\nCondition 2: The amendment to this declaration only covers the research sites that have Research Ethics Committee (REC) approval in place. Confirmation of REC approval for the amended consent protocol from Tallaght University Hospital and Galway University Hospital, that currently remains pending, must be provided to the HRCDC once it is available. \n(CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 2021 and 15 years thereafter (until August 31st, 2036), or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner","The Amendment is made commencing 11th December 2020 and shall be valid until August 31st, 2036, or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner (This timeline is in line with the duration of the consent declaration)"]
[null,"Status of Declaration","Declaration No Longer Required","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC recommended a review of the consent forms and patient information leaflets used by the researchers, to ensure there is clarity for the participants and those assenting on their behalf, regarding all strands of the research study and data processing. Specifically, the researchers should consider an appropriate layered consent approach to ensure informed assent and consent is obtained.(RECOMMENDATION CONSIDERED)\n\nRecommendation 2: The HRCDC has recommended that the 15 year data and master list retention period, be reviewed to determine whether the retention period could be shortened and master list be destroyed within a shorter timeframe. The Applicant is required to report on the review of the data retention policy when submitting the annual review to the HRCDC. (REOMMENDATION CONSIDERED)","Comment: Please ensure the wording used in the telephone script and accompanying assent/consent form is consistent and accurate. The HRCDC notes that the terms ‘assent’ & ‘consent’ are both used in this document."]

{"sheet":"19-004-AF2","index":4,"n_rows":17,"n_cols":8,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,7,12,7],[11,6,12,6],[11,2,12,2],[11,1,12,1],[11,3,12,3],[11,4,12,4],[11,5,12,5]]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3","AMENDMENT #4","AMENDMENT #5"]
[null,"Application Ref","19-004-AF2","19-004-AF2/AMD1/COV","19-004-AF2/AMD2/COV","19-004-AF2/AMD3/COV","19-004-AF2/AMD4","19-004-AF2/AMD5"]
[null,"Application Title ","Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP)","REMAP-CAP Trial: COVID-19 Domains and Consent Models","REMAP-CAP Trial: COVID-19 Domains and Consent Models","REMAP-CAP Trial: COVID-19 Domains - Vitamin C and Therapeutic Anticoagulation.","REMAP-CAP Trial: COVID-19 Domains - Vitamin C and Therapeutic Anticoagulation.","REMAP-CAP Trial: COVID-19 Domains - Vitamin C and Therapeutic Anticoagulation."]
[null,"Applicant Organisation (Data Controller)","St Vincent’s University Hospital, Dublin  (Lead Data Controller)\nUniversity Medical Centre Utrecht\nMonash University, Australia","St Vincent’s University Hospital, Dublin  (Lead Data Controller)\nUniversity Medical Centre Utrecht\nMonash University, Australia","St Vincent’s University Hospital, Dublin  (Lead Data Controller)\nUniversity Medical Centre Utrecht\nMonash University, Australia","St Vincent’s University Hospital, Dublin  (Lead Data Controller)\nUniversity Medical Centre Utrecht\nMonash University, Australia","St Vincent’s University Hospital, Dublin  (Lead Data Controller)\nUniversity Medical Centre Utrecht\nMonash University, Australia","St Vincent’s University Hospital, Dublin  (Lead Data Controller)\nUniversity Medical Centre Utrecht\nMonash University, Australia"]
[null,"Lead Applicant ","Alistair Nichol","Alistair Nichol","Alistair Nichol","Alistair Nichol","Alistair Nichol","Alistair Nichol"]
[null,"Research commenced prior to submission of application","Yes","No ","No ","No ","No ","No "]
[null,"Research Objective","This study aims to find the most optimal treatment for severe Community-acquired pneumonia (CAP) in the adult ICU population. In comparison to a conventional trail, it combines a number of novel design features and has been termed a Randomised, Embedded, Multifactorial Adaptive Platform trail. These features are designed to enhance the efficiency of trial conduct, generate new knowledge more quickly, and improve outcome for participants within the trial.","The study has been amended in response to the global COVID-19 pandemic. The amendment is to include two new domains and to amend the consent model. The two new domains are the COVID-19 Antiviral Domain and the COVID-19 Immune Modulation Domain. This will allow the researchers to investigate potential treatments for COVID-19.","An amendment is to include 2 further sites in the study.","An amendment to include 2 domains to the existing REMAP-CAP study, in response to COIVD-19 and to add Monash University as a Data Controller.",null,"This study aims to find the most optimal treatment for severe Community-acquired pneumonia (CAP) in the adult ICU population. In comparison to a conventional trail, it combines a number of novel design features and has been termed a Randomised, Embedded, Multifactorial Adaptive Platform trail. These features are designed to enhance the efficiency of trial conduct, generate new knowledge more quickly, and improve outcome for participants within the trial."]
[null,"Reason for seeking a Declaration/Amendment","Patients who are unable to provide consent to participate in the research due to the nature of the illness, are enrolled via Relative’s Deferred Assent. Subject Consent to Continue is obtained when the patient regains capacity. A Declaration is sought to enable the researchers to continue to process personal data using this model of Deferred consent/assent.","Amendment:  To add two new domains which will allow the researchers to study treatments for COVID-19. \nThe consent model will also be amdended. Typically when patients lack capacity to consent, assent is obtained from their next of kin in a face-to-face encounter and they provide written assent. During the COVID-19 pandemic family members will be placed under severe visiting restrictions due to the risk they pose to other vulnerable patients, to hospital staff and also the general public rendering a face-to-face discussion challenging. The study proposes that to contact the next of kin by telephone and seek to obtain their assent. The assent form will also be sent to the relative, signed and returned.\nFour addtional study sites will also be included in the study; Limerick University Hospital, Beacon Hospital, Mercy Hospital Cork, Cork University Hospital ","Amendment: Two additional sites will be included in the study: Waterford University Hospital and St. James's Hospital Dublin","Amendment: The addition of two domains to the existing REMAP-CAP study, in response to COVID-19. The two further domains are the use of Vitamin C as a treatment and use of a Therapeutic Anticoagulation.\n•\tThe addition of Monash University as a Data Controller.\n","The amendment request is for the following changes to the study:\n-\tThe inclusion of two additional sites: Tallaght University Hospital and Wexford General Hospital.\n-\tThe addition of new treatment domains to the trial:\no\tMechanical Ventilation domain\no\tStatin/Simvastatin Domain. Note: this domain closed 9th Jan 2023.\no\tEndothelial domain (NREC approval 15th December 2023)\no\tInfluenza Immune Modulation domain (NREC approval 15th December 2023)\n-\tExtension of the period of data storage to 25 years to align with the new Clinical Trials Regulation.","To broaden the cohort of patients to be included in this study i.e., in addition to CAP and COVID-19 patients, the consent declaration covers the processing of personal data for all patients with acute respiratory tract infection who require organ support in the intensive care unit. It is also noted that a primary outcome measure now includes an ordinal scale of trajectory of illness and recovery to day 28."]
[null,"HRCDC Meeting Date","25th July 2019","2nd April 2020","Written Procedure","23rd September 2020","30th January 2024","7th October 2025"]
[null,"HRCDC Decision Date ","25th July 2019","2nd April 2020","4th June 2020","23rd September 2020","30th January 2024","7th October 2025"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Amendment Approved","Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC has requested that all appropriate contractual arrangements (legal agreements) must be in place with the relevant institutions, regarding the transfer of personal data for the purpose of the research study. This is a safeguard that the HRCDC has requested and therefore confirmation that these agreements must be provided to the HRCDC. Until this confirmation is received the Declaration will not cover the processing activity of transferring data. (CONDITION MET)\n\nCondition 2: Confirmation of Research Ethics approval from sites currently awaiting approval (Beaumont Hospital and University Hospital Galway) must be provided to the HRCDC, once granted. No data processing can commence at these sites until such written confirmation is provided to the HRCDC. (CONDITION MET)\n\nCondition 3: The HRCDC has requested that, where a patient continues to lack capacity for a prolonged period of time and where the next-of-kin assent remains in place, the following action should be taken as an additional safeguard:  The researcher should seek confirmation from the next-of-kin  (or individuals) who provided assent,  that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. (CONDITION MET)\n\nCondition 4: The HRCDC has requested confirmation that personal identifiable data, such as name, date-of-birth, are stored locally at the Hospital site of the patients, and not transferred to the collaborative parties. (CONDITION MET)","Condition 1:  Confirmation of Research Ethics approval from sites currently awaiting approval (Limerick University Hospital, Beacon Hospital, Mercy Hospital Cork, Cork University Hospital) must be provided to the HRCDC, once granted. No data processing can commence at these sites until such written confirmation is provided to the HRCDC. (CONDITION MET)","Condition 1. Confirmation of Research Ethics approval for Limerick University Hospital as a study site must be provided to the HRCDC, once granted. No data processing can commence at this until such written confirmation is provided to the HRCDC (CONDITION MET)","Condition 1. It is a condition of this amendment that the appropriate joint data controller arrangement/agreement is in place between the joint data controllers of this study, St. Vincent's University Hospital, University Medical Centre Utrecht and the new joint data controller, Monash University. The appropriate agreement must be in place prior to any transfer of data to the new joint data controller, Monash University. (CONDITION MET)","Condition 1. The appropriate data agreements and arrangements must be in place with the two new additional sites. Data transfer cannot occur from these sites prior to the necessary data agreements being in place. (CONDITION MET)\n\nCondition 2. The study information leaflets should be updated to accurately reflect all the domains that are active in Ireland, including the new domains covered by this amendment. (CONDITION MET)","N/A"]
[null,null,null,null,null,null,"TBC","TBC "]
[null,"Deadline for meeting any conditions","N/A","N/A","N/A","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 2021 and 15 years thereafter (until August 31st, 2036), or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner.  Amendment - August 31st, 2046 ","The Amendment is made commencing 2nd April 2020 and shall be valid until 2021 and 15 years thereafter (until August 31st, 2036), or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner. (This timeline is in line with that of Conditional Declaration). Amendment - August 31st, 2046 ","The Amendment is made commencing 2nd April 2020 and shall be valid until 2021 and 15 years thereafter (until August 31st, 2036), or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner. (This timeline is in line with that of Conditional Declaration).  Amendment - August 31st, 2046 ","The Amendment is made commencing 23rd September 2020 and shall be valid until 2021 and 15 years thereafter (until August 31st, 2036), or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner, in line with the duration of the consent declaration made. Amendment - August 31st, 2046 ","The approval to the Amendment is made commencing 30th January 2024 and the consent declaration shall be valid until August 31st, 2046 [this is an extension of the original consent declaration duration].","The approval to the Amendment is made commencing 7 th October 2025 and shall be valid until 31st August 2046, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Amendment Live","Amendment Live","Amendment Live","Amendment Live","Amendment Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC recommended a review of the consent forms and patient information leaflets used by the researchers, to ensure there is clarity for the participants and those assenting on their behalf, regarding all strands of the research study and data processing. Specifically, the researchers should consider an appropriate layered consent approach to ensure informed assent and consent is obtained.  (RECOMMENDATION CONSIDERED)\n\nRecommendation 2: The HRCDC has recommended that the 15 year data and master list retention period, be reviewed to determine whether the retention period could be shortened and master list be destroyed within a shorter timeframe. The Applicant is required to report on the review of the data retention policy when submitting the annual review to the HRCDC.  (RECOMMENDATION CONSIDERED)","Recommendation 1. The Applicant is requested to consult with the Data Protection Officer regarding the Data Protection Impact Assessment for this study to ensure that any data risks continue to be reviewed and identified and that the appropriate mitigating actions and safeguards are implemented [RECOMMENDATON CONSIDERED]\n\nRecommendation 2. The HRCDC recommends a review of the assent forms and accompanying study information leaflets used by the researchers, specifically the section entitled ‘STORAGE & FUTURE USE OF INFORMATION’. A consent declaration is study specific and cannot cover the use of personal data for unknown future research studies. [RECOMMENDATION CONSIDERED]","N/A","N/A","N/A","Recommendation 1. The latest version of the study information leaflets, provides some information to the proxy/patient that anonymous data may be shared with the manufacturers; in the interest of transparency, the HRCDC is of the view that the study information leaflets should provide more clear information on what is meant by the safety and outcome data that may be shared and why e.g., what type of data may be shared."]

{"sheet":"19-005-AF2","index":5,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-005-AF2"]
[null,"Application Title ","St. James's Hospital Cancer Biobank"]
[null,"Applicant Organisation (Data Controller)","St. James's Hospital Dublin"]
[null,"Lead Applicant ","Richard Flavin"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The SJHCB commenced in 2008 and collects samples and personal data that can be used in research. The samples and data relate to colorectal and breast cancer patients. This biobank aims to facilitate research that will contribute to the development of new tests, treatments and ultimately an improvement in the clinical outcome of patients."]
[null,"Reason for seeking a Declaration","A consent declaration is required for the following limited data processing activities only, where consent originally obtained from a cohort of participants was not compliant under data protection legislation:\n(i) The storage only of this personal data for future, unspecified research studies but does not extend to the use or further processing of the personal data in other studies.\n(ii) Pseudonymisation of this personal data for the storage in the biobank, for security purposes."]
[null,"HRCDC Meeting Date","16th November 2021"]
[null,"HRCDC Decision Date ","16th November 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of the consent declaration made that:\n(i) no further processing of the personal data for specific research studies can be carried out by the data controller without seeking an amendment to the consent declaration. An amendment must be requested by way of submitting an application for HRCDC consideration, \n(ii) any subsequent amendment application submitted to the HRCDC must: \n- set out the public interest case for the processing of the data further for specific research studies, \n- outline what additional PPI engagement activities and transparency measures have been undertaken in relation to that additional data processing for the research study,\n- outline the feasibility and appropriateness for seeking or not seeking reconsent from participants. \nNOTE: Any third-party data controller seeking to process the personal data covered by this consent declaration, for the purposes of an independent research study, must apply for a separate consent declaration. [CONDITION MET]\n\nCondition 2. Public and patient involvement (PPI) is considered an important activity by the \nHRCDC and is viewed as a key data protection safeguard in situations where the participant \ncannot provide consent. PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle.It is a condition of this declaration that PPI activities are updated and enhanced through engagement with relevant individuals and/or representative groups of the study participants. Areas of consideration for PPI activity could include seeking views and perspectives on the development of specific research studies that will be undertaken, wider public transparency measures and the dissemination of research findings. Progress on meeting this condition is a reporting requirement as part of the Annual Review. [CONDITION UNDERWAY]\n\nCondition 3. The data controller is requested to enhance transparency measures to inform participants and the public about the ongoing work of the St. James’s Hospital Cancer biobank, including, where relevant, the research undertaken using the personal data and associated biological samples that are stored as part of the biobank. Enhanced transparency measures must also provide appropriate contact information should participants have any queries or wish to request information regarding the processing of their personal data and associated biological samples or if they wish to exercise their data protection rights. Consideration should be given to enhancing transparency measures by way of hospital notices, relevant websites, and other public communication channels. Progress on meeting this condition is a reporting requirement as part \nof the Annual Review  [CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until 16th November 2031 or upon confirmation that that personal data has been rendered anonymised or destroyed, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The data controller is recommended to ensure it is satisfied that the IT systems used by the SJHCB to host/store the personal data are hosted within the European Economic Area (EEA) or, if hosted outside the EEA, that it is done so in compliance with data protection legislation, and that the requisite standard contractual clauses are in place. The Applicant is recommended to discuss this matter with the data controller’s Data Protection Officer. [RECOMMENDATION CONSIDERED] "]

{"sheet":"19-006-AF3","index":6,"n_rows":20,"n_cols":7,"rows_kept":20,"cut":false,"hidden":false,"merged":[[14,2,15,2],[14,1,15,1],[14,3,15,3],[14,4,15,4],[14,5,15,5]]}
[null,null,null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref","19-006-AF3",null,null,"19-006-AF3/AMD1","19-006-AF3/AMD2"]
[null,"Application Title ","The Contribution of Whole Genome Sequencing to Brain Tumour Biology ",null,null,"The Contribution of Whole Genome Sequencing to Brain Tumour Biology ","The Contribution of Whole Genome Sequencing to Brain Tumour Biology "]
[null,"Applicant Organisation (Data Controller)","Beaumont Hospital, Dublin \n",null,null,"Beaumont Hospital, Dublin \n","Beaumont Hospital, Dublin \n"]
[null,"Lead Applicant ","Michael Farrell (Beaumont Hospital)",null,null,"Michael Farrell (Beaumont Hospital)","Michael Farrell (Beaumont Hospital)"]
[null,"Research commenced prior to submission of application","Yes",null,null,"Yes","Yes"]
[null,"Research Objective","The research project aims to establish a brain tumour information system (BTIS) which will enable researchers to interrogate biologic and genetic data, across a range of tumour types.The BTIS would be generated from two sources:  1. from archival brain tissue and 2. from the associated clinical data. The data will be processed by 1. Beaumont Hospital (deriving biologic data) and 2. Genomics Medicine Ireland (deriving genetic data). It is proposed that the BTIS would have the ability to adequately diagnose and accurately predict the behaviour of a wide variety of intrinsic brain tumours for the benefit of all new patients with brain tumour in the years ahead.  ",null,null,"The research project aims to establish a brain tumour information system (BTIS) which will enable researchers to interrogate biologic and genetic data, across a range of tumour types.The BTIS would be generated from two sources:  1. from archival brain tissue and 2. from the associated clinical data. The data will be processed by 1. Beaumont Hospital (deriving biologic data) and 2. Genomics Medicine Ireland (deriving genetic data). It is proposed that the BTIS would have the ability to adequately diagnose and accurately predict the behaviour of a wide variety of intrinsic brain tumours for the benefit of all new patients with brain tumour in the years ahead.  ","The research project aims to establish a brain tumour information system (BTIS) which will enable researchers to interrogate biologic and genetic data, across a range of tumour types.The BTIS would be generated from two sources:  1. from archival brain tissue and 2. from the associated clinical data. The data will be processed by 1. Beaumont Hospital (deriving biologic data) and 2. Genomics Medicine Ireland (deriving genetic data). It is proposed that the BTIS would have the ability to adequately diagnose and accurately predict the behaviour of a wide variety of intrinsic brain tumours for the benefit of all new patients with brain tumour in the years ahead.  "]
[null,"Reason for seeking a Declaration","The Applicants are seeking a consent declaration for the purpose of the using previously collected brain tumor samples and clinical data the health research study outlined above. Consent for the use of the tissue samples and associated data for health research was not be obtained at the time of collection. A Declaration is being sought for the purpose of ; \n1. reviewing neuropatholgy files, collecting  and de-identifying (pseudonyimising) and subsequently anonymising the data for inputting into the BTIS. \n2. Genetic analysis of anonymised archival tumor samples for the BTIS. ",null,null,"Genuity Science is withdrawing from its collaboration in this study; accordingly, the amendment is requested to remove Genuity Science as a joint data controller. Genuity Science confirms that all data and bio-samples it has received will no longer be held by them and will be repatriated to Beaumont Hospital.\nThe amendment is also requested to extend the duration of the consent declaration by 1 year to enable Beaumont Hospital to complete the anonymisation process. ","To extend the duration of the consent declaration by 1 year to 31st December 2025."]
[null,"HRCDC Meeting Date","13th June, 2019",null,null,"14th November 2023","8th December "]
[null,"HRCDC Decision Date ","13th June, 2019",null,null,"14th November 2023","8th December "]
[null,"HRCDC Decision","No Declaration",null,null,"Amendment Approved","Amendment Approved"]
[null,"Appeals Panel Meeting Date","3rd September, 2019",null,null,"N/A","N/A"]
[null,"Appeals Panel Decision Date","4th September, 2019",null,null,"N/A","N/A"]
[null,"Appeals Panel Decision ","Conditional Declaration",null,null,"N/A","N/A"]
[null,"Specific Conditions attached ","Condition 1. The Appeal Panel has requested that the Appellants undertake to make the genomic data collected during the health research project, publicly available on a recognised genomic data repository in a de-identified and appropriately controlled way. This shall be carried out in compliance with all applicable laws, including data protection laws and once public policy in this area has been formulated by the relevant authorities and in compliance with relevant legislation.(CONDITION UNDERWAY)\n\nNOTE:  \n- While Ireland does not currently have a special-purpose repository for genomic/epigenomic data, the Appellants like all other researchers working in this area, should explore the opportunities afforded by global browsers and repositories, of which there are numerous in the cancer area. A number of these have evolved to address the challenges inherent in balancing privacy risks (as set out in GDPR and the Health Research Regulations) with the benefits of making genomic data broadly available to the research community by adopting technical approaches to support controlled access to deidentified, and often aggregated data.\n - More generally, the Appellant team is advised to stay abreast of evolving national policy and guidance in the area of open data and open science. In particular, Ireland recently launched a National Framework on the Transition to an Open Research Environment (NORF) and Government Departments and funding agencies are signatories to this Framework. The Health Research Board has launched an Open Research publishing platform under this framework, is providing training in FAIR research data principles to enhance discovery and reusability and are developing Research Data Management (RDM) principles, policies and requirements to stimulate good data governance and stewardship.\n\n- The research team should be guided in all of their endeavours to the greatest extent possible by this evolving national and global landscape.\n\n","Condition 2. The Appeal Panel has requested a publicity campaign to be carried out by the Appellant, drawing attention to the health research project and affording patients the opportunity to withdraw their brain tumour samples and personal data from the health research project. Specific details of this condition are set out in Appendix I. In that context Brain Tumour Ireland (BTI) will be the appropriate patient advocacy group to be consulted in relation to the preparation of the required public notices. Those notices (and any other public information that is prepared relating to the project) will also be made available to both Beaumont Hospital and BTI for dissemination as each of those bodies deems appropriate.(CONDITION MET)\n\nNOTE: For the purpose of ensuring this condition is met, the HRCDC require a final copy of the publicity notice and be notified when the publicity campaign will commence, which shall be no later than February 29th, and which may be reasonably extended as agreed by the HRCDC. \nNOTE: This deadline has been extended into March, as agreed by the HRCDC. \nNOTE: This deadline has been extended to September 2020 by the Applicant\nNOTE: This deadline has been extended to December 31st  2020 by the Applicant. \nNOTE: This deadline has been extended to April 1st  20201by the Applicant. ","Condition 3. The Appeal Panel has requested the Appellant to publish an annual report detailing the progress of the health research project. This is in line with the standard conditions of a declaration made by the HRCDC. (CONDITION UNDERWAY)\n\nNOTE: In order to facilitate that Appellant with meeting this condition, the HRCDC will provide the Appellant with an ‘Annual Review’ template to complete. ","Condition 1. The volume of data to be transferred/repatriated from Genuity Science to Beaumont Hospital, including the tumour sequencing data, is noted. The Applicant must ensure that (i) the mechanism for the transfer of this data and (ii) the system/solution to be implemented for the ongoing storage/analysis of this data must be sufficiently secure to protect the data. In this context, it is noted that provisional approval has been provided from the Beaumont Hospital Research Ethics Committee; full research ethics approval must therefore be obtained and confirmation of this provided to the HRCDC, including confirmation that it covers the finalised data security solutions for storage/analysis before any transfer of data occurs. [CONDITION MET]\n\nCondition 2. Confirmation should be provided to the HRCDC once (i) the re-patriation of the bio\u0002samples and any associated personal data to Beaumont Hospital has been completed and (ii) Genuity Science has fully deleted all the data it has received and/or generated with regards this study. Data includes tumour sequencing data and other patient data such as clinical data etc.\n\nCondition 3. The removal of Genuity Science and their deletion of the data, the repatriation of the bio-samples and data to Beaumont Hospital and information on the tumour type that is the focus of this study going forward (i.e., meningioma tumours), should be clearly described on the study’s website. This condition is linked with Condition 3 attached by the appeal panel.  (CONDITION UNDERWAY)","N/A"]
[null,null,null,null,null,null,"N/A"]
[null,"Deadline for meeting any conditions","N/A","Condition 2: March 2020 -COMMENCED","N/A","N/A","N/A"]
[null,"Duration of Declaration ","AMENDED: The Conditional Declaration is made commencing August 8th, 2018 and shall be valid until December 31st 2023. The Applicants may request an extension to the declaration if required, by way of amendment which will be reviewed by the HRCDC - (AMENDMENT - shall be valid until 31st December 2025)",null,null,"The approval to the Amendment is made commencing 14th November 2023 and shall be valid until 31st December 2024, an extension of the duration of consent declaration. (AMENDMENT - shall be valid until 31st December 2025)","The approval to the Amendment is made commencing 31st December 2024 and shall be valid until 31st December 2025, an extension of the duration of consent declaration."]
[null,"Status of Declaration","Declaration Live",null,null,"Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","See 'NOTES' for Conditions",null,null,"N/A","N/A"]

{"sheet":"19-007-AF2","index":7,"n_rows":18,"n_cols":3,"rows_kept":18,"cut":false,"hidden":false,"merged":[[12,2,13,2],[12,1,13,1]]}
[]
[null,"Application Ref","19-007-AF2"]
[null,"Application Title ","Targeted therapeutic mild hypercapnia after resusitated cardiac arrest (TAME)"]
[null,"Applicant Organisation (Data Controller)","St Vincent’s University Hospital, Dublin (Lead Data Controller)\nUniversity College Dublin (Lead Data Controller)\nMonash University, Australia     \nLund University, Sweden    \nRegion Skane Skanevaard Sund Sweden "]
[null,"Lead Applicant ","Alistair Nichol"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The TAME Cardiac Arrest Trial is a definitive trial in cardiac arrest patients whose heart has been restarted and who are on a breathing machine in the intensive care unit. This trial will determine whether increasing carbon dioxide to above normal levels [so-called targeted therapeutic mild hypercapnia (TTMH)] during the first 24 hours on a mechanical ventilator in the intensive care unit improves brain recovery at 6 months compared to current standard care."]
[null,"Reason for seeking a Declaration","This research study will involve the collection and processing of patient data prior to the research team being able to obtain consent from the data subject; this is due to the nature of the patient’s condition and lack of capacity to provide explicit consent. Instead next-of-kin consent is obtained. A Declaration is therefore sought in relation to the processing of personal data until such time that the patient regains capacity and provides explicit consent directly to the research team."]
[null,"HRCDC Meeting Date #1","25th July, 2019"]
[null,"HRCDC Meeting Date #2","10th September, 2019 "]
[null,"HRCDC Decision Date ","10th September, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC has requested that all contractual legal arrangements governing the transfer of biological samples (from the Biobank sub-study) between the joint biobank data controllers is fully executed prior to samples leaving the Integrated biobank of Luxembourg. Specifically, any biological samples being transferred outside the EEA; ie to Monash University, must have appropriate contractual arrangements in place as a data protection. Confirmation that these arrangements are in place must be provided to the HRCDC. (CONDITION UNDERWAY)\n\nCondition 2. The HRCDC has requested that all appropriate contractual legal arrangements must be in place with the relevant institutions, regarding the transfer of personal data for the purpose of the research study. This is a safeguard that the HRCDC has requested and therefore confirmation that these agreements must be provided to the HRCDC. Until this confirmation is received the Declaration will not cover the processing activity of transferring data. \n(CONDITION MET) \n\nCondition 3: The HRCDC has requested that, where a patient continues to lack capacity for a prolonged period of time and where the next-of-kin assent remains in place, the following action should be taken as an additional safeguard:  The researcher should seek confirmation from the next-of-kin (or individuals) who provided assent,  that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.(CONDITION MET) \n"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 2021 and 15 years thereafter (until August 31st, 2036) or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner"]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC strongly recommended a review of the consent forms and patient information leaflets (PILs) used by the researchers, to ensure there is clarity for the participants and those assenting on their behalf, regarding all strands of the research study and data processing. Specifically, the researchers should consider an appropriate layered consent approach to ensure informed assent and consent is obtained. It is essential that consent forms and patient information leaflets are written from the perspective of the participant. When reviewing these forms, engagement with the research ethics committees and public/patient representatives should be considered ensure forms and PILs are comprehensible to participants and those providing assent. An update on this recommendation will be required in the Annual Report. (RECOMMENDATION CONSIDERED)"]

{"sheet":"19-008-AF2","index":8,"n_rows":18,"n_cols":3,"rows_kept":18,"cut":false,"hidden":false,"merged":[[12,2,13,2],[12,1,13,1]]}
[]
[null,"Application Ref","19-008-AF2"]
[null,"Application Title ","Targeted Hypothermia versus targeted Normothermia after Out of Hospital Cardaic Arrest (TTM2)"]
[null,"Applicant Organisation (Data Controller)","St. Vincent’s University Hospital Dublin  (Lead Data Controller)\nUniversity College Dublin (Lead Data Controller)\nMonash University, Australia   \n Lund University, Sweden   \nRegion Skane Skanevaard Sund Swede"]
[null,"Lead Applicant ","Alistair Nichol"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","To determine whether initial hypothermia (cooling to 33C initially with rewarming to normal body temperature) during post resuscitation care in the intensive care unit improves recovery at 6 months compared to current standard care, in patients who have been resuscitated following an out of hospital cardiac arrest."]
[null,"Reason for seeking a Declaration","This research study will involve the collection and processing of patient data prior to the research team being able to obtain consent from the data subject; this is due to the nature of the patient’s condition and lack of capacity to provide explicit consent. Instead next-of-kin consent is obtained. A Declaration is therefore sought in relation to the processing of personal data until such time that the patient regains capacity and provides explicit consent directly to the research team."]
[null,"HRCDC Meeting Date #1","25th July, 2019"]
[null,"HRCDC Meeting Date #2","10th September, 2019 "]
[null,"HRCDC Decision Date ","10th, September 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC has requested that all contractual legal arrangements governing the transfer of biological samples (from the Biobank sub-study) between the joint biobank data controllers is fully executed prior to samples leaving the Integrated biobank of Luxembourg. Specifically, any biological samples being transferred outside the EEA; ie to Monash University, must have appropriate contractual arrangements in place as a data protection. Confirmation that these arrangements are in place must be provided to the HRCDC. \n\nCondition 2. The HRCDC has requested that all appropriate contractual legal arrangements must be in place with the relevant institutions, regarding the transfer of personal data for the purpose of the research study. This is a safeguard that the HRCDC has requested and therefore confirmation that these agreements must be provided to the HRCDC. Until this confirmation is received the Declaration will not cover the processing activity of transferring data. \n\nCondition 3: The HRCDC has requested that, where a patient continues to lack capacity for a prolonged period of time and where the next-of-kin assent remains in place, the following action should be taken as an additional safeguard:  The researcher should seek confirmation from the next-of-kin (or individuals) who provided assent,  that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.\n\nCondition 4: Confirmation of Research Ethics approval from the Beaumont Hospital and Galway University Hospital sites must be provided to the HRCDC, once granted. No data processing can commence at this site until such written confirmation is provided to the HRCDC. "]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until July 2021 and 15 years thereafter (31st July, 2036) or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner"]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC strongly recommended a review of the consent forms and patient information leaflets (PILs) used by the researchers, to ensure there is clarity for the participants and those assenting on their behalf, regarding all strands of the research study and data processing. Specifically, the researchers should consider an appropriate layered consent approach to ensure informed assent and consent is obtained. It is essential that consent forms and patient information leaflets are written from the perspective of the participant. When reviewing these forms, engagement with the research ethics committees and public/patient representatives should be considered ensure forms and PILs are comprehensible to participants and those providing assent. An update on this recommendation will be required in the Annual Report"]

{"sheet":"19-009-AF3","index":9,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref:","19-009-AF3"]
[null,"Application Title ","Moving In Study "]
[null,"Applicant Organisation (Data Controller)","National Disability Authority (NDA)"]
[null,"Lead Applicant ","Aideen Hartney"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The NDA is undertaking the 'Moving In Study' to evaluate costs and benefits of new models of disability services and comparre them to older models of service. The research study will involve between 500-600 data subjects and is expected to end in Q1 2020. Many of the participants in the study have limited capacity to provide consent."]
[null,"Reason for seeking a Declaration","Many of the participants in the study have limited capacity to provide consent. A declaration is requested to enable the continued processing of personal data already obtained via i) proxy consent or ii) direct consent using ‘Easy Read’ but non-GDPR compliant consent forms and patient informaiton leaflets. A declaration is also sought in respect of future study participants who may not have the capacity to provide expicit consent (that is GDPR compliant)."]
[null,"HRCDC Meeting Date #1","13th June, 2019"]
[null,"HRCDC Meeting Date #2","25th July, 2019"]
[null,"HRCDC Decision Date ","13th June, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached","Condition 1. (Amended at 25th July, 2019 meeting) Confirmation of REC approval from St. John of God site must be provided to the HRCDC, once granted. No data processing can take place at this site until such written confirmation is provided to the HRCDC. (CONDITION MET)\n\nCondition 2. The HRCDC require written confirmation once the Master list (hard and soft copies) and FACE word file have been destroyed. (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration","Commencing August 8th, 2018 and shall be valid until confirmation that Master list and FACE word document file is deleted"]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The HRCDC has requested the Applicant to confirm that in the event any abuse/bullying/historical harm is disclosed during the course of the interview, and where the researcher is not clear as to whether this had been reported, that the researcher/interviewers themselves will ensure relevant authorities are notified. (RECOMMENDAITON CONSIDERED)\n\nRecommendation 2. The participant Information Sheet provided to participants states “The answers you give will not change the service you get now or in the future”. In its discussion the HRCDC, while understanding the need to reassure participants of no negative impact from refusing involvement in research, it may not fully inform the participant that the research may lead to positive service changes. The HRCDC recommends that this comment is revised to avoid this potential misinterpretation. (RECOMMENDAITON CONSIDERED)"]

{"sheet":"19-010-AF3","index":10,"n_rows":18,"n_cols":3,"rows_kept":18,"cut":false,"hidden":false,"merged":[[12,2,13,2],[12,1,13,1]]}
[]
[null,"Application Ref","19-010-AF3"]
[null,"Application Title ","Analysis of the composition of clots retrieved from acute ischaemic stroke patients and correlation of the effect of thrombolytics and mechanical thrombectomy with clot composition"]
[null,"Applicant Organisation (Data Controller)","Beaumont Hospital, Dublin\nNational University of Ireland, Galway "]
[null,"Lead Applicant ","Karen Doyle (NUIG)"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Mechanical thrombectomy is an effective procedure for the treatment of Acute Ischaemic Stroke (AIS) - the thrombectomy device used captures and removes the blood clot, restoring blood flow to the brain. The composition of the blood clot is one of the key factors that influences the performance of the procedure, but it has not been well studied. This research intends to retain up to 300 clots following the mechanical thrombectomy procedure. The clots will be analysed for cellular and protein composition by histology and immunohistochemistry and immunofluorescence. Data on the stroke case related to the sample will also be captured. \nThe aim of the project is to establish a link between clot composition and the difficulty in removing the clots and to inform therapy solutions in AIS such as by improving medical device design or through identification of novel targets for pharmaceutical development that will ultimately impact on the mortality and quality of life of stroke patients."]
[null,"Reason for seeking a Declaration","The Applicant is seeking a declaration as no consent was obtained from\nthe patients in relation to the use of blood clot biosamples and corresponding clinical data for the purpose of health research. The Applicant outlines why obtaining informed consent from the patient is not possible at the time of the thrombectomy procedure."]
[null,"HRCDC Meeting Date #1","10th September, 2019"]
[null,"HRCDC Meeting Date #2","25th November, 2019"]
[null,"HRCDC Decision Date ","10th September, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: Upon review of the application, the HRCDC noted that informed consent will be obtained from participants in future studies, unrelated to this study. Given that informed consent is therefore practicably possible, the HRCDC has requested that the Applicants must establish and implement a practice of obtaining participant consent (and/or relative/next-of-kin assent as an interim measure) for all prospective data and biological material collection for this study. Patients must have the opportunity to assent to their participation in the study at some point in their hospital journey. For the avoidance of doubt, this Declaration will cover processing activities of prospective data and biological material collected for this study only if a consent/assent process is implemented and confirmed to the HRCDC. This condition is a reporting obligation that must be fulfilled and reflected in the Annual Report. \nAmended (25.11.2019): Condition 1 is hereby amended to confirm that the Applicant may continue to collect samples and data from participants until such time REC approval has been granted for the implementation of the consent process. Where it is not possible to obtain consent or next-of-kin assent, then the scope of the declaration will cover the collection and use of prospective samples and data in such cases. These instances must be noted in the annual review. (DID NOT COMMENCE - participant recruitment ceased)\n\nCondition 2: The HRCDC has requested that the Applicant make best reasonable efforts to obtain retrospective consent from individuals whose data and biological material has been collected to date. This condition is a reporting obligation that must be fulfilled and reflected in the Annual Report.  (DID NOT COMMENCE - data of retrospective patients has been anonymised)\n\nCondition 3. The ensure robust security safeguards are in place, the HRCDC has requested that the physical transport of the pseudonymised data and biological samples from Beaumont Hospital to NUIG are transported separately, and not together.  (CONDITION MET)\n\nCondition 4. The HRCDC have requested that patient and public engagement is strengthened and more direct feedback and involvement from patients and public is sought regarding the consent process and the study itself. Additionally, the HRCDC wish to understand what specific feedback was received from stoke survivors regarding this .research study at the screening of ‘A Tiny Spark’ in December 2018 (CONDITION  MET)\n\nCondition 5. In line with the advice of the Data Controller’s Data Protection Officer, the HRCDC has requested that data protection transparency measures implemented within the Hospital setting to ensure patients and their relatives, or those accompanying patients, are aware of the study and the use of clinical data and biological samples, and role of both Data Controllers. For example, transparency measures should ensure patients are made aware of how to exercise their data privacy rights. (CONDITION  MET)\n\nCondition 6: The Joint Data Controller relationship (Beaumont Hospital and NUIG) is currently governed by a Material Transfer Agreement (MTA), which only provides for the transfer of the biological material. To ensure the appropriate safeguarding of the pseudonymised clinical data, the HRCDC has requested that the MTA is amended appropriately with suitable data transfer contractual clauses. (CONDITION MET)"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until March 2021 and 5 years thereafter (until March 31st, 2026), or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-011-AF3","index":11,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-011-AF3"]
[null,"Application Title ","Irish Traveller History Study "]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland "]
[null,"Lead Applicant ","Gianpiero Cavalleri "]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The history of the Irish Traveller population’s population is not well understood, due in large part to a lack of written records. The analysis of genetic variants from individuals representing a population such as the DNA and associated de-identifed data will be analysied to further describe population structure and history. This study falls under the definition of health research as one of the long-term goals is to improve the health of the Irish population as a whole including the Traveller subpopulation, through a better understanding population structure and history. \n\nThe data that is the subject matter of this application was initially collected via participant consent for a study that was part of a documentary series; included within this initial study was DNA analysis. The study and the associated data was later brought into the academic arena under the auspices of the RSCI . Further work with additional samples, and more dense datasets may aid the identification of new genetic groups within the Irish Travellers and provide more statistical power in investigating the origins of this population."]
[null,"Reason for seeking a Declaration","N/A"]
[null,"HRCDC Meeting Date #1","10th September, 2019"]
[null,"HRCDC Meeting Date #2","17th October, 2019"]
[null,"HRCDC Decision","Requested more information"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","Application Withdrawn"]
[null,"Additional Comments","The Applicant has confirmed that the DNA samples and associated data that were the subject matter of the application, were destroyed in February 2020. "]

{"sheet":"19-012-AF2","index":12,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-012-AF2"]
[null,"Application Title ","Breast Cancer Proteomics and Molecular Heterogeneity "]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland (Lead Data Controller)\nBeaumont Hospital\nHealth Service Executive South "]
[null,"Lead Applicant ","Leonie Young\nArnold Hill\nBryan Hennessy "]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Breast cancer is the most commonly occurring cancer in women and the second most common cancer overall. Metastatic disease arising from breast cancer occurs in approximately 30% of patients. There are limited therapeutic options, reflected in the poor prognosis of this patient’s group. Numerous genes and proteins have been identified in breast cancer cells whose presence associates with tumour outcome.\nIdentification of these may open up new possibilities to monitor disease progression and develop new therapeutic strategies. This research study aims to define these proteins and genes in breast cancer and determine their clinical relevance to improve outcomes for patients with advanced disease. The study involves recruiting patients with a confirmed diagnosis of breast cancer from whom tissue, and blood samples are collected during their treatment. These samples are subsequently analysed, and the results correlated with other health\n data including treatment history and lifestyle data. New biomarker and therapeutic targets identified in these studies are developed. "]
[null,"Reason for seeking a Declaration","The study aims to recruit up to 5,000 patients; to date all patients in the study (n=2,871) have signed a consent form and have been provided with a patient information leaflet.\nHowever, several versions of Patient Information Leaflets (PILs) have been utilised throughout the course of this study:\n•\tEarlier versions are considered non-GDPR compliant because, for example, it is not made clear to the data subject that they can withdraw their consent.\n•\tDifferent data processing activities are noted in the different versions of PILs and consent forms.\nA consent declaration is sought in relation to the processing of data obtained from patients who consented using these early PIL and consent forms which are not compliant under the HRRs. These forms contain different information on data processing activities, where it is not possible to obtain reconsent."]
[null,"HRCDC Meeting Date","25.11.2019"]
[null,"HRCDC Decision Date ","25.11.2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC acknowledges that the Applicant will establish a governance framework for researchers who wish to access personal data and samples stored in the biobank, for research studies. A governance framework is recognised as an appropriate safeguard to protect the data protection rights and freedom of the participants. Therefore, Applicant is required to provide information on the development and implementation of the governance framework as part of the annual review. (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 31st July 2025 and for 7 years after the final study publication or report, or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner"]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant is advised to consider providing further information to participants as to what will happen to their personal data and samples should they withdraw their consent or request their information to be deleted. Furthermore, the Applicant should also consider including information on the relevant GDPR derogations that they may wish to rely on in such circumstances, including Article 17. (RECOMMENDATION CONSIDERED)\n\nGeneral Points for Noting:\n• In relation to the biobank element of this study, the scope of this declaration is limited to the data processing activities as outlined in the PILs and consent forms used to communicate to and obtain consent from the participants.\n• Where participant samples and data are held in a biobank without consent, then this declaration only applies to the continued storage and maintenance of the samples and data in the biobank; it does not cover the use for future undefined studies.\n• If a researcher wishes to access and process samples and personal data from the biobank outside the scope of consent obtained (or where no consent has been obtained) a declaration maybe required for that separate study.\n• Based on the information submitted to the HRCDC by the Applicant, the declaration is not required to cover the data linkage with National Cancer Registry of Ireland, as this activity will only be carried out where consent has been obtained."]

{"sheet":"19-013-AF2","index":13,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-013-AF2"]
[null,"Application Title ","Irish Omega 3 Study"]
[null,"Applicant Organisation (Data Controller)","University College Cork "]
[null,"Lead Applicant ","Maeve Rooney "]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","To investigate whether Omega 3 fatty acid food supplements can reduce the risk of transition to psychosis in high risk individuals. Participants are randomised to take a fruit juice drink containing either placebo or Omega-3 fatty acids daily for 6\nmonths"]
[null,"Reason for seeking a Declaration","The Applicant is seeking a declaration as the current consent and study information leaflets are not compliant under the current GDPR legislation. "]
[null,"HRCDC Meeting Date","10th September, 2019"]
[null,"HRCDC Decision Date ","10th September, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC has requested that the Applicant make continued efforts to follow up with participants to reconsent and provided updated information regarding the study.  This condition is a reporting obligation that must be fulfilled and reflected in the Annual Review.(CONDITION MET)\n\nCondition 2. The HRCDC noted the that the scope of work may include ‘analysis of similar substances found in the blood which are also involved in the inflammatory process may be considered’. For the avoidance of doubt, this Conditional Declaration is made specific to the Omega-3 study and for no additional processing activities outside the scope of the study. (CONDITION MET)\n\nCondition 3. The HRCDC has requested that the appropriate data controller - data processor contractual arrangements (legal agreement) must be in place Clinical Trials EndPoint Ltd and UCC, regarding the transfer of data for the purpose of the research study. This is an essential data protection safeguard that the HRCDC has requested and confirmation that these agreements are in place must be provided to the HRCDC as soon as possible. (CONDITION MET)\n\nCondition 4. Please provide the HRCDC with a copy of the new data protection notice once approved by the Research Ethics Committee, and notice of approval from the REC. (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 10 years after the completion of the study (Completion date: December 31st, 2019) - until December 31st, 2029. "]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-014-AF2","index":14,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-014-AF2"]
[null,"Application Title ","COLOSSUS Study"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland"]
[null,"Lead Applicant ","Jochen Prehn\nAnnette Byrne"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Colorectal cancer is one of the most common cancers in Europe. This type of cancer can involve a number of different mutations (known as 'MSS RAS mt mCRC'), however there are limited treatment options for patients when they develop resistance to standard therapies. \nCOLOSSUS is an international, multi-site consortium study that aims to study patient samples and apply advanced computational modelling approaches to identify new and specific 'subtypes' of this form of cancer. Subtyping is a way of looking more closely at the differences and similarities between different tumours and grouping similar tumours together with the aim of treating them differently. This strategy aims to help predict patient outcomes and to enable the design of more targeted and personalised care. In Ireland, data for the study is obtained from clinical data and tumour samples held in Beaumont Hospital"]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the use of retrospectively collected samples and clinical data (approximately 50 samples) that has been obtained by the Beaumont Hospital Bowel Disease Biobank. \n\nThe Applicant states the biobank consented patients for the future use of their tissue and data in ethically approved studies; however, although the Applicant states that the consent obtained does not necessarily limit the nature of collaborations and use of samples and data from the biobank by either country or sector (i.e. academic/ non-academic), the work being undertaken by the COLOSSUS study may not align with the consent obtained by the biobank as the PIL and Consent form:\ni) Did not inform participants that such studies may include industrial/commercial collaborations and that there might be the potential for commercialisation\nii) Did not specifically note that the nature of future studies may involve collaborations or studies that take place outside of Ireland\niii) Originally stated that data will be held for 10 years; pseudonymised data has been retained beyond this.\n\nBased on points (i) & (ii) above, the Applicant states that this consent may be considered too broad for COLOSSUS."]
[null,"HRCDC Meeting Date","16th December, 2019"]
[null,"HRCDC Decision Date ","16th December, 2019"]
[null,"HRCDC Decision","Declaration Made"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August, 2018 and shall be valid until 31st December 2027."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-015-AF2","index":15,"n_rows":16,"n_cols":6,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3"]
[null,"Application Ref","19-015-AF2","19-015-AF2/AMD1","19-015-AF2/AMD2","19-015-AF2/AMD3"]
[null,"Application Title ","IDS - TILDA","IDS - TILDA","IDS - TILDA","IDS - TILDA"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin","Trinity College Dublin","Trinity College Dublin","Trinity College Dublin"]
[null,"Lead Applicant ","Mary McCarron","Mary McCarron","Mary McCarron","Mary McCarron"]
[null,"Research commenced prior to submission of application","Yes","No","No","No"]
[null,"Research Objective","Intellectual Disability Study-The Irish Longitudinal Study on Ageing (IDS-TILDA)  is a longitudinal study researching ageing in Ireland of a representative sample of people with an intellectual disability aged 40 and over at all levels of functioning and in all living situations. IDS-TILDA aims to identify the principle influences on successful ageing in persons with an intellectual disability, and to then determine if they are the same or different influences for the general population.\nData will be examined to determine similarities to and differences from the influences on the ageing lives of the general population and if there are changes in influences over\ntime for people with an intellectual disability, and to analyse the data to inform and guide the planning, implementation and evaluation of future national policies, programmes and services. ","An amendement to take account of the amended assent/consent protocol and additional research questions. ","An amendement to take account of the amended assent/consent protocol and additional research questions. ","An amendement to take account of the amended assent/consent protocol and additional research questions. "]
[null,"Reason for seeking a Declaration","IDS-TILDA is seeking a consent declaration for the processing of data from individuals with an intellectual disability who are not able to give explicit consent or to designate a proxy to act on their behalf.","Amendment: The Applicant requests an amendment to the existing consent declaration for the following reasons:\n•\tThe assent/consent protocol has been amended to include telephone consent/assent.\n•\tThe study protocol has been amended to incorporate questions on participant’s experience of COVID-19.","IDS-TILDA is seeking an amendment to cover the data processing of those who lack decision-making capacity to (i) include a 5th wave of the study, (ii) extend the duration of the consent declaration previously made to 31st December 2029 and (iii) include the provision of anonymised data from IDS-TILDA in a public archive – the IDDSS. The consent declaration currently in place covers IDS-TILDA up to Wave 4 only. \nThe purpose of Wave 5 is to continue the steady-state longitudinal data collection of IDS-TILDA, to examine the principal influences on successful ageing, to determine if they are the same or different from the influences on ageing in the general population, to compare results with previous waves of IDS-TILDA, and to inform future national policies, programmes and services.","The amendment to the consent declaration is for the following: - The processing of personal data of those who lack decision-making capacity for a sixth wave of the IDS-TILDA study. - The inclusion of additional intellectual disability service providers in Wave 6 and the inclusion of additional personal data. - The storage only of the personal/pseudonymised data associated with the blood, stool and oral swab bio-samples to be collected in Wave 6. - The addition of the following new data processors and data providers: o National Cancer Registry Ireland. o Digital Gait Labs/Azure o The participant’s GP. - Extension of the duration of the consent declaration to 31st December 2032."]
[null,"HRCDC Meeting Date","17th October, 2019","4th September, 2020","28th February 2023","25th March 2025"]
[null,"HRCDC Decision Date ","17th October, 2019","4th September, 2020","28th February 2023","25th March 2025"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: The Applicant is requested to review and consider amendments to the PIL and consent forms with regards to the inclusion of both ‘yes’ and ‘no’ options and information on the use of the Primary Care Reimbursement Scheme numbers. \n(CONDITION MET)\n\nCondition 2: The Applicant is requested to provide more information on the process that will be implemented to inform and support participants where the analysis of their bio-samples identifies any health issues. The HRCDC wish to seek assurances that participants with intellectual disabilities are appropriately supported in such circumstances where they may need to seek further medical advice.\n(CONDITION MET)","N/A","Condition 1. It must be ensured that the data made available in the IDDSS public archive is anonymised data. [CONDITON MET]\n\nCondition 2. For those participants with an intellectual disability who lack or may have diminished decision-making capacity, the Applicant should ensure that the participant is involved in the decision-making process and study activities to the extent that is possible, including providing the participant with the necessary support to help them engage in the study.  [CONDITON MET]\n\nCondition 3. Where a participant or their proxy wishes to withdraw from the study and have the personal data deleted (i.e., not just removing the participant’s identifiers), then the data should be deleted by the data controller where this is possible to do so, taking into account any GDPR derogations that may apply.  [CONDITON UNDERWAY]","Condition 1. The Applicant must ensure that the requisite research ethics approval is in place for each site in Ireland; if the Trinity College Dublin REC approval is not sufficient for a site, then local REC approval for that site will need to be obtained. [CONDITON UNDERWAY]\n\nCondition 2. The required data agreements and arrangements must be in place between the relevant parties prior to the transfer/sharing of data. This includes agreements with the recruitment sites, the data processors and the data providers. [CONDITON UNDERWAY]\n \nCondition 3. The Applicant must ensure that the secure measures are in place with regards the transfer of data between the research team and the participant’s GP. The Applicant is requested to report on this before the data is processed. [CONDITON UNDERWAY]\n\nCondition 4. The Applicant must ensure that the outstanding comments/observations noted in the DPIA submitted to the HRCDC are addressed. [CONDITON MET]\n\nCondition 5. In advance of Wave 6 commencing, the study information leaflets and assent/consent forms should be amended to clearly note that oral swab samples will be obtained in Wave 6. In addition, prior to Wave 6 starting, the documents must also provide additional clarity to participants and their proxies on why the Wave 6 blood, stool and oral swab samples are collected and later processed for IDS TILDA research. In addition, to amending the study information leaflets for Wave 6, there should also be a process in place, through enhanced transparency measures, for IDS TILDA to inform participants/proxies about the analysis of the samples undertaken in the future, including informing them of their right to withdraw. [CONDITON UNDERWAY]"]
[null,"Deadline for meeting any conditions","N/A","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until October 31st, 2021 and 5 years thereafter (until October 31st, 2026), or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. AMENDMENT: Amendment is made commencing 25th March 2025 and shall be valid until 31st December 2032","The Amendment is made commencing 4th September 2020 and shall be valid until 31st October 2021 and 5 years thereafter (until 31st October 2026) or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner. (This timeline is in line with the duration of the consent declaration). AMENDMENT: Amendment is made commencing 25th March 2025 and shall be valid until 31st December 2032","The approval to the Amendment is made commencing 28th February 2023 and the consent declaration shall be valid until 31st December 2029; this is an extension of the duration of the \nconsent declaration.  AMENDMENT: Amendment is made commencing 25th March 2025 and shall be valid until 31st December 2032","The approval to the Amendment is made commencing 25th March 2025 and shall be valid until 31st December 2032; this is an extension of the duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Amendment Live","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant is requested to review and consider the adequacy of the GDPR training that is completed by individuals involved in the study, specifically the 35-minute session. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2: The Applicant is requested to consider the timeframe and safeguards for the retention of personal data, in soft or hard copy format, held by the study fieldworkers.(UNDER CONSIDERATION)","N/A","Recommendation 1. The HRCDC recommends the Applicant to examine the security of the personal data, including the methods of data transfer. In particular the Applicant is requested to review and consider the security of (i) the transfer of paper/hard copy data and paper forms via post/courier \nand (ii) where paper caseload forms are sent to the fieldworkers, to ensure that a process is in place to verify that they have been shredded when they are no longer required. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2. The Applicant is requested to review the wording of the medical questions in the questionnaire to ensure that they are accessible and easy-to-understand for participants with an intellectual disability. The HRCDC considers that the wording of some of the medical questions may be technical in nature and difficult to follow for some participants for example questions on using different forms of COVID-19 tests. (RECOMMENDATION CONSIDERED)","N/A"]

{"sheet":"19-016-AF2","index":16,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-016-AF2","19-016-AF2/AMD1"]
[null,"Application Title ","CERVIVA - HPV","CERVIVA - HPV"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin (Lead Data Controller)\nThe Coombe Women and Infants University Hospital (Lead Data Controller)\nCervicalCheck - The National Cervical Screening Programme","Trinity College Dublin (Lead Data Controller)\nThe Coombe Women and Infants University Hospital (Lead Data Controller)\nCervicalCheck - The National Cervical Screening Programme"]
[null,"Lead Applicant ","Cara Martin  (TCD & Coombe)\nJohn O’Leary (TCD & Coombe)","Cara Martin  (TCD & Coombe)\nJohn O’Leary (TCD & Coombe)"]
[null,"Research commenced prior to submission of application","Yes","Yes"]
[null,"Research Objective","The current method of examining smear test samples is called PAP test where the cells from the smear test sample are looked at under a microscope to check for abnormalities. HPV testing is a slightly different way of examining the smear test sample. It involves a test that looks for the presence of Human Papillomavirus (HPV). HPV is a common virus that is linked with changes in the cells of the cervix (neck of the womb) and cervical cancer. Research has shown that HPV testing has many benefits over the PAP test. To ensure HPV testing is effective, researchers need to find out which HPV positive samples are likely to develop into cancer. This study is examining different ways to screen for cervical cancer using HPV tests and using additional tests to look for specific markers that we know are linked to HPV infection. By following women to see what happens over the course of several smear tests the researchers will be able to determine how useful these new approaches to cervical screening are.","The current method of examining smear test samples is called PAP test where the cells from the smear test sample are looked at under a microscope to check for abnormalities. HPV testing is a slightly different way of examining the smear test sample. It involves a test that looks for the presence of Human Papillomavirus (HPV). HPV is a common virus that is linked with changes in the cells of the cervix (neck of the womb) and cervical cancer. Research has shown that HPV testing has many benefits over the PAP test. To ensure HPV testing is effective, researchers need to find out which HPV positive samples are likely to develop into cancer. This study is examining different ways to screen for cervical cancer using HPV tests and using additional tests to look for specific markers that we know are linked to HPV infection. By following women to see what happens over the course of several smear tests the researchers will be able to determine how useful these new approaches to cervical screening are."]
[null,"Reason for seeking a Declaration","A consent declaration is required for the continued data processing activities that include the ongoing storage and analysis of participant data that has already been collected as well as the collection, pseudonymisation, transfer and analysis of follow-up data for the purpose of completing the study.  This study commenced prior to the new Health Research Regulations 2018 and consent was compliant under the previous data protection legislation. ","To remove the Coombe Hospital as a joint data controller of this study."]
[null,"Scheduled HRCDC Meeting Date","4th September, 2020","19th December 2024"]
[null,"HRCDC Decision Date ","4th September, 2020","19th December 2024"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC has requested that all appropriate contractual arrangements (legal agreements) must be in place with the relevant institutions, regarding the governance, transfer and use of personal data and samples for the purpose of this research study, including an appropriate joint data controller arrangement between the three joint data controllers of this study. Confirmation that these agreements are in place must be provided to the HRCDC by 30th November 2020. It is advisable to discuss this with the relevant Institution’s legal office and Data Protection Officer, as appropriate. [CONDITION MET]\n\nCondition 2. The HRCDC has requested confirmation that the research ethics committee approval is up-to-date and valid, and any subsequent changes that may have made to the study since the previous REC approval, have been reviewed and approved by the REC. Any subsequent REC approval letters should be provided to the HRCDC. [CONDITION MET]","N/A"]
[null,"Deadline for meeting any conditions","Condition 1: 30.11.2020","N/A"]
[null,"Duration of Declaration ","The Conditional Declaration is made commencing 8th August 2018 and is valid until 31st December 2028 and for 5 years thereafter (until 31st December 2033) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. ","The approval to the Amendment is made commencing 19th December 2024 and shall be valid until 31st December 2033, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A","N/A"]

{"sheet":"19-017-AF2","index":17,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-017-AF2"]
[null,"Application Title ","Prescribing in primary care patients aged 70 years or older"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland"]
[null,"Lead Applicant ","Tom Fahey"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","This research study examined whether older people with multiple morbidities (multiple chronic medical conditions) and potentially inappropriate prescriptions were more likely to have poorer health outcomes, including adverse drug reactions, emergency hospital\nadmission and poorer health related quality of life. Between 2010 and 2012, over 900 people aged 70 years and older living in the community and 15 GP practices took part in the study over two waves.\nResearchers found that people with potentially inappropriate prescriptions, measured using a set of prescribing criteria, had an increased risk of having an adverse drug reaction and also reported poorer health related quality of life.\nFurther work in this research study (Wave 3) is currently ongoing to assess whether high-risk prescriptions are being monitored with the relevant blood tests by general practitioners (GPs) and to assess the performance of tools that predict which patients will experience an adverse event related to their medications. Results from this study may\nhelp develop systems to assist prescribing decisions and to support the reduction of unnecessary medication. A 4th Wave of this study is also planned and will involve eligible participants from Wave 3"]
[null,"Reason for seeking a Declaration","The Applicant will be inviting eligible participants from Wave 3 to continue to participate in a 4th wave of the study - the support of a declaration is therefore not required for Wave 4 where the participant provides re-consent. The Applicant requests a consent declaration for:\n\ni) The retention of patient identifiers, or ‘Patient Key’, collected from Wave 1, to undertake the re-consenting process for Wave 4;\nii) The continued retention and use of personal data that was collected from Waves 1-2 of the study as a timeframe was not outlined in the original PIL and consent form;\niii) The processing of personal data for Wave 3 which received a ‘consent waiver’ from the Research Ethics Committee; this includes data linkage with the HSE- Primary Care Reimbursement Scheme. Personal data from Wave 3 data will then be retained for further use in this study. \niv) Collecting and processing new follow-up data from the GP medical record for Wave 3 participants who are not eligible to take part in Wave 4. Once completed the patient identifiers will be destroyed for this cohort rendering the dataset anonymous.\nv) Processing personal data and retaining the patient identifiers of participants who are eligible for Wave 4 but who provide no response to requests for re-consent; this includes the collection and processing of new follow-up data from the GP medical record."]
[null,"HRCDC Meeting Date","17th October, 2019"]
[null,"HRCDC Decision Date ","17th October, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC considered that a declaration cannot be made to overwrite a participant’s withdrawal of consent.  Where eligible participants actively respond and state they do not wish to continue to participate in Wave 4 of the study - then this must be regarded as a withdrawal of consent.  Therefore, where consent is withdrawn, it is a condition of this declaration that the Applicant cannot subsequently anonymise (continue to process) the personal data and must instead delete the personal data of the participant that was originally collected. The analysed results of this personal data can be retained. Please see Recommendation 1. (CONDITION UNDERWAY)\n\nCondition 2: Where it is feasible to do so, the Applicant must also provide participants who are ineligible to participate in Wave 4 of the study, the opportunity to be re-consented for the continued retention of their personal data and the collection of new follow-up data from the GP record. Where there is a non-response the support of a Declaration will extend to this processing activity until the data has been anonymised. (CONDITION UNDERWAY)\n\nCondition 3: The Applicant must provide the HRCDC with updates on the number of participants who do not respond to the request for re-consent as part of their Annual Report to the HRCDC. (CONDITION UNDERWAY)\n\nCondition 4: As was undertaken during the initial Wave of the study, participating GPs should be re-consented for Wave 4 of the study. (CONDITION UNDERWAY)\n"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid 7 years after the publication of the final report on Wave 4 of the study, or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner"]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant is advised to consider the following; where seeking participants re-consent for inclusion in Wave 4, the Applicant should provide for the participants to consent to the anonymisation of their personal data for future Wave 4 if they do not wish to participant in Wave 4.  \n\nRecommendation 2: In line with earlier REC Approvals and recommendations, the HRCDC recommend that participating GPs receive feedback on the outcomes of the study."]

{"sheet":"19-018-AF2","index":18,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-018-AF2"]
[null,"Application Title ","COMBINE"]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Mairead Kiely"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Nutrition during pregnancy and infancy has a lasting impact on a child’s physical and neurological development, with diet during the first 2 years of life a critical component for lifelong health. The COMBINE cohort study is an observational study on babies that were recruited from the IMPROVED pregnancy study. All participants are followed over the first two years of life to investigate how their diet and environment affects their growth, their neurological development and the development of their gut bacteria."]
[null,"Reason for seeking a Declaration","The Applicant states that the original consent form was not GDPR compliant as it did not outline who the data controller was, the retention period of samples and clinical data or the rights of data subjects. A GDPR compliant addendum to the original PIL and consent form has been developed, and once approved by the REC, it will be sent to all participants to obtain re-consent. It is anticipated that not all parents will return the signed addendum, therefore a declaration is requested to continue to process data for these participants. The data processing activities for which a declaration will cover is the continued analysis of the samples and personal data within the objectives of the COMBINE study and as set out in the original patient information leafelts and consent forms; it is anticipated that the planned analysis for this study will be completed by 2025"]
[null,"Scheduled HRCDC Meeting Date","2nd March, 2020"]
[null,"HRCDC Decision Date ","2nd March, 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: As data protection safeguard measure, the Applicant is requested to ensure that agreements or arrangements, as appropriate are in place between UCC and Teagasc, to ensure that the data transferred to Teagasc-Moorepark is transferred under appropriate terms and conditions to ensure is anonymity of the participants.  Specifically, that no attempts will be made to re-identify study participants by the researchers in Teagasc-Moorepark.  The Secretariat shall be informed once this condition is met as soon as practically possible. This condition will be a reporting requirement as part of the Annual Review. (Condition Met)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 31st December 2020 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner"]
[null,"Status of Declaration","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-019-AF2","index":19,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-019-AF2","19-019-AF2/AMD1"]
[null,"Application Title ","IMPROvED Study","IMPROvED Study"]
[null,"Applicant Organisation (Data Controller)","University College Cork ","University College Cork "]
[null,"Lead Applicant ","Fergus McCarthy","Fergus McCarthy"]
[null,"Research commenced prior to submission of application","Yes","Yes"]
[null,"Research Objective","Prompted by the current absence of a clinically useful screening test for pre-eclampsia, the IMPROVED consortium study aimed to develop a robust predictive blood test suitable for use in a clinical environment. In total 4,063 women were recruited to the IMPROVED study across 5 centres in 4 countries throughout Europe. In Ireland the participants were pregnant women attending Cork University Maternity Hospital. In addition, the study aimed to establish a biobank of residual tissue and samples collected during the IMPROVED study that could be accessed by the scientific community for high quality research in the future. This biobank is held in University College Cork (UCC).","Prompted by the current absence of a clinically useful screening test for pre-eclampsia, the IMPROVED consortium study aimed to develop a robust predictive blood test suitable for use in a clinical environment. In total 4,063 women were recruited to the IMPROVED study across 5 centres in 4 countries throughout Europe. In Ireland the participants were pregnant women attending Cork University Maternity Hospital. In addition, the study aimed to establish a biobank of residual tissue and samples collected during the IMPROVED study that could be accessed by the scientific community for high quality research in the future. This biobank is held in University College Cork (UCC)."]
[null,"Reason for seeking a Declaration","The Applicant has stated that a consent declaration is sought for the continued storage of the samples and the accompanying clinical data held in the IMPROVED biobank in UCC for use in future research studies. The Applicant states that the PILs and consent forms used are not considered compliant under the Health Research Regulations for a number of reasons, including that; UCC were not noted as the data controller; that the retention periods for the samples and clinical data within the biobank were not noted; and data subject rights were not outlined. The scope of the declaration is for the continued storage, retention and use of personal data associated with the samples, within the objectives of the IMPROVED study and as set out in the original patient information leaflets and consent forms.","A consent declaration has been obtained for the IMPROvED Pregnancy Study. Pregnant women were followed in the IMPROvED study from the first trimester, with detailed information and biological samples collected throughout pregnancy to investigate pregnancy complications. Iron deficiency is the most common micronutrient deficiency in the world, with pregnant women and infants the most vulnerable. Iron deficiency has lasting health consequences for both the mother and her child, but particularly for the development of the child’s brain. In the IDEA project, the data controller, UCC, is seeking to construct and validate a screening tool to identify pregnant women and infants at an increased risk of iron deficiency. The purpose of this amendment request is to process personal data from the IMPROVED study for the purpose of the IDEA study. "]
[null,"Scheduled HRCDC Meeting Date","2nd March, 2020","4th October 2022"]
[null,"HRCDC Decision Date ","2nd March, 2020","4th October 2022"]
[null,"HRCDC Decision","Declaration Made","Amendment Approved"]
[null,"Specific Conditions attached ","N/A","Condition 1. With regards the personal data of infants recruited to the IMPROVED study that is processed for the IDEA study under this amendment, the Applicant must ensure that a re-consent protocol is designed and implemented so that these children are given the opportunity to provide their explicit consent for data processing when they turn 18 years of age, should their personal data continue to be processed. Attempts to obtain their consent must be made within one year of the participant turning 18. The Applicant must report on this activity as part of each Annual Review, including where attempts to seek consent are unsuccessful (Please also see Recommendation 1).\n\nCondition 2. The Applicant is requested to ensure that clear transparency measures continue to be implemented and maintained for the IDEA study and the use of personal data from the IMPROVED study. Transparency measures should inform participants about a number of areas including the ongoing use of their data as part of the IDEA study, the dissemination of research findings, their data protection rights and withdrawal from the study. Consideration should be given to exploring and enhancing transparency via other appropriate measures, where feasible and appropriate, including through PPI engagement. [CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid for 25 years, until 31st March 2045 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner.","The approval to the Amendment is made commencing 4th October 2022 and is valid until 30th June 2036 or until the point where the personal data has been irrevocably anonymised or destroyed (this duration relates specifically to this amendment i.e., to process personal data from the IMPROVED study for the purpose of the IDEA study)."]
[null,"Status of Declaration","Declaration No Longer Required","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","As a reporting requirement of the Annual Review, the Applicant is requested to provide an update on the retention and/or destruction of the study master list.","Recommendation 1. Reconsenting children when they turn 18-years old, where feasible, is \nconsidered an important principle in research. Further to Condition 1, the Applicant is also \nrecommended to re-consent children when they turn 18 years of age for the continued processing of their personal data for the IMPROVED study more generally and, if relevant, the processing of their IMPROVED data in other research studies (i.e., obtain explicit consent). \n\nRecommendation 2. In line with the principle of data minimisation, the Applicant is requested to consider whether the personal data from the IMPROVED study can be irrevocably anonymised sooner. [RECOMMENDATION CONSIDERED]"]

{"sheet":"19-020-AF2","index":20,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-020-AF2",null,"19-020-AF2/AMD1"]
[null,"Application Title ","BASELINE Study ",null,"BASELINE Study "]
[null,"Applicant Organisation (Data Controller)","University College Cork",null,"University College Cork"]
[null,"Lead Applicant ","Deirdre Murray ",null,"Deirdre Murray "]
[null,"Research commenced prior to submission of application","Yes",null,"Yes"]
[null,"Research Objective","The BASELINE study commenced in 2008 with an aim to establish a prospective paediatric birth cohort, which will have access to detailed information on maternal health, fetal growth and childhood nutrition, growth and development in the first 2 years of life. The longitudinal monitoring of these infants has allowed direct investigation of several research areas in a way which had not previously been possible in Ireland. Three main research themes/aims where focused on (i) fetal and early life growth trajectories which foretell later disability and metabolic disorder, (ii) food allergy and eczema in early childhood and (iii) vitamin D deficiency. Although the initial proposal focused on these important areas, the formation of this birth cohort offers opportunities for further research as the cohort grows older. Building on these aims, the BASELINE study has since followed up with the children at 5 years of age and collected data on their growth and development. \nThe BASELINE study hopes to continue to follow-up at 12 and 15 years and to follow their progress until they are 16. More recently, funding has been received to study specific areas of development in these children. These areas include but are not limited to: maternal cytokine profiles during pregnancy in mothers who progress to have children with a diagnosis of autistic spectrum disorder; maternal cortisol levels in mothers with a subsequent diagnosis of cognitive and behavioural abnormalities; and lipid profiles in children with obesity at 5 years.",null,"The BASELINE study commenced in 2008 with an aim to establish a prospective paediatric birth cohort, which will have access to detailed information on maternal health, fetal growth and childhood nutrition, growth and development in the first 2 years of life. The longitudinal monitoring of these infants has allowed direct investigation of several research areas in a way which had not previously been possible in Ireland. Three main research themes/aims where focused on (i) fetal and early life growth trajectories which foretell later disability and metabolic disorder, (ii) food allergy and eczema in early childhood and (iii) vitamin D deficiency. Although the initial proposal focused on these important areas, the formation of this birth cohort offers opportunities for further research as the cohort grows older. Building on these aims, the BASELINE study has since followed up with the children at 5 years of age and collected data on their growth and development. \nThe BASELINE study hopes to continue to follow-up at 12 and 15 years and to follow their progress until they are 16. More recently, funding has been received to study specific areas of development in these children. These areas include but are not limited to: maternal cytokine profiles during pregnancy in mothers who progress to have children with a diagnosis of autistic spectrum disorder; maternal cortisol levels in mothers with a subsequent diagnosis of cognitive and behavioural abnormalities; and lipid profiles in children with obesity at 5 years."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the continued processing of personal data specifically for the BASELINE where explicit consent  from participants cannot be obtained. The processing activities  involved are: \n(i) Specifically for the purpose of the BASELINE study: the continued \nprocessing (pseudonymisation, retention and analysis) of personal data already collected from participants from gestation until the 5-year follow-up assessment and the processing of personal data from pregnant Mothers that was initially collected as part of the SCOPE study (Ref ID 19-070-AF2, considered at this meeting),\n(ii) the sharing of data with external collaborators; the Lifecycle/MOCO consortium, \n(iii) the continued storage, only, of the BASELINE data for 25 years  after the BASLINE study concludes, for unspecified future research.",null,"The scope of the amendment is for the processing of personal data from the BASELINE and SCOPE studies for the purpose of the IDEA study."]
[null,"Scheduled HRCDC Meeting Date","22nd June 2021",null,"20th July 2021"]
[null,"HRCDC Decision Date ","22nd June 2021",null,"20th July 2021"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of this declaration that the personal data and associated bio\u0002samples of participants who have withdrawn their consent following the re-consenting process, must be destroyed as soon as possible. For the avoidance of doubt this consent declaration does not cover the further processing this cohort’s data, only the storage of their data until it has been destroyed. The Applicant is required to report of the deletion of personal data and destruction bio-samples of participants who have withdrawn from the study as part of the Annual Review. [CONDITION MET]\n\nCondition 2. It is a condition of this declaration that this study has a clear protocol in place regarding what will happen a participant’s personal data if they wish to withdraw from the study. This includes providing clear information to the participant on what will happen their personal data in such circumstances, including if there is a time point at which their data cannot be destroyed.\nNOTE: a consent declaration cannot be made to override a participant’s wish to withdraw their consent. Data controllers who wish to continue to process the personal data of participants who have withdrawn their consent, are responsible for ensuring they are compliant with data protection legislation. The Data Protection Officer should be consulted where necessary. [CONDITION MET]\n\nCondition 3. For participants who have not responded to the re-consenting process, the Applicant is requested to write out and inform them that their personal data and bio-samples will continue to be processed for the purpose of the BASELINE study and further stored for future research. Information should be provided on who to contact if they wish to receive more information or to discuss their options. The Applicant should highlight that a consent declaration was made by the HRCDC to permit the processing of their data specifically for the BASELINE study in the absence of reconsenting participants. The Applicant is required to report on the progress made to fulfil this condition as part of the first Annual Review. [CONDITION MET]","Condition 4. The Applicant must ensure that a re-consent protocol is designed and implemented so that children recruited to BASELINE are given the opportunity to provide their explicit consent for data processing when they turn 18 years of age. Attempts to obtain their consent must be \nmade within one year of the participant turning 18. The Applicant must report on this activity as part of each Annual Review, including where attempts to seek consent are unsuccessful.  [CONDITION UNDERWAY]\n\nCondition 5. The Applicant is requested to enhance the transparency measures that are undertaken for the BASELINE study. Transparency measures should inform participants about a number of areas including the ongoing use of their data as part of the BASELINE study, the dissemination of research findings, their data protection rights and withdrawal from the study. Consideration should be given to enhancing transparency via updates to the BASELINE and INFANT centre websites as well as through PPI engagement. [CONDITION MET]\n\nCondition 6. The Applicant is requested to undertake public and patient involvement (PPI) activities as part of the BASELINE study, in areas such as informing future BASELINE research, the dissemination of findings, transparency measures and future consent protocols. The Applicant \nshould consider utilising the working PPI group at the UCC INFANT centre [CONDITION UNDERWAY]\n\nCondition 7. It is a condition of this consent declaration that the Applicant confirm that the data shared with Quest Diagnostics has also been deleted by Quest Diagnostics. A response should be provided as soon as possible to the HRCDC. [CONDITION MET]","Condition 1. The Applicant is required to update the data protection impact assessment (DPIA) for the BASELINE and SCOPE studies to reflect the additional data processing activities, data protection risks and mitigating actions associated with the IDEA study. [CONDITION MET]\n\nCondition 2. All standard and specific conditions attached to the consent declarations made to the BASELINE and SCOPE studies also apply to the IDEA Study. As part of this the Applicant is requested to ensure that the public and patient involvement activities to be undertaken for the \nBASELINE and SCOPE studies, a condition attached to the consent declarations made, should also extend to the IDEA study, where appropriate. [CONDITION MET]\n"]
[null,"Deadline for meeting any conditions","N/A",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 22nd June 2021 and shall be valid for 15 years, until 31st June 2036, or upon confirmation that the data has been irrevocably rendered anonymised or destroyed, or whichever occurs sooner. ",null," The approval to the Amendment is made commencing 20th July 2021 and shall be valid until 31st June 2036, or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","No longer required",null,"No longer required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation. In line with the data protection principle of data minimisation, the Applicant is requested to consider whether the personal data from the BASELINE study can be irrevocably anonymised sooner than the intended 25-year duration. [RECOMMENDATION CONSIDERED)",null,"N/A"]

{"sheet":"19-021-AF3","index":21,"n_rows":18,"n_cols":5,"rows_kept":18,"cut":false,"hidden":false,"merged":[[12,1,13,1],[12,2,13,2],[12,3,13,3],[12,4,13,4]]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref","19-021-AF3","19-021-AF3/AMD1","19-021-AF3/AMD2"]
[null,"Application Title ","National Self Harm Registry Ireland","National Self Harm Registry Ireland","National Self Harm Registry Ireland"]
[null,"Applicant Organisation (Data Controller)","National Suicide Research Foundation","National Suicide Research Foundation","National Suicide Research Foundation"]
[null,"Lead Applicant ","Paul Corcoran","Paul Corcoran","Paul Corcoran"]
[null,"Research commenced prior to submission of application","Yes","Yes","Yes"]
[null,"Research Objective","The National Self-Harm Registry Ireland is a national system of population monitoring for the occurrence of hospital-treated selfharm. Specifically, the Registry aims to quantify the extent to which presentations are made to acute public hospitals in Ireland as a result of self-harm; to identify the groups with the highest rates of self-harm presentations and repeat presentations; to identify the methods of self-harm that are employed; and to identify the areas in Ireland with the highest rates of self-harm. The uses of the Registry relate to patient care, public health and epidemiological research. The Registry is a valuable national service evaluation tool as well as a research resource and has contributed to increased knowledge and understanding of suicidal behaviour, thereby facilitating better treatment of the individuals involved. It identifies the groups and areas that most need to be targeted for prevention and intervention.","The National Self-Harm Registry Ireland is a national system of population monitoring for the occurrence of hospital-treated selfharm. Specifically, the Registry aims to quantify the extent to which presentations are made to acute public hospitals in Ireland as a result of self-harm; to identify the groups with the highest rates of self-harm presentations and repeat presentations; to identify the methods of self-harm that are employed; and to identify the areas in Ireland with the highest rates of self-harm. The uses of the Registry relate to patient care, public health and epidemiological research. The Registry is a valuable national service evaluation tool as well as a research resource and has contributed to increased knowledge and understanding of suicidal behaviour, thereby facilitating better treatment of the individuals involved. It identifies the groups and areas that most need to be targeted for prevention and intervention.","The National Self-Harm Registry Ireland is a national system of population monitoring for the occurrence of hospital-treated selfharm. Specifically, the Registry aims to quantify the extent to which presentations are made to acute public hospitals in Ireland as a result of self-harm; to identify the groups with the highest rates of self-harm presentations and repeat presentations; to identify the methods of self-harm that are employed; and to identify the areas in Ireland with the highest rates of self-harm. The uses of the Registry relate to patient care, public health and epidemiological research. The Registry is a valuable national service evaluation tool as well as a research resource and has contributed to increased knowledge and understanding of suicidal behaviour, thereby facilitating better treatment of the individuals involved. It identifies the groups and areas that most need to be targeted for prevention and intervention."]
[null,"Reason for seeking a Declaration","The consent declaration is sought for the processing (collection,recording, pseudonymisation) of personal data on self-harm presentations (11,600 p/a) to hospital emergency departments for the National Self-Harm Registry Ireland.","The purpose of the amendment is (i) to extend the duration of the consent declaration and (ii) for a change in data processor relating to the data transfer system used by the Registry. ","The National Self-Harm Registry Ireland gathers information on hospital presenting self-harm at Emergency Departments in all hospitals across Ireland. The Registry was established in 2000 at the request of the Department of Health and is funded by the Health Service Executive’s National Office for Suicide Prevention. National coverage of the Registry was obtained in 2006 thereby enabling time trends to be examined on an ongoing basis since then. Data from the Registry are also being used as an outcome measure for Connecting for Life: Ireland’s National Strategy to Reduce Suicide 2015-2024. We are seeking an amendment to extend the duration of the consent declaration to continue the work of the Registry. This project is of an indefinite duration. "]
[null,"HRCDC Meeting Date #1","2nd March 2020","10th May 2022","9th May 2023"]
[null,"HRCDC Meeting Date #2","30th April 2020","N/A","N/A"]
[null,"HRCDC Decision Date ","30th April 2020","10th May 2022","9th May 2023"]
[null,"HRCDC Decision","Conditional Declaration","Amendment approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC requests that the level of public and patient involvement is enhanced. This includes engagement with mental health support groups such as Pieta House and the Samaritans, as well as with patients and their families. As part of this engagement, the feasibility and appropriateness of obtaining patient consent or next-of-kin assent, where the patient lacks decision making capacity, for the inclusion of their data in the registry, should be discussed with public and patient representatives.  (CONDITION MET) \n\nCondition 2: The Applicant is requested to enhance the level of transparency so that participants and their families are aware of the following;\ni) the existence of the Registry and the potential inclusion of their personal data in the Registry,\nii) that medical records are accessed, and personal data collected, as part of the Registry, and \niii) how they can request to withdraw their personal data from the\nRegistry and what will happen their personal data in such circumstances.\nThe Applicant is requested to ensure that clear and robust arrangements are in place with the hospitals regarding the provision of transparency notices. In addition, the Applicant is asked to consider other transparency measures such as ensuring that notices are provided in targeted areas of the hospital and whether an information sheet with details of support groups and the Registry itself could be provided to patients upon discharge from hospital. The Applicant should also consider providing information on the Registry on the websites of support groups such as Pieta House and the Samaritans, and to widely disseminate Registry publications including to public and patient representative groups. (CONDITION MET) \n\nCondition 3: The Data Registration Officers (DROs) should only access the medical records of those who attended the hospital for suspected self-harm. In addition, the DROs should only access the required medical records of these patients and do so as minimally as possible. (CONDITION MET)","Condition 1. The Applicant is required to make satisfactory progress regarding Condition 1 (enhanced PPI activities) and Condition 2 (enhanced transparency measures) that were attached to the consent declaration of 30th April 2020. Specifically, a midterm report must be submitted to the HRCDC by 31st December 2022, detailing the progress made to meet these conditions. For the avoidance of doubt the continuation of the consent declaration for the National Self-Harm \nRegistry is subject to a satisfactory midterm report being received from the Applicant. (CONDITION MET) ","Condition 1. The previous Conditions on transparency (Condition 1) and PPI engagement (Condition 2) continue to remain valid for the duration of the consent declaration and remain a reporting requirement of the Annual Reviews. In this context, please note the following points that should also be addressed/progressed, with updates provided in the Annual Review:\n- The Applicant must ensure that the transparency measures and information provided to patients and the public remain up-to-date and fit for purpose, including the information provided on the National Self-Harm Registry website, social media, hospital sites, other third-party websites etc.\n- The Applicant should continue to engage with third parties on providing information about the Register on their respective websites. The Applicant should also expedite the discussions on providing information about the Register (e.g., information leaflets) directly to self-harm patients at an appropriate point in time. Where this is approved, such leaflets that may be provided to patients should include a link to the National Self-Harm Register website.\n- On the PPI panel, to ensure that the voices of those who have lived experienced self-harm can be heard, panel meetings should include at least one person who has such experience of self-harm or a family member. As part of the Annual Review, the Applicant is requested to provide information on the meetings and engagements that have occurred with this PPI panel, the numbers of panel members who attended such engagements and updates on how the feedback from the PPI engagement have been taken on board and implemented, where relevant. (CONDITION MET) "]
[null,null,null,null,{"$f":"- The Applicant must ensure that The transparency measures and information provided to patients and The public remain up-to-date and fit for purpose, including The information provided on The National Self-Harm Registry website, social media, hospital sites, other third-party websites etc.","v":{"$error":"#NAME?"}}]
[null,"Deadline for meeting any conditions","N/A","31st December 2022 [MET]","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 30th April 2020 and shall be\nvalid for 2 years, until 30th April 2022. The Applicant may request an extension to the duration of the declaration. Upon request for an extension to the declaration, the HRCDC will consider the progress made to met the conditions attached. The Amendment is made commencing 10th May 2022 and shall be valid for one year until 10th May 2023. (This timeline is an extension to the duration of the consent declaration). The second Amendment is made commencing 9th May 2023 and shall be valid until 10th May 2033. This timeline is an extension to the duration of the consent declaration.","The approval to The Amendment is made commencing 10th May 2022 and shall be valid for one year until 10th May 2023. (This timeline is an extension to the duration of the consent declaration).\nNOTE: This extension is subject to the submission of a satisfactory midterm report by the Applicant (See Condition 1). The second Amendment is made commencing 9th May 2023 and shall be valid until 10th May 2033. This timeline is an extension to the duration of the consent declaration.","The approval to the Amendment is made commencing 9th May 2023 and shall be valid until 10th May 2033. This timeline is an extension to the duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A","N/A","Recommendation 1. The HRCDC recommends that the Applicant/data controller review the use and security of USB memory sticks in this study and explore alternative, more secure options for the sharing and transfer of data such as an encrypted platform. The Applicant is requested to report on this Recommendation as part of the Annual Review."]

{"sheet":"19-022-AF2","index":22,"n_rows":17,"n_cols":4,"rows_kept":17,"cut":false,"hidden":false,"merged":[[7,2,8,2],[7,1,8,1],[7,3,8,3]]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-022-AF2","19-022-AF2/AMD1"]
[null,"Application Title ","The Irish Longitudinal Study on Ageing (TILDA)","The Irish Longitudinal Study on Ageing (TILDA)"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin","Trinity College Dublin"]
[null,"Lead Applicant ","Rose Anne Kenny ","Rose Anne Kenny "]
[null,"Research commenced prior to submission of application","Yes","Yes"]
[null,"Research Objective","The Irish Longitudinal Study on Ageing (TILDA) was established in 2006 with funding from the Department of Health, The Atlantic Philanthropies and Irish Life. The core vision of TILDA is “Towards making Ireland the best place in the world to grow old”. Prior to TILDA, only minimal national information was available on health, economic and social data for the ageing population, therefore impeding proper policy development and future planning that should be based on evidence. TILDA addresses this gap by providing evidence-based data on the ageing population in Ireland to inform policy; track policy changes (e.g. prescription charges) and natural experiments (e.g. effects of recession); healthcare utilisation; health and social systems; end of life experiences; comparisons with other countries; and opportunities to make new discoveries regarding physical, mental and cognitive ageing and the biology of ageing.","The Irish Longitudinal Study on Ageing (TILDA) was established in 2006 with funding from the Department of Health, The Atlantic Philanthropies and Irish Life. The core vision of TILDA is “Towards making Ireland the best place in the world to grow old”. Prior to TILDA, only minimal national information was available on health, economic and social data for the ageing population, therefore impeding proper policy development and future planning that should be based on evidence. TILDA addresses this gap by providing evidence-based data on the ageing population in Ireland to inform policy; track policy changes (e.g. prescription charges) and natural experiments (e.g. effects of recession); healthcare utilisation; health and social systems; end of life experiences; comparisons with other countries; and opportunities to make new discoveries regarding physical, mental and cognitive ageing and the biology of ageing."]
[null,"Reason for seeking a Declaration","TILDA participants are aged 50+, with a proportion over 75. When recruiting for Waves 1 to 5 of TILDA, a broad approach was taken when developing the PILs and consents forms to ensure that the information was provided in an easy to understand format and to minimise participant burden. These forms highlighted that the data would be analysed and used for research purposes by the TILDA team and collaborators and that data confidentiality is a priority although specific details of the collaborations were not provided. Anonymised datasets are also provided to the public archives and therefore fall outside of GDPR. This was not referenced in the PILs but information about data access through the public archives has been available on the TILDA website and in all TILDA publications and presentations since the archiving began. Additionally, at baseline, all adults had to be cognitively capable of providing informed consent to take part in the study. As the study progresses, some participants may become vulnerable as they experience declines in physical or cognitive function and may require a proxy interview where a close family member or friend completes the interview on their behalf. All participants requiring a proxy interview will continue to be followed up at each wave.\n\nThis consent declaration is being sought to enable TILDA to:\n•\tContinue to make anonymised datasets available nationally and internationally through the public archives in Dublin (UCD) and US (ICPSR) and to collaborate with researchers from other institutions,\n•\tSharing of anonymised data with LifePath consortium,\n•\tSharing of anonymised data with EU and/or International consortia,\n•\tSharing of blood samples (500) with collaborators,\n•\tLinkage with death registration records held by the Genera Register Office** (this processing activity will be considered separately in 19-043-AF3)\n•\tContinued use and storage of biobanked samples from previously consented participants where reconsent is not possible,\n•\tSharing of anonymised datasets through public archives with third party researchers.","To add University of Swansea as a data processor and, correspondingly, for sharing/processing TILDA data with Swansea for the purpose of VISTA to provide remote access to TILDA data."]
[]
[null,"Scheduled HRCDC Meeting Date","25th November 2019","Chairperson approval"]
[null,"HRCDC Decision Date ","25th November 2019","26th February 2025"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: A declaration cannot be made to override the withdrawal of consent. It is a condition of this declaration that the Applicant has robust procedures and processes in place to ensure that data processing activities do not include data from participants that have withdrawn from the study, as the scope of this declaration does not cover the use of personal data of participants who have withdrawn from the study. Please see Recommendation 1 below.[CONDITION MET]\n\nCondition 2: An appropriate data sharing agreement must be in place between Trinity College Dublin and the Interuniversity Consortium for Political and Social Research (ICPSR).[CONDITION MET]","Condition 1. The necessary data agreements/arrangements (e.g., data sharing and data processing agreements) must be in place. If required, Standard Contractual Clauses must also be put in place."]
[null,"Deadline for meeting any conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid indefinitely. The declaration shall be subject to the annual review. The HRCDC reserve the right to review the declaration duration at regular intervals to consider any relevant changes that may have arisen during the course of the study .","The approval to the Amendment is made commencing 26th February 2025 and shall be valid indefinitely, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: It is acknowledged that the TILDA privacy notice outlines what shall happen to the participant’s personal data if consent is withdrawn, and why continued use is necessary. To add further clarity for participants, the Applicant is advised to consider providing clear information, in plain language, as to what specific GDPR derogations they are relying upon in such circumstances. (RECOMMENDATION CONSIDERED)\n\nNOTE: Data controllers who wish to continue to process personal data of participants who have withdrawn from the study, are responsible for ensuring they are compliant with data protection legislation, including the derogations outlined within the GDPR, for example Article 17 and informing participants of what shall happen to their data should they withdraw from a study. The Data Protection Officer should be consulted where necessary. \n\nRecommendation 2: The Applicant is advised to consider, for their own clarity, whether participant withdrawal from the study relates to withdrawal from the entire study or a single Wave, or whether they should not be contacted as requested. This matter should be discussed with the Applicant’s Data Protection Officer. (RECOMMENDATION CONSIDERED)","N/A"]

{"sheet":"19-023-AF2","index":23,"n_rows":18,"n_cols":5,"rows_kept":18,"cut":false,"hidden":false,"merged":[[11,2,13,2],[12,1,13,1],[11,3,13,3]]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref","19-023-AF2","19-023-AF2/AMD1","19-023-AF2/AMD2"]
[null,"Application Title ","Effect of naïve and pre-activated MSCs on monocyte/macrophage function in patients with pulmonary and non pulmonary sepsis","Effect of naïve and pre-activated MSCs on monocyte/macrophage function in patients with pulmonary and non pulmonary sepsis","Effect of naïve and pre-activated MSCs on monocyte/macrophage function in patients with pulmonary and non pulmonary sepsis"]
[null,"Applicant Organisation (Data Controller)","Beaumont Hospital \n","Beaumont Hospital \n","Beaumont Hospital \n"]
[null,"Lead Applicant ","Ger Curley ","Ger Curley ","Ger Curley "]
[null,"Research commenced prior to submission of application","Yes","No ","No "]
[null,"Research Objective","Sepsis is a consequence of infection where the body’s immune system becomes abnormal and results in widespread damage to the body, manifest as organ failure. Sepsis is the most common condition in the Intensive Care Unit. Unfortunately, up to 40% of patients with sepsis in the ICU will die. Many patients with sepsis also have lung failure, a condition known as Acute Respiratory Distress Syndrome (ARDS). This project aims to understand why and how sepsis and ARDS develops, attempt to detect it earlier and develop new treatments.","An amendment with regards to the amended assent/consent protocol.","Sepsis is a consequence of infection where the body’s immune system becomes abnormal and results in widespread damage to the body, manifest as organ failure. Sepsis is the most common condition in the Intensive Care Unit. Unfortunately, up to 40% of patients with sepsis in the ICU will die. Many patients with sepsis also have lung failure, a condition known as Acute Respiratory Distress Syndrome (ARDS). This project aims to understand why and how sepsis and ARDS develops, attempt to detect it earlier and develop new treatments."]
[null,"Reason for seeking a Declaration","A declaration is sought to collect and process the personal data of participants who lack decision-making capacity to provide consent. Instead assent will be obtained from the participant’s next-of-kin. When the participant regains capacity, they will be provided with a patient information leaflet and asked to provide explicit consent. Where participants do not regain capacity, an ongoing consent declaration will be required.\nThe scope of the declaration being sought is for the processing of personal data i) already collected from participants since the study commenced in May 2017, and ii) from future participants who lack decision-making capacity to provide consent. Where only next-of-kin assent has been provided the scope of a declaration also includes the ongoing storage of personal data for future research but does not extend to the use of personal data in future, unknown research.","Amendment: The Applicant requests an amendment to the existing consent declaration for the following reasons:\n•\tThe assent/consent protocol has been amended to include telephone consent/assent. \n•\tThe protocol has also been amended to include deferred next-of-kin assent; in the rare case where it is not possible to obtain next-of-kin assent, the participant who lacks decision-making capacity may be enrolled in the study and their data processed, with next-of-kin assent obtained as soon as possible. ","Amendment: At present, the study seeks to examine the characteristics and function of cells such as monocytes and neutrophils during sepsis and to determine if the beneficial actions of these cells can be exploited using various treatment options. However, cells such as endothelial and epithelial cells are also believed to play an important role during sepsis but less in known compared to other cell types. We aim to use plasma from patients with sepsis to replicate conditions during infection and to observe \nwhether or not human mesenchymal stem cells influence the role of endothelial and epithelial cells in a beneficial manner. We also wish to alter the title of the study as it has expanded beyond the scope of investigating the effect of MSCs on monocyte/macrophages alone. As such, we believe that “Inflammatory Responses to Critical Illness” is a more appropriate title."]
[null,"Scheduled HRCDC Meeting Date","2nd April 2020","4th September 2020","9th May 2023"]
[null,"HRCDC Decision Date ","2nd April 2020","4th September 2020","9th May 2023"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Requested more information"]
[null,"Specific Conditions attached ","Condition 1: Where explicit consent has not been obtained from the participant at the point of discharge from hospital, the Applicant is requested to implement an appropriate process for re-contacting participants and where possible, to seek their explicit consent for data processing. The Applicant must make reasonable efforts to obtain consent via an appropriate process and must report on this as part of the Annual Review, including the number of participants where consent has and has not been obtained. (CONDITION MET)\n\nCondition 2: Where a participant continues to lack decision-making capacity for a prolonged period of time and where next-of-kin assent remains in place, the HRCDC request that the following action should be taken as an additional safeguard: the Applicant should seek confirmation from the next-of-kin who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study. (CONDITION MET)\n\nCondition 3: As a data protection safeguard the HRCDC has requested that all appropriate contractual arrangements or agreements must be in place between the data controller of the study and collaborating Institutions receiving participant data and/or biosamples.\nSpecifically;\ni) arrangements are in place with Dublin City University (DCU) and the William Harvey Research Institute (WHRI) to ensure that the data and material is transferred under appropriate terms and conditions to ensure the anonymity of the participants.\nii) appropriate data processing agreements are in place with the Royal College of Surgeons in Ireland, noted as a data processors in this study. Please inform the Secretariat once this condition is met as soon as practically possible. This condition will also be a reporting requirement as part of the Annual Review. (CONDITION MET)\n\nCondition 4: To ensure clarity for participants and their next-of-kin, the HRCDC requests the Applicant to amend the study information leaflets as follows:\n- Revise ‘next-of-kin consent’, to ‘next-of-kin assent’\n- In line with DPO feedback, consider stating ‘year of birth’ will be collected not ‘date of birth’\n- Where relevant, participants should be informed that assent was previously provided by their next-of-kin\n- Inform the next-of-kin how their relative’s consent will be sought at a later point in time should they regain capacity\n- Ensure that the description of collecting of biosamples accurately reflects the practice; i) whether samples are collected before or after next-of-kin assent or participant consent is obtained and ii) whether blood or BAL samples are collected and processed or if both are collected and processed\n- The participant information leaflets states the study ’does not require access to medical records’. This should be revised/or removed entirely, as medical records will be accessed. (CONDITION MET)","Condition 1: Where it is not possible to obtain next-of-kin assent and the participant has been enrolled into the study on the basis of deferred assent, the Applicant is requested to continue to make every effort to obtain deferred next-of-kin assent as soon as possible. (CONDITION MET)\n\nCondition 2: The Applicant is requested to report on the proportion of participants who have been enrolled into the study on the basis of deferred next-of-kin assent, as a reporting obligation under the Annual Review. Notwithstanding the above reporting requirement, the Applicant is requested to notify the HRCDC immediately should the study become more regularly reliant on deferred next-of-kin assent for the processing of the participant’s personal data, and outline what factors have contributed to this situation and what efforts have been made to meet Condition 1. (CONDITION MET)\n"]
[null,null,null,null,"TBC"]
[]
[null,"Deadline for meeting any conditions","N/A","N/A","TBC"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until 31st May 2021 and 15 years thereafter (until May 31st, 2036), or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner.","The Amendment is made commencing September 4th, 2020 and shall be valid until 31st May 2021 and 15 years thereafter (until 31st May 2036), or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. (This timeline is in line with the duration of the consent declaration)","TBC"]
[null,"Status of Declaration","No longer required","No longer required","TBC"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC acknowledge the Applicant’s experience in engaging with the public and patients on the issue of sepsis. The HRCDC recommend that the Applicant enhance the level of public and patient involvement in this specific study, including engagement with representative groups such as ICUsteps. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2: The HRCDC recommends that the Applicant consider further data minimisation measures where possible. Specifically, i) considering if the name of the participant must be recorded if other personal identifiers such as the medical record number are retained, ii) if year of birth can be recorded instead of date of birth, iii) any other data minimisation measures are appropriate. The DPO should be consulted with as necessary.(RECOMMENDATION CONSIDERED)","Recommendation 1: Where assent is obtained via telephone, the HRCDC recommends, for the purpose of record keeping, that copies of the study information leaflets, and assent forms, are forwarded to the next-of-kin and correspondingly signed and returned to the study team. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2: The HRCDC recommends that the study information leaflets and accompanying assent and consent forms, are carefully reviewed and amended as necessary, to ensure there is clarity and consistency of information provided to the participants or their next-of-kin. This will ensure there is an appropriate level of transparency. Specifically, the following points should be considered;\n-\tThe use of the term ‘assent’ rather than ‘consent’ in the next-of-kin assent study documents;\n-\tClarity that consent to continue from the participant who regains decision-making capacity, is requested for the use of study biosamples that have already been collected, and not new biosamples. ( under consideration.)","TBC"]

{"sheet":"19-024-AF2","index":24,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,1,12,1],[11,2,12,2]]}
[]
[null,"Application Ref","19-024-AF2"]
[null,"Application Title ","Seizure detection for babies "]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Geraldine Boylan"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Seizures occur in 5-13% of very low birth weight babies and 1-2 per 1000 babies born at full term and are regarded as a major risk factor for death or subsequent neurological disability. These seizures are clinically difficult to diagnose and are often a marker of important underlying conditions that require urgent diagnosis and treatment.\nThe characteristics of neonatal seizures have so far proved challenging for automated seizure detection methods. The use of Near-infrared spectroscopy (NIRS) in the first few days in neonates have been recommended. This simple and reliable technology permits bedside measurement of acute changes in the most immature and unstable neonates requiring intensive care. Simultaneous video and electroencephalogram (EEG) is the best tool for diagnosing seizures but requires highly specialised technical and medical personnel to acquire and interpret the studies; there is a need to develop an automated, effective and simple to use seizure detection system at the cot side; this study aims to develop a neonatal seizure detection algorithm (code)."]
[null,"Reason for seeking a Declaration","UCC holds the residual databank of EEG recordings, lesser number of NIRS recordings and clinical data that constitutes personal data from participants who consented to participate in the study at Cork University Maternity hospital. A consent declaration is sought for;\ni) the continued processing of the personal data (pseudonymisation, analysis and storage) for the purpose of this research study and within the scope of the consent that was previously obtained; and\nii) a fully anonymised version of the pseudonymised study dataset."]
[null,"Scheduled HRCDC Meeting Date","12th November 2020"]
[null,"HRCDC Decision Date ","12th November 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: It is a condition of the declaration that the scope of the declaration covers the processing of data within the scope of the original consent previously obtained. For the avoidance of doubt, the scope does not extend to any other processing activity that is outside the scope of the original consent. [CONDITION MET]\n\nCondition 2: The Applicant is requested to enhance transparency measures and information is available on the data protection rights of participants , including how they can withdraw their consent and their data from the study if they wish to do so, as well as the duration of data storage. Transparency measures should also provide participants with updates regarding the use of their data and the study’s progress. Strong consideration should be given to forwarding a letter or information leaflet describing the above data protection rights to the study participants and providing clear information on the study website. Efforts made to implement enhanced transparency measures are a reporting requirement of the Annual Review.[CONDITION UNDERWAY]\n\nCondition 3. The Applicant is requested to ensure that required and robust agreements or contractual arrangements governing the processing of data are in place where required. The data protection officer and/or legal office should be consulted on this matter. [CONDITION UNDERWAY]\n\nCondition 4. In your response to confirm acceptance or non-acceptance of the HRCDC’s decision, clarification must be provided as to why research ethics committee (REC) amendment approval was sought and provided from the NHS Bristol REC, rather than the London based REC. [CONDITION MET]\n\n"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until 30th April 2044 (25 years after the last follow-up session was completed) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. "]
[null,"Status of Declaration","No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-025-AF2","index":25,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,1,12,1],[11,2,12,2]]}
[]
[null,"Application Ref","19-025-AF2"]
[null,"Application Title ","Irish National AATD Registry (Alpha-1)"]
[null,"Applicant Organisation (Data Controller)","Alpha-1 Foundation Ireland\n"]
[null,"Lead Applicant ","Gerry McElvaney"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Alpha-1 is a genetic condition with a high prevalence rate in Ireland; 1 in 25 Irish people are affected which can cause lung, liver and skin disease. The Alpha-1 registry in Ireland was established in 2005 to collect information on Alpha-1 individuals.The registry is part of the spectrum of clinical care and research at the National Centre of Expertise for Alpha-1 antitrypsin deficiency (AATD) at Beaumont Hospital. It records medical and demographic information of patients with the aim of i) increasing the level of understanding of the condition, ii) helping to inform and improve clinical care and iii) providing early access to new treatments via clinical trials."]
[null,"Reason for seeking a Declaration","A consent declaration is being sought for registry participants who were consented prior to May 2019. Though approved by Beaumont Hospital REC in 2005 and meeting the standard of consent standard at that time, the 2005 National AATD Registry Patient Information Leaflet (PIL) and consent form were not considered compliant under General Data Protection Regulations\n(GDPR) and Health Research Regulations (HRRs).The scope of declaration being sought will cover the processing of personal data of individuals (~530) who consented prior to May 2019. Processing activities within the scope of the declaration being sought:\n- Collection and storage of data\n- Anonymisation of the data for sharing with third parties\n- Sharing of anonymised data with Earco.eu\n- Use of data in research studies\n- Retention of data indefinitely (unless otherwise withdrawn by the participant)"]
[null,"HRCDC Meeting Date","26th May 2020"]
[null,"HRCDC Decision Date ","26th May 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The Applicant is requested to further enhance and implement transparency arrangements to ensure that participants, their families and the public are fully informed about the registry and the use of personal data. The transparency measures should clearly outline the type of data collected and how participants can exercise their data protection rights (and steps to withdraw from the registry if they wish to do so, including what will happen to their personal data in this scenario). The Applicant is requested to consider activities such as publicising updated information on the registry’s website as well as providing information at the foundation’s annual conference or other events, as appropriate. The implementation of robust transparency arrangements is a reporting requirement as part of the annual review. (CONDITION MET)\n\nNOTE: Further information on providing transparent information can be found on the Data Protection Commission’s website;\nhttps://www.dataprotection.ie/en/organisations/knowyourobligations/transparency. It is advisable to discuss this with the institutions Data Protection Officer (DPO).\n\nCondition 2: The Alpha-1 Foundation Ireland is required to do the following;\ni) Where data is transferred from the registry to third parties, the data controller of the registry must ensure that that a contractual agreement or arrangement as appropriate should be in place governing this transfer with terms and conditions ensuring the anonymity of participants.\nii) Where data from the registry is to be shared with the European registry, the HRCDC requires clarity on the relationship between the both parties and confirmation that that a contractual agreement or arrangement as appropriate should be in place governing this transfer with terms and conditions ensuring the anonymity of participants data agreement is in place should be provided to the HRCDC.(CONDITION UNDERWAY)"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing May 26th, 2020. The Declaration has no expiry date but shall be valid until confirmation that the data has been rendered anonymised or destroyed."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-026-AF2","index":26,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-026-AF2"]
[null,"Application Title ","MAMMI study (data processing for sub-studies with University of Gothenburg and Murdoch Children’s Research Institute)"]
[null,"Applicant Organisation (Data Controller)","A. Trinity College Dublin\nB. The following collaborators are joint controllers with TCD for the respective academic sub-studies utilising MAMMI data:\n(i) University of Gothenburg, Sweden\n(ii) Murdoch Children’s Research Institute, Australia"]
[null,"Lead Applicant ","Deirdre Daly "]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The Maternal Health and Maternal Morbidity In Ireland (MAMMI) study is a longitudinal study exploring the health and health problems experienced by women during their first pregnancy up to\n12 months after the baby’s birth. A total of 3047 women were recruited from three maternity hospitals in Ireland between January 2011 and March 2017. Follow up studies are currently being conducted with consenting women after their 2nd baby’s birth and 5 years after their first baby’s birth.\nThis consent declaration relates specifically to two substudies/collaborations involving the use of MAMMI data, that are to be conducted with collaborators from Sweden and Australia."]
[null,"Reason for seeking a Declaration","The scope of the consent declaration requested is limited to processing specifically for the purpose of the two sub-studies with Australia and Sweden and where participant consent is in line with previous EU Data Protection Directive and the Data Protection Acts 1988 & 2003 only.\nThe personal data to be processed for the sub-studies and covered by the declaration, is also limited to the data collected as part of the initial MAMMI study between 2011-2018 only (i.e., first pregnancy), not the follow-up studies. The Applicant states that the consent previously obtained from participants for the MAMMI study, initially did not specify that research might be conducted by, and data shared with third parties and notes that there are different interpretations on what is meant by anonymised data."]
[null,"Scheduled HRCDC Meeting Date","14th June 2022"]
[null,"HRCDC Decision Date ","14th June 2022"]
[null,"HRCDC Decision","Declaration Made"]
[null,"Specific Conditions attached ","Condition 1. It is a condition that the scope of this consent declaration does not cover the sharing \nof participant data for the Australian and Swedish sub-studies if participant consent for data \nprocessing has been withdrawn. Where participants have withdrawn/opted-out from future \nstudy participation and contact, the Applicant must be satisfied that consent for data processing \nhas not been withdrawn and remains in place. In this context the Applicant must have due regard \nto any information and options that were provided to participants regarding the processing of \ntheir personal data if they withdraw or opted-out from further study participation or future \ncontact. \n\nCondition 2. The Applicant must ensure that the required appropriate data agreements and \narrangements are in place between Trinity College Dublin and the University of Gothenburg, \nSweden and Murdoch Children’s Research Institute, Australia. This includes appropriate data \nsharing agreements, joint data controller arrangements and the standard contractual clauses for \nthe transfer of data outside the EEA. Data sharing cannot occur until this Condition has been met. [CONDITION UNDERWAY]\n\nCondition 3. The Applicant must submit the outstanding requisite research ethics approval letter \nthat covers the Australian sub-study. The consent declaration will not be in effect for this sub\u0002study until this condition is met. [CONDITION MET]\n\nCondition 4. Aligned with the principle of data minimisation, the Applicant is requested to ensure \nthat only the minimum amount of data is shared and processed for the purpose of the Australian \nand Swedish sub-studies. The Applicant is further requested to consider if data can be deleted \nprior to 31st December 2027, if possible. [CONDITION UNDERWAY]","Condition 5. Having due regard to the practicalities and any GDPR derogations that may apply, the Applicant is requested to explore if it is feasible to remove participant data from the sub\u0002studies after it has been shared with Australia and Sweden, should a participant wish to withdraw their consent for data processing and have their data deleted. The Applicant is also requested to update the relevant section of the MAMMI website to provide clear information on if, and until when, participant data can be removed from the Australian and Swedish sub-studies if requested by a participant. [CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 14th June 2022 and is valid until 31st December 2027 or until the \npersonal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-027-AF3","index":27,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-027-AF3"]
[null,"Application Title ","Identification of predictive and prognostic biomarkers in triple negative breast cancer"]
[null,"Applicant Organisation (Data Controller)","National University of Ireland, Galway\nGalway University Hospital"]
[null,"Lead Applicant ","Sharon Glynn"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Triple Negative Breast Cancer (TNBC) is an uncommon form of the disease accounting for only 15% of breast cancers. TNBC is itself a diverse group of invasive breast cancers with some TNBCs following an indolent course but the majority have a more aggressive course with poor outcome where almost all recurrence and death occurs within five years after diagnosis. Despite advances in other areas of breast cancer, patients with TNBC still have very limited treatment options and there are no predictive biomarkers. This study aims to identify biomarkers of TNBC that can be used to predict response to treatment and survival, and thus improve the outcome for patients with TNBC. To do this, it is necessary to evaluate the biomarkers within the tumour tissue from patients who were diagnosed with TNBC that is also linked to treatment and outcome data at 5-8 years from diagnosis."]
[null,"Reason for seeking a Declaration","A declaration is requested to process the personal data associated with tumour tissues that are surplus to diagnostic requirements, from a cohort of 160 patients for the purpose of this study (collection, including of follow-up data, pseudonymisation, transfer, analysis and storage). \nThese patients were diagnosed with TNBC at Galway University Hospital prior to the introduction of the Health Research Regulations in 2018. "]
[null,"Scheduled HRCDC Meeting Date","26th January, 2021"]
[null,"HRCDC Decision Date ","26th January, 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC requests the Applicant to make significant efforts to obtain the consent of as many of the living participants as possible. \nFor participants where it is not feasible to obtain consent, the Applicant is subsequently requested to outline what additional transparency measures will be implemented to inform those participants about this study, the use of their personal data within the study and how they can exercise their data protection rights, including the right to withdraw. For the participants that cannot be consented, transparency measures should look beyond general measures and consider more participant-targeted approaches. In meeting this condition, the Applicant should also consider engagement with Patient and Public Involvement groups for consultation on the implementation of consent practices and enhanced transparency measures for these participants. \nThe Applicant must report to the HRCDC on the progress of meeting this condition within 3 months of the of the HRCDC decision letter. The continuation of the consent declaration is contingent on the Applicant reporting on this condition satisfactorily. (CONDITION UNDERWAY) \n\nCondition 2. From the information provided to the HRCDC, it was not clear what mechanisms are in place to enable participants to exercise their data protection rights, such as making a ‘subject access request’. Linked to Condition 1, the Applicant is requested to have an appropriate transparent procedure in place whereby study participants can exercise their data protection rights, if participants wish to do so.\n(CONDITION MET)\n","Condition 3. It is acknowledged that the study received research ethics approval in 2014 by the Chairman of the REC and was not required to go through full committee approval at that time. The Applicant is requested to renew the Research Ethics Committee (REC) approval for this study from Galway University Hospital and revert with confirmation of this approval within 3 months of the date of issuance of the HRCDC decision letter. Confirmation must be provided that the REC approval covers the study as outlined in the HRCDC application form. \nNOTE: The HRCDC reserves the right to amend the consent declaration should the outcome of the REC process result in amendments to the study that are relevant to the HRCDC’s decision. (CONDITION MET)\n\nCondition 4. It is a condition of this declaration that the joint controller arrangement between GUH and NUIG, as referenced in the application form, is fully implemented in accordance with GDPR requirements. Confirmation that this condition has been met is to be provided to the HRCDC as soon as possible, and no later than 3 months from the date of issuance of the HRCDC decision letter (CONDITION MET)                                 \n"]
[null,"Deadline for meeting any conditions","Condition 1 - May 5th \nCondition 3 - May 5th \nCondition 4- May 5th "]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until 31st December 2027, or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation. In line with the principle of data minimisation, the Applicant is asked to consider if participant date of birth can be replaced with year of birth or age. "]

{"sheet":"19-031-AF2","index":28,"n_rows":17,"n_cols":5,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,2,12,2],[11,1,12,1]]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref","19-031-AF2","19-031-AF2/AMD1","19-031-AF2/AMD2"]
[null,"Application Title ","Bowel Disease Bio-resource Development: Identification of Potential Biomarkers for Bowel Disease","Bowel Disease Bio-resource Development: Identification of Potential Biomarkers for Bowel Disease","Bowel Disease Bio-resource Development: Identification of Potential Biomarkers for Bowel Disease"]
[null,"Applicant Organisation (Data Controller)","The Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin","The Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin","The Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin"]
[null,"Lead Applicant ","Deborah McNamara (Beaumont Hospital)\nJochen Prehn (The Royal College of Surgeons in Ireland)","Deborah McNamara (Beaumont Hospital)\nJochen Prehn (The Royal College of Surgeons in Ireland)","Deborah McNamara (Beaumont Hospital)\nJochen Prehn (The Royal College of Surgeons in Ireland)"]
[null,"Research commenced prior to submission of application","Yes","Yes","Yes"]
[null,"Research Objective","Colorectal cancer is the second most common malignancy in the western world. Standard treatment includes surgery with or without chemotherapy; this can lead to a general over-treatment of some patients whilst high-risk patients may not be receiving optimum therapy. The purpose of this Biobank is to develop a bio-resource of tumour and normal tissue, which is removed during the surgical procedure as standard practice, which may be used to identify common proteins and genes that may be used as effective biomarkers which could lead to improved treatment and the development of potential screening programmes for those deemed to be at high-risk of developing colorectal cancer.","Colorectal cancer is the second most common malignancy in the western world. Standard treatment includes surgery with or without chemotherapy; this can lead to a general over-treatment of some patients whilst high-risk patients may not be receiving optimum therapy. The purpose of this Biobank is to develop a bio-resource of tumour and normal tissue, which is removed during the surgical procedure as standard practice, which may be used to identify common proteins and genes that may be used as effective biomarkers which could lead to improved treatment and the development of potential screening programmes for those deemed to be at high-risk of developing colorectal cancer.","Colorectal cancer is the second most common malignancy in the western world. Standard treatment includes surgery with or without chemotherapy; this can lead to a general over-treatment of some patients whilst high-risk patients may not be receiving optimum therapy. The purpose of this Biobank is to develop a bio-resource of tumour and normal tissue, which is removed during the surgical procedure as standard practice, which may be used to identify common proteins and genes that may be used as effective biomarkers which could lead to improved treatment and the development of potential screening programmes for those deemed to be at high-risk of developing colorectal cancer."]
[null,"Reason for seeking a Declaration","A declaration is  sought for i) the continued use of the biosamples and personal data for biomarker analysis and ii) continued storage of the biosamples and personal data in a biobank for future research beyond the 10 years that was originally stated in the Patient Informaiton Leaflet. ","The amendment is requested to extend the duration of the consent declaration by an additional 2 years, beyond the initial 3-year duration that was made. The Applicant was invited to submit an \namendment request to extend the duration in the original HRCDC decision letter, where the HRCDC would consider any new national policy and regulatory developments in the area of biobanking.","To extend the duration of the consent declaration by three years to 6th October 2027."]
[null,"HRCDC Meeting Date","17th October, 2019","4th October 2022","11th October 2024"]
[null,"HRCDC Decision Date ","17th October, 2019","4th October 2022","11th October 2024"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: The Applicant is requested to provide more information to support their statement that participants do not want to be re-contacted. For example, are there documented numbers of participants that actively ‘opted’ not to be contacted? (CONDITION MET)\n\nCondition 2: Through engagement with PPI representatives and advocacy groups, the Applicant is requested to examine in detail the feasibility of obtaining re-consent from participants; including seeking a perspective from both healthy and ill participants. The findings of this exercise is a reporting requirement in the first Annual Review to be submitted to the HRCDC. (CONDITION MET)\n\nCondition 3: The Applicant must develop and provide public notices to Beaumont Hospital which highlights that research is being carried out using samples and data from the biobank. (CONDITION MET)\n\nCondition 4: The HRCDC acknowledge the Applicant’s response that REC approval from RCSI was not required for this study. The Applicant is requested to provide written confirmation of this from RCSI. (CONDITION MET)\n\nCondition 5: A material transfer and data sharing agreement or legal agreement as appropriate, must be executed between RCSI and Beaumont Hospital. Please indicate the expected timeline to have the legal agreement concluded. (CONDITION MET)\n\nCondition 6: Once finalised and approved, the Applicant must seek explicit consent from prospective participants using the new GDPR compliant PIL and Consent forms. (CONDITION MET)\n","N/A ","N/A "]
[]
[null,"Deadline for meeting any conditions","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid until October 31st, 2022; 3 years after the decision of the HRCDC to make a conditional declaration. The Applicant may seek to extend the Declaration prior to the expiration date.  Amendment -  made commencing 4 th October 2024 and shall be valid until 6 th October 2027, this is an extension of the consent declaration.\n\nNote: The HRCDC review of any extension request will take into consideration new national policy and regulatory developments in the area of biobanking.","The approval to the Amendment is made commencing 4th October 2022 and shall be valid until 6th October 2024 (This timeline is an extension to the duration of the consent declaration). Amendment -  made commencing 4 th October 2024 and shall be valid until 6 th October 2027, this is an extension of the consent declaration.","The approval to the Amendment is made commencing 4 th October 2024 and shall be valid until 6 th October 2027, this is an extension of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation: The Applicant is requested to review the current process whereby personal data access requests are made via the FOI office. The Applicant could consider more appropriate mechanisms such as a Data Subject Access Request, as is allowable under Article 15 of the General Data Protection Regulations. (RECOMMENDATION CONSIDERED)","N/A","N/A"]

{"sheet":"19-033-AF3","index":29,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-033-AF3"]
[null,"Application Title ","The Medical Emergencies Responder - Integration and Training (MERIT) Programme Study (Cardiac Arrest and Pre-Hospital Thrombolysis in Irish General Practice)"]
[null,"Applicant Organisation (Data Controller)","University College Dublin"]
[null,"Lead Applicant ","Gerard Bury"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The Medical Emergencies Responder - Integration and Training (MERIT) programme began in 2005 with the aim of equipping and training at least 500 general practices in Ireland to manage out-of-hospital cardiac arrest (OHCA). To survive OHCA, Cardiac Pulmonary Resuscitation (CPR) and defibrillation must be provided to patients within minutes. Early care by trained and equipped providers is therefore vital. Over 500 general practices now participate in MERIT and since 2015, the MERIT3 project has also enrolled more than 200 doctors who are text alerted by the HSE National Ambulance Service (NAS) to OHCA in their immediate areas. Doctors provide standard clinical care to patients, monitoring the impact of that care is a key component of understanding how it can best be provided. The research component of MERIT is prospective case reporting with follow-up data from an independent national registry to determine survival. The study objectives including monitoring the incidence, content and impact of the clinical care provided by participants during resuscitation. "]
[null,"Reason for seeking a Declaration","A consent declaration is required as it is considered not feasible to obtain participant consent due to the emergency nature of the out-of-hospital cardiac arrest. A consent declaration is therefore required for the collection of clinical information on each out-of-hospital cardiac event and survival data provided to the MERIT study by (i) participating doctors in General Practices and (ii) the out-of-hospital cardiac arrest registry and the subsequent analysis and storage of this data until the point it is anonymised. "]
[null,"Scheduled HRCDC Meeting Date","26th January 2021"]
[null,"HRCDC Decision Date ","26th January 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC requests the Applicant to examine if a deferred consent process can be practicably implemented for participants who are known to the doctors who treated them for the out-of-hospital cardiac arrest event. The Applicant should engage with relevant parties on this topic, including the doctors themselves. As part of this condition, consideration should also be given to undertaking a feasibility or pilot exercise. The Applicant is requested to report to the HRCDC on the potential to implement a deferred consent process within 3 months of the date of this declaration. [CONDITION MET]\n\nCondition 2.  For participants whose consent cannot be obtained, the Applicant is requested to enhance transparency measures so that participants and the public are sufficiently informed about this study, the use of their personal data within the study and their data protection rights, including the right to withdraw. The Applicant must report on the transparency measures implemented as part of the Annual Review. [CONDITION MET]\n\nCondition 3. Public and patient involvement (PPI) is considered an\nimportant activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant cannot provide consent. PPI helps to create a more patient-centred approach by ensuring that the perspective of patients and their families are taken into account. Furthermore, PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle. It is a condition of this declaration that the study undertakes PPI or engagement activities for the reasons outlined above. Progress to meet this condition is a reporting requirement as part of the Annual Review.\n(The Applicant may also wish to consider engagement with PPI groups with regards fulfilling Conditions 1 & 2) [CONDITION UNDERWAY]\n","Condition 4. The Applicant is requested to renew the Research Ethics Committee approval for the study from the Irish College of General Practitioners and revert with confirmation of this approval within 3 months of the date of issuance of the HRCDC decision letter. Importantly, confirmation must be provided that the renewed/updated approval covers the study as outlined in the HRCDC application form. \nNOTE: that the HRCDC reserves the right to amend the consent declaration should the outcome of the REC process result in amendments to the study that are relevant to the HRCDC’s decision. [CONDITION MET]\n\nCondition 5. It is a condition of this declaration that the necessary data sharing/transfer agreements are in place between the relevant parties, including between the Data Controller, UCD, and the providers of the study data. The Applicant is requested to confirm that all necessary agreements are in place when confirming acceptance (or otherwise) of the HRCDC’s decision. [CONDITION UNDERWAY]\n\nCondition 6. It is a condition of this declaration that the National Ambulance Service case number, received for the purpose of the MERIT study, is deleted by the data controller once the required follow-up/outcome data has been collected. [CONDITION MET]"]
[null,"Deadline for meeting any conditions","Condition 1 - May 5th \nCondition 3 - May 5th \nCondition 4- May 5th\n[UPDATED DEADLINE 16th July 2021]"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid for an initial 10yrs (Until 31st August 2028) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner.  The Applicant may request an extension to the consent declaration by way of submitting an amendment request to the HRCDC for consideration. "]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation. The Applicant is asked to review the current methods of data transfer and consider if alternative, more secure methods can be used. For example, are there other, secure alternatives to transferring the defibrillator data by the postal system."]

{"sheet":"19-038-AF1","index":30,"n_rows":19,"n_cols":5,"rows_kept":19,"cut":false,"hidden":false,"merged":[[12,1,14,1]]}
[]
[null,"Application Ref","19-038-AF1"]
[null,"Application Title ","The Genomic Basis of Alzheimer's disease in Ireland"]
[null,"Applicant Organisation (Data Controller)","Genuity Science [Formerly Genomics Medicine Ireland Ltd]"]
[null,"Lead Applicant ","Emer Fallon "]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Alzheimer's Disease (AD) is one of the leading causes of dementia and represents a major cause of death globally. It is a progressive and debilitating disease with limited symptomatic treatment available. Alzheimer's disease has a strong genetic component. This project is a longitudinal, prospective, non-interventional genomic study on this disease. It's focus is on how genes, environment and lifestyle influence disease risk, disease sub-type, progression and drug response. Whole genome sequencing of blood samples will be used to conduct the analysis. The findings from the study may be used to better diagnose Alzheimer's disease, predict progression and tailor treatment based on a person's genetic makeup. It may also lead to the identification of new drug targets for the development of novel therapeutics. The genetic and phenotypic data that is generated from the blood samples, as well as the clinical and lifestyle data collected on the participant, will be made available to authorised third-parties on a GMI controlled database. Access to this data will be under contractual arrangements and third-parties may include academic institutions and for-profit companies."]
[null,"Reason for seeking a Declaration","To carry out research on AD, individuals with AD are needed to participate in the research study. This presents a challenge in advancing research in this area as people with AD will have varying degrees of capacity to provide consent. The current legal position does not provide for persons that cannot provide explicit consent which can result in their exclusion from research and further hinder the pace of progress on AD research. A Declaration is being sought to process personal data for the purpose of the study"]
[null,"HRCDC Meeting Date #1","17th October, 2019"]
[null,"HRCDC Meeting Date #2","16th December, 2019"]
[null,"HRCDC Decision Date ","16th December, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is required to develop a data sharing policy which can be implemented in practice to facilitate the controlled sharing of de-identified genomic data derived from this study, with the wider research community. The Applicant is required to provide an update on the progress of the policy and timelines of implementation in the Annual Review.\n\nCondition 2. The Applicant is required to stay abreast of and engage with stakeholders on evolving national policy and guidance in the area of open data and open science. The Applicant is required to provide updates on these discussions within the Annual Review. \n\n\n\n","Condition 3. The Applicant is required to ensure there is an established and appropriate protocol implemented for determining capacity and correspondingly obtaining assent from a relative or friend, with specific attention to the points outlined below;\n- It is essential that participants who may lack decision-making capacity, at whatever level, are afforded every opportunity to engage with the consent process and are included in all discussions.\n- There must be assurances that the individual identified to provide assent is the most appropriate individual who can communicate on behalf of a participant and understands the participant’s will and preference in this regard. Except where impossible, the individual providing proxy consent should be agreed by the participant in advance. Particular attention should be paid in the case where a non-relative carer is being considered.\n- Where it is determined that a participant does not have the capacity to provide explicit consent, the protocol should first determine if the participant has a legally appointed representative, or enduring power of attorney. It should be clearly documented on the consent forms, where appropriate.\nThe protocol and its implementation must be documented by the Applicant. \n(Condition 'underway)\n\n\n\n"]
[null,null,"Condition 4. In relation to the Patient Information Leaflet (PIL) and consent form, the Applicant is required to ensure the implementation of the following;\ni) Two versions of the PIL and consent form should be produced; one for those who have the capacity to provide consent, and one for individuals providing proxy consent (assent) on behalf of participants who lack decision making capacity; and\nii) Amend the PIL and consent form so that a participant, or the individual assenting on their behalf, is aware of the expected timeline for when the samples and personal data will be processed and subsequently included in the GMI database, after which point it will not be possible to remove the data from the study should consent be withdrawn.\niii) Reconsider the title ‘Informed Consent Form’ to state ‘Assent Form’, for cases where a relative or friend agreeing on behalf of participant. \n(Condition 'underway')","Condition 5. It is a condition of the declaration that the scope of the declaration does not extend to the processing activity of linking the Alzheimer’s Disease datasets with other disease datasets within GMI. Where the Applicant intends to use the Alzheimer’s Disease data as a comparator dataset within other GMI studies a Declaration Amendment request should be submitted to the HRCDC for this form of data processing.\n\n","Condition 6. Please confirm that those involved in the recruitment of patients and determining their capacity to consent is only undertaken by the Clinical Team within the hospitals and is not in any way determined or influenced by GMI Monitors. (CONDITION MET)"]
[null,null,"Condition 7. All appropriate contractual arrangements including those that govern the collection and transfer of samples and data, must be in place and executed with the relevant hospital sites, before data can be collected at that site. (Condition 'underway')"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing December 16th 2019 and shall be valid for 20 years after commencement of the study at the last hospital site or until December 31st, 2040, which ever is the later. "]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments","N/A"]

{"sheet":"19-040-AF3","index":31,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-040-AF3"]
[null,"Application Title ","The Interaction between Noradrenaline dosage, Troponin level and\nMortality in Septic Shock."]
[null,"Applicant Organisation (Data Controller)","Saolta Hospital – Galway University Hospital"]
[null,"Lead Applicant ","John Laffey"]
[null,"Research commenced prior to submission of application","Yes "]
[null,"Research Objective","Septic shock is a condition where severe infection causes the blood pressure to fall to below normal. This low blood pressure can be fatal. The most common medication used in intensive care units to treat this low blood pressure is called noradrenaline. Sometimes high doses of this drug are required to achieve a normal blood pressure. The likelihood of dying from septic shock is increased considerably if very high doses of noradrenaline are required. The reasons for this may be that higher doses of noradrenaline are needed if the patient has a more severe infection but it might also mean that very high doses cause damage to the heart. A blood test called “Troponin” is used to detect damage to the heart muscle in many conditions including heart attacks and this blood test is done frequently in ICU patients. This research aims to determine if patients who require high doses of noradrenaline have more an increased chance of dying if their troponin is also elevated compared to patients who are on equally the same amount of noradrenaline without an elevation of troponin. The research also aims to examine what influences the need for higher doses of noradrenaline in patients with septic shock and if these are related to a worse outcome."]
[null,"Reason for seeking a Declaration","Patients admitted to the ICU at University Hospital Galway since 2005 are recorded in a clinical information system. Over 20,000 patients have been treated in the ICU and have data stored in this system. This study seeks to use the data contained in this clinical information system on all patients admitted to ICU since 2005 for the purpose of this study. The applicant outlines reasons why it is not possible to obtain consent including the number of participants.\nThe processing activities include extracting personal data from the ICU clinical information system and subsequently pseudonymising and using the extracted data for the purpose of this study. The extracted data will be cleansed of identifying information using specialist software. Analysis undertaken by third parties outside the data controller is on irrevocably anonymised data."]
[null,"Scheduled HRCDC Meeting Date","13th October 2020"]
[null,"HRCDC Decision Date ","13th October 2020"]
[null,"HRCDC Decision","Requested more information"]
[null,"Specific Conditions attached ","TBC"]
[null,"Deadline for meeting any conditions","TBC"]
[null,"Duration of Declaration ","TBC"]
[null,"Status of Declaration","Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","TBC"]

{"sheet":"19-041-AF3-COV","index":32,"n_rows":17,"n_cols":5,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,2,12,2],[11,1,12,1],[11,3,12,3],[11,4,12,4]]}
[]
[null,"Application Ref","19-041-AF3/COV "]
[null,"Application Title ","The role of T-Regulatory and Mononuclear Phagocyte Cells causing Immune Dysfunction in Sepsis (A study on the role of immune dysfunction in sepsis and COVID-19)"]
[null,"Applicant Organisation (Data Controller)","Galway University Hospitals"]
[null,"Lead Applicant ","John Laffey"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","This is a study on the role of the immune system in patients with sepsis and with COVID-19 pneumonia. People who get an infection that results in a condition called sepsis are at a high risk of death.It is believed that a defective response by the immune system to uncontrolled infection results in sepsis. The aim of this study is to determine changes in immune cells in response to sepsis and to gain a better understanding of how the immune system affects recovery following sepsis. The role of the immune system in causing kidney injury and loss of muscle mass following sepsis is also poorly understood and is another objective of this study. The study will be carried out by isolating immune cells and serum from patients with sepsis and acute kidney injury, as well as control cases that include healthy controls and other patients admitted to the ICU. Phenotypic, genetic and functional characterization will be undertaken to demonstrate distinct changes in these cells"]
[null,"Reason for seeking a Declaration","A declaration is requested for this study where it is not possible to obtain informed consent from participants due to the nature of their illness, the risk of viral transmission, and/or because they lack decision-making capacity.\nThe data processing activities within the scope of the requested declaration includes the collection, pseudonymisation and analysis of personal data and biosamples associated with personal data. In addition, the study will collect and analyse data on the long-term outcomes of the participants. The retention of personal data for future research is also within the scope of the declaration. The\ndeclaration will not extend to the further processing"]
[null,"HRCDC Meeting Date","6th May 2020 (COVID Meeting)"]
[null,"HRCDC Decision Date ","6th May 2020 (COVID Meeting)"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: Consent/Assent\n•The HRCDC has requested that where the participant lacks decision-making capacity, the next-of-kin/relative assent, must be sought and obtained as soon as possible and at maximum within 72hrs of the participant’s enrolment into the study. \n•Where participant consent or next-of-kin/relative assent cannot be obtained in person due to the risk of transmission posed by COVID-19, then it should be obtained verbally in an appropriate manner, where possible, and within 72hrs of the participant’s enrolment in the study. \n•Until consent/assent has been obtained, no personal data collected should be further processed and analysed. Where consent/assent for the processing of personal data is not provided then the participant’s personal data that has been collected up to this point for the study must be deleted and not included in the study. \n•Where the participant regains capacity, consent to continue processing their personal data must be obtained. A clear process must also be put in place and communicated to the participant with regards to what happens their personal data if they do not wish to continue in the study (please see Condition 2 for more information).\n•The HRCDC has requested that, where a participant continues to lack capacity for a prolonged period of time and where the next-of-kin/relative assent remains in place, the following action should be taken as an additional safeguard: The Applicant should seek confirmation from the next-of-kin/relative who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to those individuals who have provided assent.  \n•The Applicant must ensure that the relevant version of the study information leaflets, and consent/assent forms (i.e. COVID-19 or non-COVID-19 cohort), are used and provided to the participant or their next-of-kin/relative at the time of seeking either consent or assent. Where consent or assent is to be obtained verbally, an appropriate script that aligns with the study information leaflets and assent forms, should be considered for use, to ensure that individuals fully understand the study and use of personal data and that the information provided is consistent for all participants. The study must also ensure that verbal consent or assent is appropriately recorded to ensure consent is valid. (CONDITION MET)\n\n","Condition 2: Information Leaflets and Consent/Assent Forms\nThe HRCDC requests the Applicant to review and amend accordingly, the study information leaflets and consent/assent forms to incorporate the following points for clarity and consistency of information; (The Data Protection Officer and Research Ethics committee should be consulted, as necessary):\n•Provide additional clear information on the purpose and scientific benefit of this study for both COVID-19 and non-COVID-19 patients.\n•Ensure that the information provided to obtain participant consent or next-of-kin/relative assent, accurately outlines and reflects the data processing activities and biosample collection and analysis that will be undertaken, and is specific to the participant reviewing the information; this includes, where relevant, if genetic analysis of bio-samples is being carried out,  and if follow-up personal data is being collected and processed.\n•Provide clear information on what will happen to the personal data and bio-samples collected for the study if the participant, once they regain capacity, does not provide consent to continue in the study or if consent or next-of-kin assent is withdrawn. Information leaflets should indicate the point in the study timeline where it is not possible to delete the data that has been collected (this process should be aligned with individual’s data protection data rights to erasure, as outlined in GDPR) \n•Although the collection and retention of biosamples alone is not data processing and falls outside the Health Research Regulations, the study information leaflets and consent/assent forms should clearly outline what bio-samples are or will be collected and retained as part of this study, including any samples collected at follow-up clinic visits.\n•Ensure that the study information leaflet and consent/assent forms provide clear information and options with regards the storage and future use of personal data and the associated bio-samples collected. \n•Provide further clarity on the disclosure of personal data to third parties.  Specifically, it is not clear what is meant by ‘relevant industry bodies’\n•Ensure that the correct perspective is used within these documents i.e. the next-of-kin assent forms should not refer ‘my data’ or ‘your data’ \nThe Applicant is required to implement the above amendments and provide a copy of the updated information leaflets and consent forms to the HRCDC in advance of using them in the study. (CONDITION MET)\n","Condition 3:\nAppropriate agreements or contractual arrangements must be in place regarding the transfer of personal data and samples to and from collaborating sites. This includes the transfer from the Galway University Hospital site to the National University of Ireland, Galway (NUIG), including samples and associated data collected and transferred from the 6 & 12 month General Practitioner visits.  (CONDITION MET)\n\n(Note: it is noted that NUIG will not receive personally identifiable data and samples. However appropriate material and data transfer agreements should be in place setting out terms and conditions of use, to ensure the anonymity of the participants is safeguarded). \n\nCondition 4:\nThe HRCDC requests that the level of public and patient involvement (PPI) in the development of this study is enhanced to ensure knowledge in context and experience can be gained through direct engagement with the public and patients. Engagement with representative groups such as ICUsteps and the PPI Ignite group at the NUIG should be considered.   (CONDITION MET)\n"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 6th May 2020 and shall be valid until August 2021 and for 15 years thereafter (August 2036), after which the data will be anonymised."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-043-AF3","index":33,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-043-AF3"]
[null,"Application Title ","The Irish Longitudinal Study on Ageing (TILDA) GRO Linkage"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin"]
[null,"Lead Applicant ","Rose Anne Kenny"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The core vision of TILDA is “Towards making Ireland the best place in the world to grow old”. Prior to TILDA, only minimal national information was available on health, economic and social data for the ageing population, therefore impeding proper policy development and future planning that should be based on evidence. TILDA addresses this gap by providing evidence-based data on the ageing population in Ireland to inform policy; track policy changes (e.g. prescription charges) and natural experiments (e.g. effects of recession); healthcare utilisation; health and social systems; end of life experiences; comparisons with other countries; and opportunities to make new discoveries regarding physical, mental and cognitive ageing and the biology of ageing."]
[null,"Reason for seeking a Declaration","The consent declaration is being sought to allow TILDA to link existing data with the death registration records held by the General Register Office (GRO), specifically for a subset of the participants who have withdrawn from the study or who have been lost to follow-up (i.e. letters returned, unable to contact, moved outside of Ireland). Some of the withdrawn and lost to follow-up participants will have passed away in which case the data falls outside of GDPR legislation, however some will still be alive. TILDA will carry out checks on www.rip.ie to identify any deaths in this cohort, however, it may not be possible to find all participants or alternatively, a participant with a similar name and address may be identified in error. The consent declaration is only required for those individuals who have withdrawn from the study or who have been lost to follow-up and are still alive at the time of linkage with the GRO database. "]
[null,"Scheduled HRCDC Meeting Date","25th November 2019"]
[null,"HRCDC Decision Date ","25th November 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: A declaration cannot be made to override the withdrawal of consent. It is a condition of this declaration that the Applicant has robust procedures and processes in place to ensure that data processing activities do not include data from participants that have withdrawn from the study as the scope of this declaration does not cover the use of personal data of participants who have withdrawn from the study. Please see Recommendation 1 below. For the avoidance of doubt, the scope of this declaration is specifically for the processing of personal data of participants who have been lost to follow up. [CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing August 8th, 2018 and shall be valid indefinitely. The declaration shall be subject to the annual review and the HRCDC reserve the right to review the declaration duration at regular intervals to consider any relevant changes that may have arisen during the course of the study."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: It is acknowledged that the TILDA privacy notice outlines clearly what shall happen to the participant’s personal data if consent is withdrawn, and why continued use is necessary. To add further clarity for participants, the Applicant is advised to consider providing clear information, in plain language, as to what specific GDPR derogations they are relying upon in such circumstances. (RECOMMENDATION CONSIDERED)\n\nNOTE: Data controllers who wish to continue to process personal data of participants who have withdrawn from the study are responsible for ensuring they are compliant with data protection legislation, including the derogations outlined within the GDPR, for example Article 17 and informing participants of what shall happen to their data should they withdraw from a study. The Data Protection Officer should be consulted where necessary.\n\nRecommendation 2: The Applicant is advised to consider, for their own clarity, whether participant withdrawal from the study relates to withdrawal from the entire study or a single Wave, or whether they should not be contacted as requested. This matter should be discussed with the Applicant’s Data Protection Officer. (RECOMMENDATION CONSIDERED)"]

{"sheet":"19-044-AF2","index":34,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-044-AF2"]
[null,"Application Title ","Rare Kidney Disease (RKD) Registry and Bioresource (collaborative\nstudy with Firalis SAS – the HELICAL Study)"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin\nFiralis SAS "]
[null,"Lead Applicant ","Mark Little "]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The purpose of this study was to set up a central repository (samples and linked data) to support research aimed at improving the prevention, diagnosis and treatment of the rare autoimmue condition vasculitis. The intention is to understand more about causes and progression with the long-term goal of research into better diagnostic tests/treatments. "]
[null,"Reason for seeking a Declaration","The scope of the declaration is for data processing being carried out in connection with an Industry collaborator, that was not detailed in the original consent forms. Specifcally for the continued sharing of data and associated samples from the RKD registry and Bioresource with an industry collaborator, Firalis SAS, for the purpose of the HELICAL study"]
[null,"Scheduled HRCDC Meeting Date","20th July 2021"]
[null,"HRCDC Decision Date ","20th July 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. Firalis SAS is confirmed as a joint-data controller with TCD for the collaborative HELICAL study accessing data from the RKD Registry/Bioresource. The consent declaration will not become effective until the following actions are completed, and this condition is fully met:\n(i) an authorised signatory on behalf of Firalis SAS must be provided on the HRCDC application form and submitted to the HRCDC. This is in line with the HRCDC processes where joint-data controllers apply for a consent declaration. [MET] \n(ii) feedback from the Firalis SAS data protection officer (DPO), or equivalent, must be provided to the HRCDC on the RKD Registry/Bioresource data protection impact \nassessment (DPIA), to ensure any data protection risks to data being processed by Firalis SAS is assessed, and risks mitigated against where necessary.  [MET] \n(iii) confirmation that Firalis SAS shall support the implementation and compliance of the consent declaration jointly with Trinity College Dublin, where required.\n\nCondition 2. The scope of this consent declaration is limited to the processing of personal data from the RKD Registry/Bioresource specifically for the purpose collaboration with Firalis SAS only. For the avoidance of doubt, the consent declaration does not extend to the processing of data for other industry collaborations. If required, an amendment request or new consent declaration application, as appropriate, can be submitted to the HRCDC for consideration.\n\n","Condition 3. The Applicant is required to confirm to the HRCDC that the contractual agreement/arrangement in place with Firalis SAS, has adequate terms and conditions with regards a joint-data controller arrangement, as required under Article 26 of GDPR. Where existing arrangements require updating, this should be carried out as soon as possible and no later than 3 months of receipt of the decision letter, with notification provided to the HRCDC. [CONDITION MET]\n\nCondition 4. The Applicant is required to continue efforts to re-consent participants. This includes efforts to obtain re-consent via the hospital/clinical visits as well as by alternative means, such as telephone or post, where participants are not attending the clinics. The efforts made to obtain re-consent from participants via clinics and other approaches, as well as the numbers who have re-consented is a reporting requirement of the Annual Review. [CONDITION UNDERWAY]"]
[null,"Deadline for meeting any conditions","Condition 3 - 30th Oct 2021"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until re-consent can be obtained, or if reconsent is not achievable, until the end of the Firalis SAS / Helical study, at which point all samples and data will be irrevocably anonymised by 31st Dec 2022. The Applicant may seek an extension to the consent declaration by way of submitting an amendment request to the HRCDC for consideration."]
[null,"Status of Declaration","Declaration No Longer Required or Expired"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-045-AF2","index":35,"n_rows":16,"n_cols":7,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref","19-045-AF2",null,null,"19-045-AF2/AMD1","19-045-AF2/AMD2"]
[null,"Application Title ","The Gynaecological Cancer Bioresource (DISCOVARY Bioresource) and ongoing studies.",null,null,"The Gynaecological Cancer Bioresource (DISCOVARY Bioresource) and ongoing studies.","The Gynaecological Cancer Bioresource (DISCOVARY Bioresource) and ongoing studies."]
[null,"Applicant Organisation (Data Controller)","A.\tTrinity College Dublin (TCD) & St James’s Hospital (SJH), Dublin are joint controllers of the DISCOVARY Bioresource.  \nB.\tThe following collaborators are joint controllers with TCD/SJH for the respective academic collaborations. These collaborators are (i) the Royal College of Surgeons in Ireland (RCSI), (ii) University College Dublin (UCD), (iii) the National Institute for Bioprocessing Research & Training (NIBRT), in conjunction with University College Cork and (iv) Georgia Institute of Technology. ",null,null,"A.\tTrinity College Dublin (TCD) & St James’s Hospital (SJH), Dublin are joint controllers of the DISCOVARY Bioresource.  \nB.\tThe following collaborators are joint controllers with TCD/SJH for the respective academic collaborations. These collaborators are (i) the Royal College of Surgeons in Ireland (RCSI), (ii) University College Dublin (UCD), (iii) the National Institute for Bioprocessing Research & Training (NIBRT), in conjunction with University College Cork and (iv) Georgia Institute of Technology. ","A.\tTrinity College Dublin (TCD) & St James’s Hospital (SJH), Dublin are joint controllers of the DISCOVARY Bioresource.  \nB.\tThe following collaborators are joint controllers with TCD/SJH for the respective academic collaborations. These collaborators are (i) the Royal College of Surgeons in Ireland (RCSI), (ii) University College Dublin (UCD), (iii) the National Institute for Bioprocessing Research & Training (NIBRT), in conjunction with University College Cork and (iv) Georgia Institute of Technology. "]
[null,"Lead Applicant ","Sharon O'Toole",null,null,"Sharon O'Toole","Sharon O'Toole"]
[null,"Research commenced prior to submission of application","Yes",null,null,"Yes","Yes"]
[null,"Research Objective","The Gynaecological cancer bioresource has been in existence since 2004 and currently contains material from over 2500 patients. Gynaecological cancers are difficult to diagnose and treat. Studying proteins in the bloodstream and in tissue might help to develop tests which may identify women who have cancer at an early stage or to decide on how best to treat a patient. In particular some gynaecological cancers such as ovarian cancer have a very poor prognosis (outcome) so any research that can help improve this is crucial to understanding this disease. Current and future research aims to better understand health and diseases and may examine genetic influences related to detection of disease, testing, treatment, quality of life and overall improvement of patient care. It is hoped that a large, organised biobank with real life patient samples and data will speed up this advancement of science and medicine, improving patient outcomes. Bloods and tissue samples have been collected from consented patients undergoing surgery for gynaecological disease and are stored in the bioresource which is used for research. ",null,null,"The Gynaecological cancer bioresource has been in existence since 2004 and currently contains material from over 2500 patients. Gynaecological cancers are difficult to diagnose and treat. Studying proteins in the bloodstream and in tissue might help to develop tests which may identify women who have cancer at an early stage or to decide on how best to treat a patient. In particular some gynaecological cancers such as ovarian cancer have a very poor prognosis (outcome) so any research that can help improve this is crucial to understanding this disease. Current and future research aims to better understand health and diseases and may examine genetic influences related to detection of disease, testing, treatment, quality of life and overall improvement of patient care. It is hoped that a large, organised biobank with real life patient samples and data will speed up this advancement of science and medicine, improving patient outcomes. Bloods and tissue samples have been collected from consented patients undergoing surgery for gynaecological disease and are stored in the bioresource which is used for research. ","The Gynaecological cancer bioresource has been in existence since 2004 and currently contains material from over 2500 patients. Gynaecological cancers are difficult to diagnose and treat. Studying proteins in the bloodstream and in tissue might help to develop tests which may identify women who have cancer at an early stage or to decide on how best to treat a patient. In particular some gynaecological cancers such as ovarian cancer have a very poor prognosis (outcome) so any research that can help improve this is crucial to understanding this disease. Current and future research aims to better understand health and diseases and may examine genetic influences related to detection of disease, testing, treatment, quality of life and overall improvement of patient care. It is hoped that a large, organised biobank with real life patient samples and data will speed up this advancement of science and medicine, improving patient outcomes. Bloods and tissue samples have been collected from consented patients undergoing surgery for gynaecological disease and are stored in the bioresource which is used for research. "]
[null,"Reason for seeking a Declaration","Whilst consent to participate in the DISCOVARY Bioresource was obtained from participants from 2004 to 2019, the Applicant has determined that elements of the consent obtained were not fully compliant with the previous data protection Directive for the following reasons: \n-\tSJH was not explicitly referenced as a data controller in earlier versions of the patient information leaflets, prior to 2018.  \n-\tThe indefinite duration of the Bioresource was not clearly outlined in earlier versions of the patient information leaflets.\n-\tThere is a lack of information on who the data may be shared with in the PILs/consent forms previously used\nA consent declaration is still required for the reasons outlined above. \n\nThe scope of the declaration requested is for the following:\n(i)\tfor the DISCOVARY Bioresource, the continued storage of the existing personal data, including data associated with the biological samples, and the continued collection of clinical follow-up personal data,\n(ii)\tthe processing of the DISCOVARY Bioresource personal data for the active gynaecological cancer research studies outlined in the application form. Specifically, the TCD studies, the SJH studies and the collaborations with other academics (RCSI/UCD/NIBRT & UCC/Georgia Tech). Where relevant, results from current studies (e.g. a biomarker results) may be stored as part of the DISCOVARY Bioresource.",null,null,"Trinity College Dublin and St James’s Hospital, the joint controllers of the bioresource/biobank, are aiming to undertake a new collaboration with TUDublin, using the personal data and associated samples that are held by the bioresource. This collaboration is titled: ‘Development of methods based on vibrational spectroscopy of minimally invasive biofluids for early detection of ovarian and endometrial cancer’.\nThe amendment is therefore sought to cover the processing of personal data from the bioresource/biobank for this new research collaboration.\nTCD, SJH and TUDublin are confirmed joint controllers on this specific collaboration.","Trinity College Dublin and St James’s Hospital, the joint controllers of the bioresource/biobank, are aiming to undertake a new collaboration with University College Dublin, using the personal data and associated samples from approximately 100 patients that are held by the bioresource. This collaboration is titled: ‘Investigating the role of NKAPL in acquired chemoresistance in high-grade serous ovarian cancer’. \nThe amendment is therefore sought to cover the processing of personal data from the bioresource/biobank for this new gynaecological cancer research collaboration. TCD, SJH and UCD are confirmed joint controllers on this specific collaboration."]
[null,"Scheduled HRCDC Meeting Date","14th December 2021",null,null,"30th January 2024","28th May 2024"]
[null,"HRCDC Decision Date ","14th December 2021",null,null,"30th January 2024","28th May 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"Amendment approved ","Amendment approved "]
[null,"Specific Conditions attached ","Condition 1. No processing (sharing, access to) of data from the DISCOVARY Bioresource can commence for the glycosylation collaboration study with the National Institute for Bioprocessing Research & Training (NIBRT), until the requisite research ethics committee approval has been granted for this study and confirmation of this approval is provided to the HRCDC. [CONDITION MET]\n\nCondition 2. Where Trinity College Dublin (TCD) and St James’s Hospital (SJH) are joint controllers of research studies with the following collaborators: \n- the Royal College of Surgeons in Ireland, \n- University College Dublin, \n- the National Institute for Bioprocessing Research & Training, in conjunction with University College cork, \n- Georgia Institute of Technology, \nthe above joint controllers should be made aware of the consent declaration and conditions attached and all joint controllers must support the implementation of and compliance with the consent declaration, as it pertains to the data processing for its respective studies. The Applicant is requested to confirm this will be the case when responding to accept, or otherwise, the HRCDC’s decision. [CONDITION MET]\n\nCondition 3. The Applicant must obtain an extension to the research ethics committee (REC) approval for the DISCOVARY Bioresource as soon as possible and no later than 30th June 2022. Once obtained, confirmation of extended REC approval must be submitted to the HRCDC. [CONDITION MET]","Condition 4. The withdrawal policy, and corresponding procedures, for the DISCOVARY Bioresource should be finalised and implemented as soon as possible. The policy should provide clear information on what will happen to the personal data and associated biosamples from the DISCOVARY Bioresource if a participant wishes to withdraw, including what will happen any data and associated biosamples that maybe processed as part of an ongoing research study. Updates on meeting this condition is a reporting requirement of the first Annual Review. \nNote: A consent declaration cannot override a participant’s wish to withdraw from the research study. [CONDITION MET]\n\nCondition 5. It is important that the data controllers are satisfied that the physical and IT arrangements in place and methods used, are sufficiently secure to protect the storage and transfer of the personal data and associated biosamples. The Applicant is requested to review the physical security arrangements that are in place regarding:\ni) the encrypted USB drive used as a back-up for the Bioresource database, \nii) the physical transfer of data and associated biosamples to the collaborators noted in the application form, including transfer to the Georgia Institute of Technology. It is recommended to carry out this review in consultation with the relevant Data Protection Officer(s) and IT authorities, if necessary. [CONDITION MET]\n\nCondition 6. The website providing information on the DISCOVARY Bioresource should be updated and enhanced to: \ni) better inform participants and the public about the ongoing work of the Bioresource, the processing of data and the use of biosamples, as well as the research studies that are accessing the Bioresource.\nii) provides transparent information on the governance of the Bioresource. \nTo further enhance transparency measures, consideration should be given to exploring if information on the DISCOVARY Bioresource can be disseminated through linkages with representative advocacy groups or through other relevant websites and platforms where appropriate. [CONDITION MET]\n\n","Condition 7. Aligned with the principle of data minimisation, the coded data and associated samples that will be transferred to NIBRT and the Georgia Institute of Technology should be destroyed, irrevocably anonymised or returned by these collaborators when they no longer required by these collaborators for that specific research purpose [CONDITION UNDERWAY]","Condition 1. The required appropriate data and material agreements, including joint controller arrangements, must be put in place between the parties for this specific collaborative study. For the avoidance of doubt, personal data and associated biosamples cannot be transferred prior to the necessary agreements being implemented. [CONDITON MET]\n\nCondition 2. The study website should be updated to inform and provide information on this new collaboration between St James’s Hospital, Trinity College Dublin and the Technological University of Dublin. This aligns with Condition 6 of the original consent declaration.[CONDITION MET]","Condition 1. The required appropriate data and material agreements, including joint controller arrangements, must be put in place between the parties for this specific collaborative study; personal data and associated biosamples cannot be transferred prior to the necessary agreements being implemented. [CONDITION MET]\n\nCondition 2. The study website should be updated to inform and provide information on this new collaboration between St James’s Hospital, Trinity College Dublin and University College Dublin. This aligns with Condition 6 of the original consent declaration (Please also see Recommendation 1) [CONDITION MET]"]
[null,"Deadline for meeting any conditions","Condition 3 - 30th June 2022",null,null,"N/A","N/A"]
[null,"Duration of Declaration ","The consent declaration is made commencing 8th August 2018 and shall be valid until 14th December 2031 or upon confirmation that that personal data has been rendered irrevocably anonymised or destroyed, whichever occurs sooner. The Applicant, on behalf of the data controller may seek an extension to the consent declaration by way of submitting an amendment request to the HRCDC for consideration.   (as per Amendment - shall be valid until 30th September 2029)",null,null,"The approval to the Amendment is made commencing 30th January 2024 and shall be valid until 14th December 2031, in line with the duration of the consent declaration made. (as per Amendment - shall be valid until 30th September 2029)","The approval to the Amendment is made commencing 28th May 2024 and shall be valid until 30th September 2029."]
[null,"Status of Declaration","Declaration Live",null,null,"Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. Where it is known that a participant in the DISCOVARY Bioresource is returning to St James’s Hospital for clinical follow-up care, the Applicant is recommended to try reconsent the participant where it is considered appropriate and feasible to do so and that does not cause undue harm or distress to the participant. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. It is recommended the data protection impact assessment is reviewed and updated where necessary, to reflect the data processing activities undertaken with the joint controller collaborators and ensure any identified data protection risks are identified and mitigated against. [RECOMMENDATION CONSIDERED]",null,null,"n/a","Recommendation 1. In addition to providing information on this collaboration on the TCD website, the researchers could consider exploring and implementing further transparency measures to \ninform participants and the public about this study, for example by proving a link to the TCD study \nwebpage on other suitable websites such as other ovarian cancer groups or similar groups. [RECOMMENDATION UNDER CONSIDERATION]"]

{"sheet":"19-052-AF1","index":36,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-052-AF1"]
[null,"Application Title ","GENESIS: the genomic landscape of neonatal Escherichia coli sepsis"]
[null,"Applicant Organisation (Data Controller)","National Maternity Hospital\nTrinity College Dublin "]
[null,"Lead Applicant ","Susan Knowles \nStephen Smith"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","This study aims to determine if there is a statistically significant relationship between E. coli isolates and the risk factors associated with the development of neonatal sepsis. Escherichia coli is associated with maternal and neonatal sepsis. Recent evidence has suggested that E. coli has become the most important pathogen associated with early-onset sepsis in preterm very low birthweight (VLBW) neonates, with a marked increase in the incidence of early-onset and late-onset sepsis arising from antibiotic-resistant E. coli. Little is known about the contemporary genetic determinants and antimicrobial susceptibility patterns of E. coli associated neonatal sepsis in Ireland (Corcoran et al. 2016). \nTherefore, through the use of next generation sequencing, the study aims to analyse the virulence factor genes, serotypes and antibiotic resistance genes of E. coli isolates from neonatal and maternal cases of early onset/late onset sepsis. This research study intends to analyse the data generated from next generation sequencing to determine the genetic relationship between E. coli isolates. Additionally, this project intends to investigate the relationship between the pathogen (E. coli) and the clinical outcomes."]
[null,"Reason for seeking a Declaration","The data to be used for this study would have already been collected during the care of the patients (Mother and Neonates) in the NMH. No extra information is being solicited from the patients. The data will be pseudonymised by clinical collaborators, the identity of the patient and hospital identifier number will be unknown to TCD/Dr. Smith or other collaborators. Consent was not obtained from the patients.\nThe study is drawing down from clinical data and E.Coli isolate samples derived from blood, urine, vaginal and placental swabs and cerebrospinal fluid."]
[null,"HRCDC Meeting Date","16th December 2019"]
[null,"HRCDC Decision Date ","16th December 2019"]
[null,"HRCDC Decision","Requested more information"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","N/A "]

{"sheet":"19-060-AF3","index":37,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-060-AF3"]
[null,"Application Title ","National Kidney Disease Surveillance System"]
[null,"Applicant Organisation (Data Controller)","University of Limerick"]
[null,"Lead Applicant ","Austin Stack"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Chronic Kidney Disease (CKD) affects at least 1 in 10 persons in Ireland and may if untreated progress to kidney failure and premature cardiovascular disease and death. Early identification of kidney disease and treatment of underlying risk factors can slow the progression and prevent or delay the need for dialysis treatment.\nFor those who develop kidney failure, the outcomes are even poorer with an average life expectancy of 5 years or less despite advancements in dialysis and introduction of evidence-based guidelines. While the epidemiology of kidney disease is well characterized in many countries, there is a major lack of information on kidney disease in Ireland. Whilst some progress has been made to expand the understanding of kidney disease in Ireland, available data are limited in scope and representation. The major goal of the NKDSS and QA Programme, is to provide meaningful high-quality information on the frequency of kidney disease (acute and chronic) and its complications in the Irish health system. The information consists of demographic (name, medical record number etc.) and clinical information from different data sources such as Laboratory Information Systems, dialysis registers, the Hospital In-patient Enquiry Scheme (HIPE) and the CSO. Using personal identifiers, UL is then able to link the data from each source to a single, unique individual to provide as complete a profile as possible of the participant’s health status. The programme will also:\n- assess the quality of care provided to patients with kidney disease\n- assess the effectiveness of different treatments for kidney disease\n- help identify areas or regions where the burden of disease is high\n- help identify areas of good clinical practice and areas where\nclinical care is suboptimal in the health system\nBy capturing information over several years, the study aims to get a better picture of how common the disease is and examine whether strategies for prevention are working."]
[null,"Reason for seeking a Declaration","A consent declaration is requested for the collection, transfer, pseudonymisation, storage and subsequent linking/merging of the personal data from all data sources. The data is irrevocably anonymised before any analysis is undertaken."]
[null,"Scheduled HRCDC Meeting Date","13th October 2020"]
[null,"HRCDC Decision Date ","13th October 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The Applicant is requested to implement enhanced transparency measures so that participants, in particular prospective participants, are made aware of the study and the use of their personal data. Transparency measures should clearly outline to a participant how they can exercise their data protection\nrights, including the right to withdraw from the study and have their data deleted. As part of these measures, consideration should be given to improving the level of information provided on the study’s website, such as posting details on a more prominent and easy-toaccess section of the website. The Applicant is requested to report on the efforts made to enhance the level of transparency as part of the Annual Review [CONDITION MET]\n\nCondition 2: The Applicant is requested to further enhance PPI by more explicit engagement with representative patient groups in areas such as the dissemination of research findings and to help enhance the level of transparency within this study. The Applicant is requested to report on the efforts made to enhance the level of\nPPI as part of the Annual Review.[CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until 13th October 2028; a period of 10 years after the decision of the HRCDC to make a conditional declaration. The Applicant may apply for an extension to this duration before the current declaration period expires."]
[null,"Status of Declaration","Expired Declaration"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-062-AF1","index":38,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-062-AF1"]
[null,"Application Title ","The relationship between Sub Epidermal Moisture (SEM) measurement and Inflammatory markers in the early identification of Pressure Ulcers"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland\nBeaumont Hospital, Dublin"]
[null,"Lead Applicant ","Zena Moore\nNatalie McEvoy"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Pressure ulcers, or bed sores are areas of skin damage that happen when too much\npressure is put on a part of the body, for a long time. Due to critical illness and\ntreatment interventions, patients in the Intensive Care Unit are at high risk of\ndeveloping pressure ulcers. The study aims to determine if the use of a Sub Epidermal\nMoisture (SEM) scanner can detect early signs of pressure ulcer development and to\nanalyse of proteins and biomarkers as indicators of ulcers and dermatitis."]
[null,"Reason for seeking a Declaration","A consent declaration is being sought as is not practicable to seek consent directly from the data subjects as this study intends to take place on intensive care patients who are oftentimes unresponsive due to the effects of critical illness and various treatment interventions. The relative’s assent will be the method of obtaining consent for this study. When participants regain capacity, they will be provided with a patient information leaflet and will be asked to consent to continue in the study. "]
[null,"Scheduled HRCDC Meeting Date","10th September, 2019"]
[null,"HRCDC Decision Date ","10th September, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC has requested that the Applicants provide details on the expected proportion of patients in the ICU who do not have capacity to consent Vs the proportion of patients in the ICU who do have capacity to consent, for this. This condition is a reporting obligation that must be fulfilled and reflected in the Annual Report. [CONDITION MET]\n\nCondition 2. The HRCDC have requested that the Applicants to;\n(i) revise the Patient Information Leaflet (PIL) and consent forms to ensure that the benefits of the study to the patient are explicitly clear to the patient and their next-of-kin; \n(ii) confirm that data privacy rights Nos. 9, 10, 11 and 12 under the ‘Data Protection’ section of the PIL (page 7) are not contravening data protection rights under GDPR. These data protection rights also appear as general statements and not necessarily tailored to the specific study in question. Specifically, it is unclear why a participant may not be able to exercise their data protection rights if it would ‘make it very difficult to conduct the research’.  [CONDITION MET]\n\nCondition 3. The HRCDC noted that page 6 of the PIL (‘Records’) stated ‘medical records and data collected for the purpose of this study will be made available for inspection by monitors and auditors acting on behalf of the sponsor (Bruin Biometrics, BI Europe Ltd)’. The HRCDC has requested the Applicant; \n(i)  clarify that medical records would only be accessed by an independent auditor/monitordesignated by Bruin Biometrics, BI Europe Ltd - and not the company itself; and \n(ii) outline what appropriate safeguards are in place when independent auditors/monitors review patient medical records; and \n(iii) revise the PIL to reflect points (i) and (ii) above, to ensure participants are fully informed of this process.  [CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 21st May 2019 and shall be valid until 31st May 2022 and 5 years thereafter (31st May, 2027) or upon confirmation that the data has been rendered anonymised, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The HRCDC has requested that direct public and patient engagement should be carried out by the Applicant to ensure these participants and relatives are engaged with and understand the study. The Applicant should consider engaging with relevant patient advocacy groups if possible. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. Data minimisation is a key principle and safeguard of data processing.  The HRCDC has requested that the Applicant consider whether it is necessary to collect the patient name from the medical record or whether a medical record number could be collected instead. [RECOMMENDATION CONSIDERED]"]

{"sheet":"19-064-AF1","index":39,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-064-AF1"]
[null,"Application Title ","Discussion Forum use for Public Health Surveillance Study"]
[null,"Applicant Organisation (Data Controller)","National University of Ireland Galway"]
[null,"Lead Applicant ","Paul Buitelaar"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Internet-based sources currently provide more than 60% of the epidemic reports. These informal health reports do not follow the same guidelines as formal reports making them more difficult to analyse using standard techniques. This research aims to develop a method (‘supervised’ and ‘unsupervised’) that can analyse and subsequently classify a report as having mentioned an infectious or chronic disease. The online discussion forum Reddit is used as the source of these informal reports"]
[null,"Reason for seeking a Declaration","The personal data is to be obtained from relevant, selected ‘sub-forums’ on the Reddit website and then processed for this study without the explicit consent of the website users (participants). The personal data includes metadata relating to the website forum as well as the entire text of the post. The username of the individual who created the post is not collected. The body of the text may contain references of other users or individuals and the content relates to health and demographic data including biometric and behavioural data. \n\nThe Applicant states that it is not possible to obtain explicit consent from the data subjects and have been unable to confirm from Reddit if the consent they have obtained cover such research activities. A Declaration is being sought to process any personal data that may inadvertently be obtained through the Reddit forum, for the purpose of the research study. "]
[null,"Scheduled HRCDC Meeting Date","25th November 2019"]
[null,"HRCDC Decision Date ","25th November 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC recognised the efforts already made and those proposed by the Applicant in relation to transparency and informing participants about the study. The Applicant is requested to establish the study website that was outlined in their application submission, including incorporating a participant opt-out feature, within three months of receipt of declaration decision. In addition, the Applicant is requested to explore other transparency measures such as public engagements. (CONDITION MET; https://dsi.nuigalway.ie/data-ethics/)\n\nCondition 2: The Applicant shall include in the annual review to the HRCDC, any issues or matters that may arise in terms of data that may be inadvertently obtained from children or other vulnerable groups. If such a scenario were to arise the study team shall outline how they dealt with such issues."]
[null,"Deadline for meeting any conditions","Condition 1: 9th March 2020 "]
[null,"Duration of Declaration ","The Declaration is made commencing November 25th 2019 and shall be valid until, 31st December 2019 and 5 years thereafter (until December 31st, 2024), or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner"]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"19-070-AF2","index":40,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-070-AF2",null,"19-070-AF2/AMD1"]
[null,"Application Title ","SCOPE Pre-eclampsia",null,"SCOPE Pre-eclampsia"]
[null,"Applicant Organisation (Data Controller)","University College Cork",null,"University College Cork"]
[null,"Lead Applicant ","Fergus McCarthy",null,"Fergus McCarthy"]
[null,"Research commenced prior to submission of application","Yes",null,"Yes"]
[null,"Research Objective","Over 48 million babies are born to first time mothers worldwide each year. Almost one in five pregnancies are complicated either by pre-eclampsia, spontaneous preterm birth (PTB) and/or a small for gestational age (SGA) baby. In approximately half the affected pregnancies, the disease necessitates hospital admission for the\nmother and/or the baby, or results in maternal or perinatal mortality. All three conditions have life-long consequences for the child.\nThere are a number of known clinical risk factors and biomarkers for these diseases. Although none are useful predictors in isolation, combinations of markers are likely to prove to be effective predictors of adverse pregnancy outcomes. The prerequisite to effective prevention is accurate predication of high-risk women who would benefit from preventative therapy. Currently there is no screening method to accurately predict which first-time mothers will develop pre-eclampsia, SGA or spontaneous PTB. Development of a reliable and valid screening test would enable first time mothers to be stratified according to obstetric risk. The primary objective of SCOPE is to produce clinically useful screening tests to detect first time mothers at risk of pre-eclampsia, spontaneous PTB and/or growth restricted babies, allowing intervention to prevent these conditions.",null,"Over 48 million babies are born to first time mothers worldwide each year. Almost one in five pregnancies are complicated either by pre14 eclampsia, spontaneous preterm birth (PTB) and/or a small for gestational age (SGA) baby. In approximately half the affected pregnancies, the disease necessitates hospital admission for the\nmother and/or the baby, or results in maternal or perinatal mortality. All three conditions have life-long consequences for the child.\nThere are a number of known clinical risk factors and biomarkers for these diseases. Although none are useful predictors in isolation, combinations of markers are likely to prove to be effective predictors of adverse pregnancy outcomes. The prerequisite to effective prevention is accurate predication of high-risk women who would benefit from preventative therapy. Currently there is no screening method to accurately predict which first-time mothers will develop pre-eclampsia, SGA or spontaneous PTB. Development of a reliable and valid screening test would enable first time mothers to be stratified according to obstetric risk. The primary objective of SCOPE is to produce clinically useful screening tests to detect first time mothers at risk of pre-eclampsia, spontaneous PTB and/or growth restricted babies, allowing intervention to prevent these conditions."]
[null,"Reason for seeking a Declaration","The Applicant outlines that it is not possible to re-consent participants due to the age and nature of the study, with participants recruited more than 10 years ago. The consent declaration is requested for:\n(i) the purpose of the SCOPE study only: the continued processing (pseudonymisation, retention and analysis) of personal data already collected from all participants (mothers, fathers, babies) in the SCOPE study, including the sharing of data with SCOPE consortium members,\n(ii) the continued storage only of the SCOPE personal data, for unspecified future research studies\n(iii) the processing of the SCOPE study data for the purposes of the IDEA study.",null,"The scope of the amendment is for the processing of personal data from the BASELINE and SCOPE studies for the purpose of the IDEA study."]
[null,"Scheduled HRCDC Meeting Date","22nd June 2021",null,"20th July 2021"]
[null,"HRCDC Decision Date ","22nd June 2021",null,"20th July 2021"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of the declaration that the scope of the consent declaration does not cover the sharing and use of the SCOPE data for the IDEA study. The Applicant may submit an amendment request or a new consent declaration application to the HRCDC in relation to the IDEA study.\n\nCondition 2. The HRCDC requests the Applicant to make efforts to reconsent the SCOPE study participants where practicably possible and appropriate, particularly where opportunities to do so arise, such as when participants attend follow up clinics. This is a reporting requirement as part of the Annual Review which should include numbers of participants reconsented and those that may withdraw from the study. [CONDITION UNDERWAY]\nNote: The declaration will continue to cover the processing of data where reconsent cannot be obtained. Where participants withdraw their participation and data from the SCOPE study further to making attempts to reconsent, the declaration will not cover the processing of data where consent has been withdrawn. A consent declaration cannot override a participants wish to have their data withdrawn from a study. Clear protocols must also be in place should a participant wish to\nwithdraw their data from the SCOPE study.\n\nCondition 3. The Applicant must ensure that a re-consent protocol is designed and implemented so that the neonate cohort recruited to SCOPE are given the opportunity to provide their explicit consent for data processing when they turn 18 years of age. Attempts to obtain their consent must be made within one year of the participant turning 18. The Applicant must report on this activity as part of each Annual Review, including where attempts to seek consent are unsuccessful. [CONDITION UNDERWAY]","Condition 4. The Applicant is requested to enhance the transparency measures that are undertaken for the SCOPE study. Transparency measures should inform participants about a number of areas including the ongoing use of their data as part of the SCOPE study, the dissemination of research findings, their data protection rights and withdrawal from the study. Consideration should be given to enhancing transparency via updates to the SCOPE and INFANT centre websites as well as through PPI engagement. [CONDITION MET]\n\nCondition 5. The Applicant is requested to undertake public and patient involvement (PPI) activities as part of the SCOPE study, in areas such as informing future SCOPE research, the  dissemination of findings, transparency measures and future consent protocols. The Applicant should consider utilising the working PPI group at the UCC INFANT centre. [CONDITION UNDERWAY] ","Condition 1. The Applicant is required to update the data protection impact assessment (DPIA) for the BASELINE and SCOPE studies to reflect the additional data processing activities, data protection risks and mitigating actions associated with the IDEA study. [CONDITION MET]\n\nCondition 2. All standard and specific conditions attached to the consent declarations made to the BASELINE and SCOPE studies also apply to the IDEA Study. As part of this the Applicant is requested to ensure that the public and patient involvement activities to be undertaken for the BASELINE and SCOPE studies, a condition attached to the consent declarations made, should also extend to the IDEA study, where appropriate. Note: Condition 1 of the consent declaration for the SCOPE study\n(i.e., that the declaration does not cover the IDEA study) is no longer\napplicable. [CONDITION MET]\n\n"]
[null,"Deadline for meeting any conditions","N/A",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 22nd June 2021 and shall be valid for 15 years, until 31st June 2036, or upon confirmation that the data has been irrevocably rendered anonymised or destroyed, or whichever occurs sooner. ",null,"The approval to the Amendment is made commencing 20th July 2021 and shall be valid until 31st June 2036, or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","No longer required",null,"No longer required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation. In line with the data protection principle of data minimisation, the Applicant is requested to consider whether the personal data from the SCOPE study can be irrevocably anonymised sooner than 2036. [RECOMMENDATION CONSIDERED]",null,"N/A"]

{"sheet":"19-072-AF2","index":41,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-072-AF2"]
[null,"Application Title ","Monitor Study"]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Eugene Dempsey"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Some babies require resuscitation when they don’t cry or move after delivery. This may occur when a baby has had a difficult or stressful time during labour or delivery, associated with an interruption of the blood and oxygen supply to the baby’s brain. If severe, this can lead to altered brain function in the first few days after birth, with seizures and decreased conscious level. This is known as hypoxic-ischaemic encephalopathy (HIE). Therapeutic hypothermia (‘Cooling’) is now standard of care for all babies with moderate to severe HIE. At present there is no single test to tell whether a baby has had a significant injury or not. By conducting a series of investigations, this study is trying to establish the degree of the injury, if present, and the long-term impact on development so that interventions can be developed, and outcomes improved. The main objectives are to document the early neurophysiological changes which occur in the first 6-12 hours following birth in infants with HIE and to establish whether the evolution of physiological changes in combination with blood biomarkers can predict outcome as defined by the development of seizures, MRI abnormalities and neurological assessment at discharge and outcome at 18-24 months"]
[null,"Reason for seeking a Declaration","The applicant is seeking a declaration as the original study information leaflet and consent form are not considered compliant under the HRRs for the following reasons:\n- They do not outline UCC as sponsor and the data controller\n- They do not outline the duration of the storage of the data\nThe study team plan to re-consent active participants to an updated, compliant consent form, however it is anticipated that not all participants can be re-consented.\nA consent declaration is requested for the continued processing of data (collection, pseudonymisation, analysis and storage) for the purpose of this research study and within the scope of the consent that was previously obtained. The scope of the declaration covers the processing of data of (i) participants whom the study is unable to re-consent and (ii) participants who have withdrawn from the study but have provided consent for the continued processing of their data after withdrawal"]
[null,"Scheduled HRCDC Meeting Date","12th November 2020"]
[null,"HRCDC Decision Date ","12th November 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: Strong efforts to obtain re-consent as outlined in the HRCDC application should be continued to be made by the Applicant. As part of the Annual Review the Applicant is expected to report on the number of participants who have re-consented and the number of participants who have not re-consented. [CONDITION UNDERWAY]\n\nCondition 2: The scope of the declaration is for the processing of data of (i) participants whom the study is unable to re-consent and (ii) participants who have withdrawn from the study but have provided consent for the continued processing of their data after withdrawal.\nFor the avoidance of doubt the scope of the declaration does not extend to participants who have or may withdraw from the study in the future but do not provide consent for the continued processing of their data.\nNote: A consent declaration cannot be made to override the withdrawal of consent. Data controllers who wish to continue to process personal data of participants who have withdrawn from the study, are responsible for ensuring they are compliant with data protection legislation, including the derogations outlined within the GDPR, for example Article 17 and informing participants of what shall happen to their data should they withdraw from a study. The Data Protection Officer should be consulted where necessary. [CONDITION MET]"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until 31st December 2021 and for 25 years thereafter, until 31st December 2046 or upon confirmation that explicit consent has been obtained or the data has been rendered anonymised or destroyed, or whichever occurs sooner. "]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation: The HRCDC recommend the use of ‘Yes/No’ tick boxes, instead of ‘tick-only’ boxes in the updated GPDR compliant consent form used to obtain re-consent. The use of ‘Yes/No’ boxes are considered by the HRCDC as a more effective way of ensuring ensure clarity for both the participant and the research team. [RECOMMENDATION CONSIDERED] "]

{"sheet":"19-073-AF3","index":42,"n_rows":18,"n_cols":4,"rows_kept":18,"cut":false,"hidden":false,"merged":[[12,1,13,1],[12,2,13,2],[12,3,13,3]]}
[]
[null,"Application Ref","19-073-AF3"]
[null,"Application Title ","Cork Epliepsey Incidence Study"]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Daniel Costello"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Epilepsy is a notable cause of disability and mortality and poses a substantial economic burden for health care systems, individuals and their families. Epidemiological studies are necessary to understand the full public health burden of epilepsy, to set public health and health care\npriorities within a population and to elucidate methods for early detection and treatment. Assessment of patients presenting with first seizures is critical to differentiating epileptic seizures from other conditions that resemble epileptic seizures, also known as ‘seizure mimics’. This study was carried out in the defined area of Cork city and county from 1st January 2017 to 31st March 2018. The study utilised multiple data sources to capture all cases of possible first seizures, new diagnosis of epilepsy and seizure mimics whose first interaction with a medical service (community and hospital setting) for the seizure event occurred during 2017. Both prospective and retrospective methods where used to ascertain the number of cases and data processed in the study was acquired during the standard delivery of healthcare."]
[null,"Reason for seeking a Declaration","A consent declaration is requested to:\n(i) continue to store and process the personal data of participants included in the 2017 incidence study, and\n(ii) to conduct a 3-year follow-up study that will involve further data collection and analysis of all participants who were included in the 2017 epilepsy incidence study (Note: the 3-year follow-up study will not include any new subjects).\nAt the time of consideration by the HRCDC, the Applicant has not yet\nrequested REC approval for the 3-year follow-up study. Therefore, the\nscope of the declaration is restricted to point (i) above"]
[null,"HRCDC Meeting Date #1","2nd April 2020"]
[null,"HRCDC Meeting Date #2","30th April 2020"]
[null,"HRCDC Decision Date","30th April 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC requests that the Applicant develop and implement a suitable protocol to obtain participant consent or next-of-kin assent for the retention of the personal data that was collected as part of the 2017 study. This protocol should include the use of appropriate and clear study information leaflets and consent/assent forms that also outlines what will happen the personal data if the participant does not want to provide consent or assent. Where the data from the 2017 study related to participants under the age of consent for data processing, the Applicant should seek consent if the individual is now aged 18 years or older. The Applicant is requested to consult with their research ethics committee, data protection officer and PPI groups such as Epilepsy Ireland on the protocol, study information leaflets and consent/assent forms. These forms must be provided to the HRCDC before implementing the protocol. [CONDITION MET]\n\n\nCondition 2: The contact letter to be sent to participants should provide clear information and options to the participant regarding what they wish to happen to their personal data, should they opt not to be contacted. [CONDITION MET]","Condition 3: Linked to the Condition 2, the Applicant is requested to provide a data management plan regarding the retention or destruction of personal data if no response is provided to the request for consent or next-of-kin assent.\n[CONDITION MET]\n\nCondition 4: Where the Applicant wishes to retain the personal data of participants who did not respond to the request for consent/assent beyond the 6-months declaration duration, a request for an extension to this declaration can be submitted to the HRCDC. As part of the submission process, the Applicant is requested to provide information on the efforts that have been made to seek consent or next-of-kin assent including the numbers of participants where consent or next-of-kin assent was not provided or where no response was received. [CONDITION MET]\n"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 30th April 2020 and shall be valid for 6 months, until 31st October 2020. The Applicant can request an extension to the duration of the declaration. A request for an extension will consider the efforts and progress made by the Applicant to obtain participant consent or next-of-kin assent"]
[null,"Status of Declaration","Expired Declaration"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: To more accurately identify if a participant\nis deceased, the Applicant is recommended to search RIP.ie before referring to the medical records, as medical records may not be updated. (RECOMMENDATION CONSIDERED) "]

{"sheet":"19-075-AF2","index":43,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-075-AF2"]
[null,"Application Title ","University of Galway-Saolta Cancer Biobank"]
[null,"Applicant Organisation (Data Controller)","University of Galway\nGalway University Hospital - Saolta University Health Care Group"]
[null,"Lead Applicant ","Michael Kerin"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","The Cancer Biobank was established in the 1990s as a resource for breast cancer research – it began as a breast cancer genetics research project (a case control association study). It has since expanded to address other common cancers - colorectal, prostate, lung and thyroid. The Cancer Biobank is a store of biospecimens (including tissue, blood, paraffin embedded blocks, saliva) and specimen associated data from consenting participants. Specimens and data are stored until they are retrieved for ethically approved research studies. Participant data is pseudonymised, i.e., participants are not identifiable to researchers. \nEach year in Ireland over 24,000 people are diagnosed with invasive cancer and over 9,000 people die from cancer. The incidence of cancer is estimated to double by 2040. Researchers need to access and study patient data and clinical specimens, to understand how cancer develops and progresses. The Cancer Biobank aims to provide access to high quality specimens and associated data to identify new biomarkers for cancer diagnosis and treatment."]
[null,"Reason for seeking a Declaration","While consent was obtained from the participants, the Applicant has determined that a consent declaration is required for the cohort of participants who were consented/recruited using early versions of the consent documents as they are deemed not to fall under the Health Research Regulation amendment on consent under the previous Data Protection Directive.\nA consent declaration is requested to cover the personal data of participants who were recruited to the biobank between 1998-2008 while versions 1-2 of the study documentation were in use; specifically, this includes the breast cancer patient cohort, the smaller colorectal cancer patient cohort and the accompanying control cohort.\nThe scope of the declaration, if made, would be limited to the storage only of the personal data in the biobank of these participant cohorts; it does not cover any other data processing activities. "]
[null,"Scheduled HRCDC Meeting Date","28th February 2023"]
[null,"HRCDC Decision Date ","28th February 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. As outlined in the responses to the HRCDC, the Applicant should review the cohort of \nbreast cancer patients recruited to the biobank using versions 1-2 of the study documentation, to \nidentify any participants who may still be attending Saolta and accordingly to make efforts to obtain \ntheir reconsent should they attend the hospital, where this is practicable. The Applicant is required \nto report on the progress made to meet this condition in the Annual Review, including the progress \non the review of this patient cohort and the number of patients who have been re-consented.\n\nCondition 2. The Applicant is requested to make direct attempts to obtain the re-consent of the \nsmall cohort of colorectal cancer participants who were recruited to the biobank between 1998-\n2008, when versions 1-2 of the consent documentation were in use. The Applicant is requested to \nmake direct attempts to reconsent each of the living colorectal cancer patients in this cohort (n=39), \nregardless of whether these patients are or will be attending Saolta hospital. The Applicant is \nrequired to report on the progress made to meet this condition as part of the Annual Review, \nincluding the number of this colorectal cancer patient cohort who are reconsented.\n\nCondition 3. It is a condition of this declaration that the biobank’s transparency measures are \nenhanced to better inform participants already included in the biobank, and the wider public, about \nthe biobank, the processing of the personal data and associated bio-samples by the biobank and \nhow participants can exercise their data protection rights, and any derogations or limits to their \nrights. Transparency should be enhanced by way of the biobank’s own website/webpage, social \nmedia and, where possible and appropriate, by other external platforms including relevant third\u0002party websites and cancer advocacy groups. Further, the biobank information videos referenced by the Applicant should be disseminated to relevant cancer patient advocacy groups and other third \nparties. ","Condition 4. Further to Condition 3, the information provided to participants on exercising their data protection rights, including withdrawing from the biobank and what will happen their personal data and associated samples in such a scenario must be clear and consistent. Further the biobank must also have in place a clear process for participant withdrawal and the deletion/destruction of personal data and the associated bio-samples if this is requested by the participant; this includes having in place a direct point of contact to whom participants can request to exercise their rights. \n\nCondition 5. Appropriate joint data controller agreement/arrangements must be in place between the joint data controllers of the biobank. The Applicant is requested to ensure that such agreements are in place as soon as practicable and within 2-months of receipt of this consent declaration. [CONDITION MET]\n\nCondition 6. The signature on the HRCDC application form and DPO feedback on the DPIA on \nbehalf of the University of Galway has been provided; however, the signature and DPO feedback of the other joint data controller remains outstanding and must be submitted as soon as practicable and within 2-months of receipt of this consent declaration. Further the DPIA must be reviewed and updated where necessary, including updated to note the University of Galway as a joint data controller and not a data processor.[CONDITION MET]"]
[null,"Deadline for meeting any conditions","Condition 5 [MET] and 6 [MET]: 10th May 2023"]
[null,"Duration of Declaration ","The Declaration is made commencing 28th February 2023 and shall be valid until 28th February \n2033 or until the personal data has been destroyed or irrevocably anonymised, whichever occurs \nsooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The Applicant is recommended to undertake PPI engagement with regards this biobank specifically, including engagement with relevant biobank and or cancer patient groups.\n\nRecommendation 2. The Applicant is requested to ensure that the information leaflets in use by \nthe biobank clearly outlined the type and extent of data that will be held by the biobank and used \nfor research. Therefore, references to storing and processing ‘limited data’ and other similar terms \nshould be amended.\n\nRecommendation 3. Reference is made to the biobank using and holding both hard and digital copies of the study documentation. The Applicant is requested to consider whether both hard and digital copies are required, or whether only one version is necessary."]

{"sheet":"19-077-AF3","index":44,"n_rows":16,"n_cols":6,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1",null,"AMENDMENT #2"]
[null,"Application Ref","19-077-AF3","19-077-AF3/AMD1",null,"19-077-AF3/AMD2"]
[null,"Application Title ","IPCOR Study","IPCOR Study",null,"IPCOR Study"]
[null,"Applicant Organisation (Data Controller)","New Data Controller: University College Dublin (UCD) (HRCDC Meeting 2nd March 2021)","New Data Controller: University College Dublin (UCD) (HRCDC Meeting 2nd March 2021)",null,"New Data Controller: University College Dublin (UCD) (HRCDC Meeting 2nd March 2021)"]
[null,"Lead Applicant ","David Galvin","David Galvin",null,"David Galvin"]
[null,"Research commenced prior to submission of application","Yes","Yes",null,"Yes"]
[null,"Research Objective","Irish Prostate Cancer Outcomes Research (IPCOR) has established a national prostate cancer disease registry, which captures high-quality clinical and quality of life information from newly diagnosed prostate cancer patients from 15 hospitals across Ireland. IPCOR generates high quality data on a range of important clinical outcomes in men with prostate cancer, assesses quality of care and provides recommendations to clinicians, hospitals, decision-makers and the National Cancer Control Programme, to promote equal access to healthcare services and improvements in care nationally.  By bringing together data on prostate cancer patients, collected over time, the IPCOR study will ultimately lead to the improvement of patient experiences and maximise quality of life for men diagnosed with prostate cancer in Ireland.","Irish Prostate Cancer Outcomes Research (IPCOR) has established a national prostate cancer disease registry, which captures high-quality clinical and quality of life information from newly diagnosed prostate cancer patients from 15 hospitals across Ireland. IPCOR generates high quality data on a range of important clinical outcomes in men with prostate cancer, assesses quality of care and provides recommendations to clinicians, hospitals, decision-makers and the National Cancer Control Programme, to promote equal access to healthcare services and improvements in care nationally.  By bringing together data on prostate cancer patients, collected over time, the IPCOR study will ultimately lead to the improvement of patient experiences and maximise quality of life for men diagnosed with prostate cancer in Ireland.",null,"Irish Prostate Cancer Outcomes Research (IPCOR) has established a national prostate cancer disease registry, which captures high-quality clinical and quality of life information from newly diagnosed prostate cancer patients from 15 hospitals across Ireland. IPCOR generates high quality data on a range of important clinical outcomes in men with prostate cancer, assesses quality of care and provides recommendations to clinicians, hospitals, decision-makers and the National Cancer Control Programme, to promote equal access to healthcare services and improvements in care nationally.  By bringing together data on prostate cancer patients, collected over time, the IPCOR study will ultimately lead to the improvement of patient experiences and maximise quality of life for men diagnosed with prostate cancer in Ireland."]
[null,"Reason for seeking a Declaration","The Data Controller of the IPCOR study wish to obtain pseudonymised clinical data from the National Cancer Registry of Ireland for the purpose of storing, analysing and further pseudonymising that data and sharing with co-investigators of the study. The nature of the clinical data being obtained is; diagnostic pathways, cancer treatment and longitudinal outcomes.","Amendment:\nData collection for this project is completed and the IPCOR dataset is currently held by the data controller CRDI. CRDI will be wound down by the end of April 2021. There is no other dataset of its kind for prostate cancer in Ireland and it is important for cancer research in Ireland that the IPCOR dataset currently held by CRDI would be available beyond the end date of the IPCOR project and the winddown of CRDI. To enable this to happen within an appropriate data governance framework, the dataset must be transferred to another data controller. UCD, one of the CRDI partners, and the institution associated with the Principal Investigator, will become the data controller for the IPCOR dataset. The Applicant requests an amendment to the existing consent declaration for the following:\n-\tchange of data controllership from CRDI to UCD \n-\ttransfer of the IPCOR dataset to UCD (this includes the clinical data obtained from the National Cancer Registry of Ireland (NCRI) and the patient reported outcomes (PROMs) data)\n-\taligned with the original declaration, the continued analysis and processing of the data by UCD for the purpose of the IPCOR study,\n-\tthe continued storage of data.\n-\tobtaining updated survival data from NCRI ",null,"To extend the duration of the consent declaration by 5 years to 31st July 2030."]
[null,"Scheduled HRCDC Meeting Date","25th June 2020","2nd March 2021",null,"17th July 2025"]
[null,"HRCDC Decision Date ","25th June 2020 ","2nd March 2021",null,"17th July 2025"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved ",null,"Amendment Approved "]
[null,"Specific Conditions attached ","Condition 1: The Applicant must ensure that appropriate agreements or arrangements governing the transfer and use of data, are in place prior to any transfer to organisations.  Special consideration should be given to arrangements required for the transfer of data to recipient organisations in the UK, which will become a third country (non-EU) once the Brexit transition period is over. [CONDITION MET]","Condition 1. The Applicant must ensure that strong transparency measures, including those outlined in the initial HRCDC application, continue to be implemented by the new Data Controller UCD and, should be further strengthened to ensure that participants can continue to be made aware of this study and how they can exercise their data protection rights. Specifically, it is a condition of this amendment approval that the following actions are undertaken as soon as possible by the Applicant:\n(i) The IPCOR study website must continue to be maintained and updated by the new data controller, UCD. \n(ii) Information with regards the change in controllership and transfer of data to UCD must bevisible and clearly communicated on the IPCOR website.\n(iii) The IPCOR website and other transparency measures must clearly outline to participants how they can continue to exercise their data protection rights including the right to withdraw from the study. It must be transparent how requestsfrom participants who wish their exercise their data protection rights will be facilitated. This includes the visibility of and ease of access to the contact form on the IPCOR website should a participant wish to withdraw, as referenced by the Applicant. This condition is a reporting requirement of the Annual Review. [CONDITION MET]","Condition 2. The HRCDC request confirmation that ethics approval, has been granted to the transfer of the data to UCD. As part of this condition, any requirements arising from the REC review and how these requirements have been met, must be provided to the HRCDC. [CONDITION MET]\n\nCondition 3: It is a condition of this amendment approval that appropriate contractual arrangements are in place between the new data controller UCD, and CRDI and NCRI with regards the transfer of the IPCOR data to UCD and the provision of updated survival data. [CONDITION MET]","N/A"]
[null,"Deadline for meeting any conditions","N/A","N/A",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th August 2018 and shall be valid until 31st July 2020 and for five years thereafter (until 31st July 2025) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. Amendment  is made commencing 17th July 2025 and shall be valid until 31st July 2030, an extension of the consent declaration. ","The Amendment is made commencing 2nd March 2021 and shall be valid until 31st July 2020 and for five years thereafter (until 31st July 2025) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. This is in line with the duration of the consent declaration made. Amendment  is made commencing 17th July 2025 and shall be valid until 31st July 2030, an extension of the consent declaration. ",null,"The approval to the Amendment is made commencing 17th July 2025 and shall be valid until 31st July 2030, an extension of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Declaration Live ",null,"Declaration Live "]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant is recommended to examine how the level of Patient & Patient Involvement for this specific study could be further enhanced. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2: The Applicant is recommended to consider strengthening transparency measures for the study to ensure that all participants can exercise their data protection rights, including the right to withdraw and understand what will happen their data in such circumstances.  It should be made clear how their personal data collected by NCRI, will be used in the IPCOR study. It is further recommended that links to the IPCOR study on the National Cancer Registry Ireland website are visible and accessible to participants. [UNDER CONSIDERATION]"]

{"sheet":"19-084-AF1","index":45,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","19-084-AF1"]
[null,"Application Title ","1 Year post-sepsis study"]
[null,"Applicant Organisation (Data Controller)","Health Service Executive"]
[null,"Lead Applicant ","Karn Cliffe"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The primary aim of this study is to identify the long-term impacts of sepsis on patients within an Irish regional context. Secondary aims of the study include identifying patient experiences of sepsis and sepsis survivorship; identifying the factors which contribute to early recognition, intervention or treatment; identifying possible delays in early recognition, intervention or treatment and identifying any service gaps to inform service provision needs for sepsis survivors."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the processing of personal data for potential participants who lack decision-making capacity and who do not have an identified legally appointed proxy to provide consent on their behalf for stage 1 consisting of pre-screening and collecting data from the participant’s healthcare records as well as follow-up questionnaires and interviews; a declaration is not sought for stage 2 of the study, which will involve implementing a tailored and augmented discharge process for sepsis survivors. "]
[null,"HRCDC Meeting Date #1","25th November, 2019"]
[null,"HRCDC Meeting Date #2","16th December, 2019"]
[null,"HRCDC Decision Date ","16th December, 2019"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. This declaration is made on the condition that the outstanding Data Controller signatories on the HRCDC application, for St. James’s Hospital and Tallaght University Hospital are submitted as soon as possible, and no later than January 17th, 2020. Processing of data from these sites cannot commence at these two sites until these signatures are provided to the HRCDC. [AMENDED 2nd MARCH, 2020 - CONDITION NO LONGER APPLICABLE]\n\nCondition 2. Confirmation of Research Ethics Committee approval from Tallaght University Hospital and St. James’s Hospital must be provided to the HRCDC, once granted. No data processing can commence at these sites until such written confirmation is provided to the HRCDC. [CONDITION MET]\n\nCondition 3. It is noted from the information provided to the HRCDC, that data sharing agreements are currently being established between the HSE and the five participating hospitals. As the HSE, St. James's and Tallaght University Hospital have now been confirmed as Joint-Data Controllers, an appropriate Joint Data Controller arrangement also should be in place between these parties. It is advisable to discuss this with your Institution’s legal office and Data Protection Office, as necessary.\n[AMENDED 2nd MARCH, 2020 - CONDITION NO LONGER APPLICABLE]"]
[null,"Deadline for meeting any conditions","N/A "]
[null,"Duration of Declaration ","The Declaration is made commencing 16th December and shall be valid for three (3) years after the commencement of the study at the last hospital site or until December 31st, 2022, whichever is the later."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A "]

{"sheet":"19-085-AF1","index":46,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","19-085-AF1","19-085-AF1/AMD1"]
[null,"Application Title ","Validation of microRNAs as novel diagnostic and therapeutic targets in ischaemic brain injury (Blood biomarkers to predict recovery from ischaemic stroke)","Validation of microRNAs as novel diagnostic and therapeutic targets in ischaemic brain injury (Blood biomarkers to predict recovery from ischaemic stroke)"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland (RCSI)\nBeaumont Hospital","Royal College of Surgeons in Ireland (RCSI)\n"]
[null,"Lead Applicant ","Shona Pfeiffer (RCSI)","Shona Pfeiffer (RCSI)"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The overall aim of the research is to examine the unique molecular profile present in blood samples from patients suffering ischaemic stroke and to examine the relationship between these blood biomarkers and clinical outcome. This will identify a unique molecular signature associated with ischaemic stroke and provide invaluable information for the development of specific miRNAs as clinically relevant diagnostic and prognostic blood biomarkers. Furthermore, identification of potential therapeutic targets has significant potential for better success in the development and translation of novel neuroprotective and therapeutic agents to limit progressive neuronal damage and death in ischaemic penumbra. ","The overall aim of the research is to examine the unique molecular profile present in blood samples from patients suffering ischaemic stroke and to examine the relationship between these blood biomarkers and clinical outcome. This will identify a unique molecular signature associated with ischaemic stroke and provide invaluable information for the development of specific miRNAs as clinically relevant diagnostic and prognostic blood biomarkers. Furthermore, identification of potential therapeutic targets has significant potential for better success in the development and translation of novel neuroprotective and therapeutic agents to limit progressive neuronal damage and death in ischaemic penumbra. "]
[null,"Reason for seeking a Declaration","The Applicant is seeking a declaration for the purpose of processing data where participants lack decision-making capacity. Specifically, participants name and MRN will be recorded prior to obtaining deferred consent, for the purposes of linking the sample to participant data once consent has been obtained.","The scope of the consent declaration made was to process personal data where participants lack decision-making capacity, specifically recording and storing the participant’s name and medical record number (MRN) prior to obtaining deferred consent.  \nThe scope of the amendment request is for the following additional data processing activities for participants who lack decision-making capacity:\n(i)\tThe collection and analysis of additional personal data, including clinical data from the medical records, data associated with the bio-samples and follow-up data collected up to day 90 for the purpose of this research study,\n(ii)\tThe sharing of data with the study collaborator, National University of Ireland Galway, for the purpose of this study,\n(iii)\tThe ongoing storage of the data for 7 years.\nProxy assent will be obtained where the participant lacks decision-making capacity. "]
[null,"Scheduled HRCDC Meeting Date","2nd March 2020","20th July 2021"]
[null,"HRCDC Decision Date ","2nd March 2020","20th July 2021"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: As part of the Annual Review, the Applicant is requested  to confirm the timeline for when the samples and personal data are destroyed if a participant does not regain capacity. The Applicant is also requested to provide numbers for those who regain capacity, those who lack capacity and the numbers of next-of-kin who did not provide next-of-kin assent. [CONDITION MET]\n\nCondition 2: The Applicant is requested to ensure that appropriate processes are in place regarding the timely destruction of samples and personal data. (CONDITION UNDERWAY)\n\nCondition 3: The Applicant is requested to enhance and strengthen the level of PPI in this study and provide information on PPI as part of the Annual Review. ","Condition 1. Proxy assent on behalf of the participant must be obtained as soon as possible following the participant’s admission to the hospital. For the avoidance of doubt, no further personal data, beyond the participant’s name and medical record number (MRN), can be collected and processed prior to obtaining proxy assent; this aligns with the scope of the declaration previously made. [CONDITION MET]\n\nCondition 2. Where a participant continues to lack decision-making capacity for a prolonged period of time and where proxy assent remains in place, the HRCDC requests that the following action should be taken as an additional safeguard:\n- the Applicant should seek confirmation from the individual who provided proxy assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. \n- confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. This is a reporting requirement as part of the Annual Review.\nNote: Prior to confirming the proxy assent, the Applicant should ensure that the participant has not regained decision making capacity such that deferred participant consent could not be sought. [CONDITION MET]\n\nCondition 3. An extension of the RCSI Research Ethics Committee (REC) approval must be obtained prior to its expiration on 10th December 2024. When made, confirmation of this extended approval must be provided to the HRCDC. (CONDITION UNDERWAY)"]
[null,"Deadline for meeting any conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing March 2nd, 2020 and shall be valid until, 31st April 2024 or upon confirmation that explicit consent has been obtained from participants once they regain capacity or that the data has been rendered anonymised or destroyed, or whichever occurs sooner.","The approval to the Amendment is made commencing 20th July 2021 and shall be valid 31st April 2031 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. This is an extension to the original duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation: The Applicant is recommended to consider revising the PIL so as to provide an indicative timeline to inform participants or those providing assent, when personal data cannot be withdrawn from the study. (Recommendation Considered)","Recommendation. The Applicant is requested to consider reviewing and amending the assent form and associated study information leaflet as follows:\n(i) It should be clear to the individual providing proxy assent, that blood samples are taken for care and treatment and for the purpose of this specific research study. In this context consideration should be given to amending the statement ‘Blood sampling is part of the normal clinical management’ to ensure clarity and consistency of information.\n(ii) As the scope of the consent declaration is limited to data processing for the purpose of the ‘Blood Biomarkers to Predict Recovery from Ischaemic Stroke’ study only, and proxy assent has no lawful basis, the Applicant is requested to consider amending or deleting the options provided in the assent form with regards the future use of personal data for research. (Recommendation Considered) "]

{"sheet":"19-086-AF1","index":47,"n_rows":17,"n_cols":6,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,1,12,1],[11,2,12,2],[11,3,12,3],[11,4,12,4],[11,5,12,5]]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref","19-086-AF1","19-086-AF1/AMD1","19-086-AF1/AMD2"]
[null,"Application Title ","Sepsis Immunosuppression in Critically Ill Patients","Sepsis Immunosuppression in Critically Ill Patients","Sepsis Immunosuppression in Critically Ill Patients"]
[null,"Applicant Organisation (Data Controller)","St James’s Hospital, Dublin","St James’s Hospital, Dublin","St James’s Hospital, Dublin"]
[null,"Lead Applicant ","Ignacio Martin-Loeches","Ignacio Martin-Loeches","Ignacio Martin-Loeches"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Sepsis is the systemic inflammatory response to infection and is a major health problem in Europe and worldwide, occurring in approximately 2% of all hospitalised patients in developed countries and in 6 -30% of all intensive care unit (ICU) patients. Despite international treatment guidelines the incidence of sepsis continues to increase. The diagnosis of sepsis relies heavily on the detection of living microorganisms by identification of the organism responsible for infection; however, the sensitivity of the available screening tests is limited, and results are not immediately available. Until the infectious organism is isolated, potent broad-spectrum antibiotics are given because delay in appropriate therapy is associated with worse outcome. The consequence is often unnecessary antibiotic prescription, which is associated with the development of antimicrobial resistance (i.e., MRSA) and further hospital infections as well as a range of avoidable adverse effects and acquisition costs of antibiotic overuse. This study is being carried out as a feasibility study to determine if a larger study is possible using the same design. The aim of this research is to develop timelier and more efficient methods (using biomarkers) in diagnosing sepsis. This will be achieved by comparing healthcare data and biomarkers across three participant groups: (a) Patients diagnosed with bacteraemia without sepsis on the general ward (b) patients diagnosed with sepsis in the ICU and (c) patients in the ICU with a diagnosis of septic shock.","Sepsis is the systemic inflammatory response to infection and is a major health problem in Europe and worldwide, occurring in approximately 2% of all hospitalised patients in developed countries and in 6 -30% of all intensive care unit (ICU) patients. Despite international treatment guidelines the incidence of sepsis continues to increase. The diagnosis of sepsis relies heavily on the detection of living microorganisms by identification of the organism responsible for infection; however, the sensitivity of the available screening tests is limited, and results are not immediately available. Until the infectious organism is isolated, potent broad-spectrum antibiotics are given because delay in appropriate therapy is associated with worse outcome. The consequence is often unnecessary antibiotic prescription, which is associated with the development of antimicrobial resistance (i.e., MRSA) and further hospital infections as well as a range of avoidable adverse effects and acquisition costs of antibiotic overuse. This study is being carried out as a feasibility study to determine if a larger study is possible using the same design. The aim of this research is to develop timelier and more efficient methods (using biomarkers) in diagnosing sepsis. This will be achieved by comparing healthcare data and biomarkers across three participant groups: (a) Patients diagnosed with bacteraemia without sepsis on the general ward (b) patients diagnosed with sepsis in the ICU and (c) patients in the ICU with a diagnosis of septic shock.","Sepsis is the systemic inflammatory response to infection and is a major health problem in Europe and worldwide, occurring in approximately 2% of all hospitalised patients in developed countries and in 6 -30% of all intensive care unit (ICU) patients. Despite international treatment guidelines the incidence of sepsis continues to increase. The diagnosis of sepsis relies heavily on the detection of living microorganisms by identification of the organism responsible for infection; however, the sensitivity of the available screening tests is limited, and results are not immediately available. Until the infectious organism is isolated, potent broad-spectrum antibiotics are given because delay in appropriate therapy is associated with worse outcome. The consequence is often unnecessary antibiotic prescription, which is associated with the development of antimicrobial resistance (i.e., MRSA) and further hospital infections as well as a range of avoidable adverse effects and acquisition costs of antibiotic overuse. This study is being carried out as a feasibility study to determine if a larger study is possible using the same design. The aim of this research is to develop timelier and more efficient methods (using biomarkers) in diagnosing sepsis. This will be achieved by comparing healthcare data and biomarkers across three participant groups: (a) Patients diagnosed with bacteraemia without sepsis on the general ward (b) patients diagnosed with sepsis in the ICU and (c) patients in the ICU with a diagnosis of septic shock."]
[null,"Reason for seeking a Declaration","The study aims to process personal data and samples from a total of 150 patients. This application is being made because this study will involve the processing of data of participants from the ICU who may lack decision-making capacity to provide explicit consent.\nRelative/next-of-kin assent for participants who lack decision-making capacity to consent, will be sought as a safeguard to represent the will and preference of the participant in relation to use of their samples and data for research. If a participant regains capacity, they will be asked to consent for continued processing of their data. Samples and data will be destroyed if consent is not provided. Some participants may not regain capacity ","Amendment: The Applicant requests an amendment to the existing consent declaration to cover the additional processing activities to be undertaken by the data processor Dalhousie University in Canada for the purpose of this study.","The amendment is requested for the following changes to the study:\n(i) the addition of new study collaborators (i.e., data processors),\n(ii) an expansion of the number of study participants to be recruited,\n(iii) an extension of the duration of study/declaration and \n(iv)the use of verbal/telephone assent."]
[null,"Scheduled HRCDC Meeting Date","2nd March, 2020","2nd March, 2021","4th October 2022"]
[null,"HRCDC Decision Date ","2nd March, 2020","2nd March, 2021 & Written Procedure","4th October 2022"]
[null,"HRCDC Decision","Conditional Declaration","Amendment approved ","Amendment approved "]
[null,"Specific Conditions attached ","Condition 1: The Applicant is requested to put in place more definite timelines as to what next-of-kin assent would be reaffirmed in situations where the participant does not regain decision making capacity and to report on this condition as part of the Annual Review. (Please see Recommendation 1) [CONDITION MET]\n\nCondition 2: The Applicant is requested to establish definitive timelines for the destruction of the samples and data if consent/next-of-kin assent is not provided or if the participant directly withdraws their consent, and to report on this in the Annual Review. [CONDITION MET]\n\nCondition 3: The HRCDC are of the view that PPI play an important role in health research studies that benefits the research and the  participants. It is also recognised that a number of PPI groups have been established in this research area, such as ICU Steps. The Applicant is therefore requested to strengthen the level of PPI within this study. [CONDITION MET]\n\nCondition 4: This Conditional Declaration is made for the processing of personal data on the basis of the REC approval that was granted to this study on 15th January 2020. Should the study obtain REC approval for the requested amendments, evidence of this approval must be provided to the HRCDC. For the avoidance of doubt the scope of this consent declaration does not extend to the amended study protocol unless REC approval has been granted [CONDITION MET]\n","Condition 1: It is a condition of this amendment that the appropriate contractual arrangement (material (and data) transfer agreements as necessary) is fully executed between St. James’s Hospital and Dalhousie University prior to the transfer of the biological samples and any associated data. The terms and conditions of use of the biological samples and associated should align with the processing activities outlined to the HRCDC. Only the minimal amount of data should be transferred to the Dalhousie University in accordance with the principle of data minimisation. Where applicable, the data controller should ensure all requirements are in place for transferring personal data outside the European Economic Area, as outlined in Chapter V of the GDPR. Please consult with the data controller’s DPO as necessary. [CONDITION MET]\n\nCondition 2: If applicable, the patient information leaflets and consent-to-continue and assent forms being used for the study, should be updated to ensure it is clear that biological samples and data are being transferred to Dalhousie University in Canada. [CONDITION MET]","Condition 1. It is a condition that the appropriate and necessary agreements and arrangements governing the transfer and processing of personal data, including pseudonymised data, are in place \nbetween the data controller of the study, St James’s Hospital, and the new additional collaborators/data processors. Such agreements should also outline what will happen the personal data sent to the collaborators once their role in the study has concluded (i.e., whether the data will \nbe deleted or returned). In addition, where data is transferred to collaborators outside the EEA, the necessary GDPR Article 5 legal basis and arrangements must also be complied with (e.g., \nstandard contractual clauses). The transfer of data should not occur prior to the required agreements being in place and the HRCDC should be informed once the agreements/arrangements are in place. For the avoidance of doubt the agreements and arrangements must cover the transfer and use of data not just bio-samples. The Applicant should discuss this matter with their DPO. [CONDITION MET]\n\nCondition 2. Where telephone/verbal assent is obtained, copies of the study information leaflet and assent form should be forwarded to the individual providing proxy assent, and a signed copy \nreturned to the research team for record purposes. [CONDITION UNDERWAY]","Condition 3. With regards the study information leaflet, the Applicant is requested to review and \namend the following\n- Review and amend the use of ‘you’ and ‘your’ in the proxy/NOK information leaflet and assent form. For example, the information leaflet for the proxy/NOK incorrectly refers to collecting ‘your samples’ and collecting data ‘on your medical condition’. The proxy is providing assent on behalf of the participant who lacks decision-making capacity; they are not providing \nconsent for use of their own samples and data.\n- To align with the information provided to the HRCDC, the information leaflet should be amended to state that up to 300 patients per group, not 150, will be recruited to the study. \n- The information on the samples to be collected, and subsequently the processing undertaken by the collaborators, should be reviewed and simplified where possible, as the current information is considered quite technical and hard to follow. [CONDITION MET]\n\nCondition 4. The DPIA which has been updated must be submitted to the HRCDC as soon as practicable and within 2 months form the receipt of this decision letter. [CONDITON MET]"]
[]
[null,"Deadline for meeting any conditions","N/A","N/A","Condition 4: 18th December 2022 (DPIA) [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing March 2nd 2020 and shall be valid until, 31st March 2025 or upon confirmation that explicit consent has been obtained from participants once they regain capacity or that the data has been rendered anonymised or destroyed, or whichever occurs sooner. ","The Amendment is made commencing 9th March 2021 and shall be valid until March 31st, 2025 or upon confirmation that explicit consent has been obtained from participants once they regain capacity or that the data has been rendered anonymised or destroyed, or whichever occurs sooner. This is in line with the duration of the consent declaration made.","The approval to the Amendment is made commencing 4th October 2022 and shall be valid until 30th April 2029, or until the point where the personal data has been irrevocably anonymised or destroyed (this is an extension of the duration of the consent declaration initially made)."]
[null,"Status of Declaration","Declaration Live","Amendement live ","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant is requested to consider the ethics of re-affirming next-of-kin assent, specifically in situations where the participant has passed away. (RECOMMENDATION CONSIDERED) \n\nRecommendation 2: The Applicant is requested to consider revising the PIL as follows in order to provide clarity to participants and their next-of-kin on the following points:\ni) That samples will be transferred to both ‘Trinity College Dublin and St. James’s Hospital’ (it is currently stated in the information leaflet that samples will be transferred to Trinity College ‘and/or’ St, James’ Hospital).\nii) Removal the term ‘legal representative’ as under data protection legislation a participant’s next-of-kin cannot lawfully consent for the processing of their relative’s personal data, except in cases where they are a legally appointed power of attorney. A more appropriate term would be ‘next-of-kin assent’\n[RECOMMENDATION CONSIDERED]"]

{"sheet":"20-001-AF1","index":48,"n_rows":17,"n_cols":5,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,2,12,2],[11,1,12,1],[11,3,12,3],[11,4,12,4]]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref","20-001-AF1",null,"20-001-AF1/AMD1"]
[null,"Application Title ","A Retrospective analysis of the Irish national Acute Coronary Syndrome (ACS) programme database",null,"A Retrospective analysis of the Irish national Acute Coronary Syndrome (ACS) programme database"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland",null,"Royal College of Surgeons in Ireland"]
[null,"Lead Applicant ","Jack Laffen",null,"Jack Laffen"]
[null,"Research commenced prior to submission of application","No",null,"No"]
[null,"Research Objective","It has been long known that the faster a patient receives emergency treatment during a severe heart attack, the better the outcome. Different treatments exist to open blocked arteries. In Ireland, since 2013, there is a compiled national heart attack registry based on an integrated emergency care system. Despite this, the follow up of patient’s actual outcomes has never been studied. This study aims to identify patients who suffered severe heart attacks in 2013/2014, and for whom accurate time intervals pre-treatment were recorded (first 999 call, first ambulance contact, time of arrival to hospital etc). The study involves accessing patient electronic records to determine the distance patients lived from the nearest specialist emergency capable heart attack hospital to determine whether this had any effect on time delays, and on 5-year all-cause mortality.",null,"It has been long known that the faster a patient receives emergency treatment during a severe heart attack, the better the outcome. Different treatments exist to open blocked arteries. In Ireland, since 2013, there is a compiled national heart attack registry based on an integrated emergency care system. Despite this, the follow up of patient’s actual outcomes has never been studied. This study aims to identify patients who suffered severe heart attacks in 2013/2014, and for whom accurate time intervals pre-treatment were recorded (first 999 call, first ambulance contact, time of arrival to hospital etc). The study involves accessing patient electronic records to determine the distance patients lived from the nearest specialist emergency capable heart attack hospital to determine whether this had any effect on time delays, and on 5-year all-cause mortality."]
[null,"Reason for seeking a Declaration","A consent declaration is requested to:\ni. Re-identify patients of interest from a pseudonymised database from the national heart attack register.\nii. Once re-identified, to access the medical records of the patients of interest in their original treating hospitals and collect no more than 3 data fields.",null,"The purpose of this amendment request is to extend the duration of the consent declaration. In addition, the Applicant outlines that they wish to expand the study from the initial 2013-2014 participant cohort to include participants up to 2018 and to include additional hospital sites to the 5 sites that were noted in the original HRCDC application form.  "]
[null,"HRCDC Meeting Date","26th May 2020",null,"12th July 2022"]
[null,"HRCDC Decision Date ","26th May 2020",null,"12th July 2022"]
[null,"HRCDC Decision","Conditional Declaration",null,"No Amendment made"]
[null,"Specific Conditions attached ","Condition 1: The Applicant is requested to ensure that appropriate and robust security measures are implemented when transferring, recording and storing personal data. Specifically, this includes measures such as encryption techniques and passwords to protect personal data on the study laptop. [Condition Met]\n\nCondition 2: The Applicant is requested to implement robust transparency arrangements to inform participants and their families about this study and the use of their personal data. The communications plan as outlined in the study’s Data Protection Impact Assessment form should be implemented. Transparency measures should also outline how participants can exercise their data protections rights, including the ability to withdraw from the study if they wish to do so, including what will happen to their personal data in such a situation. Transparency arrangements should be implemented in advance of commencing the study at each site. The implementation of robust transparency arrangements is a reporting requirement as part of the Annual Review. [Condition met]\n\nNOTE: Further information on providing transparent information can be found on the Data Protection Commission’s website; https://www.dataprotection.ie/en/organisations/knowyourobligations/transparency. It is advisable to discuss this with your institutions Data Protection Officer (DPO).\n\nCondition 3: The HRCDC considers PPI in health research an important safeguarding element, where no explicit consent is being sought, to ensure a public/patient perspective is reflected in the overall study. The Applicant is requested to enhance the level of public and patient involvement (PPI) in the study, and in advance of commencing the study. If there are constraints using normal means to engage with PPI representatives and advocacy groups in light of the ongoing coronavirus situation, the Applicant is advised to engage by alterative means such as email and videoconference as appropriate. [Condition underway]","Condition 4: The Applicant must inform the HRCDC when research ethics approval has been granted at each of the five hospital sites. For the avoidance of doubt the scope of this consent declaration is only valid for data processing at hospital sites that have received research ethics approval. [Condition underway]\n\nCondition 5: Appropriate contractual agreements or suitable arrangements, as required, must be in place between the data controller RCSI and the organisations involved in the study that are providing access to personal data for the purpose of the study. It is advisable to discuss this with your institution’s DPO and legal office’s as required. [Not met]\n\nCondition 6: The Applicant is requested to consider how the dataset collected for this study could further benefit the public and patients by being made accessible to the wider research community in a de-identified and controlled manner. The Applicant is requested to report on this condition as part of the Annual Review. [Condition Met]","N/A"]
[]
[null,"Deadline for meeting any conditions","N/A",null,"N/A "]
[null,"Duration of Declaration ","The Declaration is made commencing May 26th, 2020 and shall be valid for six months (until 31st November 2020) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner.",null,"N/A"]
[null,"Status of Declaration","Declaration Expired",null,"N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-003-AF1","index":49,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[[15,1,16,1],[15,2,16,2]]}
[]
[null,"Application Ref","20-003-AF1"]
[null,"Application Title ","Blood Brain Barrier (BBB) Disruption And Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) Changes In Severe Traumatic Brain Injury (TBI)"]
[null,"Applicant Organisation (Data Controller)","Beaumont Hospital"]
[null,"Lead Applicant ","Gerard Curley"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","There are a variety of immediate effects on the brain following head injuries, including various types of bleeding and tearing forces that injure nerve fibres and cause inflammation, metabolic changes, and brain swelling. Secondary damage may also be caused by a breakdown in the blood-brain barrier. The blood-brain barrier preserves the separation between the brain fluid and the very small capillaries that bring the brain nutrients and oxygen through the blood. Once disrupted, blood, plasma proteins, and other foreign substances leak into the space between neurons in the brain and trigger a chain reaction that causes the brain to swell. It also causes multiple biological systems to go into overdrive, including inflammatory responses which can be harmful to the body if they continue for an extended period of time. Magnetic resonance imaging (MRI) may be used after the initial assessment and treatment as it is a more sensitive test and picks up subtle changes in the brain that the CT scan might have missed. Recently there has been increasing research into the use of Dynamic Contrast Enhanced MRI (DCE-MRI) which can demonstrate changes suggestive of blood brain barrier disruption. This study proposes to use a novel sequence of DCE-MRI to diagnose disruption of the BBB in cases where traditional sequences would not identify."]
[null,"Reason for seeking a Declaration","Patients that will be enrolled in this study are unconscious, and do not have capacity to provide consent. The declaration is required until study participants regain capacity and can provide explicit consent. The data processing activities include the collection, pseudonymisation and analysis of the participant’s personal data for the purpose of this study. Pseudonymised blood samples that are associated/linked to the participant’s personal data will also be analysed."]
[null,"HRCDC Meeting Date","30th April, 2020"]
[null,"HRCDC Decision Date ","30th April, 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC has requested that, where the participant lacks decision-making capacity, a protocol is implemented whereby next-of-kin assent for data processing is obtained as soon as practicably possible and that deferred consent is subsequently obtained, as soon as possible, when the participant regains capacity. Consideration should be given to seek deferred consent at the participant’s follow-up clinic visits as part of this process. Details of the implementation of this assent/consent protocol, including the number of participants who have provided deferred consent is a reporting requirement as part of the Annual Review. (CONDITION MET)\n\nCondition 2: It is a condition of the declaration that the level of public and patient involvement (PPI) in the development of this study is enhanced to ensure knowledge in context and experience can be gained through direct engagement with the public and patients. Engagement with representative groups such as ICUsteps should be considered as should the dissemination of study findings with participants, their families and PPI groups. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review. (CONDITION UNDERWAY)\n\nCondition 3: As data protection safeguard measure, the Applicant is requested to ensure that agreements or arrangements, as appropriate, are in place with the coinvestigator’s institution, Trinity College Dublin. This is to ensure that the data transferred to the co-investigator is transferred under appropriate terms and conditions to ensure the anonymity of the study participants. Specifically, to ensure that no attempts will be made to re-identify study participants by the co-investigator. (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 30th April 2020 and shall be valid until 6 months after the recruitment of participants for the study has been completed, by 31st December 2021. "]
[null,"Status of Declaration","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The Applicant is recommended to review the DPIA to ensure the information provided for data protection risk analysis, reflects the activity being out in the study. For example, it is noted in the DPIA that ‘no patient shall be recruited into the study without informed consent’, yet next-of-kin assent will be obtained. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2: The HRCDC strongly recommends that the study information leaflets and accompanying assent and consent forms, should be carefully reviewed and amended as necessary to ensure there is clarity and consistency of information provided to the participants or their next-of-kin. This will ensure there is an appropriate level of transparency and allow informed consent and the safeguard of assent to be obtained for the study. More specifically the following information points should be reconsidered;\n\ni) The study information leaflets were considered overly technical in nature, including the section ‘Why is this study being done’. More accessible and less technical language within the information leaflets should be considered. \n\nii) Reference is made to ‘medical records’ that will be accessed to obtain relevant data for this study. It would be beneficial to provide clarity to the next-of-kin and/or participant that only the relevant hospital/ICU records, not broader medical records, will be accessed.\n\niii) The Applicant is recommended to ensure there are no inconsistencies with the information outlined in the consent and assent forms and associated information leaflets provided. Specifically, the consent and assent forms did not include the same information and options for consenting/assenting to storage and future use of personal data and biological samples or, for being contacted about potential future research, or access by commercial entities. It was the view of the HRCDC that participants should be able to clearly indicate their preferences regarding the storage and future use of their personal data and bio-samples, as well as being contacted in the future. However, all multiple ‘yes’/’no’ options should be clear and minimised to avoid any confusion.\n\niv) The Applicant is recommended to ensure that there is consistency and clarity, and use in the right context, regarding terms such ‘assent’ and ‘consent’ as they relate to participants and next-of-kin. \n\nv) The participant’s data protection rights outlined in the consent and assent forms, such as right to access and withdrawal of personal data and any relevant derogations for data protection rights, should be clear and understandable and in compliance with the General Data Protection Regulations (GDPR). (RECOMMENDATION CONSIDERED)\n"]

{"sheet":"20-004-AF1","index":50,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","20-004-AF1","20-004-AF1/AMD1"]
[null,"Application Title ","Outcome for Older People with Cognitive Impairment Attending the Emergency Department","Outcome for Older People with Cognitive Impairment Attending the Emergency Department"]
[null,"Applicant Organisation (Data Controller)","Tallaght University Hospital","Tallaght University Hospital"]
[null,"Lead Applicant ","Sean Kennelly","Sean Kennelly"]
[null,"Research commenced prior to submission of application","No","No"]
[null,"Research Objective","It is estimated that there will be more than 140,000 people living with dementia in Ireland by 2041. People living with dementia have complex care needs and are known to be at higher risk of adverse outcomes across healthcare settings. Dementia is present in almost 40% of older patients attending the ED but is under-recognised in this setting. The ED environment is often unsuitable for those living with dementia and may contribute to poorer outcomes seen in those with dementia following an ED attendance. Few patients have access to gerontological review at ED presentation. People living with dementia are a diverse group but are under-represented in research. This research study aims to recruit participants aged over 75 years to investigate the prevalence of cognitive impairment and dementia following an ED attendance, factors that may contribute to these outcomes and barriers to care for those with dementia in the ED. It is hoped that the results will allow improvements in care for all people living with dementia in the future. ","It is estimated that there will be more than 140,000 people living with dementia in Ireland by 2041. People living with dementia have complex care needs and are known to be at higher risk of adverse outcomes across healthcare settings. Dementia is present in almost 40% of older patients attending the ED but is under-recognised in this setting. The ED environment is often unsuitable for those living with dementia and may contribute to poorer outcomes seen in those with dementia following an ED attendance. Few patients have access to gerontological review at ED presentation. People living with dementia are a diverse group but are under-represented in research. This research study aims to recruit participants aged over 75 years to investigate the prevalence of cognitive impairment and dementia following an ED attendance, factors that may contribute to these outcomes and barriers to care for those with dementia in the ED. It is hoped that the results will allow improvements in care for all people living with dementia in the future. "]
[null,"Reason for seeking a Declaration","A minority of participants with dementia may be unable to give fully informed consent due to significant cognitive impairment; a declaration is therefore sought for these participants. The data processing activities include: collection, pseudonymisation, analysis and storage of personal data that is already collected as part of usual patient care (i.e. medical records) as well as data collected for the purpose of this study. This includes the collection of follow-up data at six months and one year (via medical records and phone call).","Due to delays because of COVID-19, the study requests an extension of the duration of the declaration until August 2025. Participants have yet to be recruited to this study."]
[null,"Scheduled HRCDC Meeting Date","25th June 2020","19th September 2023"]
[null,"HRCDC Decision Date ","25th June 2020","19th September 2023"]
[null,"HRCDC Decision","Declaration Made","Amendment Approved"]
[null,"Specific Conditions attached ","N/A","N/A"]
[null,"Deadline for meeting any conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 25th June 2020 and shall be valid until 30th June 2023 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. Amendment is made commencing 19th September 2023 and shall be valid until 31st August 2025","The approval to the Amendment is made commencing 19th September 2023 and shall be valid until 31st August 2025 (this is an extension to the duration of the consent declaration)."]
[null,"Status of Declaration","Declaration No Longer Required","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: As an additional safeguard, the HRCDC recommends that the Applicant considers interaction or correspondence with the participant’s GP if practically possible and as applicable, to make them aware of the study and inform them that of the individual that has provided assent. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2: The HRCDC recommends that the Applicant review the assent and consents forms and study information leaflets, to ensure there is consistency in information and consenting/assenting options for the individuals providing assent or consent. [RECOMMENDATION CONSIDERED]\n\nRecommendation 3: So as not to assume that the participant continues to lack decision-making capacity over a prolonged period of time, the HRCDC recommends considering whether it is appropriate and possible to obtain deferred consent, at the 6-month and 1-year follow-up phone calls, before contacting the relative or carer who provided assent on their behalf previously. [RECOMMENDATION CONSIDERED]\n\nRecommendation 4: Where applicable, the Applicant should first determine if the participant who lacks decision-making capacity to provide consent, has a legally appointed representative (e.g. an enduring Power of Attorney). [RECOMMENDATION CONSIDERED]","N/A"]

{"sheet":"20-005-AF1-COV","index":51,"n_rows":16,"n_cols":6,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref","20-005-AF1/COV ",null,null,"20-005-AF1/COV/AMD1"]
[null,"Application Title ","The All-Ireland Infectious Diseases Cohort Project (AIID Cohort Project)",null,null,"The All-Ireland Infectious Diseases Cohort Project (AIID Cohort Project)"]
[null,"Applicant Organisation (Data Controller)","University College Dublin\nSt. Vincent’s University Hospital Dublin\nMater Misericordiae University Hospital\nCork University Hospital\nBeaumont Hospital\nWexford General Hospital\nChildren’s Health Ireland",null,null,"University College Dublin\nSt. Vincent’s University Hospital Dublin\nMater Misericordiae University Hospital\nCork University Hospital\nBeaumont Hospital\nWexford General Hospital\nChildren’s Health Ireland"]
[null,"Lead Applicant ","Patrick Mallon",null,null,"Patrick Mallon"]
[null,"Research commenced prior to submission of application","Yes",null,null,"Yes"]
[null,"Research Objective","The All-Ireland Infectious Diseases (AIID) Cohort study aims to create a data-rich prospective dataset derived from patients attending hospitals across Ireland, including Cork University Hospital, Mater Misericordiae University Hospital, St Vincent’s University Hospital (incorporating St Michael’s Hospital, Dun Laoghaire and St Columcille’s Hospital, Loughlinstown), Beaumont Hospital and Wexford General Hospital who present with suspected Infectious Diseases including COVID-19. Patients with suspected infection including COVID-19 will be identified on admission to hospital. If the patient is willing to participate after an informed consent process, their clinical data will be collected, and samples will be taken for bio banking. This will provide a platform to answer questions related to infectious diseases including COVID-19 that may arise in the future.",null,null,"The All-Ireland Infectious Diseases (AIID) Cohort study aims to create a data-rich prospective dataset derived from patients attending hospitals across Ireland, including Cork University Hospital, Mater Misericordiae University Hospital, St Vincent’s University Hospital (incorporating St Michael’s Hospital, Dun Laoghaire and St Columcille’s Hospital, Loughlinstown), Beaumont Hospital and Wexford General Hospital who present with suspected Infectious Diseases including COVID-19. Patients with suspected infection including COVID-19 will be identified on admission to hospital. If the patient is willing to participate after an informed consent process, their clinical data will be collected, and samples will be taken for bio banking. This will provide a platform to answer questions related to infectious diseases including COVID-19 that may arise in the future."]
[null,"Reason for seeking a Declaration","A consent declaration is requested to process personal data of participants where it is impractical to obtain written informed consent due to COVID-19 infection control restrictions and/or where the participants lack decision making capacity. A deferred consent model is therefore proposed. In addition, deferred proxy assent from the next-of-kin will be obtained. \nThe data processing activities covered by the declaration, if made, is limited to (i) the collection and storage of personal data, including systematic follow-up data and personal data linked to collected, associated bio-samples and (ii) the pseudonymisation of this personal data for ongoing storage, for data security purposes.\nThe scope of the consent declaration, if made, will not cover the further processing of the personal data prior to obtaining participant consent (i.e., accessing, transferring, scientific analysis, including genetic analysis for ethically approved studies)",null,null,"The addition of St. James’s Hospital, National Orthopaedic Hospital Cappagh and Our Lady Of Lourdes Drogheda Hospital as new joint data controllers / study sites."]
[null,"Scheduled HRCDC Meeting Date","12th October 2021",null,null,"7th October 2025"]
[null,"HRCDC Decision Date ","12th October 2021",null,null,"7th October 2025"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of the consent declaration that the scope only covers the processing of personal data (i.e. collection, pseudonymisation and storage only) of participants who lack the decision-making capacity, until deferred consent is obtained.  [CONDITION UNDERWAY] \n\nCondition 2. For the avoidance of doubt the consent declaration only covers data processing at the hospital sites that have already joined the AIID Cohort study and that have received research ethics committee approval. If additional hospital sites join the study at a later date, then a consent declaration amendment request must be submitted to the HRCDC for consideration, with confirmation of REC approval.  [CONDITION MET] \nNote: Any future amendments requests should be submitted by the lead Data controller and new joint data controller.\n\nCondition 3. Authorised signatures on the HRCDC application form and data protection officer feedback on the data protection impact assessment (DPIA) must be provided to the HRCDC on behalf of the joint data controller, Children’s Health Ireland (Crumlin Hospital and Temple Street Children’s Hospital). The consent declaration will not cover these hospital sites until this condition is met. [CONDITION UNDERWAY] ","Condition 4. Where a participant continues to lack decision-making capacity for a prolonged period of time and where proxy assent remains in place, the HRCDC requests that the following action should also be taken as an additional safeguard: \n(i) the Applicant should seek confirmation from the individual who provided proxy assent, that they wish for the participant’s personal data to continue to be processed as part of this research study, with this process appropriately documented for record purposes,\n(ii) confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. This is a reporting requirement as part of the Annual Review. \nNote: Prior to confirming proxy assent, the Applicant should ascertain if that the participant has regained decision-making capacity such that deferred participant consent could be sought. [CONDITION MET] \n\nCondition 5. The HRCDC reserves the right to review the consent declaration should it transpire that deferred consent cannot be obtained from a significant number of participants due to continued and prolonged lack of decision-making capacity. The Applicant is therefore required to report on the number of participants whose deferred consent is and is not obtained due to their continued lack of decision-making capacity, as part of the Annual Review.  [CONDITION MET] ","Condition 6. A transparent and specific process for destroying the personal data and biological samples must be implemented if deferred assent or deferred consent is not provided or is \nwithdrawn. [CONDITION MET] \n\nCondition 7. In line with the data protection principle of data minimisation, the Applicant is required to ensure that only the minimum amount of personal data is collected for the purpose \nof the AIID Cohort study. [CONDITION MET] \n\nCondition 8. The Applicant is required to further strengthen Patient and Public Involvement (PPI) activities to include engagement with PPI groups representative of the wider AIID Cohort study participants, such as participants with COVID-19, Tuberculosis, Hepatitis C and other relevant co-infectious diseases. [CONDITION UNDERWAY] ","Condition 1. The required data agreements/arrangements must be in place with regards the three new joint data controllers/study sites."]
[null,"Deadline for meeting any conditions","N/A",null,null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made on 12th October 2021 and is valid for 5 years until 12th October 2026, or until participant explicit consent has been obtained or the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner. ",null,null,"The approval to the Amendment is made commencing 9 th October 2025 and shall be valid until 12th October 2026, in line with the duration of the consent declaration made"]
[null,"Status of Declaration","Declaration Live",null,null,"Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The HRCDC recommends the following actions to be considered by the Applicant:\n(i) review and amend the proxy study information leaflet and assent form to focus and emphasise that their assent is requested to only collect, pseudonymise and store the participant’s data for future research purpose. This is aligned with the scope of the consent declaration for participants who lack decision-making capacity, which is limited to the collection and storage of personal data only. \n(ii) if the personal data is to be further processed for more defined research purposes at a future point in time, it is also recommended to consider reverting to the proxy individual to provide more detailed information on the future research that will be undertaken. Correspondingly, this recommendation is linked to Condition 3 and should be considered when reaffirming proxy assent. \n(iii) it is recommended to address the following observations made by the HRCDC with regards the information provided to the proxy:\n- inaccurate use of the term ‘your’ data or sample in the proxy study documents,\n- the statement ‘If there is no known objection by your relative to be included’ should be reframed more positively to ask the proxy individual if they believe their relative would wish to participate in this study,\n- the statement ‘may have rights’ should be amended to clarify that participants do have data protection rights. It is acknowledged that there may be derogations to such rights, therefore these should be clearly outlined, where relevant. \n- clarify potentially inconsistent information on the storage of the data and biological samples.","Recommendation 2. The HRCDC recommends that the participant information leaflet (PIL) and consent form are reviewed and amended to ensure clarity, transparency and consistency of information for participants. In this context the following observations were made by the HRCDC and should be addressed:\n- the Applicant should ensure that the participant consent form clearly requests their permission for both the storage and the future use of personal data and biological samples, with the consent options on future use appropriately layered and clear to the participant, avoiding the use of ‘bundled’ consent. \n- it is noted that the participant consent form and proxy assent forms does not include the same ‘Yes/No’ options and should be cross referenced. Specifically reference to genetic analysis, data transfers outside the EEA, and engagement with commercial companies are inconsistent across forms. \n- the PIL should provide as much information as possible to ensure the participants are fully informed about the future research that maybe undertaken with their data and biological samples, including who and what organisations the data may be shared with and nature of genetic analysis.\n- Points (iii) in Recommendation 1 should also be addressed, where relevant in the participant study documents \nNote: It is the responsibility of the data controller to ensure that the consent obtained, including broad explicit consent, for future use of data complies with the Health Research Regulations.\n\nRecommendation 3. If not being implemented already, it is recommended to provide the individual providing proxy assent and the participant providing consent, with a copy of the study information leaflet and assent/consent form that they have completed and signed, for their records. [RECOMMENDATION CONSIDERED]",null,"N/A"]

{"sheet":"20-006-AF1-COV","index":52,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[[15,1,17,1],[15,2,17,2]]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref","20-006-AF1/COV","20-006-AF1/COV/AMD1"]
[null,"Application Title ","A randomized double-blind placebo-controlled trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness.","A randomized double-blind placebo-controlled trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness."]
[null,"Applicant Organisation (Data Controller)","The Royal College of Surgeons in Ireland","The Royal College of Surgeons in Ireland"]
[null,"Lead Applicant ","Gerard Curley","Gerard Curley"]
[null,"Research commenced prior to submission of application","No","No"]
[null,"Research Objective","Alpha 1 anti-trypsin (AAT) is a naturally-occurring protein in the human body. It is extremely safe, and it is already used as a therapy for patients with an illness called alpha-1 antitrypsin deficiency (AATD), among others. One of the main beneficial functions of AAT is to decrease inflammation. This is important in the context of COVID-19 as one of the key features of the disease is increased inflammation. This increase in inflammation can lead to lung damage, multi-organ failure, and, in severe cases, death. A substantial portion of patients that die from COVID-19 do so from Acute Respiratory Distress Syndrome (ARDS). ARDS is essentially lung failure due to increased inflammation in the lung, decreased oxygen and a build-up of fluid in the lung. Another key feature of ARDS is increased production of neutrophil elastase (NE), an enzyme that is destructive to lung tissue. AAT is known to bind and inactivate NE. This study will examine whether administering intravenous (IV) AAT to patients with COVID-19 and ARDS in the ICU can help to reduce the inflammatory and aid recovery.","An amendment is to include three additional sites and an extension of the consent declaration duration."]
[null,"Reason for seeking a Declaration","A declaration is sought to process the personal data of participants who, due to their condition, do not have decision-making capacity to provide consent. A deferred consent model will be implemented and next-of-kin (family) assent obtained. The scope of the consent declaration is for the following data processing activities;\n• The collection and processing of data from the medical records for this clinical trial\n• The storage (only) of personal data for future research, and\n• For the following data processing activities that are outlined the study information leaflet:\n(i) the analysis of the blood samples linked to personal data;\n(ii) from the follow-up clinic visits, the collection and processing of personal data (obtained via questionnaires and/or diaries) and the storage and analysis of newly collected blood samples that are linked to personal data ","Amendment: The addition of three hospital sites to the study (St. James’s Hospital, Dublin; Galway University Hospital; Mater Misericordiae University Hospital)\n•\tAn extension of the duration of the declaration until 31st January 2021 and for 10 years thereafter. "]
[null,"HRCDC Meeting Date","15th April 2020 (COVID Meeting) ","4th September 2020"]
[null,"HRCDC Decision Date ","15th April 2020 (COVID Meeting) ","4th September 2020"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition: The HRCDC has requested that a process is implemented whereby next-of-kin assent for data processing is obtained as soon as possible; specifically, consideration should be given to obtaining next-of-kin assent by telephone or similar means where it is not possible to obtain assent in person. (CONDITION MET)","N/A"]
[null,"Deadline for meeting any conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 15th April 2020 and shall be valid until consent can be obtained from the participant or 10 years after the study concludes in August 2020.","The Amendment is made commencing 4th September 2020 and shall be valid until 31st January 2021 and 10 years thereafter (until 31st January 2031), or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. (This timeline is an extension to the duration of the consent declaration)"]
[null,"Status of Declaration","Declaration Live","Amendment Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant is requested to consider implementing further data minimisation measures. Specifically, this includes whether both age and date of birth are required for collection. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2: The HRCDC acknowledges the Applicant’s experience with public and patient engagement, such as when disseminating research findings. The HRCDC further recommends that the level of public and patient involvement (PPI) in the development of this study is enhanced to ensure knowledge in context and experience can be gained through direct engagement with the public and patients. Engagement with representative groups such as ICUsteps and the soon to be established PPI group within the Clinical Trials Network should be considered. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review.  [RECOMMENDATION CONSIDERED]\n\nRecommendation 3: With regards to the study information leaflet and consent forms consideration should be given to the following amendments for the benefit of the study and to ensure clarity for participants and/or their next-of-kin: [RECOMMENDATION CONSIDERED]\n\ni) Additional and clear information should be outlined on what is a blind randomised placebo control trial and, specifically why there are three separate treatment groups to which their relative may be randomly assigned.\nii) The HRCDC note that the study information leaflets, and the consent/assent forms contain several different references to the storage and the use of personal data and samples for future research that may cause confusion for the next-of-kin or the participant. For example, multiple different options for the storage and future use of personal data and samples are provided in the assent and consent forms.  The study information leaflet and assent form should be amended so that the participant and/or their next-of-kin understand and can clearly indicate their preference for how personal data and samples may be stored for and used in future research.\niii) In the section ‘Consent to Future Studies’ the participant information leaflet states that ‘Your family member has put forward their preferences for both future contact and storage and future uses of the data…’. As the participant may feel pressurised not to change the preferences made by their next-of-kin, this statement in the information leaflet should be amended as appropriate.  \niv) The participants data protection rights outlined in the study information leaflets should be clearly aligned with the General Data Protection Regulations (GDPR), including any derogations from data protection rights. Specifically, the HRCDC recommend that:\n     -further clarity is provided to the participant and/or next-of-kin where it is stated that rights cannot be exercised ‘unless your request would make it impossible or make it very difficult to do the study’. These statements in the Data Protection section maybe confusing. Eg Point 10 states that incorrect data may not be corrected upon request. \n    -in the next-of-kin information leaflet, that the applicant confirms whether it is correct that family members have the right to access the personal data of their relative.\nv) The study information leaflets should also inform the participant and/or their next of kin that the destruction of the personal data will also include witness shredding as described in the HRCDC application form.\nvi) As outlined by the Secretariat in its letter dated April 9th 2020, the information leaflets should be amended to clarify the role and remit of the HRCDC. \n[RECOMMENDATION CONSIDERED]\n\n"]

{"sheet":"20-007-AF1-COV","index":53,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","20-007-AF1/COV"]
[null,"Application Title ","Integration of data analytics in critically ill patients with COVID-19 infection (INTEGRATOMICS)"]
[null,"Applicant Organisation (Data Controller)","St. James's Hopsital Dublin"]
[null,"Lead Applicant ","Ignacio Martin-Loeches"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The project will analyse data relating to medical support of COVID-19 patients in the Intensive Care Unit (ICU) to look for ‘patterns’ or correlations between treatments and responses during critical care support. The data to be analysed will come from electronic records that are generated in the hospital whilst monitoring patients continuously. Researchers will look for relationships between ‘medical support’ such as drugs that have been administered and the patient responses measured by parameters such as blood pressure, pulse, breathing, biochemistry (blood and urine). St James’s Hospital ICU will work with an academic research centre called CeADAR, that specialises in data analysis and Artificial Intelligence (AI). Large, de-identified, datasets on patient monitoring outputs will be sent to CeADAR for analysis and modelling. Computer algorithms will be used to interrogate the data and to look for relationships within the data that a clinician can interpret. It is hoped that by presenting this data as correlations to a clinician, information will be available in a format that can help them to use it more effectively to help support decisions about supporting patients in the ICU. Ultimately, this may lead to optimised treatment plans, improved patient care and cost savings."]
[null,"Reason for seeking a Declaration","The Applicant is seeking a consent declaration to review patient electronic medical records, collect data and subsequently pseudonymise data for the purpose of transferring to the data processor for interrogation using AI software."]
[null,"Scheduled HRCDC Meeting Date","15th April 2020 (COVID Meeting) "]
[null,"HRCDC Decision Date ","15th April 2020 (COVID Meeting) "]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-008-AF1-COV","index":54,"n_rows":17,"n_cols":6,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,2,12,2],[11,1,12,1],[11,3,12,3],[11,4,12,4]]}
[null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref","20-008-AF1/COV",null,null,"20-008-AF1/COV-AMD1"]
[null,"Application Title ","Clinical, laboratory and radiological characteristics as predictors of outcome in patients with COVID-19",null,null,"Clinical, laboratory and radiological characteristics as predictors of outcome in patients with COVID-19"]
[null,"Applicant Organisation (Data Controller)","Tallaght University Hospital",null,null,"Tallaght University Hospital"]
[null,"Lead Applicant ","Ana Rakovac",null,null,"Ana Rakovac"]
[null,"Research commenced prior to submission of application","No",null,null,"No"]
[null,"Research Objective","This study aims to assess the general state of health of individuals with COVID-19 before they became infected, their metabolic status, past medical history, medication intake as well as biomarkers (blood tests) clinical and radiological findings obtained as part of the routine COVID-19 healthcare in Tallaght University Hospital. The study will also save surplus plasma and serum from samples used for routine investigation and will take additional blood samples for later analysis. The study will create a biobank from these samples to be used in additional later research, as needed.",null,null,"This study aims to assess the general state of health of individuals with COVID-19 before they became infected, their metabolic status, past medical history, medication intake as well as biomarkers (blood tests) clinical and radiological findings obtained as part of the routine COVID-19 healthcare in Tallaght University Hospital. The study will also save surplus plasma and serum from samples used for routine investigation and will take additional blood samples for later analysis. The study will create a biobank from these samples to be used in additional later research, as needed."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for processing personal data of unconscious patients and those who lack decision-making capacity to provide explicit consent. The data processing activities to be undertaken include:\n• The collection, pseudonymisation and processing of personal data from the participant’s medical record, including radiological and laboratory data\n• Continued collection of data post-discharge to determine medium-term outcomes, where this applies.\n• The processing of personal data associated with blood samples to be analysed.\n• The storage only of personal data for future research.",null,null,"N/A"]
[null,"HRCDC Meeting Date","13th May 2020 (COVID Meeting)",null,null,"N/A"]
[null,"HRCDC Decision Date ","13th May 2020 (COVID Meeting)",null,null,"N/A"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"N/A"]
[null,"Specific Conditions attached ","Condition 1: It is a condition of this declaration that, if the next-of-kin does not provide assent for the study, the personal data collected for this study up that point, including personal data associated with the biosamples should be deleted. For the avoidance of doubt the processing, including retention, of personal data where next-of-kin assent is not provided will not fall under the scope of the declaration. [CONDITION MET]\n\nCondition 2: All biosamples and associated personal data should be pseudonymised at the hospital site, to ensure data protection safeguards are in place, as soon as practicably possible. [CONDITION MET]\n\nCondition 3: The HRCDC request that, where a patient continues to lack capacity for a prolonged period of time and where the nextof-kin assent remains in place, as an additional safeguard the Applicant should seek confirmation from the next-of-kin (or individuals) who provided assent, that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.  [CONDITION UNDERWAY]\n\n","Condition 4: The Applicant is requested to ensure that appropriate agreements, governing the transfer and use of personal data and samples, are in place between the data controller of the study and those who will receive personal data and samples. Where appropriate this should include suitable safeguarding arrangement to ensure the anonymity of participants, where relevant. [CONDITON UNDERWAY]\n\nCondition 5: It is a condition of the declaration that the level of public and patient involvement (PPI) in the development of this study is enhanced to ensure knowledge in context and experience can be gained through direct engagement with the public and patients. Engagement with representative groups such as ICUsteps should be considered as should the dissemination of study findings with participants, their families and PPI groups. The Applicant should also be aware of the recent statement made by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), setting out the importance of understanding the patient perspective during the COVID-19 pandemic. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review.  [CONDITION UNDERWAY]\n\n","Condition 6: For the avoidance of doubt the scope of this declaration applies only to scope of the existing Research Ethics Committee (REC) approval. Any additional activity, such as transferof identifiable personal data to the US will require an amendment to the declaration following any REC approval. [CONDITON MET)\n\nCondition 7: The HRCDC requests the Applicant to review and\namend accordingly, the study information leaflets and consent/assent forms to incorporate the following points for clarity and consistency of information; \n- It should be transparent that biosamples and coded personal data are being transferred to collaborators, including outside of Ireland to the US\n- It should be transparent to the next-of-kin what will happen to the personal data and biosamples collected, if the participant regains capacity, and does or does not provide consent to continue in the study. It should also be clear what shall happen if the participant does not regain capacity.\n- The section on ‘future research’ should be more clearly described as it confusing to follow.\n- The HRCDC’s role is inaccurate and should be amended in consultation with the Secretariat.\n- In general, more accessible and less technical language should be utilised within the information leaflets regarding data protection rights and the lawful basis for the study, rather than referencing GDPR. [CONDITON MET]\n","N/A"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Conditional Declaration is made commencing 13th May 2020 and is required for 5 years after the study concludes at the end of 2020 (until December 2025), after which the personal data will be destroyed.",null,null,"N/A"]
[null,"Status of Declaration","Declaration No Longer Required",null,null,"Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The Applicant is recommended to carefully consider more specific and clearly defined research questions, in order to determine what minimal data should be collected and used for attaining the research objective. It should also be considered if data being collected could be more generalised, such as collecting geographical location rather than the participant address. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The Applicant should ensure that when seeking assent, from 16/17yr over participants, care should be taken as to the needs of those individuals to avoid causing any unnecessary distress.[RECOMMENDATION CONSIDERED]\n\nRecommendation 3. The Applicant is recommended to consider developing a more tailored data protection policy focused on the study itself rather than rely on the Hospital data protection policy, which is more generalised and does not accurately or transparently reflect the data processing activities of this study. The Applicant should consider discussing more broadly with the Data Protection Officer how transparency measures could be improved upon for this study. [UNDER CONSIDEREATION]",null,null,"N/A"]

{"sheet":"20-010-AF1-COV","index":55,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[[15,1,16,1],[15,2,16,2]]}
[]
[null,"Application Ref","20-010-AF1/COV "]
[null,"Application Title ","COVID-IYON Study"]
[null,"Applicant Organisation (Data Controller)","University Hospital Limerick"]
[null,"Lead Applicant ","Prof Linda Coate"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","This study will collect real-time observational data regarding the impact of SARS-CoV-2 infection on patients with cancer, and on the functioning and organisation of cancer and malignant haematology services in the Republic of Ireland in response to the 2020 SARS-CoV-2 pandemic. This data is being collected in order to help coordinate national and local emergency responses to the ongoing SARS-CoV-2 pandemic within the national cancer and malignant haematology centres in the Republic of Ireland."]
[null,"Reason for seeking a Declaration","The scope of the declaration being sought is for the processing of personal data of oncology & malignant haematology inpatients diagnosed with COVID-19 at relevant study sites who are unable to provide informed consent for reasons of diminished capacity.\nThe data processing activities include; collection, pseudonymisation, analysis, transfer to lead site, storage/archiving and retention of personal data."]
[null,"HRCDC Meeting Date","30th April 2020"]
[null,"HRCDC Decision Date ","30th April 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC has requested that all appropriate contractual arrangements (legal agreements) must be in place between the lead Data Controller study site and individual Hospital study sites regarding the transfer of personal data for the purpose of the research study. The processing activity of transferring data between the sites cannot commence until these arrangements are in place. Confirmation that these agreements are in place must also be provided to the HRCDC. (Condition Met)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 30th April 2020 and shall be valid for the study duration of 1 year and a further 5 years after the study has concluded (April 2026)."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC recommends that the study information leaflets and consent forms are revised to taking into account the points herein. Please provide any updated study information leaflets to the HRCDC for information purposes.\n\ni) The HRCDC notes the reference to ‘patient’s legal representative’ (SI.190/2004) in the application, and that the study information leaflets and consent forms require a signature from a ‘Legally Acceptable Representative’. To help prevent any assumption that all relatives or next of kin are legally appointed authorised individuals to provide consent for data processing, the HRCDC recommends a clear alternative such as ‘Representative providing assent’, or ‘Next of Kin/Relative/Friend Representative’.\n\nii) The study information leaflets state ‘Your Name, Date of Birth, Hospital Number, Phone Number, Address, or any other identifiable information about you will not be collected for this study’. However, it is noted that the personal data collected is pseudonymised, and a decoding log is held at each site. To ensure clarity for participants, the HRCDC recommends revising this section of the information leaflet to reflect that identifiable information is collected, retained and pseudonymised as part of this study.\n\niii) The relative information forms states ‘We will understand if you do not want to take on this responsibility. Further clarity should be further provided on what will happen to their relative/friend in relation to participation in the study if they do not wish to provide assent on their behalf.\n[RECOMMENDATION CONSIDERED]\n\nRecommendation 2: Given the current unknown duration of the current COVID19 health crisis, the HRCDC discussed that the Applicant may need to consider extending the study duration as necessary. If the study is extended, the Applicant may submitan amendment to the HRCDC seeking an extension to the declaration. [RECOMMENDATION CONSIDERED]"]

{"sheet":"20-012-AF1-COV","index":56,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,1,12,1],[11,2,12,2]]}
[]
[null,"Application Ref","20-012-AF1/COV"]
[null,"Application Title ","COVID-19 Bioresource"]
[null,"Applicant Organisation (Data Controller)","St James's Hospital"]
[null,"Lead Applicant ","Clíona Ní Cheallaigh"]
[null,"Research commenced prior to submission of application","Yes"]
[null,"Research Objective","Principal Investigators at St James’s Hospital who will require samples and data from COVID-19/ SARS-CoV-2 patients for research are collaborating on a single project entitled ‘COVID-19 Bioresource’. This will involve a single sample and data collection point, with a single consent process linked to several project arms conducted by St James’s Hospital investigators in collaboration with Trinity College Dublin. Given the importance of COVID-19 research, and the limited time/ cohort for sample collection, this project will also establish a biobank of samples and a data registry that will be available to other researchers in Trinity/SJH and other institutions. This study will involve sample collection (blood, urine, respiratory mucus) and data collection (relevant to COVID-19 exposure risk, infection, diagnosis and symptom severity)."]
[null,"Reason for seeking a Declaration","A consent declaration is being sought for the following data processing activities where participants are unable to provide consent due to lack of decision-making capacity:\ni) The collection of personal identifiable data solely for the purpose of linking to biosamples collection, where next-of-kin assent has been obtained.\nii) The collection of personal data from participant medical records and transfer of coded data to a local study database, where next-of-kin assent has been obtained."]
[null,"HRCDC Meeting Date","20th May 2020 (COVID Meeting)"]
[null,"HRCDC Decision Date ","20th May 2020 (COVID Meeting)"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: It is a condition of this declaration that data processing is strictly limited to the collection and storage only of;\ni) personal data related to biosample collection; and\nii) all personal data uploaded onto the research study database, until such time until such time individuals regain capacity to consent.\nIt must be explicitly clear on all records of data collected that further use is not permitted until explicit consent is sought. [CONDITION MET]\n\nCondition 2: Other than those strictly permitted to manage the Bioresource, there should be no access and use by any party, including third parties, to personal data and associated biosamples until the participants regain capacity and provides their consent. [CONDITION MET]\n\nCondition 3: A subsequent application or amendment as appropriate must be submitted to the HRCDC for any further processing of the personal data and associated biosamples collected for further research, where individuals do not regain capacity to consent. [CONDITION MET]\n\nCondition 4: The HRCDC has noted and acknowledges that there will be a patient representative on the Steering group for the Bioresource. However, the level of public and patient involvement (PPI) in the development of this study should be enhanced to ensure knowledge in context and experience can be gained through\ndirect engagement with the public and patients. Engagement with representative groups such as ICUsteps should be considered as should the dissemination of study findings with participants, their families and PPI groups. The Applicant should also be aware of the recent statement made by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), setting out the importance of understanding the patient perspective during the COVID-19 pandemic. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review. [CONDITION UNDERWAY]\n"]
[]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 20th May 2020 and shall be valid until such time the participants regain decision-making capacity to provide explicit consent"]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: Where the participant regains capacity and wishes to withdraw from this study, the approximate timeframe for removing personal data and associated biosamples should be explicitly set out in information leaflets. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2: The Applicant should always confirm if there is a legally authorised representative available, prior to seeking next-of kin or friend assent. [RECOMMENDATION CONSIDERED]\n\nRecommendation 3: The Applicant should consider the appropriateness of seeking consent or assent by email and any potential privacy issues. [RECOMMENDATION CONSIDERED]\n\nRecommendation 4: Given the large-scale collection of personal data for the COVID Bioresource overall, it is recommended to consider ensuring only as minimal data as possible is collected, such as, for example, record year of birth as opposed to date of birth. [RECOMMENDATION CONSIDERED]\n\nRecommendation 5: Given the scope of the COVID19 Bioresource and its purpose to facilitate research of such public importance, it is recommended that the Applicant enhance the transparency of the Bioresource and research projects it supports, for the general public and patients. This could be achieved through, for example, the use of public notices in hospitals and the development of a website where possible. [RECOMMENDATION CONSIDERED]"]

{"sheet":"20-013-AF1-COV","index":57,"n_rows":17,"n_cols":6,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,2,12,2],[11,1,12,1],[11,3,12,3],[11,4,12,4],[11,5,12,5]]}
[null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref","20-013-AF1/COV",null,null,"20-013-AF1/COV/AMD1"]
[null,"Application Title ","WHO Solidarity Trial",null,null,"WHO Solidarity Trial"]
[null,"Applicant Organisation (Data Controller)","University College Cork\nDepartment of Health, Ireland",null,null,"University College Cork\nDepartment of Health, Ireland"]
[null,"Lead Applicant ","Joe Eustace",null,null,"Joe Eustace"]
[null,"Research commenced prior to submission of application","No",null,null,"No"]
[null,"Research Objective","Coronavirus disease 2019 (COVID-19) is a respiratory-like illness which was first identified in Wuhan, China in December 2019. It has quickly spread across the world and the World Health Organisation (WHO) declared it a pandemic in March 2020. COVID-19 is estimated to infect between 10-40% of the population and potential fatality for COVID-19 ranges from 1->3%. The first COVID-19 positive patients in Ireland were identified in March 2020. In early 2020, there were no approved anti-viral treatments for COVID, and WHO expert groups advised that four re-purposed drugs, Remdesivir, Lopinavir (given with Ritonavir, to slow hepatic degradation), Interferon (β1a), and chloroquine or hydroxychloroquine should be evaluated in an international randomised trial. SOLIDARITY is the WHO international randomised clinical trial of additional treatments for COVID-19 in hospitalised patients who are receiving the local standard of care. SOLIDARITY will test the effectiveness of the four re-purposed drugs mentioned above to treat COVID-19. ",null,null,"Coronavirus disease 2019 (COVID-19) is a respiratory-like illness which was first identified in Wuhan, China in December 2019. It has quickly spread across the world and the World Health Organisation (WHO) declared it a pandemic in March 2020. COVID-19 is estimated to infect between 10-40% of the population and potential fatality for COVID-19 ranges from 1->3%. The first COVID-19 positive patients in Ireland were identified in March 2020. In early 2020, there were no approved anti-viral treatments for COVID, and WHO expert groups advised that four re-purposed drugs, Remdesivir, Lopinavir (given with Ritonavir, to slow hepatic degradation), Interferon (β1a), and chloroquine or hydroxychloroquine should be evaluated in an international randomised trial. SOLIDARITY is the WHO international randomised clinical trial of additional treatments for COVID-19 in hospitalised patients who are receiving the local standard of care. SOLIDARITY will test the effectiveness of the four re-purposed drugs mentioned above to treat COVID-19. "]
[null,"Reason for seeking a Declaration","A declaration is being sought for the purpose of processing (collecting, storing and pseudonymising, analysing, transferring, archiving) personal data of study participants who lack decision making capacity.",null,null,"The amendment request relates to a change in the study’s treatment arms and an extension of the duration of the consent declaration, from 5 years from the end of the study to 25 years, as per the new Clinical Trials Regulations.  "]
[null,"HRCDC Meeting Date","20th May 2020 (COVID Meeting)",null,null,"8th November 2022"]
[null,"HRCDC Decision Date ","20th May 2020 (COVID Meeting)",null,null,"8th November 2022"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. Public and Patient Involvement (PPI): \nThe HRCDC acknowledges that engagement with the patient support group ICUsteps has commenced. The Applicant is asked to further enhance the level of PPI in the development of this study. In particular, the HRCDC requests that a PPI representative is brought onto the Oversight Group to provide patient and public representation, if this representation is not already in place. Engagement with other representative groups where possible should be considered. Dissemination of study findings with participants, their families and PPI groups should also be carried out to strengthen patient and public engagement. The HRCDC notes the recent statement made by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), setting out the importance of understanding the patient perspective during the COVID-19 pandemic. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review. [Condition underway]\n\nCondition 2. Data Minimisation: The HRCDC requests that data minimisation safeguards are further enhanced by ensuring that only the Patient Study ID number is noted on Form A and not the Medical Record Number/hospital chart number. [Condition met]\n\n","Condition 3. Consent and Assent Protocols: The HRCDC has requested that the Applicants review and amend specific consenting and assenting protocols as follows;\nAssent:\n- Separate study information leaflets and assent forms should be developed for those individuals who are providing assent by telephone.\n- To ensure the individual has time to reflect on the information verbally given by the research team, the study information leaflets should be sent to the individual providing assent by email/electronically or post where appropriate and as safe to do so.\n- The individual providing assent should be asked if their relative/friend/cared has ever discussed views on research or their ‘will and preference’ on this area.\n- Assent obtained by telephone should be witnessed where possible, for record purposes. \n\nConsent:\n- It is not clear from the consent protocol if sufficient paper or photocopy records of the signed consent forms are kept by both the participant and research team. It is not clear if the participant will have a copy of the Patient information leaflet for their own records. The consent protocol should be carefully reviewed to ensure informed consent is recorded adequately for the benefit of both the research team and the participant.\n- Where a participant regains capacity to consent, they should be provided with a specific ‘continuation in the study’ consent form and information leaflet, which clearly explains what has happened to them, how they became enrolled in the study and by whom, and their options going forward.  [Condition met]","Condition 4. Information Leaflets and Consent/Assent Forms:\nThe HRCDC has requested that the study information leaflets and accompanying assent and consent forms, should be carefully reviewed and amended as necessary to ensure there is clarity and consistency of information provided to the participants or individual providing assent. This will ensure there is an appropriate level of transparency and allow informed consent and the safeguard of assent to be obtained for the study. More specifically the following information points should be addressed;\n- The information leaflets describe what side effects may occur, how a participant may join the study and then learn more about the specific risks of treatment they are receiving. This section of the form should be revised and tailored for individuals who are providing assent. \n- The information leaflets should more clearly explain if personal data is archived or destroyed in scenarios where i) assent is not provided ii) the participant withdraws from the study at any stage\nand ii) the participant becomes deceased.\n- The Information leaflets states that data will be retained for 25yrs, which is misaligned with the information set out in application form stating that data will be archived for 5yrs after the study has commenced. This should be corrected. [Condition met]","Condition 1. The Applicant is requested to ensure that a copy of the study information leaflet and proxy assent form is forwarded to the individual who provides proxy assent on behalf of the participant who lacks decision making capacity; a copy of the study documentation should therefore be provided to the participants (n=9) who have already been recruited to study regarding the two new treatment arms (Infliximab and Imatinib), if not already done so, and a copy also forwarded to the individual providing proxy assent for future prospective participants as a standard study procedure.  "]
[]
[null,"Deadline for meeting any conditions","N/A",null,null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 20th May 2020 and shall be valid for 5 years after the study has been completed. If an extension the declaration is required, an amendment to the declaration should be submitted to the HRCDC for consideration\n",null,null,"The Declaration is made commencing 20th May 2020 and shall be valid for 25 years after the study has concluded. This is an extension of the duration of the declaration initially made."]
[null,"Status of Declaration","Declaration No Longer Required",null,null,"Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: As this is a largescale multi-site clinical trial, the HRCDC recommends that the Data Controllers ensure that all information set out in data protection policies and other protocols is clear and consistent across all hospital sites participating in the trial. [Recommendation considered]\n\nRecommendation 2: In line with the information available on the World Health Organisation website which states ‘“Solidarity” clinical trial for COVID-19 treatments’, it should be transparent in all communications that this study is a multi-site clinical trial.[Recommendation considered]\n\nRecommendation 3: ‘The Privacy Notice for COVID -19 Research’ should be revised for clarity to state ‘that an independent committee (Health Research Consent Declaration Committee) may allow your personal data to be used for the research study to take place without your consent.’ (The HRCDC role specifically relates to data processing for health research). It should also be made clear that assent from a next-ok-kin or suitable individual will be sought as a safeguard and to ensure their will and preference can be taken into consideration.[Recommendation considered]\n\nRecommendation 4: It is noted that a communication strategy will be put in place by the Oversight Group. It is recommended that the details of the progress and implementation of this strategy is provided to the HRCDC as part of the Annual Review. [Recommendation considered]",null,null,"N/A"]

{"sheet":"20-015-AF1-COV","index":58,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","20-015-AF1/COV "]
[null,"Application Title ","The ESMO-CoCARE Registry for patients with a Malignancy who are diagnosed with COVID-19"]
[null,"Applicant Organisation (Data Controller)","European Society For Medical Oncology (ESMO)"]
[null,"Lead Applicant ","Maccon Keane"]
[null,"Research Objective","The European Society for Medical Oncology (ESMO) has launched an international collaborative registry, ESMO-CoCARE, to further the understanding of the COVID-19 and its impact on the care and management of cancer patients who are diagnosed with COVID-19. This is part of a global initiative, in collaboration\nwith the CCC19 (COVID-19 & Cancer Consortium), to pool real world data and thus rapidly accumulate knowledge, which will inform and provide guidance on the clinical management of these patients. The purpose of this international registry is:\ni. The identification of factors potentially associated with disease severity;\nii. The development of a tailored risk assessment strategy for cancer patients;\niii. To provide a means of proposing recommendations for cancer patient management that are based on reliable, real-world observations. "]
[null,"Reason for seeking a Declaration","A declaration is requested for the following data processing activities to be carried out in Ireland for the purpose of the ESMOCoCARE Registry:\ni. The collection and pseudonymisation of existing patient data from medical records at the hospital by staff in that hospital, and\nii. The uploading/transferring of pseudonymised data to ESMOCoCARE Registry by the hospital staff."]
[null,"HRCDC Meeting Date","26th May 2020"]
[null,"HRCDC Decision Date ","26th May 2020"]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-016-AF1-COV","index":59,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","20-016-AF1/COV "]
[null,"Application Title ","Clinical Characteristics of Dysphagia and Communication Difficulties among Hospitalised Adults with COVID-19 in Ireland: An Observational Cohort Study"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dubin"]
[null,"Lead Applicant ","Dr Julie Regan"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","This multi-site observational cohort study aims to establish to clinical characteristics of people presenting with swallowing and communication (speech, voice, language) difficulties due to COVID-19 in hospital settings across Ireland and to identify factors associated with positive outcomes in this population. It also seeks to establish the swallowing and communication rehabilitation needs and services provided within this clinical population. A dataset has been developed and will be used by nominated speech and language therapists (SLTs) across healthcare settings to obtain demographic and clinical data from adults with confirmed COVID19 who have been admitted into hospital or rehabilitation settings in Ireland and referred to speech and language therapy services."]
[null,"Reason for seeking a Declaration","For the purpose of accessing, collecting, pseudonymising and analysis of personal data of patients who have been referred to a Speech and Language Therapist post COVID19.  "]
[null,"Scheduled HRCDC Meeting Date","10th June 2020"]
[null,"HRCDC Decision Date ","10th June 2020"]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-020-AF1-COV","index":60,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref","20-020-AF1/COV "]
[null,"Application Title ","Irish Coronavirus Sequencing Consortium"]
[null,"Applicant Organisation (Data Controller)","Teagasc"]
[null,"Lead Applicant ","Paul Cotter"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","This study aims to discover the genetic makeup of coronavirus (SARS-CoV-2), the virus that is causing the current pandemic of COVID-19, by looking at the cDNA sequence of the virus from samples taken from COVID–positive patients throughout Ireland. Coronaviruses can mutate or change the proteins on their surface, making it more difficult to develop an effective vaccine against them. These mutations or changes have not been observed as much in the coronavirus causing COVID-19 (SARS-CoV-2). However, it is important to keep monitoring this to ensure the coronavirus doesn’t change in such a way that makes it even more difficult to treat or vaccinate against. By sequencing samples from all over the country, the study will be able to help show how the virus is spreading in the community and, also, between Ireland and other countries. "]
[null,"Reason for seeking a Declaration","Consent has or will be obtained from many participants. \nA declaration is therefore only required to process the data of retrospective patients whose samples have already been obtained and were tested for COVID-19 in the National Viral Reference Laboratory (NVRL) and in the consortium hospital labs at the beginning of the pandemic; this includes clinical and community tested samples.  A declaration is also required for future/prospective patients who will be tested for COVID-19 in the community as part of standard detection testing for the virus (e.g. drive through testing centres). These samples are tested in the NVRL and consortium hospital labs. The data processing activities include the collection, pseudonymisation and transfer of patient data for the purpose of this study. When sequenced, the viral genome and the associated pseudonymised/de-identifed data will be uploaded to publicly accessible database websites for analysis."]
[null,"Scheduled HRCDC Meeting Date","25th June 2020"]
[null,"HRCDC Decision Date ","25th June 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The Applicant must ensure that all appropriate legal agreements or arrangements, as required, governing the transfer and use of data and associated samples are concluded between the Data Controller and Data Processors, and other parties as required. The agreements/arrangements should have clear terms and conditions regarding the retention and destruction/return of the data and associated samples once the data processing activities have concluded. This condition must be met prior to the commencement of data processing.  (CONDITION MET)\n \nCondition 2: The Applicant is requested to enhance the level of transparency for this study such that the retrospective participant cohort, can be made aware of the existence of the study. For both retrospective and prospective participants, the Applicant is requested to clearly outline in transparency notices and study information leaflets, the participant’s data protection rights and specify the options available if the participant wishes to withdraw from the study, including if there is a point in time when data cannot be withdrawn. The Applicant is requested to report on the measures taken as part of the Annual Review.  (CONDITION MET)\n\nCondition 3: The HRCDC considers public and patient involvement (PPI) in health research an important safeguarding element, in particular, where no explicit consent is being sought, to ensure a public/patient perspective is reflected in the overall study. The Applicant is requested to enhance the level of PPI in the study. If there are constraints using normal means to engage with PPI representatives and advocacy groups in light of the ongoing coronavirus situation, alternative means should be considered such as email and videoconference, as appropriate. The HRCDC notes the recent statement made by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), setting out the importance of understanding the patient perspective during the COVID19 pandemic. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review.  (CONDITION MET)"]
[null,"Deadline for meeting any conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 25th June 2020 and shall be valid for six months, and 15 years thereafter (until 31st December 2035) or upon confirmation that the data has been irrevocably rendered anonymised or destroyed, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC recommend that the Data Controller of the study, limit uploading of pseudonymised/de-identified data associated with the viral genome data, to the EMBL’s European Bioinformatics Institute COVID-19 Portal, as it is aligned with European Open Science Cloud (EOSC) principles. The EOSC enables FAIR data use (Findable, Accessible, Interoperable, Reusable) in a trusted and safe manner and facilities research productivity and improved reproducibility in science, which would be in the public interest for this particular study. If other non-EU open access databases are used, it is recommended to ensure that there are robust security measures of GDPR standard, and data sharing principles similarly aligned to, and no less stringent, than European Open Science Cloud (EOSC) principles. It is recommended to consult with the Data Controller’s Data Protection Officer to ensure that all public databases meet appropriate data protection standards. (RECOMMENDATION CONSIDERED)\n \nRecommendation 2:  The Applicant must ensure that data is transferred securely between all the parties in the study. Specifically, where data is to be transferred using USB device the Applicant is requested to examine other secure methods of transfer to mitigate data protection risks. (RECOMMENDATION CONSIDERED)"]

{"sheet":"20-021-AF1-COV","index":61,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-021-AF1/COV "]
[null,"Application Title ","ReCaP: Rectal cancer Management During the COVID-19 Pandemic"]
[null,"Applicant Organisation (Data Controller)","University Hospital Waterford"]
[null,"Lead Applicant ","Fiachra Cooke"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The ReCap study is a multicentre study being conducted by surgical researchers in the UK and Ireland. The study is being performed to assess the impact of changes in rectal cancer management during the COVID-19 pandemic on patient outcomes from rectal cancer. \n \nThe study will be performed in two stages: Phase I - Audit: The first stage will involve collection of audit data regarding rectal cancer management from patients diagnosed with and treated for rectal cancer during the COVID-19 pandemic. This data will be compared with standard pre-pandemic rectal cancer management using pre-pandemic guidelines and rectal cancer audit data collected prior to the pandemic. The survival data from these patients will be collected to complete the audit data collection at 5 years post-pandemic. \n \nPhase II - Research: The second stage of the study will involve inviting patients who were diagnosed or treated for rectal cancer during the COVID-19 pandemic to complete surveys assessing their experience of treatment and their quality of life after treatment. Surveys will be performed at 1 and 3 years post-pandemic."]
[null,"Reason for seeking a Declaration","A declaration is being sought for the following data processing activities: \ni)\tcollecting, transferring, storing, pseudonymising multi-site audit data of participants for research purposes;  \nii)\tcollecting survival data from medical records for the same participants at 3 and 5 years, post treatment;  \niii)\t linking the audit survival data with survival data collected by the National Cancer Registry of Ireland (NCRI);\niv)\t review of the identifiable, multi-site audit data, for the purpose of inviting participants to Phase II (Research) of the study;\nv)\tsurvival data from the participant’s medical records will be collected and cross-referenced with NCRI if explicit consent for the Phase II surveys cannot be obtained i.e. if participants do not respond to an invite to participate."]
[null,"Scheduled HRCDC Meeting Date","23rd September 2020"]
[null,"HRCDC Decision Date ","23rd September 2020"]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-022-AF1","index":62,"n_rows":16,"n_cols":7,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref ID","20-022-AF1",null,"20-022-AF1/AMD1","20-022-AF1/AMD2"]
[null,"Application Title ","PHIND Study",null,"PHIND Study","PHIND Study"]
[null,"Applicant Organisation (Data Controller)","Queens University Belfast\nSt Vincent's University Hospital\nBelfast Health and Social Care Trust",null,"Queens University Belfast\nSt Vincent's University Hospital\nBelfast Health and Social Care Trust","Queens University Belfast\nSt Vincent's University Hospital\nBelfast Health and Social Care Trust"]
[null,"Lead Applicant ","Alistair Nichol",null,"Alistair Nichol","Alistair Nichol"]
[null,"Research commenced prior to submission of application","No",null,"No","No"]
[null,"Research Objective","Severe lung failure called acute respiratory distress syndrome (ARDS) is frequently encountered in intensive care units throughout the world. Various causes such as infection in the lung or elsewhere in the body, trauma, blood transfusion etc. can lead to this clinical\ncondition. While supportive care has improved the outcomes, there is still no definitive drugbased treatment for this condition. Current treatment is limited to supportive care with lung support (ventilation), antibiotics and other routine care as required.\nThe research efforts of the critical care community over the last decade has led to the identification of sub-types of ARDS that might help us provide personalised therapy and reduce death and disability. The laboratory tests required to identify patients of a specific sub-type are currently not available as a routine test or a rapid bedside test. Rapid bedside identification of patients with a specific sub-type of ARDS could influence the therapy provided to them including drug therapy and enable the development of newer therapies. In this trial we will test blood samples from patients with ARDS to confirm the presence of the subtypes of ARDS identified in previous studies and test a novel rapid bedside test. From this we can work out how accurate or useful these new tests might be. This study is observational in nature and the results of these new tests will not change the care received.",null,"Severe lung failure called acute respiratory distress syndrome (ARDS) is frequently encountered in intensive care units throughout the world. Various causes such as infection in the lung or elsewhere in the body, trauma, blood transfusion etc. can lead to this clinicalcondition. While supportive care has improved the outcomes, there is still no definitive drugbased treatment for this condition. Current treatment is limited to supportive care with lung support (ventilation), antibiotics and other routine care as required.The research efforts of the critical care community over the last decade has led to the identification of sub-types of ARDS that might help us provide personalised therapy and reduce death and disability. The laboratory tests required to identify patients of a specific sub-type are currently not available as a routine test or a rapid bedside test. Rapid bedside identification of patients with a specific sub-type of ARDS could influence the therapy provided to them including drug therapy and enable the development of newer therapies. In this trial we will test blood samples from patients with ARDS to confirm the presence of the subtypes of ARDS identified in previous studies and test a novel rapid bedside test. From this we can work out how accurate or useful these new tests might be. This study is observational in nature and the results of these new tests will not change the care received.","Severe lung failure called acute respiratory distress syndrome (ARDS) is frequently encountered in intensive care units throughout the world. Various causes such as infection in the lung or elsewhere in the body, trauma, blood transfusion etc. can lead to this clinicalcondition. While supportive care has improved the outcomes, there is still no definitive drugbased treatment for this condition. Current treatment is limited to supportive care with lung support (ventilation), antibiotics and other routine care as required.The research efforts of the critical care community over the last decade has led to the identification of sub-types of ARDS that might help us provide personalised therapy and reduce death and disability. The laboratory tests required to identify patients of a specific sub-type are currently not available as a routine test or a rapid bedside test. Rapid bedside identification of patients with a specific sub-type of ARDS could influence the therapy provided to them including drug therapy and enable the development of newer therapies. In this trial we will test blood samples from patients with ARDS to confirm the presence of the subtypes of ARDS identified in previous studies and test a novel rapid bedside test. From this we can work out how accurate or useful these new tests might be. This study is observational in nature and the results of these new tests will not change the care received."]
[null,"Reason for seeking a Declaration","A consent declaration is required for the processing of personal data of participants who lack decision-making capacity. The data processing activities include: \n-\tProcessing personal data for the purpose of the trial (i.e. access, collection, pseudonymisation, transfer, analysis and archiving of personal data obtained from the patient’s and hospital records as well as their relative or decision maker) \n-\tCollecting and analysing survival data from the participant’s GP\n-\tStorage of personal data only for future research (including personal data associated with the samples)",null,"The amendment is to reflect a change to the study’s consent model. Some participants will lack decision-making capacity to consent due to the nature of their illness; assent is obtained from their next-of-kin/proxy in a face-to-face encounter, and they provide written assent. During a pandemic, family members are placed under severe visiting restrictions as per hospital policy, rendering a face-to-face discussion challenging. The study proposes to contact the next-of-kin by telephone and seek to obtain their assent over the phone. The assent form will also be sent to the relative to be signed and returned. ","The amendment is requested for the following activities:\n(i)\tThe addition of two new hospital sites to the study who will also be data processors i.e., Beaumont Hospital and Galway University Hospital. RCSI are also added as a data processor given their involvement in the study at Beaumont Hospital. \n(ii)\tThe inclusion of patients with Acute Hypoxemic Respiratory Failure (AHRF), which is in addition to those patients with ARDS. "]
[null,"Scheduled HRCDC Meeting Date","4th September 2020",null,"20th July 2021","13th June 2023"]
[null,"HRCDC Decision Date ","4th September 2020",null,"20th July 2021","13th June 2023"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. For participants who lack decision-making capacity and next-of-kin assent has been obtained, the scope of this declaration does not extend to the sharing of personally identifiable data (e.g. names, address) with data controllers outside the jurisdiction of the State for the purpose of collecting the 60-day follow-up data. This is an important safeguard in line with the data protection principle of data minimisation. (CONDITION MET)\n\nCondition 2. Where the participant passes away within the 7 days of study enrolment, relative assent should still be sought to process the participant’s personal data for the purpose of this study. (CONDITION MET)\n\nCondition 3. All necessary contractual arrangements including joint data controller arrangements, must be in place with the relevant institutions regarding the governance, transfer and use of personal data and associated biosamples for this research study. The Data Controller should ensure the terms of any transfer of personal data has regard for the post-Brexit transition period. \n-\tFor the avoidance of doubt the sharing and transfer of personal data and associated biosamples to other data controllers and processors cannot commence until this condition is confirmed to be met by the HRCDC, as substantiated by the Applicant. \n-\tIt is advisable to discuss this condition with the relevant Institution’s legal office and Data Protection Officers, as appropriate. (CONDITION MET)\n","Condition 4. The data protection officer (DPO) feedback on the data protection impact assessment, on behalf of the joint data controller Belfast Health and Social Care Trust, must be provided to the HRCDC prior to the sharing transfer of personal data to this Data Controller, in line with the timeline for meeting Condition 1. This feedback provided by the DPO, should note any data protection risks and mitigating actions, that has or will be sufficiently addressed or implemented by the Applicant. (CONDITION MET)\n\nCondition 5. An authorised signature on the HRCDC Application on behalf of Belfast Health and Social Care Trust, must be provided in line with the timeline of Condition 4. (CONDITION MET)\n\nCondition 6. As part of the annual review the Applicant is requested to report on the proportion of participants who continue to lack decision-making capacity and whose personal data therefore remains subject to the consent declaration that has been made. (CONDITION MET)","N/A","Condition 1. The Applicant must ensure that the required data agreements/arrangements are in place between the data controllers of this study and the new data processors. The processing and transfer of personal data by these processors for this study cannot commence prior to the required agreements being in place.  [CONDITON MET]\n\nCondition 2. It is noted that research ethics approval for the Galway site has been made by the Chairperson of the Galway REC, which is due to be ratified by the full research ethics committee. The Chairperson approval must be ratified by the full REC as stated in the REC letter, and confirmation of such must be submitted to the HRCDC. The consent declaration does not cover Galway University Hospital unless approval has been ratified by the full REC. [CONDITON MET]\n\nCondition 3. It is noted that the proxy assent forms for the Beaumont Hospital site includes options to destroy the biological samples and associated data or to destroy the samples but to still retain the data derived from the sample for future research. If the study wishes to retain/store data for future research in circumstances where the samples are still destroyed, then clear information \nshould be provided to the proxy, and their assent for this continued data storage should be obtained. If these options also apply to other sites outside of Beaumont, then it should also be included in that site’s study documents. Further, it remains that deferred consent should still be obtained from the participant when they regain decision-making capacity to continue to store \nand/or use data associated with already destroyed bio-samples for future research. [CONDITON MET]","Condition 4. To ensure clarity and consistency of information for the participants and those providing proxy assent on their behalf, the study information leaflets and consent/assent forms should be reviewed and amended as follows prior to recruiting new participants:\n- The information provided by the Applicant outlined that the participant’s GP may be contacted/follow-up after 60-days. However, it is noted that the versions of the study information leaflets submitted with the amendment request do not provide such a timeframe; accordingly, the timeframe for contacting the GP could be seen as open-ended in the study information leaflets. The study documentation should therefore be clear that GPs will be contacted at 60-days. \n- Yes/no options for contacting the GPs should be included in the assent and consent forms for all sites.\n- The original information leaflets for St Vincent’s University Hospital and the new documents for Beaumont Hospital refer to measurement of genetic markers, however this is not included in the new information leaflets for Galway University Hospital. \n- The advice of the Beaumont DPO regarding more transparency on the future use with the consent of the participant, including genetic/genomic data and research should be addressed. \n- More generally, review the PILs across the study sites in Ireland to ensure the information is aligned and consistent throughout."]
[null,"Deadline for meeting Conditions","N/A",null,"N/A","N/A"]
[null,"Duration of Declaration ","The Conditional Declaration is made commencing 4th September 2020 and is valid until 31st December 2026 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner.",null,"The approval to the Amendment is made commencing 20th July 2021 and shall be valid until 31st December 2026 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner, in line with the duration of the consent declaration made.","The approval to the Amendment is made commencing 13th June 2023 and shall be valid until 31st December 2026 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner, in line with the duration of the consent declaration made. [This is in line with the previous consent declaration made]"]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1.  Where a patient continues to lack capacity for a prolonged period of time and where the next-of-kin assent remains in place, the Applicant should seek confirmation from the individual who provided assent, that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2. The Applicant is requested to review and amend the study information leaflets provided to participants to ensure that there is clarity and consistency of information that aligns with the data processing activities to be undertaken. Specifically, where study participants who are in a position to provide explicit consent and are not covered under this consent declaration, it should be clear from the information leaflets that personally identifiable information may be shared with researchers in Northern Ireland for the purpose of conducting the 60 day follow-up by contacting their GP. (RECOMMENDATION CONSIDERED)",null,"Recommendation. The HRCDC recommends the following actions for consideration regarding the telephone assent form: \n(i) a copy of the associated study information leaflet should be forwarded to the individual who is providing proxy assent on behalf of the study participant, prior to obtaining assent where possible,\n(ii) the assent form should request the proxy to confirm that they have had the opportunity to ask further questions about the study,\n(iii) contact information should be provided on the assent form should the proxy wish to discuss the study further. (RECOMMENDATION CONSIDERED)","Recommendation 1. Aligned with the scope of the consent declaration made, the Applicant is strongly recommended to review the proxy information leaflets and assent forms across all Irish sites and remove references that request the proxy to provide their assent for the use of the \nparticipant’s personal data in future research studies. As the consent declaration made is limited to the PHIND study only and the subsequent storage of this data thereafter, proxy assent for any future use should be limited to continued storage of the data only; the proxy should not be \nrequested to provide assent or permission to use/process the participant’s personal data in future research studies. Reference should also be made that a consent declaration has been made by the HRCDC. Where a participant regains decision-making capacity and provides deferred consent, the Applicant is also recommended to ensure that any consent for future research that is requested from the participants is compliant with data protection legislation. It is the responsibility of the data controller to ensure that participant consent for future research is valid and sufficient.\n\nRecommendation 2. A DPIA and DPO feedback from the Beaumont hospital site has been submitted with the amendment request form; it is also noted that the DPO from Queen’s University had no further comment following review. The Applicant is requested to ensure that a DPIA is kept up to date and covers all the sites in Ireland, including the Galway University Hospital site, and to seek equivalent feedback from the data controller(s) DPO. The DPO feedback from the hospital sites is also recommended.  "]

{"sheet":"20-023-AF1-COV","index":63,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-023-AF1/COV"]
[null,"Application Title ","Dysphagia and Communication Difficulties amongst Adults Hospitalised with COVID-19 across Ireland (DISCOVER): A multi-site retrospective cohort study \n "]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin"]
[null,"Lead Applicant ","Dr Julie Regan"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","This multi-site retrospective cohort study is being conducted to address the following research questions:  1. What are the clinical characteristics of swallowing and communication (voice, speech, language) difficulties amongst adults hospitalized with COVID19 across Ireland?  2. What variables are associated with swallowing and communication outcomes?  3. What are the swallowing and communication rehabilitation needs and services delivered to this clinical cohort?  \n \nPatients admitted into twenty-one participating clinical sites across Ireland with confirmed COVID-19 and who are referred to speech and language therapy are eligible for inclusion in this study. Verbal consent (if patients are unwell/inaccessible, verbal proxy assent plus deferred verbal consent) must be obtained to include data in this dataset as per NREC ethical approval. Clinical partners responsible for data entry at each clinical site will populate the local dataset and transfer data into researchers in TCD at two timepoints. Merged data will be analysed by TCD researchers. "]
[null,"Reason for seeking a Declaration","For the purpose of accessing, collecting, pseudonymising, transferring and analysis of pseudonymised data of COVID-19 positive participants who lack decision-making capacity and who have been referred to Speech and Language Therapy (SLT). Processing will also include the storage of personal data for future research purposes only.  "]
[null,"Scheduled HRCDC Meeting Date","28th July 2020"]
[null,"HRCDC Decision Date ","28th July 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to carefully review and revise the consent and assent protocol and documentation to ensure clarity and consistency of information provided, and that informed consent and assent is appropriately recorded. Specifically, the Applicant is requested to amend the protocol and documentation as follows:\n - Revise the study information leaflet being used as a script to obtain verbal consent/assent, to ensure information is provided in an appropriate format.  - Verbal consent/assent being obtained by the researcher, should where possible, be witnessed and recorded, for example by a witness countersignature. \n- Where verbal consent/assent is obtained, a copy of the study information leaflet and consent/assent forms should also be forwarded to the participant and/or those providing assent on their behalf. Where the participant resides in a residential care home, a copy should be kept on file in the participant’s records.  \n- Correspondingly, the signature of the participant, or those providing assent on their behalf, should be obtained on the consent/assent form and returned to the research team once verbal consent or assent has been provided. Infection control procedures, such as sealing the returned document for 14 days, should be undertaken. - A ‘consent to continue’ information leaflet and deferred consent form should be developed and used to obtain consent from those who regain decision-making capacity.  - Where assent is provided by an appropriate individual who understands the will and preference of the participant, references to ‘your explicit consent’ should be removed from the study information leaflets and assent forms. The Applicant should also outline the reasons why assent is being sought and that deferred consent will be obtained when the participant regains decisionmaking capacity. - It should be clarified in the documentation that consent/assent is requested to access records for the purpose of the research study, separate to care and treatment.  The Applicant is requested to report on the implementation of the above points as part of the Annual Review.  [CONDITION MET]\n ","Condition 2. It is a condition of the declaration that public and patient involvement (PPI) in the development of this study is enhanced to ensure knowledge in context and experience can be gained through direct engagement with the public and patients. Engagement with representative groups such as ICUSteps should be considered. The Applicant should also be aware of the recent statement made by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), setting out the importance of understanding the patient perspective during the COVID-19 pandemic. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review."]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The declaration is made commencing 28th July 2020 and valid until 31st December 2020 and for 7 years thereafter or until consent has \nbeen obtained from the participants or the personal data has been irrevocably anonymised or destroyed.   "]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The Applicant is recommended to review, and where necessary, update the DPIA form in consultation with the relevant data protection officer(s) to ensure that the data protection risks and mitigating actions remain applicable with regards to the updated study protocol. [RECOMMENDATION CONSIDERED]\n \nRecommendation 2. With regards to the implementation of the assent protocol, which is considered an important safeguard, the Applicant should be satisfied that; - decision-making capacity is established by the appropriate health care team, which may include health care teams within a residential care home. - the most appropriate individual who understands the will and preference of the participant and is providing assent on behalf of a participant who lacks decision-making capacity, is identified.  - if assent is being obtained outside a hospital setting, such as in a residential care home, it is done so in accordance with the residential care home’s policies and procedures.  [RECOMMENDATION CONSIDERED]"]

{"sheet":"20-024-AF1-COV","index":64,"n_rows":17,"n_cols":7,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1",null,null,"AMENDMENT #2"]
[null,"Application Ref ID","20-024-AF1/COV","20-024-AF1/COV/AMD1",null,null,"20-024-AF1/COV/AMD2"]
[null,"Application Title ","Genetics of Mortality in Critical Care (GenOMICC)","Genetics of Mortality in Critical Care (GenOMICC)",null,null,"Genetics of Mortality in Critical Care (GenOMICC)"]
[null,"Applicant Organisation (Data Controller)","St Vincent's University Hospital\nUniversity of Edinburgh\nNHS Lothian Health Board.","St Vincent's University Hospital\nUniversity of Edinburgh\nNHS Lothian Health Board.",null,null,"St Vincent's University Hospital\nUniversity of Edinburgh\nNHS Lothian Health Board."]
[null,"Lead Applicant ","Alistair Nichol","Alistair Nichol",null,null,"Alistair Nichol"]
[null,"Research commenced prior to submission of application","No","No",null,null,"No"]
[null,"Research Objective","Research has found that when individuals get an infection the extent to which they get sick (their susceptibility) varies depending on the person’s genetics (their DNA). Most cases are mild, but some people become very unwell. Individuals who get a more serious infection are considered to be more ‘susceptible’ to the pathogen (the organism eg bacteria, virus) causing the infection. Research has found that this susceptibility is specific to the cause of the infection. The likelihood of the patient doing well and recovering may also be related to their genetics among other factors. If these genetic factors which make an individual more susceptible could be identified then treatments which could make the susceptible patient more similar to people who have a mild infection could be developed. The study will look at genetic factors which make a patient more susceptible to critical illness from COVID-19 and genetic factors which may influence their recovery with the hope that such findings may further understanding of this infection and support future development of treatments. COVID-19 is a lung infection caused by a novel Coronavirus. Most patients experience a mild illness but some patients become critically ill. The study will try to determine why this is the case.","Research has found that when individuals get an infection the extent to which they get sick (their susceptibility) varies depending on the person’s genetics (their DNA). Most cases are mild, but some people become very unwell. Individuals who get a more serious infection are considered to be more ‘susceptible’ to the pathogen (the organism eg bacteria, virus) causing the infection. Research has found that this susceptibility is specific to the cause of the infection. The likelihood of the patient doing well and recovering may also be related to their genetics among other factors. If these genetic factors which make an individual more susceptible could be identified then treatments which could make the susceptible patient more similar to people who have a mild infection could be developed. The study will look at genetic factors which make a patient more susceptible to critical illness from COVID-19 and genetic factors which may influence their recovery with the hope that such findings may further understanding of this infection and support future development of treatments. COVID-19 is a lung infection caused by a novel Coronavirus. Most patients experience a mild illness but some patients become critically ill. The study will try to determine why this is the case.",null,null,"Research has found that when individuals get an infection the extent to which they get sick (their susceptibility) varies depending on the person’s genetics (their DNA). Most cases are mild, but some people become very unwell. Individuals who get a more serious infection are considered to be more ‘susceptible’ to the pathogen (the organism eg bacteria, virus) causing the infection. Research has found that this susceptibility is specific to the cause of the infection. The likelihood of the patient doing well and recovering may also be related to their genetics among other factors. If these genetic factors which make an individual more susceptible could be identified then treatments which could make the susceptible patient more similar to people who have a mild infection could be developed. The study will look at genetic factors which make a patient more susceptible to critical illness from COVID-19 and genetic factors which may influence their recovery with the hope that such findings may further understanding of this infection and support future development of treatments. COVID-19 is a lung infection caused by a novel Coronavirus. Most patients experience a mild illness but some patients become critically ill. The study will try to determine why this is the case."]
[null,"Reason for seeking a Declaration","For the purpose of collecting, storing, pseudonymising, analysing, sharing and archiving personal data of participants in the GenOMICC study, who lack decision-making capacity and who are COVID-19 positive. The declaration will also cover the storage only of personal data for future use. ","The amendment is requested to add a number of additional disease \ncohorts to this study i.e., disease cohorts beyond COVID-19 which  was the subject of the original HRCDC application. There are no  further changes to the study (e.g., data processing activities, assent/consent process etc.) ",null,null,"This amendment primarily relates to changes to the GenOMICC study for new participants. This amendment is requested for the following:\n1.\tData Controllership and data processors for prospective participant data:\n•\tGoing forward, each country in the GenOMICC study will, where possible, have their own local sponsor/data controller who will own the data/samples from their country. For new participants who will be enrolled in Ireland, there is now an Ireland specific GenOMICC protocol, with UCD the sponsor and data controller for Ireland; the purpose of the GenOMICC study in Ireland, the study procedures, the consent/assent process and data collection remain the same as was described the original application.\n•\tOn the processing of data of these prospective participants from Ireland, the University of Edinburgh is now a data processor. St Vincent’s University Hospital and the other Irish hospital sites are now data processors.\n•\tGenseq has also been added as a new data processor for this study in Ireland; they are undertaking the genetic analysis of samples of new participants who will be enrolled in Ireland.\n\n2.\tInclusion of new disease areas and amending Condition 1 attached to AMD1:\n•\tTo include the following additional disease areas for GenOMICC study in Ireland: Dengue, RSV, Burns, Extra-corporeal life support.\n•\tWith regards ‘emerging infections’ and ‘critical illness syndromes’, the amendment is also requesting that these areas are included. \n\n3.\tAddition of 8 new hospital sites to the study in Ireland. \n\n4.\tExtension of the consent declaration to 25 years; original declaration was for 10 years after the study concludes. \n\n5.\tWith regards the data that has already been collected under the original declaration, the amendment also requests the removal of NHS Lothian as a joint data controller as this was an error in the original application. Note; for the data that has already been collected and processed under the original consent declaration for GenOMMIC, the University of Edinburgh and St Vincent’s University Hospital remain the joint data controllers. "]
[null,"Scheduled HRCDC Meeting Date","4th September 2020","6th September 2022",null,null,"25th February 2025"]
[null,"HRCDC Decision Date #1","4th September 2020","6th September 2022",null,null,"25th February 2025"]
[null,"HRCDC Decision Date #2","N/A","4th October 2022",null,null,"N/A"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved",null,null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. All necessary contractual arrangements including joint data controller arrangements, must be in place with the relevant institutions regarding the governance, transfer and use of personal data and associated biosamples for this research study. The Data Controller should ensure the terms of any transfer of personal data has regard for the post-Brexit transition period. \n-\tFor the avoidance of doubt the sharing and transfer of personal data and associated biosamples to other data controllers and processors cannot commence until this condition is confirmed to be met by the HRCDC, as substantiated by the Applicant. \n-\tIt is advisable to discuss this condition with the relevant Institution’s legal office and Data Protection Officers, as appropriate. (CONDITION MET)\n\nCondition 2. The data protection officer (DPO) feedback on the data protection impact assessment, on behalf of the joint data controller NHS Lothian Health Board, must be provided to the HRCDC prior to the sharing and transfer of personal data to this Data Controller, in line with the timeline for meeting Condition 1. This feedback provided by the DPO, should note any data protection risks and mitigating actions, that has or will be sufficiently addressed or implemented by the Applicant. (CONDITION MET)\n\nCondition 3. The Applicant is requested to report in the annual review on the proportion of participants who continue to lack decision-making capacity and whose personal data therefore remains subject to the consent declaration that has been made. (CONDITION MET)","Condition 1. The scope of the consent declaration is amended to cover the following disease areas outlined in the information provided by the Applicant to the HRCDC:\n(i) Influenza, \n(ii) Secondary pneumonia,\n(iii) Cellulitis, \n(iv) Pneumonia, \n(v) Pancreatitis, \n(vi) Life threatening complications of vaccines against COVID-19.\nThe consent declaration does not cover the following open-ended disease areas/categories (i) emerging infection and (ii) emerging critical illness syndrome.(CONDITION MET)\n\n","Condition 2. The following section in the study information leaflet is noted: \n“If you withdraw your relative from the study, pseudonymised data recorded up to the point of withdrawal will be included in the study analysis unless you request otherwise. We will also seek your permission to continue to collect patient data during their hospital admission and to follow up to ascertain their long-term health status as we would like to keep and use the information about your relative that we have already obtained”\nThe HRCDC is of the view that the above statement may unintentionally pressurise individuals to provide permission for the study to continue to process personal data after they have decided to withdraw. While it is important to clearly outline if the study would like to continue to process personal data after withdrawal, it is also important to ensure that the individual understands that the personal information can still be deleted if this is their wish. If it is the wish of the individual to have the personal data deleted and no longer processed, then this should occur until the point in the study where it is no longer possible to do so. \nThe Applicant is therefore requested to reframe the above statement, and overall review the study documentation, to ensure it is clear that the personal data can be deleted and that individuals are not pressurised to provide permission for the continued processing of personal data after they withdraw. [CONDITION UNDERWAY]\nNote: It is acknowledged that relevant GDPR derogations may apply and at a certain point in the study it may not be possible to delete or otherwise cease to process personal data even when requested to do so by an individual. It is important that information on this is also provided in the study documentation. ","Condition 3. As per Condition 3 attached to the original declaration, the Applicant is requested to \ncontinue to report in the Annual Review on the proportion of participants who do not regain \ndecision-making capacity and whose personal data therefore remains subject to the consent \ndeclaration that has been made. This applies to the original participant cohort recruited due to \nCOVID-19 and those recruited under the new disease areas. (CONDITION MET)\n\nCondition 4. Signatures on the amendment request form have been provided on behalf of St \nVincent’s University Hospital. Authorised signatures from the other joint data controllers, \nUniversity of Edinburgh and NHS Lothian Health Board, must also be submitted to the HRCDC as \nsoon as practicable and within 2 months of receipt of this decision letter[CONDITION MET]","Condition 1. With regards the ‘emerging infections’ category, it is condition that the data controller reports in the Annual Review on the number of patients recruited to this category, including the type of emerging infection that is involved."]
[null,"Deadline for meeting Conditions","N/A","Condition 4: 18th December 2022 (Signatures) ",null,null,"N/A"]
[null,"Duration of Declaration ","The Conditional Declaration is made commencing 4th September 2020 and is valid until 31st August 2029 and for 10 years thereafter (31st August 2039) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. ","The approval to the Amendment is made commencing 4\nth October 2022 and shall be valid until 31st August 2029 and for 10 years thereafter (until 31st August 2039), in line with the duration of the consent declaration previously made.",null,null,"The approval to the Amendment is made commencing 25th February 2025 and shall be valid until 31st August 2054; this is an extension of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Declaration Live",null,null,"Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The HRCDC recommends that the study information leaflets and accompanying assent and consent forms, should be carefully reviewed and amended as necessary to ensure there is clarity of information provided to the participants or their next-of-kin. Specifically, the following points should be considered;\n-\tProvide additional clarity to participants and their next-of-kin regarding the practical steps to take if they wish to withdraw from the study\n-\tAmend the documents to clarify that REC approval was provided by the National REC for COVID-19 and not the St. Vincent’s University Hospital REC.\n-\tEnsure the information provided accurately reflects what parties are accessing or inspecting medical records for the purpose of the study. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2.  Where a participant continues to lack capacity for a prolonged period of time and where the next-of-kin assent remains in place, the Applicant should seek confirmation from the individual who provided assent, that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. (RECOMMENDATION CONSIDERED)","Recommendation 1. The Applicant is requested to continue PPI engagement throughout the study’s lifetime. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. It is recommended that the updated DPIA covering the expansion of the study has been reviewed by each of the joint data controllers of the study  [RECOMMENDATION CONSIDERED]",null,null,"Recommendation 1. It is noted that the study information leaflets and the proxy assent and participant consent forms include references and options on future research, however the HRCDC commented that this text is not fully clear and, in places, the references to future research that may be conducted is very broad in nature, for example: - ‘We would like your permission, to store any remaining sample left at the end of the study for future use related to this study.’ - ‘We do not know for sure what these future studies will be, but they may involve genetic analysis, sharing samples with other researchers abroad or commercial companies’ - ‘Future studies will most likely relate to critical illness’. - ‘Pseudo-anonymised information about your friend/relative will be kept for 25 years as the stored research data is likely to be of significant value in the future’. It is also noted that, as well as the breadth of potential future research, the research also involves sensitive participant data (generated from Whole Genome sequencing). It is recommended that the Applicant review/amend the study information leaflets to ensure that it is clear as possible on what type of future research might be undertaken with regards the participant’s GenOMMIC data, including their DNA/genetic data; the Applicant is requested to particularly review the proxy documentation. Note: it is the responsibility of the data controller/study to ensure that any consent for future research is sufficient, including any broad consent for future research.\n\nRecommendation 2. Further to recommendation 1, the consent/assent options provided to the participant or proxy on future research should be tiered and unbundled where possible: - Assent/consent for (i) storage and (ii) the future use of data and associated samples should be unbundled and separated; this includes the separate option on storage and future use of DNA (i.e., options 10 and 12 of the assent/consent forms) - Separate specific assent/consent options should also be provided with regards the potential sharing of, and use of data and associated samples for future research by (i) commercial companies and (ii) researchers abroad. Note: in relation to recommendation 1-2 and future use of data/samples, the Applicant should consider the requirements of the HSE’s policy on consent in health and social care research.\n\nRecommendation 3. The Applicant is also requested to consider the following with regards the study information leaflets: - The description on withdrawing from the study, specifically the options that will be provided to the proxy/participant upon withdrawal, should be better aligned with the withdrawal form; this includes that the study information leaflets should note that they can request for the data/samples to be deleted. The information outlined on withdrawal should also be presented under a separate, distinct heading in the study information leaflets. - The proxy assent form includes the statement: ‘Do you believe your friend/relative would wish to take part in this study?’; however, the accompanying proxy information leaflet refers to the participant being included ‘If there is no known objection by your relative/friend’. It was commented that this statement in the proxy study information leaflet should be reframed more positively to ask whether the relative/friend would wish to be included in this study.  \n\nRecommendation 4. It is noted that the biosamples and associated data of existing Irish patients already recruited to GenOMMIC and covered under the current consent declaration, will continue to be stored by Edinburgh. It was also noted that biosamples and associated data obtained from new participants to be recruited may also be stored by Edinburgh. Based on the information provided, it was not clear to the HRCDC if the biosamples obtained from the new participants will be returned to Ireland once processing by Edinburgh has concluded. The Applicant is asked to consider if such biosamples can be returned and stored locally in Ireland."]

{"sheet":"20-025-AF1-COV","index":65,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-025-AF1/COV"]
[null,"Application Title ","Using contact tracing data to gain insights into the epidemiology of COVID-19 infection in Ireland"]
[null,"Applicant Organisation (Data Controller)","University College Dublin"]
[null,"Lead Applicant ","Conor McAloon"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Over the course of the COVID-19 pandemic, a number of mathematical models have been developed to aid with decision making. These models require knowledge of a number of parameters which describe how the virus behaves in the population. Irish models have used values from international scientific literature. However, some of these values may not be accurate for Ireland and may change over the course of the outbreak. During the COVID outbreak in Ireland, contract tracing data were collected at a number of call centres throughout the country. Through these calls, a range of data are collected including the most likely source, onset and description of clinical signs and dates and type/nature of contacts. These data are held by the Central Statistics Office (CSO). Using this data in a pseudonymised data format this study will link transmission 'pairs' (that is primary and secondary cases) within the dataset. A range of values of epidemiological interest will be calculated. Next, the data will be investigated to isolate cohorts of testing that might further answer additional questions relating to the proportion and infectiousness of individuals who were infected but did not show clinical signs. A recent summary of the international literature has highlighted a lack of evidence to support assumptions regarding the infectiousness of asymptomatic individuals. This proposed study of Irish data might shed further light on these influential parameters and will refine estimates from the international literature for use in the Irish population."]
[null,"Reason for seeking a Declaration","The data controller seeks to access and analyse COVID-19 contact tracing data in a pseudonymised format for the purpose of this study. Pseudonymised data will be accessed via the CSO remote platform. Outputs will be anonymised."]
[null,"Scheduled HRCDC Meeting Date","4th September 2020"]
[null,"HRCDC Decision Date ","4th September 2020"]
[null,"HRCDC Decision","Declaration Made"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 4th September 2020 and shall be valid until 30th April 2021. "]
[null,"Status of Declaration","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The Applicant is requested to consider enhancing the transparency measures to inform participants and the public about the study. For example, consideration should be given to providing information and/or publishing study findings on the website of the data controller, University College Dublin. (RECOMMENDATION CONSIDERED)"]

{"sheet":"20-026-AF1-COV","index":66,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","20-026-AF1/COV","20-026-AF1/COV/AMD1"]
[null,"Application Title ","Can Nebulised HepArin Reduce acuTE lung injury in Patients with SARS-CoV-2 Requiring Mechanical Ventilation in Ireland (CHARTER-Irl)","Can Nebulised HepArin Reduce acuTE lung injury in Patients with SARS-CoV-2 Requiring Mechanical Ventilation in Ireland (CHARTER-Irl)"]
[null,"Applicant Organisation (Data Controller)","National University of Ireland, Galway","National University of Ireland, Galway"]
[null,"Lead Applicant ","John Laffey","John Laffey"]
[null,"Research commenced prior to submission of application","No","No"]
[null,"Research Objective","The aim of this research is to study the effect of administration of a drug called unfractionated heparin, via a nebuliser device. The research will evaluate the effect of this drug on the severity of lung injury and the inflammation in patients requiring invasive mechanical ventilation in the intensive care unit for SARS-CoV-2 lung disease. As this is the first study of nebulised heparin in COVID 19 lung disease the research will assess the safety of this treatment as a co-primary outcome.   Heparin will be administered via a device called a nebuliser, which converts the liquid medication into tiny droplets which are deposited directly in the lungs via the ventilator. Patients selected for inclusion in the study will already be requiring respiratory support (i.e. invasive ventilation) through a breathing tube in their throat, and have high oxygen requirements, and a diagnosis (clinical and awaiting laboratory confirmation or laboratory confirmed) of COVID19.  The study will assess blood samples for markers of inflammation and any unwanted side effects, or harm caused by the drug, along with some clinical outcomes. ","The aim of this research is to study the effect of administration of a drug called unfractionated heparin, via a nebuliser device. The research will evaluate the effect of this drug on the severity of lung injury and the inflammation in patients requiring invasive mechanical ventilation in the intensive care unit for SARS-CoV-2 lung disease. As this is the first study of nebulised heparin in COVID 19 lung disease the research will assess the safety of this treatment as a co-primary outcome.   Heparin will be administered via a device called a nebuliser, which converts the liquid medication into tiny droplets which are deposited directly in the lungs via the ventilator. Patients selected for inclusion in the study will already be requiring respiratory support (i.e. invasive ventilation) through a breathing tube in their throat, and have high oxygen requirements, and a diagnosis (clinical and awaiting laboratory confirmation or laboratory confirmed) of COVID19.  The study will assess blood samples for markers of inflammation and any unwanted side effects, or harm caused by the drug, along with some clinical outcomes. "]
[null,"Reason for seeking a Declaration","A declaration is requested for the processing of personal data (collecting, transferring, storing, pseudonymising and analysing) of study participants who lack decision-making capacity specifically for the purpose of undertaking this clinical trial. A protocol of deferred patient consent and proxy assent will be implemented for these participants.    \n","For the addition of Connolly Memorial Hospital as a clinical site to the CHARTER-Irl study to improve patient enrolment. The amendment covers additional data processing at this site"]
[null,"HRCDC Meeting Date","23rd September 2020","14th December 2021"]
[null,"HRCDC Decision Date ","23rd September 2020","14th December 2021"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. In line with the provisional approval from the National Research Ethics Committee for COVID-19, where telephone assent is obtained from the participant’s proxy, a copy of the study information leaflet and assent form must be sent to the proxy, and preferably before seeking telephone assent. Once telephone assent has been obtained, a signed copy of the assent form should also be returned to the study team as a record of the assent obtained. When obtaining proxy telephone assent, the Applicant should ensure there is clear information provided to the proxy such that they can subsequently request that the research participant and their data can be withdrawn from the study if they so wished.  (Please see Recommendation 4). [CONDITION MET]\n\nCondition 2. The HRCDC requests that the research team ensure they seek explicit consent /assent from the participants and/or the proxy to contact the participant’s GP and request follow-up data at 28 and 60-days recovery. [CONDITION MET]\n\nCondition 3. The HRCDC considers public and patient involvement (PPI) in health research an important safeguarding element. It is a condition of the declaration that public and patient involvement (PPI) in the development of this study is enhanced to ensure knowledge in context and experience can be gained through direct engagement with the public and patients. Engagement with representative groups such as ICUSteps should be considered. If there are constraints using normal means to engage with PPI representatives and advocacy groups in light of the ongoing coronavirus situation, the Applicant is advised to engage by alternative means such as email and videoconference as appropriate. The Applicant should also be aware of the recent statement made by the Irish Platform for Patient Organisations, Science and Industry (IPPOSI), setting out the importance of understanding the patient perspective during the COVID-19 pandemic. The Applicant is requested to report on efforts to enhance PPI as part of the Annual Review. [CONDITION MET]\n\n","N/A"]
[null,"Deadline for meeting Conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 23rd September and shall be valid until 31st September 2021, and for 15 years thereafter (until 31st September 2036) or upon confirmation that the data has been irrevocably rendered anonymised or destroyed, or whichever occurs sooner. ","The approval to the Amendment is made commencing 14th December 2021 and shall be valid until 31st September 2036, or upon confirmation that the data has been irrevocably rendered anonymised or destroyed, or whichever occurs sooner (this is in line with the duration of the consent declaration made)."]
[null,"Status of Declaration","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. As an additional data protection safeguard, where a participant continues to lack decision-making capacity for a prolonged period of time and where the proxy assent remains in place, the Applicant should seek confirmation from the individual who provided assent, that they wish for the study participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The Applicant is requested to carefully review and amend the study information leaflets and the consent and assent forms to ensure clarity and consistency of information are provided with regards the use of data/samples in future research, including future research involving commercial companies. The Applicant should ensure that the consent obtained for the future use of data is compliant with data protection legislation. [RECOMMENDATION CONSIDERED]\n\nRecommendation 3. The HRCDC recommends reviewing and revising the information being verbalised via the telephone assent script to ensure that it is easily understood by the individual providing proxy assent, whilst being sufficiently informative about the study. As part of this process, the Applicant should consider testing the telephone script with public and patient representatives. [RECOMMENDATION CONSIDERED]\n\nRecommendation 4. The Applicant is requested to ensure that information on the process for withdrawing from the study, and options for what will happen the data already collected, are clearly outlined in the study documents provided to the participant and their proxy. It should be also be clear at what point data can or cannot be withdrawn from the study, & what happens to data if they withdraw. The HRCDC also recommends that the timeframe for responding to requests to erase data should be reduced from the current 1-month deadline, if possible. [RECOMMENDATION CONSIDERED] ","N/A"]

{"sheet":"20-027-AF1","index":67,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-027-AF1"]
[null,"Application Title ","Immune Dysfunction in Acute Brain Injury "]
[null,"Applicant Organisation (Data Controller)","Beaumont Hospital, Dublin"]
[null,"Lead Applicant ","Ger Curley "]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Acute brain injuries are a common cause of death and serious disability. Patients with acute brain injury frequently require admission to the intensive care unit because of the serious nature\nof these conditions. This group of diseases includes: traumatic brain injury, subarachnoid haemorrhage and stroke (ischaemic stroke and intracerebral haemorrhage), as well as others. Though the causes of these conditions differ, they all share a number of similarities in the way in which they affect patients. For example, such patients often experience a “systemic inflammatory response”, whereby the immune system appears clinically to be more active than normal, or alternatively appearing more vulnerable to infection than we would typically expect. White blood cells are the body’s, ‘immune system’ cells. Whilst these cells are important for fighting infection through the generation of inflammation, when their function is abnormal or dysregulated they can be harmful to the individual. There are a large number of chemical substances made by the body that control the movement of immune cells in the body and how they behave in the blood and in the other organs. This research wishes to study the immune system of individuals with acute brain injuries. To achieve this, researchers will examine the white blood cells and the chemical substances (inflammatory mediators) that they produce in critically ill patients with and without\nacute brain injury, as well as healthy people (for comparison). This will be done by looking at both blood samples and samples of “washings” from the lungs (called “bronchoalveolar lavage”)"]
[null,"Reason for seeking a Declaration","A consent declaration is sought for participants who lack the decision-making capacity to provide consent. In such circumstances, next-of-kin assent will be sought prior to enrolment,\nfollowed by deferred consent if the participant regains capacity.\nThe data processing activities include the collection, pseudonymisation, transfer, analysis and storage of personal data.\nIn addition, the scope of the consent declaration includes the storage of data only for future research where next-of-kin assent has been provided. The declaration does not extend to participants recruited for the ‘healthy control’ cohort. "]
[null,"Scheduled HRCDC Meeting Date","13th October 2020"]
[null,"HRCDC Decision Date ","13th October 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The inclusion of patients and the public in research is considered an important data protection safeguard to ensure the perspective of the participant is always considered. The HRCDC\nrequests the Applicant to substantially enhance the level of public and patient involvement in this specific study. In fulfilling this condition, the Applicant is expected to undertake PPI activities\nbeyond the dissemination of the research findings that will result in a more patient-centred approach regarding the development and implementation of the study. Consideration should be given to active engagement and consultation with the Acute Brain Injury  group, Irish Critical Care- Clinical Trials Network and other relevant groups. The Applicant is requested to report on the progress made to enhance PPI by 31st January 2021. [CONDITION MET]\n\nCondition 2: Where a participant continues to lack decisionmaking capacity for a prolonged period of time and where next-ofkin assent remains in place, the HRCDC request that the following actions should be taken as an additional safeguard:\n- the Applicant should seek confirmation from the next-of-kin who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.\n- where participants have already been discharged from the hospital and prior to assent being reaffirmed, it should also be determined whether the participant has re-gained capacity and, where possible to do so, to obtain their consent for data processing.\nThe Applicant must report on this as part of the Annual Review, including the number of participants where deferred consent has and has not been obtained [CONDITION UNDERWAY]"]
[null,"Deadline for meeting Conditions","Condition 1: 31.03.2021 [Extended deadline]"]
[null,"Duration of Declaration ","The Declaration is made commencing 13th October 2020 and shall be valid until 31st March 2021 and for 10 years thereafter, until 31st March 2031 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. "]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: To ensure clarity and transparency for participants and/or their next-of-kin, the HRCDC requests that the Applicant ensures that template study information leaflets are tailored specifically for each study, removing unrelated or irrelevant content. In that regard, the HRCDC recommends amending the study information leaflet and assent/consent forms as follows:\ni) The information and options provided to participants and/or their next-of-kin regarding the future storage and use of data and samples is unclear and may cause confusion. For example, it is noted that samples will not be used in other research studies, however the assent/consent forms provide several options regarding the future storage and use of samples and data. The information and options provided for the future storage and use of samples and data should be consistent and clear to the participant and/or their next-of-kin so that they can clearly indicate their preferences. On the future use of data, it should also be clear to individuals that assent from the next-of-kin extends to the storage of data only. The Applicant should ensure that the consent obtained for the future use of data is compliant with data protection legislation.\nii) The term ‘assent’ rather than ‘consent/explicit consent’ in the next-of-kin assent study documents should be utilised.\niii) Point 8 under ‘data protection’ states that ‘family members have the right to access the personal data of their relative’. It is recommended that this statement is discussed directly with the Data Controller’s Data Protection Officer to ensure that is in line with data protection legislation.\niv) It should be made very clear to the next-of-kin/proxy or participant, that they have the option to have their data withdrawn from the study or destroyed, and at what point in time they can no longer withdraw their data from study. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2: The HRCDC recommends that the Applicant considers further data minimisation measures where possible. Specifically, consider if age, date of birth, full address and contact numbers are required if the medical record number is also collected. The DPO should be consulted with as necessary. [RECOMMENDATION CONSIDERED]\n "]

{"sheet":"20-029-AF1","index":68,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-029-AF1"]
[null,"Application Title ","Models of Care for people Ageing with an Intellectual Disability "]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin\nThe National Disability Authority"]
[null,"Lead Applicant ","Fintan Sheerin"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","People ageing with an intellectual disability are more likely to have complex health issues. Given that complexity, this study looks at the different ways in which services (specialist intellectual disability services and nursing homes) provide for their care and support. It will explore how effective those different care models are in terms of health and quality of life and what the cost implications are now and into the future. It will do this through reviewing the existing evidence, interviewing the management teams in intellectual disability services and nursing homes, interviewing older individuals living in those services and their family members. It will also survey all intellectual disability services to find out what types of services and supports are offered, to give an overall national picture of what is available."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the processing of personal data (collection, pseudonymisation, transfer, analysis) of participants who lack decision-making capacity to provide consent for data processing. In addition, the scope includes the storage of data only for future research."]
[null,"HRCDC Meeting Date #1","13th October 2020"]
[null,"HRCDC Meeting Date #2","11th December 2020"]
[null,"HRCDC Decision Date ","11th December 2020"]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-030-AF1","index":69,"n_rows":17,"n_cols":4,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,2,12,2],[11,1,12,1],[11,3,12,3]]}
[]
[null,"Application Ref ID","20-030-AF1"]
[null,"Application Title ","Efficacy, Safety and Tolerability of Nangibotide in Patients with Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study"]
[null,"Applicant Organisation (Data Controller)","INOTREM S.A. "]
[null,"Lead Applicant ","INOTREM S.A. "]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The study is a Phase IIb clinical trial (under the remit of S.I. 190 of 2004 and Directive 2001/20/EC). The trial is a double-blind, placebo-controlled dose-selection, multinational, multi-centre trial to evaluate the efficacy of two doses of nangibotide on organ dysfunction (Sequential Organ Failure Assessment; SOFA score) in patients with septic shock in relation to their soluble TREM-1 (sTREM-1) plasma levels (patients with high sTREM-1 levels at baseline and all patients). The main purpose of this trial is to obtain more information on how effective and well tolerated nangibotide combined with standard of care is in patients with septic shock, compared with standard of care alone. This trial also intends to investigate the clinical effectiveness of two doses of nangibotide in terms of organ dysfunction and reversal of shock."]
[null,"Reason for seeking a Declaration","A declaration is required to collect, store and process personal data of participants with septic shock that lack decision-making capacity, for the purpose of the ASTONISH study. "]
[null,"Scheduled HRCDC Meeting Date","12th November 2020"]
[null,"HRCDC Decision Date ","12th November 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","NOTE: It is acknowledged that this is an international multi-site study. The HRCDC has reviewed and considered the application for a consent declaration in the context of the Irish regulatory framework and clinical practices. The Applicant must therefore ensure that the practices conducted within this study are aligned and consistent with relevant Irish legislation and practices. \n\nCondition 1: Public and patient involvement (PPI) is considered an important activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant lacks decision-making capacity to provide consent. PPI helps to create a more patient-centred approach by ensuring that the perspective of patients and their families are taken into account when designing and conducting the study and determining the most appropriate method of obtaining consent/assent. Furthermore, PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle.\nIt is a condition of this declaration that the study undertakes PPI or engagement activities for the reasons outlined above. Examples of possible groups to engage with include ICUSteps and the HSE’s Surviving Sepsis Group.(https://www.hse.ie/eng/about/who/cspd/ncps/sepsis/contact/). Progress to meet this condition is a reporting requirement as part of the Annual Review. \n\nCondition 2: It is a condition of the declaration that the scope of the declaration will only cover the processing of personal data where proxy assent is obtained from an appropriate individual who understands the will and preference of the participant. Correspondingly and for the avoidance of doubt, the scope does not therefore extend to the processing of data where assent has been obtained from the study doctor.\nNote for context: It is acknowledged that the Applicant sought to obtain assent from the study doctor in specific circumstances where proxy assent was not possible. In attaching this condition, the HRCDC considered that obtaining assent from the study doctor is not usual practice within Ireland and that the study doctor would not be the most appropriate individual to understand the participant’s will and preferences.(CONDITION MET)\n\nCondition 3: It is a Condition of this declaration that deferred consent is obtained from participants who regain decision-making capacity. Where participants have been discharged from hospital and still lack decision-making capacity, it should be determined at an appropriate point in time whether they have regained capacity and, where possible to do so, to obtain their consent for data processing. As part of the Annual Review, the Applicant must report the number of participants where deferred consent has been obtained and the number of participants where consent has not been obtained. \n\nCondition 4. Where a participant continues to lack decision-making capacity for a prolonged period of time and where proxy assent remains in place, the HRCDC requests that the Applicant should seek confirmation from the individual who provided assent, that they wish for the participant’s personal data to continue to be processed as part of the research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. \n","Condition 5: To ensure clarity and transparency for participants and/or their proxy/relatives, the HRCDC requests that the study information leaflet and assent/consent forms are reviewed and/or amended as follows, where appropriate:\n- minimise, where possible, the degree of technical and legalistic language to improve readability and are comprehensible.\n- tailor the content of documents to reflect the study being conducted in Ireland, for example, by using of Hospital logos;\n- the participant and/or relative/proxy should also be provided with appropriate contact details of the Irish hospital should they have any queries and/or wish to exercise their data protection rights;\n- consider whether the study information leaflet provided should separately to the assent and consent forms. In addition, the documents used to obtain (i) assent and (ii) consent/deferred consent should not be combined together but instead provided to participants and/or their relative as distinct and separate documents;\n- the participant’s data protection rights, specifically the right to withdraw, should be clearly set out within a separate section of the information leaflet. Where it is not possible to delete the participant’s personal data when consent is withdrawn, then the reasons for this should be clearly outlined.\n- in line with information in the application form, outline that data will be destroyed after the archiving period rather than anonymised, as is currently stated.\n- More generally the Applicant should ensure that information provided to the participant and/or their relative is consistent and aligns with the data processing activities to be undertaken and ensure that any consent obtained for the future use of data is compliant with data protection legislation.\nThe study information leaflets, and assent/consent forms must be reviewed and amended, as appropriate, prior to the enrolment of participants in the study. The HRCDC also request confirmation that the Irish hospital sites and local Lead Investigator have reviewed and approved the use of the amended consent/assent documents.(CONDITION MET)\n\nCondition 6. The Applicant must ensure compliance with the principle of data minimisation. Please discuss with the relevant data protection officers to ensure that only the minimal amount of data, including demographic data, is collected and only stored for as long as is necessary. Please confirm what specific demographic data is being collected when responding to confirm acceptance or not of the HRCDC’s decision. (CONDITION MET)\n\nCondition 7. It is assumed that the study’s follow-up activities are to be undertaken by the Irish hospital and not the data controller/sponsor or other third party. Please confirm that this understanding is correct when responding to confirm acceptance or not of the HRCDC’s decision. (CONDITION MET)"]
[]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 12th  November 2020 and shall be valid for 25 years after the completion of the study, until 31st October 2047, or upon confirmation that explicit consent has been obtained or the data has been rendered anonymised or destroyed, or whichever occurs sooner. \n "]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The Applicant should consider differentiating consent for processing data for future research from the consent for the core ASTONISH study. In the interest of ensuring clarity for participants, the Applicant should give consideration to obtaining consent for future research via a separate consent document. (Recommendation Considered)\n\nRecommendation 2: Consideration should be given as to how proxy assent and subsequent deferred consent will be sought given the ongoing COIVD-19 restrictions. (Recommendation Considered)\n\nRecommendation 3: The Applicant should review that the terms and conditions of all legal agreements governing the processing and sharing of data between the data controller/sponsor of the study and the Irish hospital sites, to ensure they met the requirements under GDPR. (Recommendation Considered)"]

{"sheet":"20-031-AF1","index":70,"n_rows":18,"n_cols":5,"rows_kept":18,"cut":false,"hidden":false,"merged":[[12,1,13,1],[12,2,13,2],[12,3,13,3],[12,4,13,4]]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","20-031-AF1",null,"20-031-AF1/AMD1"]
[null,"Application Title ","The effect of fluid resuscitation with 20% albumin versus crystalloid on the microcirculation in septic shock",null,"The effect of fluid resuscitation with 20% albumin versus crystalloid on the microcirculation in septic shock"]
[null,"Applicant Organisation (Data Controller)","St James's Hospital, Dublin",null,"St James's Hospital, Dublin"]
[null,"Lead Applicant ","Ignacio Martin-Loeches ",null,"Ignacio Martin-Loeches "]
[null,"Research commenced prior to submission of application","No",null,"No"]
[null,"Research Objective","Septic shock is a disease of the microcirculation. The microcirculation is a network of small blood vessels (< 100 μm diameter), which consists of arterioles, capillaries and venules. The microcirculation is structured such that every cell has at least one capillary adjacent to it for the purpose of passive diffusion of oxygen from the blood into the cell, and maintenance of organ function. In septic shock there is an inadequate flow of red blood cells through capillaries. This leads to an inadequate supply of oxygen to tissues, and the development of organ failure. Resuscitation with intravenous fluids partially corrects this pathology. The research objective is to evaluate which fluid is better for improving perfusion of the microcirculation in septic shock - Crystalloid (compound sodium lactate or 0.9% saline) or 20% albumin (Grifols).",null,"Septic shock is a disease of the microcirculation. The microcirculation is a network of small blood vessels (< 100 μm diameter), which consists of arterioles, capillaries and venules. The microcirculation is structured such that every cell has at least one capillary adjacent to it for the purpose of passive diffusion of oxygen from the blood into the cell, and maintenance of organ function. In septic shock there is an inadequate flow of red blood cells through capillaries. This leads to an inadequate supply of oxygen to tissues, and the development of organ failure. Resuscitation with intravenous fluids partially corrects this pathology. The research objective is to evaluate which fluid is better for improving perfusion of the microcirculation in septic shock - Crystalloid (compound sodium lactate or 0.9% saline) or 20% albumin (Grifols)."]
[null,"Reason for seeking a Declaration","A consent declaration is requested to process the personal data of participants, who lack decision-making capacity to provide consent, for the purpose of this study. Processing includes the collection, pseudonymisation, analysis and storage of personal data.",null,"An amendment to the consent declaration is requested to the proxy assent protocol and allow for deferred proxy assent to be obtained. In addition, the amendment covers additional data processing that is associated with the use of the ‘Pulmovista’ device. "]
[null,"HRCDC Meeting Date #1","12th November 2020",null,"14th December 2021"]
[null,"HRCDC Meeting Date #2","N/A",null,"25th January 2022"]
[null,"HRCDC Decision Date ","12th November 2020",null,"25th January 2022"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: The consent declaration shall only become effective upon confirmation that full research ethics committee (REC) approval has been granted. Once obtained, evidence of full REC approval should be provided to the HRCDC as soon as possible. In addition, the declaration has been made on the basis that relative/proxy assent is obtained prior to the enrolment of the participant in the study and the subsequent processing of their data; this aligns with the information outlined within the provisional REC approval letter. Should this protocol change such that a deferred relative/proxy assent protocol is used, then the Applicant should submit an amendment request for HRCDC consideration, subject to obtaining the relevant REC approval. [CONDITION MET]\n\nCondition 2: Public and patient involvement (PPI) is considered an important activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant lacks decision-making capacity to provide consent. PPI helps to create a more patient-centred approach by ensuring that the perspective of patients and their families are taken into account when designing and conducting the study and determining the most appropriate method of obtaining consent/assent. Furthermore, PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle.\nIt is a condition of this declaration that the study undertakes PPI or engagement activities for the reasons outlined above. Examples of possible groups to engage with include ICUSteps and the HSE’s Surviving Sepsis Group; (https://www.hse.ie/eng/about/who/cspd/ncps/sepsis/contact/)\nProgress to meet this condition is a reporting requirement as part of the Annual Review. [CONDITION UNDERWAY]\n \nCondition 3: Where a participant continues to lack decision-making capacity for a prolonged period of time and where next-of-kin assent remains in place, the HRCDC request that the following actions should be taken as an additional safeguard:\ni) the Applicant should seek confirmation from the relative/proxy who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.\nii) where participants have already been discharged from the hospital and prior to assent being reaffirmed, it should also be determined whether the participant has re-gained capacity and, where possible to do so, to obtain their consent for data processing.\nThe Applicant must report on this as part of the Annual Review, including the number of participants where deferred consent has been obtained, and where deferred consent has not been obtained. [CONDITION MET]","Condition 4. To ensure clarity, transparency and consistency of information for participants and/or their relatives/proxy, the HRCDC requests that the study information leaflet and assent/consent forms are reviewed and/or amended as follows:\n- To further differentiate from the relative assent form, the documents used to obtain deferred consent when the participant regains capacity, should make it clearer to the participant that they have already been enrolled into the study on the basis of relative assent and therefore are being asked to provide consent to continue in the study;\n- remove inaccurate references to ‘relative’s deferred assent’ and that ‘Trinity College Dublin’ is conducting the study;\n- aligned with the information in the HRCDC application form, outline that data is anonymised within 5 years, rather than destroyed as is currently indicated in the study information leaflet;\n- both ‘study title’ and ‘name of study’ are provided and are not the same. Please ensure that the title/name of study is consistent throughout the documents.\n- more generally the Applicant should ensure that information provided to the participant and/or their relative is consistent and aligns with the study and data processing activities to be undertaken.\nThe study information leaflets, and assent/consent forms must be reviewed and amended prior to the enrolment of participants in the study and confirmation provided to the HRCDC when this is completed. [CONDITION MET]","Condition 1. Confirmation must be provided to the HRCDC that the requisite research ethics committee approval is in place for the telephone assent protocol. Confirmation must be provided as soon as possible and no later than 25th March 2022. [CONDITION MET]\n\nCondition 2. When obtaining assent by telephone, the Applicant should ensure that the study information leaflet and proxy assent form is forwarded for signing by the proxy, and that a copy of the signed assent form is returned to the study team for their records, as soon as is practicable. [CONDITION MET]\n\nCondition 3. The Applicant is requested to ensure that Condition 4 attached to the original consent declaration, is addressed thoroughly and as soon as possible to ensure any inaccurate or inconsistent information is amended in the assent/consent documentation.  \n\nCondition 4. The Applicant is requested to review the study’s Data Protection Impact Assessment (DPIA) to identify any potential new or emerging data protection risks and mitigating actions, and, where appropriate, to consult with the data controller’s Data Protection Officer on any revisions that have been made. [CONDITION MET]"]
[]
[null,"Deadline for meeting Conditions","N/A",null,"25th March 2022 - Condition 1 (REC) [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 12th  November 2020 and shall be valid until 31st December 2022 and for 5 years thereafter (until 31st December 2027) or upon confirmation that explicit consent has been obtained or the data has been rendered anonymised or destroyed, or whichever occurs sooner.",null,"The approval to the Amendment is made commencing 25th January 2022 and shall be valid until 31st December 2022 and for 5 years thereafter (until 31st December 2027) or upon confirmation that explicit consent has been obtained or the data has been rendered anonymised or destroyed, \nor whichever occurs sooner, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration No Longer Required",null,"Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. Consideration should be given to how the relative assent and subsequent deferred consent protocol will be implemented in the context of the ongoing COIVD-19 restrictions. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. It should be ensured that there are robust protocols in place for the shredding/destruction of paper records. [RECOMMENDATION CONSIDERED]",null,"Recommendation 1. Further to Condition 3, the HRCDC recommends that the Applicant reviews the participant and proxy study information leaflets to ensure that the description of the Pulmovista device, transparently and accurately reflects its use in clinical practice in St. James’s Hospital. Furthermore, the following observations are also made and should be considered by the Applicant:\n- page 5 of the participant consent to continue information leaflet states ‘If you do not want to be part of the study then we will delete the information from the secure network’. A statement to this effect, tailored for those who are asked to provide proxy assent, should also be included in the proxy assent documentation,\n- inaccurate use of ‘consent’, as opposed to ‘assent’, should be amended in the proxy information leaflet -specifically, page 2 of the proxy information leaflet states ‘this process is known as informed consent’,\n- the following statement in the consent/assent should be revised for clarity, as it could be misinterpreted that personal data from GP records are also being processed for the study:\n‘I agree to my GP being informed of my participation in the study and providing information from my medical records to the study team as described in this information sheet.’ [RECOMMENDATION CONSIDERED)\n"]

{"sheet":"20-032-AF1","index":71,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-032-AF1"]
[null,"Application Title ","Molecular Epidemiology of Mumps in Dublin Ireland"]
[null,"Applicant Organisation (Data Controller)","St James's Hospital"]
[null,"Lead Applicant ","Deirdre Broderick"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Mumps is an acute viral illness affecting the salivary glands, which can spread to glands in the reproductive system e.g. testes in men and ovaries in women, and the brain. Whole genome sequencing allows detailed examination of the genetic material of the virus, and comparison with other mumps strains to determine if the strains circulating in this patient group are all similar or different. The aim of the study is to perform whole genome sequencing on samples positive for mumps from the past 2 – 5 years, in order to examine if the mumps viruses are similar or different genetically. "]
[null,"Reason for seeking a Declaration","For the purpose of receiving pseudonymised biosamples with an associated sample identifier from the National Virus Reference Laboratory (NVRL) in University College Dublin and carrying out subsequent anonymisation and analysis of the samples."]
[null,"Scheduled HRCDC Meeting Date","11th December 2020"]
[null,"HRCDC Decision Date ","11th December 2020"]
[null,"HRCDC Decision","Requested more information"]
[null,"Specific Conditions attached ","TBC"]
[null,"Deadline for meeting Conditions","TBC"]
[null,"Duration of Declaration ","TBC"]
[null,"Status of Declaration","Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","TBC"]

{"sheet":"20-033-AF1","index":72,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-033-AF1"]
[null,"Application Title ","Epidemiologic study of LGV"]
[null,"Applicant Organisation (Data Controller)","St James's Hospital"]
[null,"Lead Applicant ","Deirdre Broderick"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Lymphogranuloma venereum (LGV) is a sexually-transmitted infection caused by Chlamydia Trachomatis. It is endemic in some areas of Africa, Southeast Asia, India, the Caribbean and South America. In the past 10 years it has been increasingly recognized in industrialised countries including North America, Europe and the UK. It causes genital ulceration followed by swelling of lymph nodes and if untreated can result in disfiguring ulceration and enlargement of the external genitalia. It is diagnosed using nucleic acid amplification techniques to detect the presence of viral DNA. The study aims to examine the LGV isolates collected in St. James’s Hospital since the introduction of NAAT testing and, using the clinical patient records, identify common risk factors and symptoms, which may help identify interventions to reduce spread. The study will also look at molecular typing data, to determine the genotypes circulating in this population.  "]
[null,"Reason for seeking a Declaration","For the processing of personal data, which includes the access and collection, analysis and pseudonymisation of clinical data associated with biosamples."]
[null,"Scheduled HRCDC Meeting Date","11th December 2020"]
[null,"HRCDC Decision Date ","11th December 2020"]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"20-034-AF1","index":73,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[[11,1,12,1],[11,2,12,2]]}
[]
[null,"Application Ref ID","20-034-AF1"]
[null,"Application Title ","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opiate Use in Ireland (2015 – 2019) "]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Ivan Perry"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","This research study aims to estimate the number of problematic opiate drug users in the Republic of Ireland from 2015-2019. Problematic opiate use is a significant problem in Ireland and across the globe. Opiates include drugs such as heroin, morphine, methadone, codeine, hydrocodone, fentanyl and tramadol. While some of these have valid medical purposes, their misuse as “street drugs” can lead to many health and social issues for users and society. The study aims to estimate the number of problematic opiate drug users in the Republic of Ireland from 2015 – 2019. This data will be used to compare trends in opiate use over time and inform government and policy makers regarding the scale of the problem. As measuring the prevalence of drug users is difficult, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) recommend the use of indirect methods such as the capture-recapture method or the multiplier method to estimate the prevalence of high-risk drug users."]
[null,"Reason for seeking a Declaration","A declaration is required to process (access, obtain, match, consolidate and subsequently anonymise prior to analysis) the personal data previously collected by other agencies, for the purpose of this study"]
[null,"Scheduled HRCDC Meeting Date","11th December 2020"]
[null,"HRCDC Decision Date ","11th December 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: It is a condition that this declaration is not effective until confirmation has been received by the HRCDC that the required data transfer agreements are in place between UCC (the data controller of the study) and the providers of the personal data. Correspondingly, the agreements in place should include appropriate terms and conditions setting out obligations of confidentiality for researchers with direct access to the data on-site, where relevant. For the avoidance of doubt, no transfer of personal data and/or direct access to personal data can occur until the appropriate agreements are concluded. [CONDITION MET]\n\nCondition 2: The Applicant is requested to implement enhanced transparency measures in order for participants and the public to be made aware of the study and the use of their personal data. It is a condition of this declaration that enhanced transparency measures are implemented prior to the commencement of the study. Specific transparency measures for consideration are as follows; \n-\tIn addition to using the UCC and HRB websites and the National Drugs Forum as a platform for communication, the Applicant should consider publicising the study on websites of relevant representative and advocacy organisations and social media.  Where possible the Applicant should engage with the data providers for publicising on its websites. \n-\tInformation on the study should also be posted on prominent and easy-to-access sections of websites.  \n-\tThe information provided should also clearly outline to a participant their data protection rights and how they can exercise these rights, where applicable. A point of contact for the participant to engage with regarding the study and data protection rights should be provided. \nThe Applicant is requested to report on the efforts made to enhance the level of transparency as part of the Annual Review\n[CONDITION MET]\n \nCondition 3: The Applicant is requested to enhance the level of PPI through direct engagement with representative participant support and advocacy groups. Engagement should be undertaken to inform and seek views from representative groups regarding the research design, dissemination of research findings and enhance the level of transparency within this study. The Applicant is requested to commence PPI activities within 3 months of the date of this declaration and confirm details of such in writing for the HRCDC. This is also a reporting requirement as part of the Annual Review. [CONDITION MET]\n\nCondition 4: The HRCDC acknowledges that future studies on the prevalence of problematic opiate drug users in Ireland may be conducted. For the avoidance of doubt this declaration only applies to the ‘2015-2019’ prevalence study and should not be construed as setting a precedent for future applications that may be made to the HRCDC. "]
[]
[null,"Deadline for meeting Conditions","Condition 3: 21.03.2021"]
[null,"Duration of Declaration ","The Conditional Declaration is made commencing 11th December 2020 and is valid for 1 year (until 11th December 2021) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","Comment. Future applications to the HRCDC seeking a declaration must demonstrate that the safeguards set out in the conditions attached to this declaration, will be applied to future studies prior to commencement; specifically, robust transparency measures and PPI activity. Consideration should also be given as to how future patients can be consented to and/or informed of the research when they engage with health care services."]

{"sheet":"20-035-AF1","index":74,"n_rows":17,"n_cols":6,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref ID","20-035-AF1",null,"20-035-AF1/AMD1","20-035-AF1/AMD2"]
[null,"Application Title ","A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit treated (ICU) patients with complicated influenza infection (IV Zanamivir Effectiveness Study)",null,"A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit treated (ICU) patients with complicated influenza infection (IV Zanamivir Effectiveness Study)","A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10mg/ml solution for infusion in a cohort of intensive care unit treated (ICU) patients with complicated influenza infection (IV Zanamivir Effectiveness Study)"]
[null,"Applicant Organisation (Data Controller)","GlaxoSmithKline Research & Development Ltd",null,"GlaxoSmithKline Research & Development Ltd","GlaxoSmithKline Research & Development Ltd"]
[null,"Lead Applicant ","Ignacio Martin-Loeches ",null,"Ignacio Martin-Loeches ","Ignacio Martin-Loeches "]
[null,"Research commenced prior to submission of application","No",null,"No","No"]
[null,"Research Objective","Despite vaccination and available treatments, seasonal influenza accounts for approximately 3-5 million severe infections and 250,000-500,000 deaths worldwide annually. This study will gain an understanding of the clinical management of complicated influenza in ICUs in Europe. It will also investigate the clinical effectiveness of intravenous (IV) zanamivir (Dectova) in the treatment of patients with complicated influenza in this setting, compared to patients who do not receive treatment with Dectova. The collection of historical data for influenza seasons 2017/18 and 2018/19 will begin after the Site Initiation Visit has been performed at each of the participating sites. The historical part is designed to gain an understanding of the clinical management of complicated influenza in European ICUs. The data collection for the comparative part of the study, for influenza season 2019/20 will begin after the data collection for the historical part is completed and for current influenza season, 2020/21, data collection will start after the season have finished, to ensure the retrospective nature of this study. Both parts will be conducted in patients infected with influenza and admitted to ICU. This study will involve patients in ICU with severe influenza in various tertiary hospitals in the United Kingdom and other countries in the European Union.",null,"Despite vaccination and available treatments, seasonal influenza accounts for approximately 3-5 million severe infections and 250,000-500,000 deaths worldwide annually. This study will gain an understanding of the clinical management of complicated influenza in ICUs in Europe. It will also investigate the clinical effectiveness of intravenous (IV) zanamivir (Dectova) in the treatment of patients with complicated influenza in this setting, compared to patients who do not receive treatment with Dectova. The collection of historical data for influenza seasons 2017/18 and 2018/19 will begin after the Site Initiation Visit has been performed at each of the participating sites. The historical part is designed to gain an understanding of the clinical management of complicated influenza in European ICUs. The data collection for the comparative part of the study, for influenza season 2019/20 will begin after the data collection for the historical part is completed and for current influenza season, 2020/21, data collection will start after the season have finished, to ensure the retrospective nature of this study. Both parts will be conducted in patients infected with influenza and admitted to ICU. This study will involve patients in ICU with severe influenza in various tertiary hospitals in the United Kingdom and other countries in the European Union.","Despite vaccination and available treatments, seasonal influenza accounts for approximately 3-5 million severe infections and 250,000-500,000 deaths worldwide annually. This study will gain an understanding of the clinical management of complicated influenza in ICUs in Europe. It will also investigate the clinical effectiveness of intravenous (IV) zanamivir (Dectova) in the treatment of patients with complicated influenza in this setting, compared to patients who do not receive treatment with Dectova. The collection of historical data for influenza seasons 2017/18 and 2018/19 will begin after the Site Initiation Visit has been performed at each of the participating sites. The historical part is designed to gain an understanding of the clinical management of complicated influenza in European ICUs. The data collection for the comparative part of the study, for influenza season 2019/20 will begin after the data collection for the historical part is completed and for current influenza season, 2020/21, data collection will start after the season have finished, to ensure the retrospective nature of this study. Both parts will be conducted in patients infected with influenza and admitted to ICU. This study will involve patients in ICU with severe influenza in various tertiary hospitals in the United Kingdom and other countries in the European Union."]
[null,"Reason for seeking a Declaration","A consent declaration is requested to process personal data from hospital medical records for the purpose of this study (access, collect, pseudonymise, transfer, analyse and store). ",null,"The amendment is requested to extend the processing of personal data for the study to include the 2021/2022 flu season participant cohort. This is due to the low number of study participants in the previous two flu seasons. As per the previous seasons, the data for the 2021/2022 will be collected retrospectively. ","The amendment is requested to extend the study to another flu season i.e., 2022/2023 season and to reflect a change in the ratio of controls to cases from 1:1 to 2:1. An amendment to the declaration was previously granted to extend the study to include 2021/2022 flu season. of 422 the mortality rate has been reassessed."]
[null,"Scheduled HRCDC Meeting Date #1","26th January 2021",null,"25th January 2022","28th February 2023"]
[null,"Scheduled HRCDC Meeting Date #2","13th April 2021",null,"N/A","N/A"]
[null,"HRCDC Decision Date ","13th April 2021",null,"25th January 2022","28th February 2023"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Applicant must directly contact each participant whose data will be included in this study to clearly inform them about (i) the study, (ii) their data protection rights and (iii) provide participants with the opportunity to opt-out of the study and withdraw their data. As part of this enhanced transparency and communication activity, the Applicant must provide participants with an easy-to-reach contact point should they wish to discuss the study, exercise their data protection rights or withdraw. For the avoidance of doubt, in order to meet this condition substantively, this enhanced transparency activity must include the option for participants to withdraw from the study. Where participants are ‘lost to contact’, the applicant needs to demonstrate the robust efforts that were made to contact them and report on these efforts in the Annual Review.\n\nCondition 2. Further to Condition 1, this condition sets out the scope of the consent declaration as follows: \ni) It shall apply to the personal data of participants who do not withdraw from the study and/or do not respond to the Applicant’s direct communication, including where participants are lost to contact. \nNOTE: The declaration does not extend to participants who choose to withdraw from the study. \nii) It does not extend beyond the 2020/21 participant cohort. Any future waves will require an amendment to the consent declaration.","Condition 3. The Applicant must ensure that the appropriate legal agreements, including terms and conditions governing the transfer and use of data collected in Ireland, are in place with St. James’s Hospital and the other study parties where relevant, prior to the transfer of personal data. In addition, the Applicant must ensure that the terms and conditions of the legal agreements accurately reflect data protection legislation as it pertains to Ireland, including the General Data \nProtection Regulation. (CONDITION MET)\n\nCondition 4. Confirmation of full research ethics approval, when obtained, must be provided to the HRCDC as soon as possible. The conditional declaration shall not be in effect until this condition is met. (CONDITION MET)","Condition 1. The Applicant is requested to review the study’s Data Protection Impact Assessment (DPIA) to identify any potential new or emerging data protection risks and mitigating actions, and, where appropriate, to consult with the data controller’s Data Protection Officer on any revisions that have been made. (CONDITION MET)","N/A"]
[null,"Deadline for meeting Conditions","N/A",null,"N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 13th April 2021 and is valid until 30th April 2022 and for 30 years thereafter or upon confirmation that the personal data has been destroyed or rendered anonymised, whichever is sooner. The declaration shall not however be effective until full REC approval is granted.",null,"The Amendment is made commencing 25th January 2022 and shall be valid until 31st August 2022 and for 30 years thereafter or upon confirmation that the personal data has been destroyed or rendered anonymised, whichever is sooner. (This is an extension of the duration of the consent declaration, to reflect that the end of study is now due in August 2022. The original end date was projected as April 2022). ","The approval to the Amendment is made commencing 28th February 2023 and shall be valid until 31st August 2023, and for 30 years thereafter or upon confirmation that the personal data has been destroyed or rendered anonymised, whichever is sooner; this is an extension of the duration of the consent declaration to reflect the addition of the new flu season. "]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","The HRCDC recommends that careful consideration should be taken by the data controller and the Applicant as to how public and patient involvement (PPI) should be implemented for future studies that maybe undertaken in Ireland. The HRCDC strongly views PPI as an important activity and a key data protection safeguard in situations where consent is not or cannot be obtained from participants for research.  PPI helps to create a more patient-centred approach by ensuring that the perspective of the public, patients, carers and their families are taken into account when designing and conducting a study. Furthermore, PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle and a requirement under the Health Research Regulations. The data controller Applicant should inform the HRCDC of any progressive activity carried out in this area of PPI as part of the Annual Review. ",null,"N/A","N/A"]

{"sheet":"20-036-AF1","index":75,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref ID","20-036-AF1","20-036-AF1-AMD1","20-036-AF1-AMD2"]
[null,"Application Title ","EPO-TRAUMA","EPO-TRAUMA","EPO-TRAUMA"]
[null,"Applicant Organisation (Data Controller)","Monash University\nUniversity College Dublin","Monash University\nUniversity College Dublin","Monash University\nUniversity College Dublin"]
[null,"Lead Applicant ","Alistair Nichol","Alistair Nichol","Alistair Nichol"]
[null,"Research commenced prior to submission of application","No","No","No"]
[null,"Research Objective","The World Health Organization has forecast that, by 2030, trauma will become the third leading cause of disability and death globally. Erythropoietin is a hormone that is essential for red blood cell production. Drugs with a similar function are available for use in the treatment of humans and are called erythropoiesis stimulating agents (ESAs). Erythropoietin has many effects beyond increasing red blood cell numbers. Studies in animals have shown erythropoietin can have protective effects following injury to vital organs including the brain, kidney, liver and heart. Previous research suggests the use of the ESA called epoetin, increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive. An analysis which pooled all relevant studies evaluating the use of ESAs in critically ill trauma patients showed a reduced mortality by at least 20%. This finding may have important implications for patient management. The study aims to conduct an international multicentre trial of the ESA epoetin alfa in 2,500 critically ill trauma patients in Australia, New Zealand and Europe.","The World Health Organization has forecast that, by 2030, trauma will become the third leading cause of disability and death globally. Erythropoietin is a hormone that is essential for red blood cell production. Drugs with a similar function are available for use in the treatment of humans and are called erythropoiesis stimulating agents (ESAs). Erythropoietin has many effects beyond increasing red blood cell numbers. Studies in animals have shown erythropoietin can have protective effects following injury to vital organs including the brain, kidney, liver and heart. Previous research suggests the use of the ESA called epoetin, increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive. An analysis which pooled all relevant studies evaluating the use of ESAs in critically ill trauma patients showed a reduced mortality by at least 20%. This finding may have important implications for patient management. The study aims to conduct an international multicentre trial of the ESA epoetin alfa in 2,500 critically ill trauma patients in Australia, New Zealand and Europe.","The World Health Organization has forecast that, by 2030, trauma will become the third leading cause of disability and death globally. Erythropoietin is a hormone that is essential for red blood cell production. Drugs with a similar function are available for use in the treatment of humans and are called erythropoiesis stimulating agents (ESAs). Erythropoietin has many effects beyond increasing red blood cell numbers. Studies in animals have shown erythropoietin can have protective effects following injury to vital organs including the brain, kidney, liver and heart. Previous research suggests the use of the ESA called epoetin, increases the number of patients surviving severe trauma and reduces the risk of disability in those who survive. An analysis which pooled all relevant studies evaluating the use of ESAs in critically ill trauma patients showed a reduced mortality by at least 20%. This finding may have important implications for patient management. The study aims to conduct an international multicentre trial of the ESA epoetin alfa in 2,500 critically ill trauma patients in Australia, New Zealand and Europe."]
[null,"Reason for seeking a Declaration","For the purpose of processing, including review, collecting, pseudonymising, sharing pseudonymised data, storing, analysis, archiving, destruction of personal data of participants who lack decision-making capacity. The scope also includes the storage only of personal data for future research purposes.","The amendment request is for the following changes to the study:\n(i)\t the addition of a new hospital site and data processor, Cork University Hospital,\n(ii)\t the extension of the consent declaration by 1 year,\n(iii) a change to the 6-month follow-up assessment whereby it will be conducted by a central assessor from the Irish Critical Care - Clinical Trials Network at UCD - St. Vincent’s University Hospital, instead of each hospital site. ","The amendment is requested to add Tallaght University Hospital (TUH) and the Mater Misericordiae University Hospital (MMUH) as participating sites and data processors to this study. (Note: the MMUH was outlined as a site in the original HRCDC application form). "]
[null,"Scheduled HRCDC Meeting Date","11th December 2020","16th November 2021","19th September 2023"]
[null,"HRCDC Decision Date ","11th December 2020","16th November 2021","19th September 2023"]
[null,"HRCDC Decision","Conditional Declaration ","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC have requested that further, broader PPI should be carried out for the study and not limited to the single representative individual. [CONDITON MET]\n\nCondition 2: The HRCDC request that the Applicant implement further data minimisation measures where at all possible. Specifically, consider if age, date of birth, full address and contact number, medical record number are all required in addition to the Patient Study Number. Similarly, for all data being stored and archived with Research Path, data minimisation measures should be implemented to reduce data protection risks over the lifetime of the retention period. This is a reporting requirement of the Annual Review.  [CONDITON MET]\n\nCondition 3: Where a participant continues to lack decision-making capacity for a prolonged period of time and where next-of-kin assent remains in place, the HRCDC request that the following actions should be taken as an additional safeguard: \ni) the Applicant should seek confirmation from the next-of-kin who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.\nii) where participants have already been discharged from the hospital and prior to assent being reaffirmed, it should also be determined whether the participant has re-gained capacity and, where possible to do so, to obtain their consent for data processing. This includes determining capacity to consent at the 6-month follow-up visit. \nThe Applicant must report on this condition as part of the Annual Review, including the number of participants where deferred consent has and has not been obtained. [CONDITION UNDERWAY]","N/A","N/A"]
[null,"Deadline for meeting Conditions","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 11th December 2020 and shall be valid until consent can be obtained from the participants once decision-making capacity is regained and shall cover the duration of the study (4 years) and for 15 years after the study concludes i.e. 31st December 2039 (Extended via AMD#1 31st December 2040)","The approval to the Amendment is made commencing 16th November 2021 and the consent declaration shall remain valid until deferred consent can be obtained from participants, once decision-making capacity is regained. Where participant’s decision-making capacity is not regained, the consent declaration shall cover the duration of the study until 31st Dec 2025 and for 15 years after the study concludes i.e., until 31st December 2040. This timeline reflects the extension of the consent declaration by 1 year as per the amendment request.","The approval to the Amendment is made commencing 19th September 2023 and shall be valid until 31st December 2040, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: To ensure clarity, transparency and consistency of information for participants and/or those providing assent, the HRCDC requests that the study information leaflet and assent/consent forms are reviewed. The following points are highlighted by the HRCDC for consideration by the Applicant:\n(i) The HRCDC considered the Patient Information Leaflets (PILs)/Research Study information leaflets to be quite technical in parts and should be readable from the perspective of the participant and those providing assent. This recommendation is in line with the feedback from the Research Ethics Committee.\n(ii) Section 10 of the Study Information Leaflet further outlines for the individual providing assent, how the study participant may lodge a complaint with the data protection authority. The Applicant is requested to review this form to ensure it is clear how the individual providing assent may lodge a complaint if necessary.\n(iii) The study information leaflets should clearly outline the participant’s data protection rights, including information on any limitations/derogations to these rights; the use of broad statements such as ‘you may have data protection rights’ should be avoided.\n(iv) In the option for permitting the storage of data for future research, the telephone assent form provides a specific timeframe of 15 years, however this is not outlined in the other assent/consent forms. [RECOMMENDATION CONSIDERED]","N/A","Recommendation 1. The HRCDC is of the view that the points outlined in Recommendation 1 should be further considered by the Applicant where possible, including the use technical language and the readability of the documents (e.g., reviewing/amending the use of non-defined acronyms) \nas well as the use of statements such as ‘you may have data protection rights’ (this statement should be amended to note that participants do have such rights). It was noted also that the researchers have engaged with a PPI group, and they have produced an additional patient \ninformation brochure. The Applicant is asked to submit this new patient brochure at the next annual review due for the study.[RECOMMENDATION CONSIDERED]"]

{"sheet":"20-037-AF1-COV","index":76,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","20-037-AF1/COV"]
[null,"Application Title ","Home monitoring of respiration in COVID-19 patients using smartphone technology: analysis of retrospective data"]
[null,"Applicant Organisation (Data Controller)","University College Dublin\n"]
[null,"Lead Applicant ","Emer Doheny"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The patientMpower for COVID-19 app has been used in Irish hospitals to remotely monitor COVID-19 patients following discharge since March 2020.  The app prompts users to monitor their oxygen saturation, breathlessness, temperature and heart rate, four times daily, and automatically generates clinical alerts using these data.  The resulting database has enormous value in improving the understanding of symptom presentation and progression in COVID-19. The study aims to investigate the temporal characteristics and correlations between symptoms monitored using the app and to predict symptom progression in Covid-19 patients"]
[null,"Reason for seeking a Declaration","The data processing activities include the transfer, analysis and storage of pseudonymised, retrospective data of the app users for the purpose of this study. The users are limited to those who have already consented to the use of their data in research. "]
[null,"Scheduled HRCDC Meeting Date","11th December 2020"]
[null,"HRCDC Decision Date ","11th December 2020"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1: The HRCDC notes that information on this study will be published on the UCD and patientMpower websites. To ensure that participants and the public are made aware of this study and the use of their personal data:\n-\tInformation should be posted on a prominent and easy-to-locate section of both organisation’s websites. \n-\tConsideration should be given to providing information on the study via other suitable platform including the COVID-19 app, social media and other relevant websites. \n-\tTransparency measures should clearly outline how participants can exercise their data protection rights, including the right to withdraw from the study and have their data deleted; \n-\t A relevant contact point for the study and data protection matters should be provided. \nThis is a reporting requirement as part of the Annual Review [CONDITION MET]\n\nCondition 2: The inclusion of patients and the public in research is considered an important data protection safeguard to ensure the perspective of the participant is always considered and to create a more patient-centred approach.\nThe Applicant is requested to undertake public and patient involvement (PPI) in this study through, for example, direct engagement with representative COVID-19 patient and advocacy groups to inform the development of the study, dissemination of research findings and enhance the level of transparency for this study. This is a reporting requirement as part of the Annual Review. [CONDITION UNDERWAY]\n\nCondition 3: The Applicant is requested to submit a copy of the completed balancing rights document referenced in the HRCDC application form as part of the first Annual Review. [CONDITON MET]"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Conditional Declaration is made commencing 11th December 2020 and is valid until 1st January 2023 or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: In line with the principal of data minimisation and to reduce the risk of re-identifying the patient, the Applicant is requested to consider if obtaining ‘clinical site’ is a required data point for the purpose of this study. [RECOMMENDATION CONSIDERED]"]

{"sheet":"20-039-AF1","index":77,"n_rows":16,"n_cols":7,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref ID","20-039-AF1",null,null,"20-039-AF1/AMD1","20-039-AF1/AMD2"]
[null,"Application Title ","A pilot multicentre randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock ",null,null,"A pilot multicentre randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock ","A pilot multicentre randomized controlled trial comparing an approach of individualized blood pressure targets to standard care among critically ill patients with shock "]
[null,"Applicant Organisation (Data Controller)","Hunter New England Health Local Health District",null,null,"Hunter New England Health Local Health District","Hunter New England Health Local Health District"]
[null,"Lead Applicant ","Bairbre McNicholas",null,null,"Bairbre McNicholas","Bairbre McNicholas"]
[null,"Research commenced prior to submission of application","No",null,null,"No","No"]
[null,"Research Objective","Blood pressure (BP) is a vital parameter and maintaining an adequate BP is one of the most fundamental tenets of management of shock. It is a decision that ICU clinicians make every time they assess such patients and it is plausible that their decisions regarding BP targets may directly impact on outcomes of those patients. Conventional practice often results in a varying degree of untreated relative hypotension that is inadvertently accepted in real world setting. Minimizing such variation by targeting a patient’s own basal BP can be a simple strategy or a management approach that can potentially improve outcomes. Although it has been suggested by the guidelines, this approach has never been tested in an RCT among ICU patients with shock. Therefore, high-quality evidence from a well-designed RCT is needed to influence strength of recommendations regarding choice of BP targets for vasopressor support. The study will compare standard care to a strategy of targeting patients' usual pre-illness blood pressure (BP) during management of shock in ICU. The study will also collect information on hospital mortality and incidence of any major complications. These clinical outcomes and the data on achieved-BP will be compared in between the two groups to assess feasibility and efficacy of the intervention in relation to the standard care.",null,null,"Blood pressure (BP) is a vital parameter and maintaining an adequate BP is one of the most fundamental tenets of management of shock. It is a decision that ICU clinicians make every time they assess such patients and it is plausible that their decisions regarding BP targets may directly impact on outcomes of those patients. Conventional practice often results in a varying degree of untreated relative hypotension that is inadvertently accepted in real world setting. Minimizing such variation by targeting a patient’s own basal BP can be a simple strategy or a management approach that can potentially improve outcomes. Although it has been suggested by the guidelines, this approach has never been tested in an RCT among ICU patients with shock. Therefore, high-quality evidence from a well-designed RCT is needed to influence strength of recommendations regarding choice of BP targets for vasopressor support. The study will compare standard care to a strategy of targeting patients' usual pre-illness blood pressure (BP) during management of shock in ICU. The study will also collect information on hospital mortality and incidence of any major complications. These clinical outcomes and the data on achieved-BP will be compared in between the two groups to assess feasibility and efficacy of the intervention in relation to the standard care.","Blood pressure (BP) is a vital parameter and maintaining an adequate BP is one of the most fundamental tenets of management of shock. It is a decision that ICU clinicians make every time they assess such patients and it is plausible that their decisions regarding BP targets may directly impact on outcomes of those patients. Conventional practice often results in a varying degree of untreated relative hypotension that is inadvertently accepted in real world setting. Minimizing such variation by targeting a patient’s own basal BP can be a simple strategy or a management approach that can potentially improve outcomes. Although it has been suggested by the guidelines, this approach has never been tested in an RCT among ICU patients with shock. Therefore, high-quality evidence from a well-designed RCT is needed to influence strength of recommendations regarding choice of BP targets for vasopressor support. The study will compare standard care to a strategy of targeting patients' usual pre-illness blood pressure (BP) during management of shock in ICU. The study will also collect information on hospital mortality and incidence of any major complications. These clinical outcomes and the data on achieved-BP will be compared in between the two groups to assess feasibility and efficacy of the intervention in relation to the standard care."]
[null,"Reason for seeking a Declaration","A consent declaration is required to process the personal data of participants who lack the decision-making capacity to provide explicit consent for the purpose of this specific study. Processing activities include access, collection, pseudonymisation and subsequent transfer/uploading of data, including of follow-up data, to the electronic Case Report Form (eCRF) for analysis by the study sponsor University of Newcastle, New South Wales, Australia. The declaration also includes the storage only of personal data for future research purposes.",null,null,"The purpose of the amendment is for (i) the inclusion of telephone proxy assent and (ii) the addition of Tallaght University Hospital as an additional hospital site/data processor. ","The amendment is requested to reflect a change in data controllership from Galway University Hospital to Hunter New England Health Local Health District as the sole data controller of the study. GUH is now a data processor. In addition, the original consent declaration application outlined that \nthe sharing/transfer of data would be with the George Institute Australia; this has changed to the Hunter Medical Research Institute in Newcastle, Australia which is the research institute co\u0002located/affiliated with the data controller, i.e., the Hunter New England Local Health District"]
[null,"Scheduled HRCDC Meeting Date","2nd March 2021",null,null,"13th December 2022","22nd August 2023"]
[null,"HRCDC Decision Date ","2nd March 2021",null,null,"13th December 2022","22nd August 2023"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The HRCDC notes that Research Ethics Committee (REC) approval for this study has been granted by the Chair of the Galway University Hospital (GUH) REC, which is to be formally ratified at the next meeting of the REC. It is a condition of this consent declaration that full REC approval must be granted by the GUH REC for this consent declaration to come into effect. Any matters raised or actions required by the GUH REC must be addressed by the Applicant and anyresponses provided to the HRCDC. Evidence of full REC approval from Galway must be provided to the HRCDC as soon as possible in order for the consent declaration to become effective. [CONDITION MET]\n\nCondition 2. Linked to Condition 1, this consent declaration only covers data processing at theresearch sites that have been granted full REC approval. Confirmation of full REC approval from Beaumont Hospital and St. Vincent’s University Hospital, that currently remains pending, must therefore be provided to the HRCDC once available, for the consent declaration to cover these sites.\n\nCondition 3. All appropriate contractual arrangements must be in place with the relevant parties to govern the transfer and use of data for the purpose of this research study. Robust terms and conditions should be set out to safeguard the anonymity of the research participants. For international transfers of data to Australia, the data controller must also ensure that such transfers are done in compliance with Chapter V of the General Data Protection Regulation (GDPR). It is advisable to consult with the Data Controller’s DPO on this matter to ensure the appropriate legal basis for international transfer of personal data is used. [CONDITION MET]\n","Condition 4. In line with the principal of data minimisation, only the minimal amount of data required for the purpose of this study should be transferred for analysis to the Sponsor and the data custodian in Australia. No identifiable data should be transferred to, or accessed by, these parties, such that the data remains fully anonymised to the recipient. The Applicant is also requested to consider whether the data retention period of 15 years is necessary and can be reduced to a shorter timeframe. [CONDITION MET]\n\nCondition 5. The Applicant must ensure clear and consistent information is provided to the individuals providing assent on behalf of the participants that lack decision-making capacity, and the participant with regards withdrawing from the study and the options available for what will happen their personal data should they wish to withdraw. Given the small numbers of participants in this study, particular care should also be given to avoid unduly or unintentionally pressurisingparticipants or their assenting relatives to permit the continued processing of personal data if they wish to withdraw from the study. \n","Condition 6. The HRCDC requests that the study information leaflets, and assent/consent forms are reviewed and amended to ensure clarity, transparency and consistency of information for participants and/or individuals providing assent. In this context the following observations weremade by the HRCDC:\n(i) For correctness, relative or next-of-kin ‘consent’ for data processing should be replaced with ‘assent’, when referring to a proxy individual providing assent on behalf of the research participant. Correspondingly ‘consent’ should only be used when engaging directly with the research participant. It is important to ensure these terms are not used interchangeably. Assent is an important data protection safeguard but has no lawful basis for data processing\n(ii) References to ‘your relatives’ data should be removed where appropriate from the participant’s study information leaflet,\n(iii) Different information on the storage and future use of data is outlined, with one document referring to future research relating to lung infections and the other future research on sepsis.The Applicant should ensure that clear, informed and consistent information is provided to both participants and individuals providing assent with regards the storage and processing of data for future research and the areas of research that maybe undertaken, \n(iv) It is noted that there are references to the University of Newcastle, Canberra as opposed to New South Wales. The roles of the Australian parties within this study and extent of the data that will be transferred to Australia should be clear and consistent,\n(v) The information leaflets state that ‘pseudonymised’ and ‘personal’ data will be shared/transferred to Australia, however other sections state that ‘personal data/information’ will not be shared. Under GDPR pseudonymised data is considered personal data. It should be clearly outlined that pseudonymised or coded/de-identified data, is provided to the parties in Australia, and shall be anonymised to the recipient,\n(vi) Amend the information leaflets to state that 50, not 30, participants will be included in this study\n(vii) The assent form should be positively framed to ask the individual providing assent if the will and preferences of the research participant are known and whether they would wish to be included in the research, as opposed to asking if they are aware of any objections,\n(viii)The Applicant is requested to ensure that the relevant potential risks of the study have been appropriately outlined in the study information leaflets. Specifically, the HRCDC discussed that there are likely to be identifiable potential risks from high blood pressure that could be outlined. The relevant ‘Surviving Sepsis’ clinical guidelines should be used to identify and comment on any potential risks. [CONDITION MET]","Condition 1. Further to Condition 2 attached to the original consent declaration, the Applicant must provide confirmation that full REC approval for Beaumont Hospital and St Vincent’s University Hospital, when obtained, covers the use of telephone proxy assent at these sites. The consent declaration will not cover the Beaumont Hospital or SVUH sites, or the use of telephone proxy assent at these sites, until the requisite REC approval is in place and that such confirmation is provided to the HRCDC.\n\nCondition 2. Based on the updated study information leaflets and assent/consent forms submitted with the HRCDC amendment request form, it is noted that the observations outlined in Condition 6 attached to the original consent declaration have not been fully addressed throughout the latest version of the study information and assent/consent forms. The Applicant must therefore revisit the study information leaflets and assent/consent forms and ensure that Condition 6 is fully addressed. In this context the following observations are provided, which include some additional observations from that already outlined previously in Condition 6:\n• Pg 1 of the Participant Information Leaflet/Consent to continue document references that the patient has been enrolled in the study based on the ‘consent’ of the next-of-kin – this should be changed to ‘assent’. As per point (i) of Condition 6, for correctness, relative or next-of-kin ‘consent’\nfor data processing should be replaced with ‘assent’, when referring to a proxy individual providing assent on behalf of the research participant throughout the study documentation. \n• Pg 2 of both the Participant Information Leaflet/Consent to continue form and the relative/next\u0002of-kin information sheet still refers to 30/thirty participants being recruited, not 50/fifty as was confirmed by the Applicant. \n• Pg 4 of the Participant Information Leaflet/Consent to continue form incorrectly uses the term ‘they’, rather than ‘your’, in several places e.g., when referring to the participant’s data rights.\n• Review and amend both the proxy assent/participant consent form provided on pages 6-7 of the Participant Information Leaflet/Consent to continue form and the relative/next-of-kin information sheet, to ensure that the correct wording and terms are used. For example, the consent to continue \nform for the participant is incorrectly entitled ‘Person Responsible Consent Form’ and states ‘I have been asked to give permission for the following person to participate….’. Correspondingly the proxy assent form for the next-of-kin provides a space for ‘Participant Signature’ and not ‘Proxy signature’ [CONDITION MET]","Condition 1. The Irish hospital sites must, alongside the data controller Hunter New England Health Local Health District, be responsible for the implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participant if a participant has queries or otherwise wishes to exercise their rights."]
[null,"Deadline for meeting Conditions","N/A",null,null,"N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 2nd March 2021 and shall be valid until 2nd March 2022 and for 15 years thereafter (until 2nd March 2037) or upon confirmation that explicit consent has been obtained or the personal data have been rendered anonymised or destroyed, or whichever occurs sooner.",null,null,"The approval to the Amendment is made commencing 13th December 2022 and shall be valid until 2 nd March 2037, in line with the duration of the consent declaration made.","The approval to the Amendment is made commencing 22nd August 2023 and shall be valid until 2ndMarch 2037, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration No Longer Required",null,null,"Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1: The HRCDC recommends that the Applicant continues to engage with PPI representatives to leverage their perspectives and experiences to inform and improve upon data protection measures such as greater transparency measures within the ICU setting in general. [RECOMMENDATION CONSIDERED]",null,null,"Recommendation. While not part of Condition 6 attached to the original consent declaration, the Applicant may wish to seek more explicit proxy assent/participant consent with regards contacting the participant’s GP at 3 months to request serum creatinine results (e.g., an yes/no tick option in \nthe assent/consent form).","N/A"]

{"sheet":"21-001-AF1","index":78,"n_rows":17,"n_cols":3,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-001-AF1"]
[null,"Application Title ","Determination of HPV status of Oropharynx cancer using p16 immunohistochemistry, morphology, and RNAscope (RNA ISH)"]
[null,"Applicant Organisation (Data Controller)","South Infirmary Victoria University Hospital (SIVUH) "]
[null,"Lead Applicant ","Patrick Sheahan"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","There is currently no international consensus on the optimal approach to Human Papilloma Virus (HPV) testing in oropharynx squamous cell carcinoma (OPSCC - throat/tonsil cancer) and at least a minority of patients are misclassified as having HPV positive disease. Accurate assignation of HPV status in OPSCC is essential given the improved prognosis of patients with HPV associated tumours, divergence in staging for HPV positive and negative cases and potential differences in patient management. The objective of the study is to establish the optimal approach to HPV testing for OPSCC in Ireland, the analysis will be based on comparison of survival outcomes and cost effectiveness of the testing approaches. The study will predominantly take the form of a retrospective chart review, but with the additional step of retrospective HPV RNA in situ hybridization (ISH) testing of the p16 positive cases, which will be performed on existing tissue blocks. This is a new test which only became commercially available in Ireland in 2020 and reportedly has very high sensitivity and specificity. "]
[null,"Reason for seeking a Declaration","A consent declaration is required as the Applicant states it is not feasible to obtain the explicit consent of participants. The data processing activities for the above referenced study includes access, collection, pseudonymisation, transfer and storage of personal data. Once the data collection is completed the data will be irrevocably anonymised prior to statistical analysis. \nThe data to be processed is that already obtained for care and treatment and data associated with and generated from pre-existing bio-samples. Follow-up survival data will also be collected during the course of the study.  "]
[null,"Scheduled HRCDC Meeting Date #1","2nd March 2021"]
[null,"Scheduled HRCDC Meeting Date #2","22nd June 2021"]
[null,"HRCDC Decision Date ","22nd June 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is required to submit a midterm report detailing the progress that has been made with regards (i) undertaking PPI activities, (ii) designing and implementing aconsenting process and (iii) enhancing transparency measures. This midterm report must besubmitted 6 months from the date of the consent declaration being made. [CONDITON MET]"]
[null,"Deadline for meeting Conditions","Condition 1: 22.12.2021 [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 22nd June 2021 and shall be valid until 31st March 2024 (24 months from the start of the study in Q1 2022) at which point the data will be irrevocably anonymised, or upon confirmation that the personal data have been rendered anonymised or destroyed sooner."]
[null,"Status of Declaration","Declaration No Longer Required"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation. The Applicant is recommended to bring forward (i) the establishment of the PPI network and (ii) the consultations with PPI representatives as early as possible so that the consent process and transparency measures can be explored in a timely manner in advance of  the study commencing in 2022. [RECOMMENDATION CONSIDERED]"]

{"sheet":"21-002-AF1","index":79,"n_rows":16,"n_cols":6,"rows_kept":16,"cut":false,"hidden":false,"merged":[[15,1,16,1],[15,2,16,2]]}
[null,null,null,"AMENDMENT #1",null,"AMENDMENT #2"]
[null,"Application Ref ID","21-002-AF1","21-002-AF1/AMD1",null,"21-002-AF1/AMD2"]
[null,"Application Title ","The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets (Mega-ROX)","The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets (Mega-ROX)",null,"The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets (Mega-ROX)"]
[null,"Applicant Organisation (Data Controller)","Medical Research Institute of New Zealand (MRINZ)","Medical Research Institute of New Zealand (MRINZ)",null,"Medical Research Institute of New Zealand (MRINZ)"]
[null,"Lead Applicant ","Alistair Nichol","Alistair Nichol",null,"Alistair Nichol"]
[null,"Research commenced prior to submission of application","No","No",null,"No"]
[null,"Research Objective","The Mega-ROX study is to determine the effect of two approaches to oxygen therapy on the risk of death in patients who need emergency life support (a breathing machine) in the ICU. Oxygen is essential for life and is given to all patients on life support. Often these patients receive more oxygen than they need to make their body oxygen levels normal. Some research suggests that giving more oxygen than is needed to achieve normal oxygen levels may be harmful while other research suggests that it is not, and it may even be beneficial. This study compares two ways of giving oxygen to patients on life support. The first is to give a little more oxygen and the second is to give a little less. Both approaches are safe but it is not clear which approach is the most effective. All patients in this study can be allocated to either of the approaches to oxygen therapy being tested.","The Mega-ROX study is to determine the effect of two approaches to oxygen therapy on the risk of death in patients who need emergency life support (a breathing machine) in the ICU. Oxygen is essential for life and is given to all patients on life support. Often these patients receive more oxygen than they need to make their body oxygen levels normal. Some research suggests that giving more oxygen than is needed to achieve normal oxygen levels may be harmful while other research suggests that it is not, and it may even be beneficial. This study compares two ways of giving oxygen to patients on life support. The first is to give a little more oxygen and the second is to give a little less. Both approaches are safe but it is not clear which approach is the most effective. All patients in this study can be allocated to either of the approaches to oxygen therapy being tested.",null,"The Mega-ROX study is to determine the effect of two approaches to oxygen therapy on the risk of death in patients who need emergency life support (a breathing machine) in the ICU. Oxygen is essential for life and is given to all patients on life support. Often these patients receive more oxygen than they need to make their body oxygen levels normal. Some research suggests that giving more oxygen than is needed to achieve normal oxygen levels may be harmful while other research suggests that it is not, and it may even be beneficial. This study compares two ways of giving oxygen to patients on life support. The first is to give a little more oxygen and the second is to give a little less. Both approaches are safe but it is not clear which approach is the most effective. All patients in this study can be allocated to either of the approaches to oxygen therapy being tested."]
[null,"Reason for seeking a Declaration","For the purpose of processing personal data of individuals who lack decision-making capacity for this specific study, until such time deferred consent can be obtained from the individuals. Data processing activities includes data collection, pseudonymisation, analysis, sharing of pseudonymised data, storage, archiving, destroying. ","The amendment is requested for the following:\n(i)\tthe addition of Beaumont Hospital and Our Lady's Hospital, Drogheda to the study who are also data processors. RCSI are also added as a data processor given their involvement in the study at Beaumont Hospital. \n(ii)\tthe inclusion of a sub-study known as 'LOGICAL’ and the associated data processing for this sub-study for those who lack-decision making capacity, including transfer of pseudonymised data to the data controller MRINZ and the subsequent full anonymisation and transfer of anonymised data to Monash University, Australia. ",null,"To add the Mater Hospital (MMUH) as a new site/data processor.\nAn update to the study protocol that reflects the collection of additional baseline data for both new prospective participants and participants who have already been enrolled into the study. \nTo continue to process the participant’s personal data if they are withdrawn from the study, where assent for such continued processing is provided by the proxy; the original consent declaration application noted that data would be deleted upon withdrawal. "]
[null,"Scheduled HRCDC Meeting Date","13th April 2021","13th June 2023",null,"8th October 2024"]
[null,"HRCDC Decision Date ","13th April 2021","13th June 2023",null,"8th October 2024"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. Where a participant continues to lack decision-making capacity for a prolonged period of time and where proxy assent remains in place, the HRCDC requests that the Applicant should seek confirmation from the individual who provided assent, that they wish for the participant’spersonal data to continue to be processed as part of the research study. Confirmation of proxy assent should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned. The Applicant must report on this as part of the Annual Review including the number of participants where deferred consent has and has not been obtained. [CONDITION UNDERWAY]\n\nCondition 2. The Applicant must ensure that the appropriate legal agreement setting out the terms and conditions governing the transfer and use of data collected in Ireland, is executed between St. Vincent’s University Hospital and the data controller MRINZ and including arrangements with other study parties where relevant. [CONDITION MET]\n\nCondition 3: Considering the principle of data minimisation, the Applicant is requested to examine the length of the data archiving period of 15-years and whether this timeframe can be reduced. The Applicant is requested to report on this condition as part of the Annual Review. [CONDITION MET]\n\nCondition 4. Confirmation of full research ethics approval from St. Vincent’s University Hospitalmust be provided to the HRCDC, once granted. The conditional declaration shall not be in effect until this condition is met. [CONDITION MET]","Condition 1. The Applicant must ensure that the required data agreements/arrangements are in place between the data controllers of this study and the new hospital sites and data processors. The processing and transfer of personal data by these processors for this study cannot commence prior to the required agreements being in place.\n\nCondition 2. It is noted that final, full research ethics approval for the Drogheda site remains pending. The consent declaration does not cover Our Lady’s Hospital Drogheda until full REC approval for this site is in place. Confirmation of this approval should also be provided to the HRCDC when obtained. With regards the use of a telephone assent process, this will not be covered for the Drogheda site unless the REC approval for Drogheda covers the use of telephone assent.\n\nCondition 3. The Applicant/data controller is requested to revisit the matter of data minimisation for the LOGICAL sub-study to ensure only the minimal amount and type of data is collected and processed. For example, to review and consider if data on both educational attainment and \nemployment required for the purpose for the LOGICIAL study. The data controller should ensure compliance with the principle of data minimisation throughout the course of the study timeframe. [CONDITION MET]\n\nCondition 4. The data controller must ensure that the data from the LOGICAL study that is to be transferred to Monash University is fully anonymised.","Condition 5. To ensure clarity and consistency of information for the participants and those providing proxy assent on their behalf, the study information leaflets and consent/assent forms for each of the sites in Ireland should be reviewed and amended as follows prior to recruiting new participants:\n- it is noted that the terms ‘consent’ and ‘assent’ are not used correctly throughout the study documentation, for example page 2 of the Beaumont Hospital consent to continue information leaflet refers to a ‘person responsible’ having previously ‘consented’. The term ‘consent’ should be used when referring to seeking the permission of the study participant, not their next-of-kin or proxy; the term ‘assent’ should be used when referring to seeking permission form a proxy \nindividual on behalf of a participant who lacks decision-making capacity. The Applicant is requested to review the study documents for each site and ensure the correct term is used.\n- references to UCD in the study documentation should be removed as it has been confirmed that UCD are not involved in this study.\n- the study information leaflets should clearly outline that if a participant is unable to complete the 6-month follow-up assessment due to lack of capacity, that the person who provided proxy assent may be asked to complete the assessment.\n- the phrase ‘If there is no known objection by your relative to being included’should be rephrased more positively to ask the proxy if they believed the individual would wish to be included in this study.\nLastly, it should be ensured that the feedback provided by the Drogheda REC on the studyinformation leaflets and assent/consent forms are addressed and, more generally, ensure that the information within the documents used for each of the sites in Ireland are aligned and consistent. \n(Please also see Recommendation 1).\n\nCondition 6. As part of the Annual Review, the Applicant is requested to provide information on \nthe number of participants that have been recruited at the Irish sites with regards (i) the main \nMega-ROX study and (ii) the LOGICAL sub-study. [CONDITION MET]","Condition 1. Data agreements/arrangements must be in place between the data controller of the \nstudy (MRINZ) and the Mater Hospital.\n\nCondition 2. Research ethics committee approval must be in place for each site to cover the \nadditional baseline data to be collected."]
[null,"Deadline for meeting Conditions","N/A","N/A",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made on 13th April 2021 and is valid until deferred consent is obtained from participants who regain decision-making capacity. Where participants do not regain capacity, the declaration shall be valid until 31st December 2024 and for 15 years thereafter (until March 2039) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner.","The approval to the Amendment is made commencing 13th June 2023 and shall be valid until deferred consent is obtained from participants who regain decision-making capacity. Where participants do not regain capacity, the declaration shall be valid until 31st December 2024 and \nfor 15 years thereafter (until March 2039) or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner. ",null,"The approval to the Amendment is made commencing 8 th October 2024 and shall be valid until deferred consent is obtained from participants who regain decision-making capacity. Where participants do not regain capacity, the declaration shall be valid until 31st March 2039 (i.e., until 31st December 2024 and for 15 years thereafter), or upon confirmation that the data has been rendered anonymised or destroyed, or whichever occurs sooner (this is in line with the duration of the consent declaration made)"]
[null,"Status of Declaration","Declaration Live","Declaration Live",null,"Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The HRCDC notes that proxy assent will be obtained after the participant’s has been assessed for study eligibility and randomisation. Where possible to do so, the HRCDC requests the Applicant to attempt to obtain proxy assent prior to these steps. [RECOMMENDATION UNDERWAY]\n\nRecommendation 2. As a reporting requirement of the Annual Review, the Applicant is requested to report on the PPI activities that will be carried out for this study. [RECOMMENDATION CONSIDERED]\n\nRecommendation 3. The HRCDC requests that the study information leaflets, and assent/consent forms are reviewed and amended as appropriate to ensure clarity, transparency, and consistency \nof information for participants and/or individuals providing assent. In this context the following specific observations were made by the HRCDC:\n- It should be more clearly set out within the assent/consent documents how participants can practicably withdraw from the study, including what will happen the personal data, biological samples and results, if assent or deferred consent is not provided or withdrawn,\n- It should be examined how clear and concise information on data protection rights could be provided in an easy to read and understandable format, in consultation the DPO,\n- The use of the term ‘your responsible person’ in the deferred consent documents may not be an appropriate description. Consideration should be given to an alternative descriptor, such as ‘proxy’,\n- The term ‘assent’ rather than ‘consent’ should be used study documents when referring to proxy assent,\n- Reference should also be made to the HRCDC consent declaration when referring to deferred assent as standard practice in ICU research,\n- The statement ‘If there is no known objection by your relative to be included’ should reframed more positively to ask the proxy individual if they believe their relative would wish to participate in this study,\n- Reference to the future use of data/samples in the assent documents should be amended to reflect that this consent declaration is for the Mega-Rox study only and does not extend to the processing of personal data in unknown, future research. As a general point the Applicant \nshould also ensure that any consent obtained for the future use of data from the participant is compliant with data protection legislation. [RECOMMENDATION UNDERWAY]","Recommendation 1. The Applicant is requested to consider and take on board the points outlined in Recommendation 3 that was attached to the original consent declaration with regards the \nupdated study information and assent/consent forms for all the hospital sites in Ireland. \n\nRecommendation 2. The Applicant is requested to ensure that the DPIA for this study remains up to date and applicable for all the hospital sites in Ireland, including Our Lady’s Hospital Drogheda, and correspondingly to consult with the relevant DPOs, including the DPO of the data controller of \nthe study.\n\nRecommendation 3. The DPIA states that the study will gain ‘explicit informed consent’ from individuals. The DPIA should be amended to reflect that this study involves a deferred assent process, followed by consent to continue when the participant regains capacity.",null,"Recommendation 1. The consent declaration for MEGA-ROX was made for the duration of the study and for a further 15 years to include the archiving/storage of the pseudonymised data i.e., until 31st March 2039. However, it is noted that the study information leaflets and assent/consent documents for the Mater Hospital site provide inconsistent information on what will happen the personal/pseudonymised data after the study concludes and on data archiving: - The Mater documents state that data will be anonymised by destroying the master list as soon as the data is cleaned - Elsewhere, the documents note that all study documents / data will be retained or archived for either 10 or 15 years The study documents for the Mater should be amended to clarify that pseudonymised data will be archived for 15 years after the study, as per the duration of the consent declaration and previous informaiton provided."]

{"sheet":"21-003-AF1","index":80,"n_rows":17,"n_cols":7,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2",null,"AMENDMENT #3"]
[null,"Application Ref ID","21-003-AF1","21-003-AF1/AMD1","21-003-AF1/AMD2",null,"21-003-AF1/AMD3"]
[null,"Application Title ","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans","Investigating the Epidemiology of Mycobacterium bovis Infection in Humans",null,"Investigating the Epidemiology of Mycobacterium bovis Infection in Humans"]
[null,"Applicant Organisation (Data Controller)","St. James's Hospital \nNew Data Controller: Trinity College Dublin","St. James's Hospital \nNew Data Controller: Trinity College Dublin","St. James's Hospital \nNew Data Controller: Trinity College Dublin",null,"St. James's Hospital \nNew Data Controller: Trinity College Dublin"]
[null,"Lead Applicant ","Tom Rogers ","Tom Rogers ","Tom Rogers ",null,"Tom Rogers "]
[null,"Research commenced prior to submission of application","No","No","No",null,"No"]
[null,"Research Objective","Bovine Tuberculosis, a form of TB caused by Mycobacterium bovis, was a common disease in Ireland prior to pasteurization of milk and programmes to eliminate this infection in cattle herds. The aim of this study is to investigate whether a recent rise in human M. bovis infection is due to reactivation of latent bovine TB infection with M. bovis that had been acquired years earlier - prior to widespread milk pasteurisation - or whether it is due to new infection transmitted to humans from infected cattle. The study will also review the potential role of recently licenced immunomodulatory medications in the development of M. bovis. \nThis study plans to carry out a retrospective review of the healthcare records of patients who attended St James’s Hospital (SJH) for investigation or treatment of their M. bovis infection. In parallel to this, it will perform whole genome sequencing (WGS) on DNA extracted from approximately 100 M. bovis isolates. These microorganisms are originally from patients attending SJH or other Irish hospitals, and a small number of domestic animals, that have been collected by the Irish Mycobacteria Reference Laboratory (IMRL; SJH) and stored over the last 20 years as part of routine clinical care, diagnosis, and national reference work. \nThe study will compare its genome sequenced isolates to genome sequences that are already in the public domain in peer-reviewed journals and from genome sequences of M. bovis from infected cattle herds across Ireland and internationally. This may enable the study to identify clusters or possible transmission events between animals and humans and the timelines involved. Finally, it will link the available patient metadata collected by reviewing patient charts to their corresponding sequenced M. bovis isolates to hopefully give a better understanding of risk factors for and epidemiology of M. bovis in Ireland.","Bovine Tuberculosis, a form of TB caused by Mycobacterium bovis, was a common disease in Ireland prior to pasteurization of milk and programmes to eliminate this infection in cattle herds. The aim of this study is to investigate whether a recent rise in human M. bovis infection is due to reactivation of latent bovine TB infection with M. bovis that had been acquired years earlier - prior to widespread milk pasteurisation - or whether it is due to new infection transmitted to humans from infected cattle. The study will also review the potential role of recently licenced immunomodulatory medications in the development of M. bovis. \nThis study plans to carry out a retrospective review of the healthcare records of patients who attended St James’s Hospital (SJH) for investigation or treatment of their M. bovis infection. In parallel to this, it will perform whole genome sequencing (WGS) on DNA extracted from approximately 100 M. bovis isolates. These microorganisms are originally from patients attending SJH or other Irish hospitals, and a small number of domestic animals, that have been collected by the Irish Mycobacteria Reference Laboratory (IMRL; SJH) and stored over the last 20 years as part of routine clinical care, diagnosis, and national reference work. \nThe study will compare its genome sequenced isolates to genome sequences that are already in the public domain in peer-reviewed journals and from genome sequences of M. bovis from infected cattle herds across Ireland and internationally. This may enable the study to identify clusters or possible transmission events between animals and humans and the timelines involved. Finally, it will link the available patient metadata collected by reviewing patient charts to their corresponding sequenced M. bovis isolates to hopefully give a better understanding of risk factors for and epidemiology of M. bovis in Ireland.","Bovine Tuberculosis, a form of TB caused by Mycobacterium bovis, was a common disease in Ireland prior to pasteurization of milk and programmes to eliminate this infection in cattle herds. The aim of this study is to investigate whether a recent rise in human M. bovis infection is due to reactivation of latent bovine TB infection with M. bovis that had been acquired years earlier - prior to widespread milk pasteurisation - or whether it is due to new infection transmitted to humans from infected cattle. The study will also review the potential role of recently licenced immunomodulatory medications in the development of M. bovis. \nThis study plans to carry out a retrospective review of the healthcare records of patients who attended St James’s Hospital (SJH) for investigation or treatment of their M. bovis infection. In parallel to this, it will perform whole genome sequencing (WGS) on DNA extracted from approximately 100 M. bovis isolates. These microorganisms are originally from patients attending SJH or other Irish hospitals, and a small number of domestic animals, that have been collected by the Irish Mycobacteria Reference Laboratory (IMRL; SJH) and stored over the last 20 years as part of routine clinical care, diagnosis, and national reference work. \nThe study will compare its genome sequenced isolates to genome sequences that are already in the public domain in peer-reviewed journals and from genome sequences of M. bovis from infected cattle herds across Ireland and internationally. This may enable the study to identify clusters or possible transmission events between animals and humans and the timelines involved. Finally, it will link the available patient metadata collected by reviewing patient charts to their corresponding sequenced M. bovis isolates to hopefully give a better understanding of risk factors for and epidemiology of M. bovis in Ireland.",null,"Bovine Tuberculosis, a form of TB caused by Mycobacterium bovis, was a common disease in Ireland prior to pasteurization of milk and programmes to eliminate this infection in cattle herds. The aim of this study is to investigate whether a recent rise in human M. bovis infection is due to reactivation of latent bovine TB infection with M. bovis that had been acquired years earlier - prior to widespread milk pasteurisation - or whether it is due to new infection transmitted to humans from infected cattle. The study will also review the potential role of recently licenced immunomodulatory medications in the development of M. bovis. \nThis study plans to carry out a retrospective review of the healthcare records of patients who attended St James’s Hospital (SJH) for investigation or treatment of their M. bovis infection. In parallel to this, it will perform whole genome sequencing (WGS) on DNA extracted from approximately 100 M. bovis isolates. These microorganisms are originally from patients attending SJH or other Irish hospitals, and a small number of domestic animals, that have been collected by the Irish Mycobacteria Reference Laboratory (IMRL; SJH) and stored over the last 20 years as part of routine clinical care, diagnosis, and national reference work. \nThe study will compare its genome sequenced isolates to genome sequences that are already in the public domain in peer-reviewed journals and from genome sequences of M. bovis from infected cattle herds across Ireland and internationally. This may enable the study to identify clusters or possible transmission events between animals and humans and the timelines involved. Finally, it will link the available patient metadata collected by reviewing patient charts to their corresponding sequenced M. bovis isolates to hopefully give a better understanding of risk factors for and epidemiology of M. bovis in Ireland."]
[null,"Reason for seeking a Declaration","The Applicant states that it is not feasible to obtain explicit consent from participants. A consent declaration is required to process personal data, including personal data associated with bio-samples, for the purpose of this research study which involves the following activities:\n(i) Identifying eligible patients, accessing patient records/charts and collecting, pseudonymising and analysing the personal data from these sources,\n(ii) The processing of personal data associated with the existing M.bovis isolates from the Irish Mycobacteria Reference Laboratory (IMRL); the isolates will either be further analysed (i.e whole genome sequencing), or, where available, already have undergone whole genome sequence by the IMRL,\n(iii) Where possible, linking the personal data collected in point (i) with the whole genome sequencing in point (ii) for the purpose of analysis. Subsequent publication of results will be on anonymised data.","To add Trinity College Dublin as a joint controller of the study with St James's Hospital. ","The amendment is requested to (i) extend the duration of the consent declaration until May 2024 and (ii) to extend the patient cohort to include those patients diagnosed in 2021-2022.",null,"To extend the duration of the consent declaration to 31st May 2026."]
[null,"Scheduled HRCDC Meeting Date #1","13th April 2021","12th April 2022","13th June 2023",null,"2nd September 2024"]
[null,"Scheduled HRCDC Meeting Date #2","18th May 2021","N/A","N/A"]
[null,"HRCDC Decision Date ","18th May 2021","12th April 2022","13th June 2023",null,"2nd September 2024"]
[null,"HRCDC Decision","Conditional Declaration ","Amendment Approved","Amendment Approved",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. Provisional Research Ethics Committee approval is currently in place. Confirmation of full research ethics approval from St. James’s Hospital must be provided to the HRCDC, once granted. The conditional declaration shall not be effective until this condition is met. (CONDITION MET)\n\nCondition 2. The Applicant must implement the enhanced transparency measures as outlined in the responses to the HRCDC, to inform patients and public about the study, the use of their personal data and their data protection rights and how they can exercise these rights. Specifically, the Applicant must provide suitable study information notices in the St. James’s Hospital clinics. The Applicant should also continue to engage with third parties with regards the potential to advertise the study on their respective websites. Information on how condition is being implemented is a reporting requirement of the Annual Review (Please see Recommendation) [CONDITION MET]","N/A","Condition 1. It is a condition that the Applicant/joint data controllers make reasonable efforts to obtain the explicit consent of the 2021-2022 participant cohort who are/were TB patients, in particular those who are/were TB patients of St James’s Hospital, including those who may still be receiving follow-up care at St James’s Hospital for their condition. The Applicant is requested to report within three months on the efforts made to seek explicit consent for these participants, including the numbers of those who have been contacted and who have consented. The consent declaration will cover the processing of participant’s personal data where reasonable efforts are made to seek their consent but there is no response from the participant. Where a participant actively decides not to provide their consent then they are not covered by this consent declaration. [CONDITION MET]","Condition 2. The Applicant is requested to enhance transparency measures as follows:\n- It is the view of the HRCDC that the project notice on the St James’s Hospital website is not as effective or user-friendly as the notice poster that is displayedin the TB clinics in St James’s Hospital. The project notice on the St James’s Hospital website should therefore be amended to align more closely with and look and read as user-friendly as the clinic notice poster. It was also noted that it is not clear where the project notice on the St James’s Hospital website can be found; \nthis project notice should also be made available in an easy to locate part of the website. \n- the Applicant should continue to follow-up with the Irish Thoracic Society to see if information about the study can be made available on their platforms. It was also the view of the HRCDC that similar engagement should occur with other relevant organisations to enhance study transparency, for example with the Irish Lung Foundation. \n- the Applicant should explore and implement enhanced transparency measures by other methods such as social media; for example, utilising the twitter and Facebook pages of St James’s Hospital, Trinity College Dublin and others, linking them to the study’s webpage and notices. [CONDITION UNDERWAY]\n\nCondition 3. Ethical approval for the extended study duration must be obtained and confirmationof this submitted to the HRCDC. The amendment is not in effect until this required ethical approval has been obtained. [CONDITION MET]","N/A"]
[null,"Deadline for meeting Conditions","N/A","N/A","Condition 1: Consent - 30th September 2023",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 18th May 2021 and shall be valid until 31st May 2023 at which point the data will be anonymised, or until the personal data has been destroyed, whichever occurs sooner. AMENDMENT MADE - The approval to the Amendment is valid until 31st May 2026","The approval for the amendment is made commencing 12th April 2022 and shall be valid until 31st May 2023 at which point the data will be anonymised. This is in line with the duration of the consent declaration made. AMENDMENT MADE - The approval to the Amendment is valid until 31st May 2026","The approval to the Amendment is made commencing 13th June 2023 and shall be valid until 31st May 2024 [This is an extension of the original consent declaration made] AMENDMENT MADE - The approval to the Amendment is valid until 31st May 2026",null,"The approval to the Amendment is made commencing 2nd September 2014 and shall be valid until 31st May 2026, an extension to the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live",null,"Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation: For the purpose of clarity, the Applicant is asked to consider amending the public information notice to state that if a participant does not contact the study team it is assumed they are satisfied to have their personal data and bio-samples processed for the purpose of this study. [RECOMMENDATION CONSIDERED]","Recommendation 1: Notwithstanding that a joint data controller agreement is in place between the joint data-controller parties (Ref; application form), the Applicant should ensure that the data agreements/arrangements in place between St James’s Hospital Dublin and Trinity College Dublin, \nclearly outline the roles and responsibilities of each party for this specific study. This includes clearly outlining the role and responsibilities of the study investigators, including the TCD medical student accessing the medical records. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2: The privacy notice submitted as part of the amendment request form outlines that TCD are involved in this study. More broadly and linked to Condition 2 attached to the original consent declaration, the Applicant is recommended to ensure that other transparency measures to \nbe implemented will highlight the role and responsibility of TCD in this study, if not done so already. [RECOMMENDATION CONSIDERED]","N/A",null,"N/A"]

{"sheet":"21-004-AF1","index":81,"n_rows":17,"n_cols":7,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","21-004-AF1",null,null,null,"21-004-AF1/AMD1"]
[null,"Application Title ","AP-recAP-AKI-03-01 (REVIVAL)",null,null,null,"AP-recAP-AKI-03-01 (REVIVAL)"]
[null,"Applicant Organisation (Data Controller)","AM-Pharma B.V. ",null,null,null,"AM-Pharma B.V. "]
[null,"Lead Applicant ","Alistair Nichol",null,null,null,"Alistair Nichol"]
[null,"Research commenced prior to submission of application","No",null,null,null,"No"]
[null,"Research Objective","This study is a Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group,  Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant  Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury (SA-AKI).\nSepsis is the leading cause of acute kidney injury (AKI) and a major cause of death.  Patients with SA-AKI have a high mortality and morbidity and are at risk of developing  chronic kidney disease (CKD). AM-Pharma B.V. is developing Alkaline phosphatase (AP) which is a compound normally present in many human tissues. AP has many functions  including helping the body fight infection and reducing organ injury during sepsis, as a novel AP medicinal product, called recAP, to be used as an intravenous (IV) infusion for  the treatment of SA-AKI. The Phase 3 trial based on the significant survival benefit \nobserved in Phase 2 trials and favourable safety profile observed in the Phase 1 and  Phase 2 studies.",null,null,null,"This study is a Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group,  Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant  Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute \nKidney Injury (SA-AKI).\nSepsis is the leading cause of acute kidney injury (AKI) and a major cause of death.  Patients with SA-AKI have a high mortality and morbidity and are at risk of developing  chronic kidney disease (CKD). AM-Pharma B.V. is developing Alkaline phosphatase (AP) which is a compound normally present in many human tissues. AP has many functions  including helping the body fight infection and reducing organ injury during sepsis, as a novel AP medicinal product, called recAP, to be used as an intravenous (IV) infusion for  the treatment of SA-AKI. The Phase 3 trial based on the significant survival benefit \nobserved in Phase 2 trials and favourable safety profile observed in the Phase 1 and  Phase 2 studies."]
[null,"Reason for seeking a Declaration","A declaration is sought for the purpose of processing personal data of individuals who lack decision-making capacity for this study, until such time deferred consent can be obtained from the individuals. Where the participant lacks decision-making capacity, proxy assent will be obtained.\nData processing activities for which a declaration is required is for processing personal data for the purpose of the above referenced REVIVAL study (accessing, collecting, pseudonymising, transferring, analysing) as well as the storage/archiving only of personal data.",null,null,null,"Change in data processing/study actitity with regards access to participant medical records in the event participants are lost to follow up. "]
[null,"Scheduled HRCDC Meeting Date #1","13th April 2021",null,null,null,"N/A"]
[null,"Scheduled HRCDC Meeting Date #2","18th May 2021",null,null,null,"N/A"]
[null,"HRCDC Decision Date ","18th May 2021",null,null,null,"N/A"]
[null,"HRCDC Decision","Conditional Declaration",null,null,null,"N/A"]
[null,"Specific Conditions attached ","Condition 1.\n▪ The means by which data is transferred electronically by email and/or OneDrive, to and from the Illingworth Research Group and the Irish hospital sites for the purpose of the off-site home visits, significantly fall short of the standards required for robust cybersecurity. \n▪ Until such time more robust cybersecure methods are employed, the transfer of all identifiable and pseudonymised data must be limited to physical means, including via courier or recorded delivery as described by the Applicant. \n▪ For the avoidance of doubt, the transfer of identifiable and pseudonymised data by email and OneDrive must not be carried out. \n▪ Should the Applicant subsequently devise and implement an alternative, more secure approach to electronically transferring identifiable and pseudonymised data, between Illingworth and the Irish hospital sites, (i) the HRCDC must be notified and (ii) an updated DPIA and DPO feedback must accompany this notification. \n▪ It is strongly advised to discuss this matter with the relevant data protection officers. \n\nCondition 2. It is a condition of the consent declaration that remote (off site) access to Irish participant’s medical charts and other documents such as the assent/consent forms, for monitoring and data verification purposes shall not be undertaken, unless in very exceptional circumstances. Remote access should only be permitted under extenuating circumstances, where on-site visits cannot be undertaken. Where remote access for monitoring and data verification purposes must be carried out, it should be aligned with the guidance issued by the Irish Health Products Regulatory Authority (HPRA) (http://www.hpra.ie/homepage/medicines/regulatory\u0002information/clinical-trials/covid-19-(coronavirus)-and-cts/guidance-on-the-management-of\u0002clinical-trials-during-covid-19) \nAs part of the Annual Review the Applicant is required to report on the extent of remote access that has been undertaken with regards participants in Ireland, providing a clear rationale and justification for undertaking this activity (CONDITION MET)","Condition 3. Only the minimal amount of data required for the study should be transferred to third parties involved in the trial. In addition, appropriate agreements/arrangements, with terms and conditions governing the transfer and use of the data, must be in place between the parties prior to the transfer of any data. Confirmation that the required agreements are in place should be provided to the HRCDC as soon as possible. [CONDITION MET i.e. confirmation of agreements]\n\nCondition 4. Where a participant continues to lack decision-making capacity for a prolonged period of time and where proxy assent remains in place, the HRCDC request that the following actions should be taken as an additional safeguard:\n(i) confirmation should be sought from the proxy who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.\n(ii) further to point (i), where participants have already been discharged from the hospital it should also be determined whether the participant has re-gained decision-making capacity and, where possible to do so, to obtain their deferred consent for data processing. This should be carried out prior to proxy assent being reaffirmed. \nThe Applicant must report on this as part of the Annual Review, including the number of participants where deferred consent has and has not been obtained. [CONDITON MET]\n\nCondition 5. Confirmation of full research ethics approval from St. Vincent’s University Hospital must be provided to the HRCDC, once granted. The conditional declaration shall not come into until this condition is met. [CONDITION MET]","Condition 6. The responses provided by Applicant regarding the information sheet are acknowledged by the HRCDC. The HRCDC requests that the study information leaflets, and assent/consent forms are further reviewed and amended to ensure clarity, transparency and consistency of information for participants and/or individuals providing assent and to ensure they are appropriate for an Irish context. In this context the following observations were made by the HRCDC and should be addressed prior to the commencement of the study: \n(i) the information leaflets are overly technical and should be further reviewed for readability to avoid potential confusion where possible, \n(ii) the information leaflets set out that the individual providing proxy assent has substantial responsibilities beyond assenting to the participant’s inclusion in study and the processing of their data, such as informing the trial doctor about changes to the participant’s health. These \nresponsibilities and expectations placed on the proxy individual should be removed, wherethis is not considered appropriate, with due consideration given to what is appropriate in in the context of an Irish clinical site involved in this trial.\n(iii) a proxy individual cannot waive a participant’s rights, including rights to any commercial value that may arise from the use of their data and bio-samples. References to such waivers of rights in the proxy information leaflet and assent form should therefore be removed or revised for correctness,\n(iv) with regards the retention of the bio-samples and personal data, the study information leaflets are inconsistent, stating they are discarded after the results are obtained, stored for 5 years or stored for 15 years. These sections should be amended as appropriate, \n(v) as this is a regulated clinical trial, it should be feasible to provide specific details on where the bio-samples and data will be transferred to as part of this trial. Ambiguous statements regarding the transfer of data and bio-samples should be avoided,\n(vi) the statement ‘If there is no known objection by your relative to be included’ should be reframed more positively to ask the proxy individual if they believe their relative would wish to participate in this study, \n(vii) as the data controller is located outside of Ireland, the study information leaflets should clearly reflect and communicate that data processing for the purpose of this study will comply with Irish data protection legislation and that the data protection rights of the study \nparticipants in Ireland will be upheld. The Applicant is requested to confirm at the points outlined above are addressed in prior to the \ncommencement of the study. Where the above observations cannot be addressed to meet this condition, please provide confirmation that the St. Vincent’s University Hospital REC have approved the consent/assent forms for appropriateness for use at an Irish clinical trial site. [CONDITION MET]","Condition 7. As a reporting requirement of the Annual Review, the Applicant is requested to report on the PPI activities that will be carried out for this study, including the feedback received from the SVUH Clinical Trial Network PPI meeting and any outcomes from consultations with Sepsis groups in other countries. [CONDITION MET]","N/A"]
[null,"Deadline for meeting Conditions","N/A",null,null,null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 18th May 2021 and shall be valid until the patient provides  explicit consent or until 31st March 2024 and for 15 years thereafter (until March 2039) or until the personal data has been destroyed or rendered irrevocably anonymised, whichever is sooner.",null,null,null,"N/A"]
[null,"Status of Declaration","Declaration No Longer Required",null,null,null,"Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","N/A",null,null,null,"N/A"]

{"sheet":"21-005-AF1","index":82,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","21-005-AF1","21-005-AF1/AMD1"]
[null,"Application Title ","Collaboration to reduce Antimicrobial use and Resistance and identify opportunities for \nimprovement and Awareness (CARA study)","Collaboration to reduce Antimicrobial use and Resistance and identify opportunities for \nimprovement and Awareness (CARA study)"]
[null,"Applicant Organisation (Data Controller)","National University of Ireland Galway","National University of Ireland Galway"]
[null,"Lead Applicant ","Akke Vellinga","Akke Vellinga"]
[null,"Research commenced prior to submission of application","No ","No "]
[null,"Research Objective","The CARA projects aims to provide an infrastructure to visualise data in relation to the occurrence and spread of infections and antimicrobial resistance (AMR). HIPE data (Hospital Inpatient Enquiry) is collected by HIPE coders in every hospital in Ireland after which it is combined centrally. The HIPE data set includes demographic, clinical and administrative data of every patient who has been discharged from a hospital. The CARA project wants to use this data to provide visualisations, for instance graphs, which can be viewed by users, such as hospitals or researchers. By analysing and comparing data, it will be possible to identify factors and interventions that influence the spread of (hospital) infections and AMR. Not all the collected HIPE data is relevant for our project, and in general the HIPE data is considered anonymous. However, certain combinations of data from HIPE are considered pseudo-anonymous because together they contain more specific information on an individual. This is the reason why we apply for HRCDC approval to use HIPE data for our CARA project. The HPO, Health Pricing Office, who collects and holds the HIPE data, have identified our request to include the hospital and admission & discharge date as falling under pseudonymised  data, and request the approval of the HRCDC to allow these additional variables to be provided to CARA. ","The CARA projects aims to provide an infrastructure to visualise data in relation to the occurrence and spread of infections and antimicrobial resistance (AMR). HIPE data (Hospital Inpatient Enquiry) is collected by HIPE coders in every hospital in Ireland after which it is combined centrally. The HIPE data set includes demographic, clinical and administrative data of every patient who has been discharged from a hospital. The CARA project wants to use this data to provide visualisations, for instance graphs, which can be viewed by users, such as hospitals or researchers. By analysing and comparing data, it will be possible to identify factors and interventions that influence the spread of (hospital) infections and AMR. Not all the collected HIPE data is relevant for our project, and in general the HIPE data is considered anonymous. However, certain combinations of data from HIPE are considered pseudo-anonymous because together they contain more specific information on an individual. This is the reason why we apply for HRCDC approval to use HIPE data for our CARA project. The HPO, Health Pricing Office, who collects and holds the HIPE data, have identified our request to include the hospital and admission & discharge date as falling under pseudonymised  data, and request the approval of the HRCDC to allow these additional variables to be provided to CARA. "]
[null,"Reason for seeking a Declaration","A declaration is being sought to obtain and store pseudonymised HIPE data from the Healthcare Pricing Office (HPO) for the purpose of this study. When obtained the data controller will aggregate and fully anonymise this data, and subsequently provide users (hospitals, researchers, public etc.) with access to this anonymised data, via the CARA data visualisation infrastructure.","CARA will provide a structure to explore data from various sources on infections, antibiotics and AMR. Data will be linked on a common factor, such as the hospital or an area and a data infrastructure will be set up to allow basic visualisations in custom made dashboards. These dashboards will be developed with and for particular groups, such as GPs, healthcare workers, hospitals or researchers, providing them with data to improve antibiotic use, identify infection control opportunities or investigate associations.\nSetting up the CARA network has been approached by focusing on two areas, hospital and general practice. In relation to hospital data, we have requested HIPE data and through the exploration of this data, we will obtain an in-depth knowledge on how hospital data can be linked. \nFor the GP data, we have worked closely with the ICGP (Partner on CARA is Prof Claire Collins) and will provide secure server space as well as act as DPO. \nThe HIPE data was obtained after receiving ethical and HRCDC approval and has been stroed, as previously outlined, on NUIG servers. Since, the PI of CARA, Prof Akke Vellinga, moved to the UCD and with the set up of the GP data servers at the ICGP, we have requested additional separate secure space to allow the full development of CARA. This amendment is to notify that the HIPE data will, form approval, be stored and securely accessed on the ICGP servers and with the ICGP providing DPO."]
[null,"Scheduled HRCDC Meeting Date","18th May 2021","TBC"]
[null,"HRCDC Decision Date ","18th May 2021","TBC"]
[null,"HRCDC Decision","Conditional Declaration","TBC"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of the consent declaration that the scope of the declaration covers the processing of the HIPE data only and does not cover the processing of data from other sources. In addition, the data provided to users via the CARA data visualisation infrastructure must be fully anonymised. \n\nCondition 2. It is a condition of the consent declaration that no access to and obtaining data can take place until the required contractual agreement is in place between the Hospital Pricing Office and National University of Ireland Galway. The agreement in place should include appropriate terms and conditions regarding the transfer and processing of data. Confirmation that this agreement is in place should be provided to the HRCDC as soon as possible. [CONDITON MET]\n\nCondition 3. As part of the Annual Review, the Applicant is requested to report on the public and patient involvement (PPI) activity that is being undertaken for this study. This includes the PPI activities outlined by the Applicant in the HRCDC application form.","TBC"]
[null,"Deadline for meeting Conditions","N/A","TBC"]
[null,"Duration of Declaration ","The Declaration is made on 18th May 2021 and is valid 5 years for duration of the study, until 31st May 2026, or until the personal data has been irrevocably anonymised or destroyed, whichever is sooner.","TBC"]
[null,"Status of Declaration","Declaration No Longer Required","Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. The HRCDC acknowledges the Applicant’s response with regards data \nminimisation. Considering the scale and extent of the data to be collected, the Applicant is \nrequested to consider what data is essential for this study and if the data to be obtained can be further minimised. For example, it should be considered whether marital status and exact dates of hospital stay are required. The Applicant is requested to report on what additional data minimisation has be undertaken as part of the Annual Review.\n\nRecommendation 2. The HRCDC recommends that clear and accurate information is\ntransparently and publicly available regarding the existence of the study, the use of HIPE data for the study and information on data protection rights as appropriate.","TBC"]

{"sheet":"21-006-AF1-CSO","index":83,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-006-AF1/CSO"]
[null,"Application Title ","SARS-CoV-2 clusters and superspreading events in workplaces in Ireland: a retrospective \nanalysis"]
[null,"Applicant Organisation (Data Controller)","University College Dublin"]
[null,"Lead Applicant ","Carla Perrotta"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","The COVID-19 pandemic has infected more than 220,000 people in Ireland, and killed more than 4,000, in one year. It has become clear that infected individuals do not transmit COVID-19 equally, and relatively few infectious individuals (~10%) are responsible for most (~80%) of local transmission. Environmental factors likely contribute to COVID-19 clusters, or ‘superspreading’ events. Cramped and/or crowded indoor settings, with poor ventilation, and long contact exposures create high-risk environments for COVID-19 clusters and associated superspreading events. Familiar workplaces such as meat-processing plants and retail outlets possess such environmental features that facilitate explosive COVID-19 clusters. Consequently, this retrospective, longitudinal study aims to (i) identify the characteristics of workplace settings that experience COVID-19 clusters, and (ii) investigate the relationship between COVID-19 clusters in workplace settings and community transmission/epidemic trajectory. Study findings will inform targeted control efforts that can mitigate the risk of COVID-19 and future infectious disease outbreaks in workplace settings. "]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and process pseudonymised data (research microdata files) from the COVID-19 Data Research Hub, hosted by the Central Statistics Office (CSO). As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the COVID-19 data hub, a consent declaration is required."]
[null,"Scheduled HRCDC Meeting Date","22nd June 2021"]
[null,"HRCDC Decision Date ","22nd June 2021"]
[null,"HRCDC Decision","Conditional Declaration "]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the COVID-19 Data Research Hub has been granted by the CSO. Confirmation of final CSO approval must be provided to the HRCDC as soon as possible. [CONDITION MET]\n\nCondition 2. Aligned with the recommendations of the RDGB with regards wider public \nengagement and dissemination, the Applicant is requested to implement transparency measures so that participants, the public and other relevant stakeholders, can be made aware of this study, the study findings and the use of the CSO COVID-19 Data Research Hub. Consideration should be given to providing information on the data controller’s website, the CSO website and other relevant platforms. The Applicant is required to report on the efforts made to implement transparency measures as part of the Annual Review. [CONDITION UNDERWAY]"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 22nd June 2021 and shall be valid for one year, until 22nd June 2022, in line with the duration of the Officer of Statistics appointment made to the Applicant by the Central Statistics Office (CSO)."]
[null,"Status of Declaration","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","N/A"]

{"sheet":"21-007-AF1-COV","index":84,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-007-AF1/COV"]
[null,"Application Title ","Irish National Pandemic Biological Sampling in critically ill -COIVD-19 (INPBS-COIVD 19)"]
[null,"Applicant Organisation (Data Controller)","University College Dublin"]
[null,"Lead Applicant ","Alistair Nichol"]
[null,"Research commenced prior to submission of application","No"]
[null,"Research Objective","Infectious disease is the single biggest cause of death worldwide. New infectious diseases such as COVID-19 require investigation to understand how the infections develops and how it effects patients. This study wishes to develop an understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed. It is necessary to understand the infection characteristics associated with a severe infection, how the infection multiples in the patient and how the infection effects the patient. \nThe study aims to understand how the patient responds to the infection and how quickly they mount this response. It hopes to better understand how antibiotics or other therapies work in this instance. It is necessary to understand how the disease is transmitted and the reasons or factors certain people are more prone to the infection."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the processing of personal data (accessing, collecting, pseudonymising, transfer, analysis etc) for the purpose of this study where participants lack decision-making capacity to provide consent. The declaration also covers the storage only of personal data for future, unspecified research studies but does not extend to the use or further processing of the personal data in other studies. "]
[null,"Scheduled HRCDC Meeting Date","18th May 2021"]
[null,"HRCDC Decision Date ","18th May 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of the consent declaration that the scope of data processing is \nlimited to the data processing activities as approved by the Research Ethics Committee and as \ndescribed in the HRCDC application form, specifically involving St. Vincent’s University Hospital \nand University College Dublin. For the avoidance of doubt, the consent declaration does not \ncover:\n(i) the unspecified future data processing such as pseudonymisation or anonymisation of data \nfor sharing analysis with other collaborators,\n(ii) genetic analysis and providing data in an anonymised format in data-sharing repositories, \n(iii) the processing of data in other, separate future research studies beyond the INPBS-COIVD \n19 study. [CONDITION MET]\n\nCondition 2. Where a participant continues to lack decision making capacity for a prolonged \nperiod of time and where proxy assent remains in place, the HRCDC request that the Applicant \nshould seek confirmation from the individual who provided proxy assent, that they wish for the \nparticipant’s personal data to continue to be processed as part of this research study. \nConfirmation should be obtained at an appropriate stage of the study that does not cause undue \ndistress or harm to the individuals concerned.\nThe Applicant must report on this condition as part of the Annual Review, including the number \nof participants where deferred consent has and has not been obtained. [CONDITION MET]","Condition 3. It is a condition of the consent declaration that no transfer of personal data and \nassociated bio-samples can take place until the required contractual agreement is in place\nbetween UCD and St. Vincent’s University Hospital. Correspondingly, the agreement in place \nshould include appropriate terms and conditions regarding the transfer and processing of data, as \nwell as bio-samples. Confirmation that this agreement is in place should be provided to the \nHRCDC as soon as possible.  [CONDITION UNDERWAY]\n\nCondition 4. The Applicant is requested to further strengthen public and patient involvement by \nensuring the Clinical Trials Network PPI group are involved in this specific study throughout the \nlifetime of the study. This is a reporting requirement of the Annual Review. [CONDITION UNDERWAY]\n\nCondition 5. It is a condition of this declaration that where a Translator is involved in the assent/consent process that may act as a witness to the consent/assent protocol, they do not sign on behalf of the participant. Only the proxy individual providing assent, or individual\nconsenting should sign, otherwise the consent/assent protocol maybe compromised.  [CONDITION UNDERWAY]"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 18th May 2021 and is valid for 15 years until 31st May 2036, or until participant explicit consent has been obtained or the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. In line with the principle of data minimisation, the HRCDC recommends that \nthe Applicant considers if the 15-year period for retaining personal data can be reduced (i.e can \nthe personal data be anonymised or destroyed sooner). [RECOMMENDATION CONSIDERED]\n\n","Recommendation 2. The HRCDC recommends that the study information leaflets, and \nassent/consent forms are reviewed and amended to ensure clarity, transparency and consistency of information for participants and/or individuals providing assent prior to the commencement of the study. In this context the following observations were made by the HRCDC and should be addressed:\n(i) The statement ‘If there is no known objection by your relative to be included’ should be \nreframed more positively to ask the proxy individual if they believe their relative would wish \nto participate in this study, \n(ii) further information regarding potential collaborations with other institutions as part of the \nINPBS-COVID-19 study, including the proposed National COVID-19 Biobank, and those \noutside Ireland in the UK, such as Sprint-Sari UK, and Australia, should be provided where \npossible,\n(iii) if genetic analysis is undertaken as part of this study, clear information should be provided \non the type of analysis that will occur, where possible. The applicant should avoid the use of \ngeneral, ambiguous statements on the type of genetic analysis that maybe undertaken \nwithin this study, (iv) it should be highlighted that participants in this study maybe also co-enrolled in other approved studies, including interventional trials,\n(v) the consent forms state that samples will be stored for 15 years for future research, \nhowever the assent forms states that samples will be stored indefinitely. This inconstancy \nshould be amended and a specific timeline for the retention of the personal data should also \nbe provided,\n(vi) it should be clear to the participant and/or proxy individual what samples will be collected as part of this study. The HRCDC noted that other samples, such as urine, stool or cerebral \nspinal fluid, are detailed in the study protocol but are not mentioned in the study \ninformation leaflets, \n(vii) clear information should be set out with regards what options are available to the \nparticipant regarding their personal data and bio-samples if (i) assent is withdrawn or (ii) \ndeferred consent is not provided or later withdrawn, \n(viii) there should be a clear ‘yes’ or ‘no’ option to consent/assent for the processing of data for \nthe study,\n(ix) reference to the future use of data/samples in the proxy assent documents should be \namended to reflect that this consent declaration is for the INPBS-COVID19 study only and \ndoes not extend to the processing of personal data in unknown, future research. [RECOMMENDATION CONSIDERED]"]

{"sheet":"21-008-AF1","index":85,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-008-AF1"]
[null,"Application Title ","Evaluation of the 24/7 EEGTM SubQ system in subjects with uncontrolled epilepsy across two important common epilepsy syndromes"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland"]
[null,"Lead Applicant ","Norman Delanty"]
[null,"Research commenced prior to submission of application","No "]
[null,"Research Objective","The purpose of this study is to evaluate to the performance of a portable brainwave (EEG) recording system for home monitoring of epileptic seizures. People with epilepsy (idiopathic or symptomatic generalised epilepsy) who are still experiencing seizures despite receiving treatment will be invited to participate in the study. At present there is no other minimally invasive system or device available for ultra long-term (weeks to months) EEG recording in the home environment. This study investigates the performance of such portable device for the better detection and monitoring of epilepsy seizures. The study will take place in the epilepsy monitoring unit (EMU) at Beaumont hospital and throughout 3 \nmonths of home recording."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the purposes of processing personal data of individuals who lack decision-making capacity. Specifically patient records will be reviewed and data collected, integrated and analysed with study data to be collected prospectively. Approximately 50% of patients in this study will have been diagnosed with symptomatic generalised epilepsy who almost always have significant intellectual disability. "]
[null,"Scheduled HRCDC Meeting Date","20th July 2021"]
[null,"HRCDC Decision Date ","20th July 2021"]
[null,"HRCDC Decision","Requested more information"]
[null,"Specific Conditions attached ","TBC"]
[null,"Deadline for meeting Conditions","TBC"]
[null,"Duration of Declaration ","TBC"]
[null,"Status of Declaration","Application Withdrawn"]
[null,"Additional Comments/Recommendations from HRCDC","TBC"]

{"sheet":"21-009-AF1","index":86,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","21-009-AF1","21-009-AF1/AMD1"]
[null,"Application Title ","Including best practices and the voices of experience in developing post-diagnostic dementia support guidelines for people with an intellectual disability","Including best practices and the voices of experience in developing post-diagnostic dementia support guidelines for people with an intellectual disability"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin ","Trinity College Dublin "]
[null,"Lead Applicant ","Mary McCarron ","Mary McCarron "]
[null,"Research commenced prior to submission of application","No","No"]
[null,"Research Objective","People with an intellectual disability are at greater risk of developing dementia than the general population, but services are ill prepared to provide post-diagnostic support to people with an intellectual disability and dementia and their carers. This study aims to advance such efforts by examining post-diagnostic supports for people with an intellectual disability and dementia through the development of accessible best practice guidelines for post-diagnostic dementia supports for people with an intellectual disability in Ireland. This will be achieved through: (1) examining the current landscape of post-diagnostic care; (2) considering barriers to access; (3) incorporating existing best practices; and (4) giving due consideration of the experiences and recommendations of people with an intellectual disability living with dementia and their families/carers. A consent declaration is requested as the study will be recruiting people with an intellectual disability and dementia, who may have limited capacity to consent to taking part in the research","People with an intellectual disability are at greater risk of developing dementia than the general population, but services are ill prepared to provide post-diagnostic support to people with an intellectual disability and dementia and their carers. This study aims to advance such efforts by examining post-diagnostic supports for people with an intellectual disability and dementia through the development of accessible best practice guidelines for post-diagnostic dementia supports for people with an intellectual disability in Ireland. This will be achieved through: (1) examining the current landscape of post-diagnostic care; (2) considering barriers to access; (3) incorporating existing best practices; and (4) giving due consideration of the experiences and recommendations of people with an intellectual disability living with dementia and their families/carers. A consent declaration is requested as the study will be recruiting people with an intellectual disability and dementia, who may have limited capacity to consent to taking part in the research"]
[null,"Reason for seeking a Declaration","The declaration is requested to process the personal data of participants who lack decision-making capacity to provide explicit consent (work packages 3 & 4). Data processing for the purpose of undertaking this research study includes collection, pseudonymisation, transfer, analysis and storage of personal data. ","The amendment request is for the additional processing of personal data of new participants being recruited for the study, from sixteen new disability services. "]
[null,"Scheduled HRCDC Meeting Date","20th July 2021","25th January 2022"]
[null,"HRCDC Decision Date ","20th July 2021","25th January 2022"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The scope of this declaration is limited to participants recruited via the National Intellectual Disability Memory Service (NIDMS). \n\nCondition 2. When obtained, confirmation of research ethics committee (REC) approval from the St. James’s Hospital / Tallaght University Hospital Joint REC must be provided to the HRCDC. No data processing can commence from service sites that will be covered by this REC approval, until such approval is confirmed. [CONDITION MET]\n\nCondition 3. The Applicant is required to ensure that the protocol for obtaining proxy assent on behalf of the participant must ensure that the individual who provides proxy assent sufficiently understands the will and preferences of the participant, in particular where proxy assent is obtained from a key worker or support worker. [CONDITION MET]\n\nCondition 4. Given the nature and objectives of the study, and that support/key workers involved in supporting the participants that lack decision-making capacity, may also be participants themselves in the qualitative interviews, the Applicant must ensure that sufficient processes are in place to ensure potential conflict of interests are managing accordingly if they arise. The confidentiality of information provided by the participant should also be safeguarded where possible. [CONDITION MET]","Condition 1. The amendment to the consent declaration is effective for the 8 services named in the amendment request form, where confirmation has been provided that the requisite research ethics committee (REC) approval is in place. For each of the 8 remaining services named in the amendment request form, the amendment will not be effective until the requisite REC approval is in place to conduct the study at that service. Once this is provided, confirmation of REC approval for that service should be submitted to the HRCDC as soon as possible. [CONDITION MET]"]
[null,"Deadline for meeting Conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 20th July 2021 and shall be valid until 31st December 2022 or upon confirmation that the personal data have been rendered anonymised or destroyed, or whichever occurs sooner.","The Amendment is made commencing 25th January 2022 and shall be valid until 31st December 2022, or upon confirmation that the personal data have been rendered irrevocably anonymised or destroyed, or whichever occurs sooner. (This timeline is in line with the duration of the consent declaration)"]
[null,"Status of Declaration","Declaration Expired","Declaration Expired"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. To provide clarity and consistency of information, the Applicant is requested to review and amend the study information leaflet and assent/consent forms as follows:\n(i) it should be made clear to the participants and the individual providing proxy assent that individuals will be recruited from other services besides the NIDMS.\n(ii) the signature page of the accessible consent form should specifically name the study to clearly outline to the participants that they are consenting for this study.\n(iii) ensure that the ‘Family member/guardian agreement form’ clearly outlines that their assent is requested to process the personal data of the participant who lacks decision-making capacity.[RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The Applicant is requested to ensure that feedback from the data protection officer with regards the security and encryption of study devices, is addressed if not addressed already. [RECOMMENDATION CONSIDERED]","N/A"]

{"sheet":"21-010-AF1","index":87,"n_rows":16,"n_cols":7,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","21-010-AF1",null,null,null,"21-010-AF1"]
[null,"Application Title ","A Phase 3, Multi-Arm Multi-Stage Covariate-Adjusted Response-Adaptive Randomised Trial to Determine Optimal Early Mobility Training after Stroke (AVERT DOSE)",null,null,null,"A Phase 3, Multi-Arm Multi-Stage Covariate-Adjusted Response-Adaptive Randomised Trial to Determine Optimal Early Mobility Training after Stroke (AVERT DOSE)"]
[null,"Applicant Organisation (Data Controller)","University of Limerick Hospital",null,null,null,"University of Limerick Hospital"]
[null,"Lead Applicant ","Edel Hennessy, Fiona Lucey",null,null,null,"Edel Hennessy, Fiona Lucey"]
[null,"Research commenced prior to submission of application","No",null,null,null,"No"]
[null,"Research Objective","AVERT DOSE involves participants who have had a stroke, and subsequently experience difficulty with mobility activities such as sitting, standing and walking. The main aim of the research project is to test different mobility intervention regimens in the early days after stroke to determine which provides the most benefit. Baseline assessments will be completed. Participants will be assigned to one of four different therapy groups within 48 hours of stroke onset. Each group will involve mobility training aimed at improving outcome after stroke. This training will continue until discharge from the ward or for up to 14 days. Follow-up visits will occur at 3 months and 6 months after the stroke.Patients admitted to the Stroke Unit of UHL with stroke of mild or moderate severity who have mobility difficulties.Personal information such as date of birth, living arrangements and past medical history will be collected, together with details of stroke. All information will be treated as confidential and stored securely. Information leaving the hospital will not have identifying information. Results from each treatment group will be compared to determine which therapy is associated with improved unassisted walking, fewer and less severe complications, and better quality of life in the 6 months after stroke.",null,null,null,"AVERT DOSE involves participants who have had a stroke, and subsequently experience difficulty with mobility activities such as sitting, standing and walking. The main aim of the research project is to test different mobility intervention regimens in the early days after stroke to determine which provides the most benefit. Baseline assessments will be completed. Participants will be assigned to one of four different therapy groups within 48 hours of stroke onset. Each group will involve mobility training aimed at improving outcome after stroke. This training will continue until discharge from the ward or for up to 14 days. Follow-up visits will occur at 3 months and 6 months after the stroke.Patients admitted to the Stroke Unit of UHL with stroke of mild or moderate severity who have mobility difficulties.Personal information such as date of birth, living arrangements and past medical history will be collected, together with details of stroke. All information will be treated as confidential and stored securely. Information leaving the hospital will not have identifying information. Results from each treatment group will be compared to determine which therapy is associated with improved unassisted walking, fewer and less severe complications, and better quality of life in the 6 months after stroke."]
[null,"Reason for seeking a Declaration","A consent declaration is sought to process personal data for the purpose this study, where participants lack the decision-making capacity to provide consent. \nData processing activities include access, collection, pseudonymisation, transfer, analysis and storage of personal data, including follow-up data collected up until 6-months. The data collected and pseudonymised is transferred to the study sponsor for analysis. Data is also provided to the Virtual International Stroke Trials Archive (VISTA) and is anonymised in this archive.  ",null,null,null,"(i) Change in data controllership to the Florey Institute of Neuroscience and Mental Health, with all the named Irish hospital sites now data processors. (ii) The addition of Mayo University Hospital as a study site. (iii) To extend the duration of the consent declaration to 30th June 2025"]
[null,"Scheduled HRCDC Meeting Date","17th August 2021",null,null,null,"20th May 2024"]
[null,"HRCDC Decision Date ","17th August 2021",null,null,null,"20th May 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,null,null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The consent declaration does not come into effect until full research ethics committee (REC) approval from the University of Limerick Hospital REC has been submitted to the HRCDC. [CONDITON MET]\n\nCondition 2. Further to Condition 1, no data processing including transfer of data, for which the consent declaration is required, can commence at the other 5 Irish hospital sites until confirmation of full REC approval for these sites has been provided to the HRCDC. [CONDITON UNDERWAY]\n\nCondition 3. Where a participant continues to lack decision-making capacity for a prolonged period of time and where proxy assent remains in place, the HRCDC request that the following actions should be taken as an additional safeguard:\n(i) confirmation should be sought from the proxy who provided assent, that they wish for the participant’s personal data to continue to be processed as part of this research study. Confirmation should be obtained at an appropriate stage of the study that does not cause undue distress or harm to the individuals concerned.\n(ii) further to point (i), during the course of the study it should also be determined whether the participant has re-gained decision-making capacity (prior to or after discharge from hospital) and, where possible to do so, to obtain their deferred consent for data processing. This should be carried out prior to proxy assent being reaffirmed.\nThe Applicant must report on this as part of the Annual Review, including the number of participants where deferred consent has and has not been obtained (See Condition 4 on capacity to consent) [CONDITION MET]","Condition 4. This consent declaration is made for participants who lack decision-making capacity to provide consent. Where a participant experiences a language/communication impairment as a result of their stroke, it must not be automatically assumed that they lack decision-making capacity. Where participants have decision-making capacity, their consent must be obtained. Full assistance must be provided by the study to support participants who have communication impairments and ensure their inclusive engagement in the consenting process. \n\nCondition 5. The data controller must ensure the following arrangements are in place prior to the transfer of personal data between the parties: \n(i) The Clinical Trial Research Agreement (CTRA) and the appropriate legal agreements/arrangements for data processing must be fully executed prior to the transfer of data between the data controller of the study, the University of Limerick Hospital Group (ULHG), and the study sponsor and data processor, the Foley Institute of Neuroscience and Mental Health. \n(ii) all other Irish hospital sites must also have in place the required legalagreements/arrangements, including a CTRA with the Foley Institute of Neuroscience and Mental Health as well as the appropriate data processing agreement/arrangement with ULHG as the data controller of the study. The transfer and processing of data at a hospital site cannot commence until the necessary agreements are in place for that site.\nNOTE: it is the responsibility of each party to ensure that the required agreements/arrangements are in place. [CONDITON UNDERWAY]\n","Condition 6. Public and patient involvement (PPI) is considered an important activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant cannot provide consent. PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle. It is a condition of this declaration that the study (i) undertakes PPI or engagement activities in Ireland for the reasons outlined above and (ii) enhances the transparency measures implemented for this study, for example via a study website or other public communication channels. Progress to meet this condition is a reporting requirement as part of the Annual Review [CONDITON MET]","Condition 7. The HRCDC requests that the study information leaflets, and assent/consent forms are reviewed and amended to ensure clarity, transparency and consistency of information for participants and/or individuals providing assent, to ensure they are appropriate for an Irish context and conform with the requirements of GDPR. The documents should also be amended to align with the information provided by the Applicant as part of the HRCDC application process. In this context the following observations were made by the HRCDC and should be addressed as part of this condition prior to the commencement of the study:\n(i) the term ‘assent’ rather than ‘consent’ should be used when referring to the agreement provided from a proxy individual to process the participant’s personal data. ‘Consent’ should only be used when engaging directly with the research participant. It is important to ensure these terms are not used interchangeably. Assent is an important data protection safeguard but has no lawful basis for data processing.\n(ii) the term ‘person responsible’ is not a standard term used in Ireland and should not be used when referring to the individual who provides proxy assent of behalf of the participant who lacks decision-making capacity, \n(iii) references to the collection and analysis of salvia and DNA should be removed as this is no longer undertaken and not covered by the scope of the declaration,\n(iv) the GDPR Article 6 and Article 9 basis of explicit consent in the study information leaflet does not align with the Applicant’s response to the HRCDC and should be amended,\n(v) the information provided on what happens the personal data and the options available should consent, proxy assent or deferred consent be withdrawn does not align with the information provided to the HRCDC and therefore should be amended,\n(vi) the study information leaflet recommends that the proxy individual and/or study participant informs the participant’s local doctor that they have decided to take part in this study. The HRCDC queried the purpose of this approach and considers it more appropriate for the research or medical team to inform and communicate with the participant’s local doctor about this study, or at minimum, assist the participant with communicating their \ninvolvement in the study to their local doctor. Therefore, the Applicant is requested to review the necessity of this statement and amend as appropriate to reflect a suitable approach. [CONDITON MET]","Condition 1. The Irish hospital sites must, alongside the data controller, The Florey Institute of Neuroscience and Mental Health, be responsible for the implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participants if a participant has queries or otherwise wishes to exercise their rights. [CONDITON MET]\n\nCondition 2. As per Condition 5 attached to the original declaration, the required legal agreements,and arrangements, including data agreements, must be in place prior to the transfer of personal data between the parties, including between the new data controller (Foley Institute) and all the \nIrish sites. Full REC approval must also be obtained for each of the Irish sites and proof of these approvals should be submitted to the HRCDC, when obtained. \n\nCondition 3. The Applicant must ensure that research ethics committee approvals cover the extended study duration of 30th June 2025. \n\nCondition 4. Feedback on the DPIA from the Data Protection Officer of Foley Institute of Neuroscience and Mental Health (i.e., the new data controller) must be submitted as soon as\npossible and in no later than 3 months. [CONDITON MET]"]
[null,"Deadline for meeting Conditions","N/A",null,null,null,"Condition 4: DPO Feedback - 21.08.2024 [MET]"]
[null,"Duration of Declaration ","The Declaration is made on 17th August 2021 and is valid until 30th June 2024 and for 7 years thereafter until 30th June 2031 or until participants explicit consent has been obtained or the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner. (Amendment 30.06.2032)",null,null,null,"The approval to the Amendment is made commencing 20 th May 2024 and shall be valid until 30th June 2025, an extension of the duration of the consent declaration previously made, and for 7 years thereafter until 30th June 2032 or until participants explicit consent has been obtained or the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live",null,null,null,"Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","Recommendation 1. As a further data protection measure, and in line with the principle of data minimisation, the HRCDC recommends that the Applicant considers whether the collection and transfer of the participants initials is necessary for this study. [RECOMMENDATION CONSIDERED]",null,null,null,"N/A"]

{"sheet":"21-011-AF1-CSO","index":88,"n_rows":16,"n_cols":6,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3"]
[null,"Application Ref ID","21-011-AF1/CSO","21-011-AF1/CSO/AMD1","21-011-AF1/CSO/AMD2","21-011-AF1/CSO/AMD3"]
[null,"Application Title ","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland","Examination of the relationship between the COVID-19 pandemic, unemployment, and social disadvantage in Ireland"]
[null,"Applicant Organisation (Data Controller)","Economic and Social Research Institute","Economic and Social Research Institute","Economic and Social Research Institute","Economic and Social Research Institute"]
[null,"Lead Applicant ","Seamus McGuinness","Seamus McGuinness","Seamus McGuinness","Seamus McGuinness"]
[null,"Research commenced prior to submission of application","No","No","No","No"]
[null,"Research Objective","It has been well documented internationally that the impacts of the COVID-19 pandemic have been disproportionately felt by low-income households, both from health and economic perspectives. Many low paid workers are in essential occupations, such as retail and medical auxiliary services, and have a higher exposure to the virus. Low\u0002income households are also more likely to be of higher density, which makes social \ndistancing problematic leading to a greater spread of the virus. Sectors such as accommodation and food, which contains a high proportion of minimum wage employees, were forced to furlough or close, which again disproportionately impacts low-income households. In this study, we propose to explore the relationship between the COVID-19 pandemic and spatial variations in social deprivation. This will be done by examining infection rates and hospitalisations. ","It has been well documented internationally that the impacts of the COVID-19 pandemic have been disproportionately felt by low-income households, both from health and economic perspectives. Many low paid workers are in essential occupations, such as retail and medical auxiliary services, and have a higher exposure to the virus. Low\u0002income households are also more likely to be of higher density, which makes social \ndistancing problematic leading to a greater spread of the virus. Sectors such as accommodation and food, which contains a high proportion of minimum wage employees, were forced to furlough or close, which again disproportionately impacts low-income households. In this study, we propose to explore the relationship between the COVID-19 pandemic and spatial variations in social deprivation. This will be done by examining infection rates and hospitalisations. ","It has been well documented internationally that the impacts of the COVID-19 pandemic have been disproportionately felt by low-income households, both from health and economic perspectives. Many low paid workers are in essential occupations, such as retail and medical auxiliary services, and have a higher exposure to the virus. Low\u0002income households are also more likely to be of higher density, which makes social \ndistancing problematic leading to a greater spread of the virus. Sectors such as accommodation and food, which contains a high proportion of minimum wage employees, were forced to furlough or close, which again disproportionately impacts low-income households. In this study, we propose to explore the relationship between the COVID-19 pandemic and spatial variations in social deprivation. This will be done by examining infection rates and hospitalisations. ","It has been well documented internationally that the impacts of the COVID-19 pandemic have been disproportionately felt by low-income households, both from health and economic perspectives. Many low paid workers are in essential occupations, such as retail and medical auxiliary services, and have a higher exposure to the virus. Low\u0002income households are also more likely to be of higher density, which makes social \ndistancing problematic leading to a greater spread of the virus. Sectors such as accommodation and food, which contains a high proportion of minimum wage employees, were forced to furlough or close, which again disproportionately impacts low-income households. In this study, we propose to explore the relationship between the COVID-19 pandemic and spatial variations in social deprivation. This will be done by examining infection rates and hospitalisations. "]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and obtained pseudonymised data (research microdata files) from the COVID-19 Data Research Hub, hosted by the Central Statistics Office. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the COVID-19 data hub, a consent declaration is required.","An extension is needed to allow the research team to complete the study, ideally this extension would be for one calendar year (until 17th August 2023). This would give time for the work to be completed and then to be peer reviewed etc. ","The amendment requests an extension of the consent declaration \nby 1 year to August 2024. The extension is due to delays that have \noccurred in accessing the data.","To extend the duration of the declaration until 31st August 2025."]
[null,"Scheduled HRCDC Meeting Date","17th August 2021","Written Procedure","22nd August 2023","2nd September 2024"]
[null,"HRCDC Decision Date ","17th August 2021","Written Procedure","22nd August 2023","2nd September 2024"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the COVID-19 Data Research Hub has been granted by the CSO. Confirmation of final CSO approval must be provided to the HRCDC as soon as possible [CONDITION MET]","Condition 1. The Applicant must continue to be appointed as an Officer of Statistics and have the continued approval of the CSO to access the COVID-19 Data Research Hub for a further year. Confirmation of this must be provided to the HRCDC as soon as possible. [CONDITION MET]\n\nCondition 2. The Applicant is requested to provide confirmation from the ESRI research ethics \ncommittee (REC) that the current ethical approval for this study covers the 1-year study \nextension. If updated REC approval is required, then this must be sought, and confirmation of the updated approval submitted to the HRCDC. The Applicant is requested to provide confirmation of REC approval as soon as is practicable and no later then 3 months from receipt of the HRCDC’s decision letter. [CONDITION MET]","Condition 1. The Applicant must ensure that extended approvals from the CSO and REC are obtained and last for the duration of the consent declaration.  [CONDITION MET]","Condition 1. The Applicant must ensure that extended approvals from the CSO and REC are obtained and last for the duration of the consent declaration. Note: this includes REC approval covering the duration of the study until August 2025; the REC approval obtained notes approval until July 2025."]
[null,"Deadline for meeting Conditions","N/A","Condition 2: REC approval 18th November 2022 [MET]","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 17th August 2021 and shall be valid for one year until 17th August 2022, in line with the duration of the Officer of Statistics appointment made to the Applicant by the Central Statistics Office (CSO). (17th August 2023 in line with the Amendment approved) \nAmendment #2 - Amendment is made commencing 22nd August 2023 and shall be valid until 31st August 2025, an extension to the duration of the original consent declaration.","The approval to the Amendment is made commencing 18th August 2022 and shall be valid for one year until 17th August 2023; this is an extension to the duration of the consent declaration that was previously made. Amendment - Amendment is made commencing 22nd August 2023 and shall be valid until 31st August 2025, an extension to the duration of the original consent declaration.","The approval to the Amendment is made commencing 22nd August 2023 and shall be valid until 31st August 2025, an extension to the duration of the original consent declaration.","The approval to the Amendment is made commencing 2nd September 2024 and shall be valid until 31st August 2025, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","N/A","HRCDC Comment: Lastly, the HRCDC wishes to highlight to the Applicant the importance of ensuring that the transparency measures that were outlined in the original HRCDC application, continue to be implemented for the duration of this extended study. ","N/A","N/A"]

{"sheet":"21-012-AF1","index":89,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-012-AF1"]
[null,"Application Title ","Everolimus for drug-resistant seizures associated with GATOR1 complex epilepsies"]
[null,"Applicant Organisation (Data Controller)","Beaumont Hospital Dublin"]
[null,"Lead Applicant ","Norman Delanty"]
[null,"Research Objective","Genetic abnormalities are emerging as an important cause of epilepsy, particularly in people with difficult-to-treat seizures. Tuberous sclerosis is perhaps the best-known cause of genetic epilepsy and is associated with excessive activation of a signalling system, known as the mTOR pathway. Everolimus is a drug that reduces activation of the mTOR pathway and is used to treat drug-refractory seizures in tuberous sclerosis. The GATOR1 complex epilepsies are closely related to tuberous sclerosis. They are caused by mutations in 3 genes: DEPDC5, NPRL2 and NPLR3. Like tuberous sclerosis, they are characterised by hyperactivation of the mTOR pathway and difficult-to-treat seizures. As the GATOR1 complex epilepsies have a similar pathophysiology to tuberous sclerosis this is a proposed research study of Everolimus for the treatment of refractory seizures in the GATOR1 complex epilepsies. This is an open-label observational study."]
[null,"Reason for seeking a Declaration","The majority of participants will have capacity to consent to participation in the research study. However, these disorders cause devastating epilepsy, often with associated intellectual disability, such that individuals may lack decision-making capacity. \nThe declaration is required to cover the processing of personal data for this study (access, collection, pseudonymisation, analysis, storage etc.) where participants lack the decision-making capacity to provide consent. "]
[null,"Scheduled HRCDC Meeting Date","7th September 2021"]
[null,"HRCDC Decision Date ","7th September 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is required to make all reasonable efforts to limit the risk of participant re-identification in publications and presentations in so far as is possible to do so. In addition, as an additional data security measure, the Applicant is requested to use a wholly separate unique participant study identifier during the dissemination of the study findings, that is different to the identifier applied for the study and used during other study phases such as the collection and analysis stage. [CONDITION UNDERWAY]\n\nCondition 2. Public and patient involvement (PPI) is considered an important activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant cannot provide consent. PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle. It is a condition of this declaration that PPI or engagement activities are undertaken with relevant individuals and groups for the reasons outlined above. Areas of consideration for PPI activity could include the development of the research, wider public transparency measures, the dissemination of research findings and the design, content and suitability of study information leaflets and assent/consent forms. Progress to meet this condition is a reporting requirement as part of the Annual Review. [CONDITION MET]","Condition 3. As part of the assent/consent process the Applicant is requested to ensure thatsuitable processes are in place for the following:\n(i) to identify the most appropriate individual who can provide proxy assent on behalf of the adult participant who lacks decision-making capacity, and who understands the will and preferences of the participant. \n(ii) where proxy assent is being provided by the participant’s Carer, it must be ensured that the Carer has good knowledge of the participant and understands their will and preferences.[CONDITION MET]\n\nCondition 4. The Applicant must ensure that the content,\nlanguage and design of the study information leaflets, and\nassent/consent forms provided to adults with an intellectual\ndisability are comprehensible and suitable for this cohort, and are\ntailored appropriately to adults with an intellectual disability.\nSpecifically, the Applicant should:\n- avoid using the same documents that have been designed for\nchildren when engaging with adults with an intellectual\ndisability as their communication needs may differ.\n- engage with organisations with expertise in communications in\nthe area of intellectual disabilities, that could assist with\nreviewing these documents to ensure suitably for adults with\nan intellectual disability. (Please also see Condition 5) [CONDITION MET]","Condition 5. The HRCDC requests that the study information leaflets, and assent/consent forms \nare further reviewed and amended to ensure clarity, transparency and consistency of information for participants and/or individuals providing assent. In this context the following observations were made by the HRCDC and should be addressed prior to the commencement of the study:\n(i) it is noted that the study information leaflet contains duplicated information which should be removed,\n(ii) clear information should be set out regarding withdrawing from the study, including what options are available with regards the personal data if proxy assent/consent is withdrawn \nand at what point in the study data cannot be deleted, \n(iii) in addition to an email address, a phone number should be provided so that the participant or the proxy can contact the research team if they wish to discuss the study or exercise their data protection rights. Contact information must be provided in each of the study information leaflets used,\n(iv) for adult participants who lack decision-making capacity, the terms ‘proxy’ and ‘assent’ should be used instead of ‘legal guardian’ and ‘consent’ when referring to or requesting agreement of the proxy to process the adult participant’s personal data,\n(v) the option for the storage of the data for future research provided in the participant consent\nform should state ‘only if participant consent is obtained’. For the proxy assent form it should state ‘only if participant consent/proxy assent is obtained’ [CONDITION MET]."]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to consider whether the study information leaflet for the 10-18 year old cohort could be broken down into more age specific cohorts for example 10-13 year olds, 14-15 year olds, 16-17 year olds. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. As part of the assent/consent process it is recommended that the Applicant ensures that functional capacity is re-assessed periodically during the course of the study and participant consent obtained.  [RECOMMENDATION CONSIDERED] "]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 7th September 2021 and shall be valid until 30th September 2023 and for 7 years thereafter (until 30th September 2030) or upon confirmation that the personal data have been rendered anonymised or destroyed, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]
[null,"Additional Comments/Recommendations from HRCDC","TBC"]

{"sheet":"21-013-AF1","index":90,"n_rows":15,"n_cols":4,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-013-AF1"]
[null,"Application Title ","Mammographic breast density and breast cancer outcomes in a population-based breast screening programme"]
[null,"Applicant Organisation (Data Controller)","National Screening Service\nRoyal College of Surgeons in Ireland"]
[null,"Lead Applicant ","Maeve Mullooly"]
[null,"Research Objective","Prior research (not relating to or utilising National Screening Service-controlled \npersonal data) has identified breast radiological features that are associated with a \nhigher risk of developing breast cancer. One such radiological feature is \nmammographic breast density. Mammographic breast density refers to the areas that \nappear white on a breast mammogram. It collectively represents the non-fatty tissue \nwithin the breast. This study aims to build upon this existing knowledge and provide \nthe first step into assessing mammographic breast density among women who \nparticipate in the breast screening programme in Ireland. This study will provide new \ninsights into the influence of mammographic breast density on clinical characteristics. \nIt will expand our knowledge of this radiological feature and provide data for future \nstudies that will investigate how it can be used to identify women at higher risk of \nbreast cancer development."]
[null,"Reason for seeking a Declaration","A consent declaration is required as the Applicant states it is not feasible/practical to obtain consent from participants for a number of reasons include the size of the study. \nData processing activities include collecting, pseudonymising, transferring, analysing and storing personal data."]
[null,"Scheduled HRCDC Meeting Date","7th September 2021"]
[null,"HRCDC Decision Date ","7th September 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. Public and patient involvement (PPI) is considered an important activity by the \nHRCDC and is viewed as a key data protection safeguard in situations where the participant \ncannot provide consent for the processing of their personal data for health research. PPI provides a valuable and meaningful way seeking perspectives and opinions from representative groups in areas such as support for the research, transparency, communication, and dissemination of the research study. \nIt is a condition of this declaration that PPI and engagement activities are undertaken for the reasons outlined above. Specifically, PPI and engagement must:\n- involve seeking meaningful representative views and perspectives on the benefits and impact of the study, and \n- explore the level of support for this research as it involves processing mammographic and \npersonal data, and\n- explore other areas such as the study’s communication strategy and dissemination of findings.\nPPI activity must occur prior to the commencement of the study. The Applicant is required to report on the progress made to meet this condition within 3 months of the effective date of the consent declaration. This report must highlight the findings of PPI engagement, including the opinions of the PPI representatives on the design, benefit and level of support for this research and outline how any issues raised have been considered and have been/will be addressed.\nNOTE: The continuation of the consent declaration will be reviewed on the basis of the report that is submitted to the HRCDC.\n(Note: HRCDC meeting 16.11.2021 extended the deadline for Condition 1 to 30th March 2022) [CONDITION MET]\n","Condition 2. The Applicant must implement a robust communication strategy to clearly inform participants and public about this research study, the remit and outputs of the study, the parties involved, how and until when data can be withdrawn and what will happen to their data when it is withdrawn. Correspondingly, a clear and robust process for participant withdrawal must be implemented. \nAs part of this condition, the Applicant must explore and consider other potential channels and methods of communication to maximise the level of transparency, beyond providing information on the BreastCheck website. Linked to Condition 1, strong consideration should be \ngiven to engaging with PPI representatives on this matter. The Applicant is required to undertake robust transparency measures prior to the commencement of the study. [CONDITION MET]\n\nCondition 3. Appropriate data sharing agreements/arrangements must be in place between the joint data controllers of this study prior to any data processing taking place. In addition, individual confidentiality agreements must be signed by the RCSI researchers prior to accessing to personal \nidentifiable data from the National Screening Service. Note that access and sharing of data cannot occur until the necessary appropriate agreements/arrangements are in place and confirmation of\nthis is provided to the HRCDC. [CONDITION UNDERWAY]\n\nCondition 4. The Applicant must ensure that relevant GDPR training is completed by all of the research project team members, prior to their involvement of the study. [CONDITION UNDERWAY]"]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","Condition 1: 30th March 2020 (extended deadline)"]
[null,"Duration of Declaration ","The Declaration is made commencing 7th September 2021 and shall be valid until 30th September 2026 or upon confirmation that the personal data have been rendered anonymised or destroyed, or whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"21-015-AF1-CSO","index":91,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-015-AF1/CSO"]
[null,"Application Title ","UPCOM (Understanding and Preventing Covid-19 Outbreaks in Meat Processing Plants-Prepared for the Future)"]
[null,"Applicant Organisation (Data Controller)","Dublin City University\nUniversity College Dublin"]
[null,"Lead Applicant ","Andrew McCarren"]
[null,"Research Objective","Rapid response to the COVID-19 pandemic requires infection prevention and control measures that can anticipate the eruption of hot-spots throughout society and act effectively to exclude infection from such environments, while also building a series of urgent measures should initial defences fail. Meat processing plants in Ireland and abroad have proved to be flashpoints for super-spreader and rapid fire events that threaten spill-over into broader society. Our proposal will enhance knowledge of the dynamics and underlying physics, chemistry and biology of such events, hereby safeguarding and enhancing the sustainability of Ireland's food production and processing sectors. In addition to internal plant datasets the use of external data feeds such as the aggregated movements from datasets such as the covid19 contract tracing datasets will be invaluable to understand the movements between areas of infection and those that are less affected, and those understand the potential exposure a meat plant may face."]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and obtained pseudonymised data (research microdata files) from the COVID-19 Data Research Hub, hosted by the Central Statistics Office. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the COVID-19 data hub, a consent declaration is required."]
[null,"HRCDC Meeting Date #1","16th November 2021"]
[null,"HRCDC Meeting Date #2","14th December 2021"]
[null,"HRCDC Decision Date ","14th December 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the COVID-19 Data Research Hub has been granted by the CSO. Confirmation of final CSO approval must be provided to the HRCDC as soon as possible. \n\nCondition 2. The Applicant is requested to provide a copy of the data protection impact \nassessment (DPIA) to the Data Protection Officer (DPO) of University College Dublin (UCD), as a joint data controller of the study. Feedback on the DPIA from the UCD DPO must be provided to the HRCDC within 1 month of receipt of this decision letter. [CONDITION MET]\n\nCondition 3. The Applicant is requested to review and enhance the transparency measures on the study’s website to ensure there is clarity of information on the purpose of this study, how and where the data is accessed for this study, and the extent of the data that will be processed, including data accessed and obtained from the CSO. This is a reporting requirement of the Annual review. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. For the benefit of the research study and to enhance transparency, where appropriate and feasible to do so the Applicant is recommended to engage with representative groups in the meat factory industry to get their perspective and views on the on the development of this research study.\n\nRecommendation 2. In addition to providing a report to the Department of Agriculture, Food and the Marine, the Applicant is also recommended to provide a report and disseminate study findings to relevant health authorities"]
[null,"Deadline for meeting Conditions","Condition 2 - 20th January 2022 [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 14th December 2021 and shall be valid for one year, until 14th December 2022, in line with the duration of the Officer of Statistics appointment made to the Applicant by the Central Statistics Office (CSO). \nNOTE 1: The consent declaration will not come into effect until Condition 1 is met. \nNOTE 2: The Applicant may submit an amendment request to the consent declaration if an \nextension to the duration of the consent declaration is required, subject to the Applicant’s \nreappointment as an Officer of Statistics and approval by the CSO."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"21-016-AF1","index":92,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-016-AF1"]
[null,"Application Title ","Medication review for frail older adults in primary care: use of the STOPPFrail (version 2) tool in nursing home populations."]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Elaine Walsh"]
[null,"Research Objective","This study is being undertaken because we would like to learn more about medication safety \nand appropriate medication prescribing in older patients in nursing home settings. The \npurpose of this study is to apply an evidence-based tool called STOPPFrail (Screening Tool \nof Older Persons Prescriptions in frail adults with limited life expectancy) to the medications \nof patients residing in a nursing home setting. STOPPFrail (version 2) is a set of 25 statements \nwhich highlight medication classes that may be inappropriate in a frail older adult with limited \nlife expectancy. This tool has been developed to reduce inappropriate prescribing. It is \nintended to be used as an aid when reviewing the medications of frail older adults. In this \nstudy we are looking at the practical issues surrounding using the STOPPFrail tool in nursing \nhomes. Potential participants for the study in this setting often lack the mental capacity to \nprovide informed consent and therefore a consent declaration is being sought. "]
[null,"Reason for seeking a Declaration","Due to the population of frailer older nursing home residents that will be included in this study, some may have cognitive impairment and it may not be possible to always get explicit consent from the participants themselves. Therefore, a consent declaration is sought to process the personal data of participants who lack decision-making capacity. "]
[null,"Scheduled HRCDC Meeting Date #1","12th October 2021"]
[null,"Scheduled HRCDC Meeting Date #2","16th November 2021"]
[null,"HRCDC Decision Date ","12th October 2021 & 16th November 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The scope of this consent declaration does not cover further access and collection of personal data from GP and/or nursing home medical records by the UCC researcher, that follows and is additional to pre-screening. An alternative process should be implemented whereby only the relevant and strictly required personal data from the medical record is extracted by GP or nursing home staff and subsequently securely transferred to the research team for further processing for the purpose of this study.\nAMENDED [16.11.2021]: \nThe declaration is amended to cover the following additional processing activities: access to, review of, collection of, transfer and receipt of personal data from General Practitioner (GP)\npractice or nursing home medical records and further data processing of pseudonymisation, analysis, storage and retention for the purpose of the STOPPFrail study where participants lack\nthe decision-making capacity to provide consent.\nCondition 1 is therefore amended as follows:\n(i) Prior to the retrospective chart review element of the study and subsequent access to and \ncollection of the personal data, the researcher must liaise with staff at each site to discuss the \nmost appropriate way to collect the data required, to minimise access to non-relevant personal \ndata within the medical records.(UNDERWAY)\n(i) The extent of data being accessed by the UCC researcher, during both the pre-screening stage \nand retrospective chart review stage, should be discussed as part of the public and patient \ninvolvement (PPI) activities and highlighted through the transparency measures being \nundertaken (linked to Condition 5 and 7).(MET)\n\nCondition 2. The data controller must ensure that appropriate data sharing arrangements are in \nplace between UCC as the data controller of the study, and the GPs and nursing homes, as data \ncontrollers of the personal data being accessed, prior to the sharing of personal data between \nthe parties. Personal data cannot be disclosed, shared/transferred until such arrangements are in place. [CONDITION MET]\nNote: Reference to an ‘authorised persons’ agreement is noted and correspondingly, from the information provided by the Applicant, prescreening is not covered by this consent declaration. However, such an agreement relates to pre-screening activities only. Therefore, the Applicant must ensure that appropriate data sharing arrangements, with appropriate data protection terms and conditions, are in place between the relevant parties for the purpose of this study. It is the responsibility of each party to ensure that the required agreements/arrangements are in place.\n","Condition 3. Full assistance must be provided by the research team to support participants and  ensure they are included and engagement in the consenting process. When determining  decision-making capacity, consideration must be given to assessing capacity from a functional perspective rather than a determining capacity from a primarily medical perspective. This aligns with the principles of the Assisted Decision-Making Act 2015. Further consideration should also be given as how deferred consent could be sought in some cases where functional capacity may fluctuate, such that there is decision-making capacity. [CONDITION MET]\n\nCondition 4. As part of the assent/consent process the Applicant is requested to ensure that suitable robust processes are in place to identify the most appropriate individual who can provide proxy assent on behalf of the participant who lacks decision-making capacity, and who understands the will and preferences of the participant. In this regard proxy assent should be obtained from the next-of-kin/relative and not from the nursing home. The Applicant is requested to report on the number of participants where proxy assent has been obtained.\nNote: The use of ‘your relative/resident’ is noted throughout the proxy information leaflet and assent form and it is unclear who specifically is providing proxy assent. Assent should be obtained from the next-of-kin or relative as opposed to the nursing home itself. [CONDITION MET]\n\nCondition 5. Public and patient involvement (PPI) is considered an important activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant cannot provide consent. PPI also provides a valuable way of enhancing the level of transparency, which itself is an important data protection principle.\nIt is a condition of this declaration that PPI or engagement activities are undertaken with relevant individuals and/or representative groups of the study participants and/or their relatives for the reasons outlined above as soon as possible. Areas of consideration for PPI activity could include the development of the research, wider public transparency measures and the dissemination of research findings. Progress on meeting this condition is a reporting requirement as part of the Annual Review [CONDITION MET]\n\n","Condition 6. Confirmation must be provided to the HRCDC that the GP specific information  leaflet and consent form has been amended and approved by the research ethics committee to clarify that the intention of these documents relates to the GP’s own participation study and are not aimed at requesting proxy assent from the GP on behalf of the study participant. [CONDITION MET]\n\nCondition 7. The HRCDC requests that the study information leaflets, and assent/consent forms are further reviewed and amended to ensure clarity, transparency and consistency of information for participants and/or individuals providing assent who are reading the information. The following observations were made by the HRCDC and should be addressed prior to the commencement of the study:\n(i) it should be clearly outlined what will happen the personal data if participant consent or proxy assent is withdrawn and where the personal data is sourced from, \n(ii) references to ‘their data’ as opposed to ‘your data’ in the participant information leaflet, and the heading ‘Do you have to take part’ in the proxy information leaflet should be amended,\n(iii) aligned with Condition 4, references to ‘resident’, for example ‘we would like to invite your relative/resident’ should be amended,\n(iv) a consent declaration is not a legal basis for data processing, but a data protection safeguard. Correspondingly the Article 6 legal basis/Article 9 relevant condition noted in the study information leaflets should be reviewed and amended. This matter should be discussed with your data protection officer, \n(v) a statement should be included in both the proxy and participant information leaflets and assent/consent forms to request positive confirmation that the participant wishes or would \nwish to participate in this study. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. The HRCDC notes the use of secure online methods to share and store \npersonal data amongst the research team. To further reduce data protection risks, the Applicant \nis requested to consider if there are alternative offline, encrypted methods that could be used to \nfurther minimise potential data risks, including those that may result from human error. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The HRCDC recommends that the Applicant explores how the findings from \nthis study can be disseminated to a wider audience than may benefit from the study findings, \nother than to academic audiences. [UNDER CONSIDERATION] \n\nRecommendation 3. In line with the principle of data minimisation the Applicant is requested to \nconsider whether the personal data can be anonymised or destroyed sooner than the referenced \ndata retention period of 10 years. [RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 12th October 2021 and is valid for 2 years and a further 10-year \nretention period until 12th October 2033, or until participant explicit consent has been obtained or the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"21-017-AF1-CSO","index":93,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-017-AF1/CSO"]
[null,"Application Title ","COVID-19 in Ireland: A retrospective analysis of general practice’s contribution to assessment and testing"]
[null,"Applicant Organisation (Data Controller)","Irish College of General Practitioners"]
[null,"Lead Applicant ","Michael O’Callaghan"]
[null,"Research Objective","General practice in Ireland plays an important role in screening services and is often the first point of contact with the health service for those with new, potentially serious complaints. This project aims to determine the number of GP electronic referrals (‘eReferrals’) for COVID-19 PCR testing and community hub assessments.\nTime spent on testing eReferrals and community hub assessments means that other areas of care may have been impacted by reduced availability of GP staff.Accurately describing general practice’s contribution to the national COVID-19 testing efforts and hub assessments will allow us to estimate how much time GPs and practice staff dedicated to these activities. This may help inform how general practice services are best utilised, during this ongoing health crisis and in future."]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and obtained pseudonymised data (research microdata files) from the COVID-19 Data Research Hub, hosted by the Central Statistics Office. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the COVID-19 data hub, a consent declaration is required."]
[null,"Scheduled HRCDC Meeting Date","12th October 2021"]
[null,"HRCDC Decision Date ","12th October 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the COVID-19 Data Research Hub has been granted by the CSO. Confirmation of final CSO approval must be provided to the HRCDC as soon as possible. [CONDITION MET]\n\nCondition 2. The Applicant is requested to implement transparency measures so that \nparticipants, the public and other relevant stakeholders, can be made aware of this study, the study findings and the use of the COVID-19 Data Research Hub. Consideration should be given to providing information on the data controller’s website and other relevant platforms. The Applicant is required to report on the efforts made to implement transparency measures as part of the Annual Review."]
[null,"Recommendation made","Recommendation 1. The scope of this consent declaration does not cover the access to \nvaccination data for this study. Should this data become available within the COVID-19 Data Research Hub, it is recommended that the ICGP/Data controller, apply for an amendment to the consent declaration for the processing of this data, for HRCDC consideration. A new application should not be required. \n\nRecommendation 2. The Data Protection Impact Assessment form (pg5) states ‘A consent declaration from the HRB must be in place before any access to CSO RMFs will be allowed’. It is recommended that the Applicant revise to state ‘from the Health Research Consent Declaration Committee’ and correct other references to the HRB throughout. For clarity this should be amended to reflect that a consent declaration is made by the HRCDC."]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 12th October 2021 and is valid for one year, until 12th October 2022, in line with the duration of the Officer of Statistics appointment made to the Applicant by the Central Statistics Office (CSO)."]
[null,"Status of Declaration","Declaration Expired"]

{"sheet":"21-018-AF1-CSO","index":94,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","21-018-AF1/CSO"]
[null,"Application Title ","Quantifying the Effects of Public Health Interventions in Ireland"]
[null,"Applicant Organisation (Data Controller)","National University of Ireland Galway"]
[null,"Lead Applicant ","Alberto Alvarez-Iglesias"]
[null,"Research Objective","One of the most powerful ways to slow the COVID-19 pandemic is to limit the spread of the virus between people. In practice, this can mean communities going into ‘lockdown’, individuals keeping physically distant from each other and people wearing masks when in shops and on public transport. This study has developed software to help forecast the outcome of applying such public health measures in Ireland during the COVID-19 pandemic. \nThe interactive web-based application will help decision makers to assess the likely impact of a public health measure on how quickly the virus spreads, the costs and effects on the health system and the likely outcome for people in Ireland. The app will also map out potential alternative interventions and assess their likely outcomes for comparison. A consent declaration will enable predictions that are timely, and are based on the most accurate and representative data on COVID-19 patients in Ireland."]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and obtained pseudonymised data (research microdata files) from the COVID-19 Data Research Hub, hosted by the Central Statistics Office. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the COVID-19 data hub, a consent declaration is required."]
[null,"Scheduled HRCDC Meeting Date","16th November 2021"]
[null,"HRCDC Decision Date ","16th November 2021"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the COVID-19 Data Research Hub has been granted by the CSO. Confirmation of final CSO approval must be provided to the HRCDC as soon as possible.\n\nCondition 2. The Applicant is requested to implement transparency measures so that \nparticipants, the public and other relevant stakeholders, can be made aware of this research study, the study findings and the use of the COVID-19 Data Research Hub. Consideration should be given to providing information about the study, beyond the publication of the findings in a research paper, on platforms such as the data controller’s website and other relevant platforms. The Applicant is required to report on the efforts made to implement transparency measures as part of the Annual Review.\n\nCondition 3. Aligned with the feedback from the Data Protection Officer, all relevant staff \nmembers involved in study must complete data protection training.\n\nCondition 4. As part of the Annual Review the Applicant is requested to provide additional \ninformation on the data fields that have accessed for this study from the CSO COVID-19 Research Data Hub."]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 16th November 2021 and shall be valid for one year in line with the duration of the Officer of Statistics appointment made to the Applicant."]
[null,"Status of Declaration","Declaration No Longer Required"]

{"sheet":"22-001-AF1-CSO","index":95,"n_rows":15,"n_cols":8,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3","AMENDMENT #4"]
[null,"Application Ref ID","22-001-AF1/CSO",null,"22-001-AF1/CSO/AMD1","22-001-AF1/CSO/AMD2","22-001-AF1/CSO/AMD3","22-001-AF1/CSO/AMD4"]
[null,"Application Title ","Study of the impact of lifestyle factors on COVID-19 outcomes",null,"Study of the impact of lifestyle factors on COVID-19 outcomes","Study of the impact of lifestyle factors on COVID-19 outcomes","Study of the impact of lifestyle factors on COVID-19 outcomes","Study of the impact of lifestyle factors on COVID-19 outcomes"]
[null,"Applicant Organisation (Data Controller)","University College Dublin",null,"University College Dublin","University College Dublin","University College Dublin","University College Dublin"]
[null,"Lead Applicant ","Prof Patricia Fitzpatrick",null,"Prof Patricia Fitzpatrick","Prof Patricia Fitzpatrick","Prof Patricia Fitzpatrick","Prof Patricia Fitzpatrick"]
[null,"Research Objective","This is a study that will be carried out over a period of 6 months in the UCD School of Public Health, Physiotherapy and Sport Science. A pseudonymised secondary dataset will be utilised, which is available from the CSO on behalf of the HSE. The objective of the study is to assess the impact of modifiable risk factors including weight, height and BMI, smoking status, taking into account the effect of age, gender, ethnicity and co-morbidities including diabetes, hypertension, cancer and hypertension, on outcomes of COVID-19. The available pseudonymised dataset includes follow up detail by COVID-19 case on hospitalisation and ICU admission with associated data.",null,"This is a study that will be carried out over a period of 6 months in the UCD School of Public Health, Physiotherapy and Sport Science. A pseudonymised secondary dataset will be utilised, which is available from the CSO on behalf of the HSE. The objective of the study is to assess the impact of modifiable risk factors including weight, height and BMI, smoking status, taking into account the effect of age, gender, ethnicity and co-morbidities including diabetes, hypertension, cancer and hypertension, on outcomes of COVID-19. The available pseudonymised dataset includes follow up detail by COVID-19 case on hospitalisation and ICU admission with associated data.","This is a study that will be carried out over a period of 6 months in the UCD School of Public Health, Physiotherapy and Sport Science. A pseudonymised secondary dataset will be utilised, which is available from the CSO on behalf of the HSE. The objective of the study is to assess the impact of modifiable risk factors including weight, height and BMI, smoking status, taking into account the effect of age, gender, ethnicity and co-morbidities including diabetes, hypertension, cancer and hypertension, on outcomes of COVID-19. The available pseudonymised dataset includes follow up detail by COVID-19 case on hospitalisation and ICU admission with associated data.","This is a study that will be carried out over a period of 6 months in the UCD School of Public Health, Physiotherapy and Sport Science. A pseudonymised secondary dataset will be utilised, which is available from the CSO on behalf of the HSE. The objective of the study is to assess the impact of modifiable risk factors including weight, height and BMI, smoking status, taking into account the effect of age, gender, ethnicity and co-morbidities including diabetes, hypertension, cancer and hypertension, on outcomes of COVID-19. The available pseudonymised dataset includes follow up detail by COVID-19 case on hospitalisation and ICU admission with associated data.","This is a study that will be carried out over a period of 6 months in the UCD School of Public Health, Physiotherapy and Sport Science. A pseudonymised secondary dataset will be utilised, which is available from the CSO on behalf of the HSE. The objective of the study is to assess the impact of modifiable risk factors including weight, height and BMI, smoking status, taking into account the effect of age, gender, ethnicity and co-morbidities including diabetes, hypertension, cancer and hypertension, on outcomes of COVID-19. The available pseudonymised dataset includes follow up detail by COVID-19 case on hospitalisation and ICU admission with associated data."]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and obtain pseudonymised data (research microdata files) from the COVID-19 Data Research Hub, hosted by the Central Statistics Office. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the COVID-19 data hub, a consent declaration is required.",null,"To extend the duration of the consent declaration by 1 year.  ","A request to extend the duration of the consent declaration to 30th June 2024.","To extend the duration of the consent declaration to 31 st March 2025.","An extension to the duration of the consent declaration to 30th September 2025."]
[null,"HRCDC Meeting Date","12th April 2022",null,"13th December 2022","17th October 2023","7th August 2024","11th April "]
[null,"HRCDC Decision Date ","12th April 2022",null,"13th December 2022","17th October 2023","7th August 2024","11th April "]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved","Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1: It is a condition of this consent declaration that the Applicant must seek and obtain full ethical review from the University College Dublin research ethics committee (REC). For the avoidance of doubt the consent declaration will not become effective until full ethical review and approval is obtained for this study and confirmation of this is provided to the HRCDC. \nNote: Any material changes to the study and data processing activities that may result from the full ethical review must be highlighted to the HRCDC. The HRCDC reserve the right to review the consent declaration made based on the decision and feedback of the UCD REC. [CONDITION MET]\n\nCondition 2. Further to Condition 1, this consent declaration is not effective until final approval to access the COVID-19 Data Research Hub has been granted by the CSO. Confirmation of final CSO approval must be provided to the HRCDC as soon as\npossible. [CONDITION MET]\n\nCondition 3: In consultation with the Central Statistics Office, the Applicant must review the extent of data that will be accessed and processed from the COVID-19 Data Research Hub for the purpose of this study, and thoroughly examine whether the necessary data to be processed can be further minimised. [CONDITION MET]\n\n","Condition 4. The Applicant is required to implement enhanced transparency measures that go beyond the dissemination of the study findings. To meet this condition substantively, such measures should: \n(i) inform participants and the public about the existence of this study and the use of personal data in this study,\n(ii) ensure there is clarity of information on the purpose of this study, how and where the data is accessed for this study, and \n(iii) the extent of the data that will be accessed and processed from the CSO. \nTransparency measures could include an easy-to-locate study website/webpage, social media channels and other communication platforms. Such measures should be implemented prior to the commencement of the study and in place during the 6-month study timeframe. This is a reporting requirement of the Annual review. [CONDITION MET]","Condition 1. Extended research ethics approval for this study must be obtained as soon as practicable and confirmation of the extended REC approval submitted to the HRCDC. [CONDITION MET]","N/A","Condition 1. Aligned with Condition 2 of the original consent declaration the study must continue to have approval from the CSO to access the COVID-19 Data Research Hub.  [CONDITION MET]","Condition 1. Aligned with Condition 2 of the original consent declaration the study must continue to have approval from the CSO to access the COVID-19 Data Research Hub. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. In discussion with the data controller’s data protection officer, the Applicant is recommended to review and consider the appropriateness of the selected Article 9 relevant conditions for the processing of special category personal data. Specifically, the Applicant is requested to consider if Article 9(2)(j) ‘Scientific Research’ may be more appropriate in the context of this research study. (RECOMMENDATION CONSIDERED)\n\nRecommendation 2. Public and patient involvement (PPI) is considered an important data protection safeguard in situations where it is not possible to seek participant consent. The Applicant is requested to explore and consider what PPI activities could be undertaken with regards this specific study, for example engagement with relevant representative groups or other individuals. PPI activities can inform and benefit the development of this study and other matters such as transparency measures. (RECOMMENDATION CONSIDERED)",null,"N/A","N/A","N/A","N/A"]
[null,"Deadline for meeting Conditions","N/A",null,"N/A","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 12th April 2022 and shall be valid until 31st October 2022, which is the expected duration of the study.\nNOTE 1: The consent declaration will not come into effect until Condition 1 and 2 is met. \nNOTE 2: The Applicant may submit an amendment request to the consent declaration if an extension to the duration of the consent declaration is required, subject to the Applicant’s continued appointment as an Officer of Statistics and approval by the CSO. (Amendment extended to 31.10.2023)Amendment is made commencing 11th April 2025 and shall be valid until 30th September 2025",null,"The approval of the Amendment is made commencing 13th December 2022 and shall be valid until 31st October 2023 (an extension of the duration of the consent declaration.  Amendment is made commencing 11th April 2025 and shall be valid until 30th September 2025","The approval to the Amendment is made commencing 17th October 2023 and shall be valid until 30th June 2024, an extension to the duration of the consent declaration made. Amendment is made commencing 11th April 2025 and shall be valid until 30th September 2025","The approval to the Amendment is made commencing 7 th August 2024 and shall be valid until 31st March 2025; this is an extension of the duration of the consent declaration. Amendment is made commencing 11th April 2025 and shall be valid until 30th September 2025","The approval to the Amendment is made commencing 11th April 2025 and shall be valid until 30th September 2025, an extension of the duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live","Declaration Live","Declaration Live","Declaration Live"]

{"sheet":"22-002-AF1","index":96,"n_rows":16,"n_cols":5,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","22-002-AF1"]
[null,"Application Title ","Understanding the wishes and support needs of people with intellectual disability as they grow older."]
[null,"Applicant Organisation (Data Controller)","Avista – St Anne’s"]
[null,"Lead Applicant ","Michelle O’Brien"]
[null,"Research Objective","This study proposes to carry out a service-wide review of current support for residential service users at St Anne’s, Roscrea and how their anticipated care needs at times of change and transition are met, including supports to ensure positive aging and ageing in place for individuals.\nThe study will involve collecting a range of data to develop a profile of the current needs of individual service users, supports currently received, anticipated future needs and potential gaps in services based on the current model and provision. Data sources will include administrative data from study participant’s care plans; an environmental audit to assess the suitability of existing residences for meeting current and anticipated future needs of individuals; and interviews and focus groups with a range of stakeholders including service users, family, staff, management and key external stakeholders including HIQA and the HSE. \nCurrent research and policy will be reviewed, the National Positive Ageing Strategy and National Dementia Strategy, to compare current service provision at St Anne’ to national standards and guidance. \nThe study aims to gather data in relation to people being supported health and wellbeing, their age profile and how this will impact on changing needs in the future; and assess where they currently live, the services they receive and how these residences and services meet their current and anticipated future needs. The resulting data will inform service planning moving forward and help St Anne’s to be a service responsive to the needs of people being supported into the future. "]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the processing of personal data (access, collection, sharing, analysis, storage) of service user participants who lack decision making capacity for the purpose of this study. Data is collected via medical records, questionnaires and focus groups."]
[null,"HRCDC Meeting Date #1","14th June 2022"]
[null,"HRCDC Meeting Date #2","6th September 2022"]
[null,"HRCDC Decision Date ","6th September 2022"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The family of service user participants with an intellectual disability should be informed about this study, the proposed inclusion of their relative within this study and be invited to provide input to help determine their relative’s will and preferences. Importantly, family member input should be sought to help understand what the will and preference of the participant is; if the family member, when informed, does not wish for their relative to participate, and the participant is enrolled in the study, the Applicant should document how the will and preference of the participant was determined and how the family members’ view was considered as part of this. [CONDITION MET]\n\nCondition 2. It is a condition of this declaration that the study questionnaire should be completed in the presence of the service user participant with an intellectual disability, and with their involvement in relevant questions, in particular those questions that relate to friends, family and social interactions. Further, where possible, Avista staff with sufficient knowledge and understanding of the participant should be involved in and support the completion of the questionnaire. An appropriate family member with a close relationship with the service user participant should also support their relative during their focus groups, where possible. [CONDITION MET]\n\n\n","Condition 3. Appropriate safeguards should be implemented to prevent the audio recording of personally identifiable information. Further safeguarding steps should also be taken if it is found that identifiable information has been unintentionally recorded and transferred in the material sent to the data processor, Trinity College Dublin (TCD). For example, beyond the audio file, TCD should not transcribe or otherwise capture, record or hold any such identifiable information when processing the audio. In line with the principle of data minimisation the Applicant should ensure that the audio recordings are held for the shortest time possible. Consideration should also be given as to whether the audio files can be deleted before 12 months. [CONDITION MET]\n\nCondition 4. The appropriate agreements/arrangements must be in place between the data controller, Avista and the data processor, TCD, governing the transfer and use of the data, including pseudonymised data. Such agreements/arrangements should also cover the transfer and use of the audio files. In addition, the agreements/arrangements should, as is normal in these agreements, outline that TCD would undertake not to attempt to re-identify the participants. For the avoidance of doubt the transfer of data between Avista and TCD cannot occur until this condition has been met. [CONDITION UNDERWAY]\n\nCondition 5. The Applicant is requested to publish/disseminate the findings of this study to relevant researchers, appropriate organisations and the wider public. [CONDITION UNDERWAY]\n\n","Condition 6. The Applicant is requested to review and amend the easy-to-read (ETR) version of study documentation to ensure that clarity and consistency of information is provided to service users participants with an intellectual disability. The following specific observations are made by the HRCDC and should be addressed in the ETR documentation:\n• Reference is made to undertaking focus groups. The ETR documentation should also note the use of medical records/care plans and the completion of questionnaires, and who will be collecting this data. Reference should also be made that other stakeholders (e.g., family members, staff) will be completing their own focus groups. \n• It is noted that the initial ETR version submitted to the HRCDC included a page on GDPR that outlined the participant’s data protection rights, however this page has been removed. Information regarding GDPR and data protection rights should be re-incorporated in the latest version of the ETR study documentation.\n• It should be clearly outlined how long personal data and the audio recordings will be retained.\n• Reference to an expression of interest form should be removed as the Applicant has confirmed it will not be used in this study\n• The initial ETR consent form submitted, included a number of yes/no options that have been removed from the updated version. Consideration should be given to re-incorporating these yes/no options in the updated version of the ETR consent form\n• Ensure that clear and concise information is outlined in the ETR form regarding withdrawing from the study and the deletion of the participant’s data. This includes withdrawing and deleting data both before and after the publication of the study findings:\n            o Should they wish to withdraw prior to publication, it should be clearly outlined to what extent it is or isn’t possible to remove the service user participant’s data and contributions from the study analysis and findings. In addition, if there is a timeline after which data cannot be removed from analysis and publication then this should also be outlined.\n           o It should be clearly outlined that if a participant withdraws after the publication of findings that they will not be identifiable from the published report. \n          o Further to withdrawal and removing data prior to publication, the updated standard information leaflet for the family outlines that they can ask for their stored data to be destroyed up until has been anonymised. Similar information should be provided to service user participants within the ETR version of the consent form. It should also be clear that if they don't wish for their data to be deleted then it will continue to be held and processed as the default situation. If a participant withdraws, clear options on what will happen their data should be provided. \nA consent declaration cannot override a participant’s decision to withdraw from the study. Where a participant withdraws it is the responsibility of the data controller to ensure data protection compliance. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. In line with the principle of data minimisation, the Applicant is requested to consider deleting or irrevocably anonymising the personal data prior to September 2029. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The Applicant is requested to review the standard family information leaflet and consent form to ensure it is tailored specifically for the recruitment of the family member to this study and that it provides clear and accurate information on the study and the data processing. The following observations have been made by the HRCDC and should be considered by the Applicant:\n       •Aligned with the details in Condition 6, clear information should be provided in the family information leaflet regarding withdrawing from the study and the deletion of data. This includes clearly outlining to what extent it is or isn’t possible to remove the participant’s data and contributions from the study analysis and findings, should they wish to withdraw prior to publication, and if there is a timeline after which data cannot be removed from the analysis and publication. It should also be clearly outlined that if a participant withdraws after the publication of findings that they will not be identifiable from the published report\n      • The family information leaflet states: ‘By law we can use your personal information for scientific research (in the public interest)’ with footnotes referring to the Art 6 and Art 9 legal basis for processing personal data. The HRCDC discussed that this statement as currently worded may be misinterpreted by the family member. For example, it could be interpreted that the family member has limited say on the use of their data. The Applicant is therefore requested to amend this statement and just outline what the Art 6 and Art 9 legal basis is for the processing of personal data. \n       • The standard family information leaflets refer to storing data for 7 years but also to deleting names and pseudonyms 1 year after submission of the final report. Aligned with the information submitted to the HRCDC, it should be clear that the duration of data storage is 7 years.\n      • Remove reference to AudioTrans\n      • As the standard version of the study document is for family members only, it should be ensured that the document is written for the perspective and purpose of consenting the family member for their own participation in the study, and not a document that is seeking proxy assent from the family member on behalf of the service user participant with an intellectual disability. For example, references such as ‘You/ your family member who is supported in Avista’ should be amended given that it is the family member who receives support from Avista. In addition, requesting access to ‘your medical records’ should be removed from the family study documentation as they will not be accessed. Other sections that read as if the family member is being asked to provide proxy assent on behalf of their relative should also be amended. [RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 6th September 2022 and is valid until 30th September 2029, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"22-003-AF1","index":97,"n_rows":16,"n_cols":8,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","22-003-AF1",null,null,null,null,"22-003-AF1/AMD1"]
[null,"Application Title ","A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type",null,null,null,null,"A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type"]
[null,"Applicant Organisation (Data Controller)","Otsuka Pharmaceutical Development & Commercialization Inc. (OPDC) \n(Note: Avanir Pharmaceuticals is no longer involved in this study)",null,null,null,null,"Otsuka Pharmaceutical Development & Commercialization Inc. (OPDC) \n(Note: Avanir Pharmaceuticals is no longer involved in this study)"]
[null,"Lead Applicant ","Caroline Mason",null,null,null,null,"Caroline Mason"]
[null,"Research Objective","AVP-786 is being developed by Avanir Pharmaceuticals Inc. (Avanir) for the treatment of neuropsychiatric conditions. The current study (Study 20-AVP-786-307) is designed to evaluate the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type. ",null,null,null,null,"AVP-786 is being developed by Avanir Pharmaceuticals Inc. (Avanir) for the treatment of neuropsychiatric conditions. The current study (Study 20-AVP-786-307) is designed to evaluate the efficacy, safety, and tolerability of AVP-786 for the treatment of agitation in patients with dementia of the Alzheimer’s type. "]
[null,"Reason for seeking a Declaration","The scope of the consent declaration is for the processing of personal data (access, collection, transfer, analysis) for the purpose of this specific trial and for data storage after the study concludes, where participants lack decision-making capacity to provide explicit consent. Personal data is collected from several sources outlined by the Applicant including medical records, diaries, questionnaires/interviews. \nThe study will be undertaken in Ireland at 4 participating sites: St James’s Hospital Dublin, Mercy University Hospital Cork, St Finbarr’s Hospital Cork & Tallaght University Hospital. ",null,null,null,null,"The scope of the amendment covers the change in data controllership from joint controllership to the sole controllership of Otsuka Pharmaceutical Development & Commercialization, Inc. The amendment also covers data processing by additional data processors."]
[null,"HRCDC Meeting Date #1","10th May 2022",null,null,null,null,"9th May 2023"]
[null,"HRCDC Meeting Date #2","22nd August 2023",null,null,null,null,"22nd August 2023"]
[null,"HRCDC Decision Date ","22nd August 2023",null,null,null,null,"22nd August 2023"]
[null,"HRCDC Decision","Conditional Declaration",null,null,null,null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. \n(i) to ensure that the will and preference of participants can be heard and respected to the greatest extent possible, detailed information is required as to how the study will meaningfully involve and support all participants during the consent and assent process, irrespective of their determined level of decision-making capacity.\n(ii) the HRCDC requests an assurance that participant decision-making capacity will be reviewed at appropriate timepoints during the study, and deferred participant consent obtained wherever possible. \n(iii) where proxy assent for data processing is to be obtained from a legally designated representative as defined under Irish law for the purpose of clinical trials, information is required on how it will be determined that the proxy identified for the purposes of data processing is the person best placed to understand and interpret the participant’s will and preference; this applies whether the identified proxy is a family member, friend, or a clinician. \n(iv) provide information on how study will meaningfully engage with and support the participant’s family throughout the assent/consent process and during the study, in particular, where the participant lacks decision-making capacity and where proxy assent will be obtained from a clinician.\n\n","Condition 2. Further to Condition 1, the Applicant is requested to: \n(i) develop and utilise a more appropriate, accessible, and easier-to-read study information \nleaflet and consent and assent forms, as applicable, that is suitable and tailored for participants with Alzheimer’s disease who may have diminished, or who lack, decision\u0002making capacity. \n(ii) when seeking proxy assent for data processing from a legally designated representative, to employ a specific proxy information leaflet and assent form that is separate to the study documents provided to the study participant. Separate documents should therefore be used when obtaining (a) consent/assent from participants with Alzheimer’s disease and (b) proxy assent from the representative.\n(iii) review and amend accordingly, the study information leaflets and consent/assent forms for clarity and consistency of information as follows; (The Data Protection Officer and Research Ethics committee should be consulted, as necessary):\n- note the specific GDPR Art.6 legal basis and Art.9 relevant condition for data processing,\n- clearly outline the parties that are involved in the study, their location, and their role in \nthis study. This includes the joint data controllers, the data processors (contract research organisation, laboratory, audio recording reviewers etc.) and all the participating Irish hospital sites,\n- for the proxy information leaflet and assent form, amend or delete the options provided with regards the future use of personal data, as the scope of the consent declaration for participants who lack decision making capacity to provide explicit consent is limited to data processing for the purpose of this Phase 3 AVP-786 clinical trial and subsequent data archiving only. Proxy assent for data processing from a legally designated representative including for future research purposes, has no lawful basis, \n- provide information on who is responsible for any costs should an adverse event occur during the trial, \n- clearly outline what will happen the already collected personal data, including the audio recordings, if participant consent or proxy assent from the legally designated representative, is withdrawn. Where the personal data cannot be deleted and will continue to be stored and processed, the Applicant must ensure that the reasons for this are clearly noted in the consent/assent documentation. \nNote: data controllers that wish to continue to process personal data of participants after assent/consent is withdrawn are responsible for ensuring they are compliant with data protection legislation. \n- more generally, review the study information leaflets and assent/consent forms to ensure there is clarity and consistency of information that aligns with the data processing activities to be undertaken (e.g., data retention period) and that information is provided in an understandable manner.\nIn responding to this condition, please provide a copy of the new and updated study  documentation outlined above.","Condition 3. Public, patient and carer involvement (PPI) is considered an important activity by the HRCDC and is viewed as a key data protection safeguard in situations where the participant cannot provide consent. It is condition of this declaration that PPI activities are undertaken with relevant individuals and/or representative groups of the study participants (e.g., Alzheimer’s Society of Ireland) to discuss the inclusion and meaningful engagement of participants in the study’s consent/assent process (Condition 1) and the development of more appropriate, accessible and easier to read study information leaflets and consent/assent forms for participants \n(Condition 2). \n\nCondition 4. Full research ethics committee approval must be obtained from the St James’sHospital/Tallaght University Hospital joint REC, and confirmation of this full approval is to be submitted to the HRCDC as soon as is practicable. In addition, the scope of this consent declaration does not cover the use of audio recordings until confirmation is provided that the full approval from the St James’s Hospital/Tallaght University Hospital REC covers this data processing. [CONDITION UNDERWAY]","Condition 5. When accepting, or otherwise responding, to this consent declaration, the Applicant is requested to confirm that joint data controller Avanir Pharmaceuticals Inc., as an affiliate of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), is authorised to sign the HRCDC application form and provide DPO feedback on behalf of OPDC. If this is not the case, then a signature and DPO feedback on behalf of OPDC is required to be submitted to the HRCDC. The consent declaration will not be in effect until this condition is met [CONDITION UNDERWAY] - NOTE: Update from Applicant that Avanir will not be involved in the study.\n\nCondition 6. The Irish Hospital sites should be made aware of the consent declaration and \nconditions attached. Further the joint controllers and the Irish hospital sites must support the implementation of and compliance with the consent declaration. [CONDITION UNDERWAY]\n\nCondition 7. All appropriate contractual legal arrangements regarding the processing and use of personal data (i.e., joint data controller arrangement, data processing agreement, data transfer agreements) are to be in place with between the relevant institutions. The Applicant should also ensure that the relevant data protection requirements are met for the transfer and processing of personal data outside the EEA for the purpose of this study. This includes the requirements outlined in Chapter V of the GDPR and having due regard to the requirements arising from the \n‘Schrems II’ decision of the European Court of Justice. \n","Condition 8. It is a condition of the consent declaration that remote (off site) access to Irish \nparticipant’s medical charts for the purpose of monitoring shall not be undertaken. The Applicant \nshould also ensure that appropriate security and safeguard arrangements are in place and adhered to for all monitoring activities. Information on meeting this Condition is a reporting requirement of the Annual Review. \n\nCondition 9. Subject to Condition 4 being met, appropriate safeguards should be implemented to prevent the audio recording of identifiable data and data that is irrelevant for the purpose of this study. Should such data be recorded then the audio should be deleted. \n\nCondition 10. It is a condition that study records are not transferred to Avanir or OPDC if the Principal Investigator is no longer in a position to retain these records. Records should instead continue to be retained at the local site. \n\nCondition 11. Aligned with the principle of data minimisation, personal data, including pseudonymised data, should be retained and processed only for the minimum period of time that is necessary. This includes data transferred/accessed by relevant parties such as the laboratory analysing the collected bio-samples, monitors and the company reviewing audio-recordings.","Condition 1. Where samples and associated data are transferred/shared with the data processor laboratories named in your amendment request form, they must be either returned or deleted after the data processors have concluded their activities for this study. The data processor laboratories should not continue to process and retain samples and associated data for longer than is required for the purpose of this specific study. Linked to this, the data controller must ensure that the principle of data minimisation is adhered to i.e., only the minimum level of data should be transferred to these data processor laboratories. This condition is a reporting requirement of the Annual Review. \n\nCondition 2. The requisite research ethics committee approval for Ireland must be in place for the change in data controllership and it must be ensured that ethical approval covers the new data processors covered by this amendment. Confirmation that the required ethical approval is in place \nshould be submitted to the HRCDC.\n\nCondition 3. The required data agreements/arrangements must in place between all the parties that are sharing and receiving data and associated samples; this includes required agreements or arrangements when sharing data of Irish based participants to the named parties outside the EEA to ‘third countries’ not covered by an adequacy decision, as defined in the GDPR, for example putting in place Standard Contractual Clauses. In this context the Applicant must also have regards \nto the requirement to undertake a Transfer Impact Assessment when transferring data to such parties in third countries as per the 2021 decision of the Court of Justice of the European Union"]
[null,"Recommendation made","Recommendation. The Applicant should review and where necessary, update the DPIA to ensure it is applicable and reflects data processing activities, risks and mitigating actions across all the Irish hospital sites involved in this study. ",null,null,null,null,"N/A"]
[null,"Deadline for meeting Conditions","N/A",null,null,null,null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made on 10th May 2022 and is valid for the duration of the clinical trial (July 2022 – July 2025) and for 20 years thereafter for data archiving (until 31st July 2045), or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner. \nThe consent declaration will only come into effect when the\nApplicant has received confirmation from the HRCDC of a\nsatisfactory response to the conditions attached.",null,null,null,null,"The approval to the Amendment is made commencing 22nd August 2023 and shall be valid until 31st July 2045, in line with the duration of the original consent declaration made."]
[null,"Status of Declaration","Declaration No Longer Required",null,null,null,null,"Declaration Live"]

{"sheet":"22-005-AF1","index":98,"n_rows":15,"n_cols":7,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3"]
[null,"Application Ref ID","22-005-AF1",null,"22-005-AF1/AMD1","22-005-AF1/AMD2","22-005-AF1/AMD3"]
[null,"Application Title ","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE Phase 2)",null,"Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE Phase 2)","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE Phase 2)","Longitudinal analysis of clinical markers of response to treatment in people with epilepsy (EPIDIVE Phase 2)"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland ",null,"Royal College of Surgeons in Ireland ","Royal College of Surgeons in Ireland ","Royal College of Surgeons in Ireland "]
[null,"Lead Applicant ","Norman Delanty",null,"Norman Delanty","Norman Delanty","Norman Delanty"]
[null,"Research Objective","The aim of this project is to reveal factors associated with a positive response to seizure control sustained over time, focusing on use of anti-epileptic drug (AED) treatment, vagus nerve\nstimulation (VNS) and epilepsy surgery. This will be done through the analysis of current and historical clinical encounters contained in de-identified healthcare records of a population of people with epilepsy (PwE) from Beaumont Hospital and St James’s Hospital.",null,"The aim of this project is to reveal factors associated with a positive response to seizure control sustained over time, focusing on use of anti-epileptic drug (AED) treatment, vagus nerve\nstimulation (VNS) and epilepsy surgery. This will be done through the analysis of current and historical clinical encounters contained in de-identified healthcare records of a population of people with epilepsy (PwE) from Beaumont Hospital and St James’s Hospital.","The aim of this project is to reveal factors associated with a positive response to seizure control sustained over time, focusing on use of anti-epileptic drug (AED) treatment, vagus nerve\nstimulation (VNS) and epilepsy surgery. This will be done through the analysis of current and historical clinical encounters contained in de-identified healthcare records of a population of people with epilepsy (PwE) from Beaumont Hospital and St James’s Hospital.","The aim of this project is to reveal factors associated with a positive response to seizure control sustained over time, focusing on use of anti-epileptic drug (AED) treatment, vagus nerve\nstimulation (VNS) and epilepsy surgery. This will be done through the analysis of current and historical clinical encounters contained in de-identified healthcare records of a population of people with epilepsy (PwE) from Beaumont Hospital and St James’s Hospital."]
[null,"Reason for seeking a Declaration","The consent declaration is requested for the processing (sharing, analysis, storage etc.) of participant data that is already collected as part of care and treatment for the purpose of this specific study.  Once the study is concluded, fully anonymised data will be made available in an appropriate data scientific repository. \nThe Applicant outlines the reasons why explicit consent is not possible, including the number of participants involved and the feasibility of a consent process.",null,"This amendment request is to (i) add Beaumont and St James’s Hospitals as joint data controllers with RCSI and (ii) extend the duration of the consent declaration by 6-months","Due to delays the study only commenced during summer 2023 and therefore the data controller requests an extension of the duration of the consent declaration until 31st July 2024.","An extension to the duration the consent declaration to 31st July 2026."]
[null,"HRCDC Meeting Date","14th June 2022",null,"13th December 2022","19th September 2023","22nd July 2024"]
[null,"HRCDC Decision Date ","14th June 2022",null,"13th December 2022","19th September 2023","22nd July 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to further enhance transparency measures more generally with regards the processing of personal data from the electronic epilepsy patient record (eEPR) for health research purposes. The FutureNeuro website, and the information leaflets and notices made available to patients in the hospitals, should be updated to provide clear information on the use of data from the eEPR for health research purposes. The website, leaflets and notices should further provide clear information on the participant’s data protection rights and how to exercise these rights, including the right to withdraw their eEPR data from health research studies. In addition, information should be provided on how data for health research is pseudonymised and transferred from the epilepsy warehouse reporting system, rather than extracted directly from the eEPR. [CONDITION MET]\n\nCondition 2. Confirmation that full research ethics committee approval has been obtained from Beaumont Hospital and St James’s Hospital must be provided to the HRCDC. The consent declaration will not be come into effect until this condition is met. [CONDITION MET]\n\nCondition 3. The scope of this declaration is for processing personal data for the purpose of the EPIDIVE Phase 2 study, covering the Beaumont Hospital and St James’s Hospital sites only. St. Vincent’s University Hospital is not covered by this consent declaration. An amendment request form should be submitted for consideration by the HRCDC to cover other sites beyond Beaumont Hospital and St James’s Hospital, subject to the requisite REC approval being in place.\n\n","Condition 4. A signature on the HRCDC application from the study’s Principal Investigator, Prof Delanty, must be submitted to the Secretariat as soon as is practicable. The consent declaration will not be in effect until this condition is met. [CONDITION MET]\n\nCondition 5. Aligned with the principle of data minimisation, the Applicant must ensure that only the minimum volume of personal data is obtained and processed for the purpose of this study and to fully anonymise the data as soon as is practicable. With regards data on ethnicity, the Applicant is requested to consider whether this data is required for the purpose of this study. Linked to Condition 2, if data on ethnicity is to be processed then the Applicant must confirm that full research ethics committee approval covers the use of such data.\n\nCondition 6. The Applicant must ensure that the necessary appropriate agreements governing the transfer and processing of personal data are in place prior to data transfer. [CONDITION UNDERWAY]\n\nCondition 7. The Applicant must ensure that the data that will be made available in an appropriate scientific repository at the end of this study is anonymised. \n\nCondition 8. As part of the Annual Review the Applicant is requested to provide updates on the progress made to incorporate a consenting process into the electronic epilepsy patient record.","Condition 1. Authorised signatures on behalf of Beaumont Hospital and St James’s Hospital on the HRCDC amendment request form must be submitted to the HRCDC as soon as practicable. The amendment will not be in effect until this condition is met. [CONDITION MET]\n\nCondition 2. Appropriate joint data controller arrangements must be in place between RCSI, Beaumont Hospital and St James’s Hospital.[CONDITION MET]","N/A","Condition 1. The outstanding data controller signatures on the HRCDC amendment request form must be submitted as soon as possible and within 1 month.\n\nCondition 2. REC approval for St James’s Hospital must be obtained and submitted to the HRCDC\nas soon as practicable; the amendment does not extend to St James’s Hospital until REC approval \nis in place."]
[null,"Recommendation made","Recommendation. For the benefit of the EPIDIVE Phase 2 study and future studies, it is recommended that the Applicant undertakes continued public and patient involvement (PPI) activities, including on a project specific basis. [RECOMMENDATION CONSIDERED]",null,"HRCDC Comment: A consent declaration is made to the data controller/joint data controllers of the research study; accordingly, it is important that researchers and their institutions are clear from the \noutset when applying to the HRCDC on the roles and responsibilities of the institutions involved in the study i.e., data processors, data controllers etc.","N/A","N/A"]
[null,"Deadline for meeting Conditions","N/A",null,"N/A","N/A","Condition 1. 23rd August 2024"]
[null,"Duration of Declaration ","The Declaration is made commencing 14th June 2022 and shall be valid until 31st January 2023, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner. The consent declaration will not be in effect until Conditions 2 & 4 have been met. (Amendment made - valid until 30th June 2023) - Amendment is made commencing 22nd July 2024 and shall be valid until 31st July 2026",null,"The approval to the Amendmentis made commencing 13th December 2022 and shall be valid until 30th June 2023 (this is an extension of the duration of the consent declaration).Amendment is made commencing 22nd July 2024 and shall be valid until 31st July 2026","The approval to the Amendment is made commencing 19th September 2023 and shall be valid until 31st July 2024 (this is an extension to the duration of the consent declaration). Amendment is made commencing 22nd July 2024 and shall be valid until 31st July 2026","The approval to the Amendment is made commencing 22nd July 2024 and shall be valid until 31st July 2026, an extension of the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live","Declaration Live","Declaration Live"]

{"sheet":"22-006-AF1","index":99,"n_rows":15,"n_cols":8,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3","AMENDMENT #4"]
[null,"Application Ref ID","22-006-AF1",null,"22-006-AF1/AMD1","22-006-AF1/AMD2","22-006-AF1/AMD3","22-006-AF1/AMD4"]
[null,"Application Title ","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age (HPO study)",null,"A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age (HPO study)","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age (HPO study)","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age (HPO study)","A description of the evolution of phenotype in epilepsy from paediatrics through adulthood and old age (HPO study)"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland \n",null,"Royal College of Surgeons in Ireland \n","Royal College of Surgeons in Ireland \n","Royal College of Surgeons in Ireland \n","Royal College of Surgeons in Ireland \n"]
[null,"Lead Applicant ","Gianpiero Cavalleri",null,"Gianpiero Cavalleri","Gianpiero Cavalleri","Gianpiero Cavalleri","Gianpiero Cavalleri"]
[null,"Research Objective","The aim of this project is to use analytics and visualisations to track the evolution of phenotypical characteristics associated with epilepsy in adults over time (in years) and to determine if there is significant variation in the frequency of occurrence of those characteristics across the historical course of epilepsy. These characteristics will be standardised and mapped to an internationally recognised clinical research language to facilitate adult/paediatric comparison with an existing standardised analysis conducted on a paediatric epilepsy dataset from a US research group.",null,"The aim of this project is to use analytics and visualisations to track the evolution of phenotypical characteristics associated with epilepsy in adults over time (in years) and to determine if there is significant variation in the frequency of occurrence of those characteristics across the historical course of epilepsy. These characteristics will be standardised and mapped to an internationally recognised clinical research language to facilitate adult/paediatric comparison with an existing standardised analysis conducted on a paediatric epilepsy dataset from a US research group.","The aim of this project is to use analytics and visualisations to track the evolution of phenotypical characteristics associated with epilepsy in adults over time (in years) and to determine if there is significant variation in the frequency of occurrence of those characteristics across the historical course of epilepsy. These characteristics will be standardised and mapped to an internationally recognised clinical research language to facilitate adult/paediatric comparison with an existing standardised analysis conducted on a paediatric epilepsy dataset from a US research group.","The aim of this project is to use analytics and visualisations to track the evolution of phenotypical characteristics associated with epilepsy in adults over time (in years) and to determine if there is significant variation in the frequency of occurrence of those characteristics across the historical course of epilepsy. These characteristics will be standardised and mapped to an internationally recognised clinical research language to facilitate adult/paediatric comparison with an existing standardised analysis conducted on a paediatric epilepsy dataset from a US research group.","The aim of this project is to use analytics and visualisations to track the evolution of phenotypical characteristics associated with epilepsy in adults over time (in years) and to determine if there is significant variation in the frequency of occurrence of those characteristics across the historical course of epilepsy. These characteristics will be standardised and mapped to an internationally recognised clinical research language to facilitate adult/paediatric comparison with an existing standardised analysis conducted on a paediatric epilepsy dataset from a US research group."]
[null,"Reason for seeking a Declaration","The consent declaration is requested for the processing (sharing, analysis, storage etc.) of participant data that is already collected as part of care and treatment for the purpose of this specific study.  Aggregated, analysed outputs will be shared with the Children’s Hospital of Philadelphia Research Institute for adult/paediatric comparison. Once the study is concluded, fully anonymised data will be made available in an appropriate data scientific repository. The Applicant outlines the reasons why explicit consent is not possible, including the number of participants involved and the feasibility of a consent process.",null,"The scope of the amendment requested is (i) to extend the duration of the consent declaration by 9 months and (ii) for a change in controllership of the study to include Beaumont Hospital and St James's Hospital as joint controllers with RCSI.","The amendment requests an extension to the duration the consent declaration to July 2024.","An extension to the duration the consent declaration to 31st July 2025.","An extension of the consent declaration by another 12 months, taking the study to 31st July 2026."]
[null,"HRCDC Meeting Date","14th June 2022",null,"28th February 2023","22nd August 2023","10th July 2024","11th July 2025"]
[null,"HRCDC Decision Date ","14th June 2022",null,"28th February 2023","22nd August 2023","10th July 2024","11th July 2025"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved","Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to further enhance transparency measures more generally with regards the processing of personal data from the electronic epilepsy patient record (eEPR) for health research purposes. The FutureNeuro website, and the information leaflets and notices made available to patients in the hospitals, should be updated to provide clear information on the use of data from the eEPR for health research purposes. The website, \nleaflets and notices should further provide clear information on the participant’s data protection rights and how to exercise these rights, including the right to withdraw their eEPR data from health research studies. In addition, information should be provided on how data for health research is pseudonymised and transferred from the epilepsy warehouse reporting system, \nrather than extracted directly from the eEPR. [CONDITION MET]\n\nCondition 2. Confirmation that full research ethics committee approval has been obtained from Beaumont Hospital and St James’s Hospital must be provided to the HRCDC. The consent declaration will not be in effect until this condition is met. [CONDITION MET]\n\nCondition 3. The scope of this declaration is for processing data for the purpose of the HPO study, covering the Beaumont Hospital and St James’s Hospital sites only. St. Vincent’s University Hospital is not covered by this consent declaration. An amendment request form should be submitted for consideration by the HRCDC to cover other sites beyond Beaumont Hospital and St James’s Hospital, subject to the requisite REC approval being in place.\n\nCondition 4. A signature on the HRCDC application from the study’s Principal Investigator, Prof Cavalleri, must be submitted to the Secretariat as soon as is practicable. The consent declaration will not come into effect until this condition is met. [CONDITION MET]","Condition 5. Aligned with the principle of data minimisation, the Applicant must ensure that only the minimum volume of personal data is obtained and processed for the purpose of this study \nand to fully anonymise the data as soon as is practicable. With regards data on ethnicity, the Applicant is requested to consider whether this data is required for the purpose of this study. \nLinked to Condition 2, if data on ethnicity is to be processed then the Applicant must confirm that full research ethics committee approval covers the use of such data.\n\nCondition 6. The Applicant must ensure that the necessary appropriate agreements governing the transfer and processing of personal data are in place prior to data transfer. [CONDITION MET]\n\nCondition 7. The Applicant must ensure that the data that will be made available in an appropriate scientific repository at the end of this study is anonymised. \n\nCondition 8. As part of the Annual Review the Applicant is requested to provide updates on the progress made to incorporate a consenting process into the electronic epilepsy patient record.","Condition 1. The amendment does not cover the change in the data controllership of the study until confirmation is provided that the requisite research ethics committee approval covers this. Confirmation of this approval should be provided to the HRCDC within 2 months. [CONDITION MET]\n\nCondition 2. Appropriate joint data controller arrangements should be in place between RCSI, St James’s Hospital and Beaumont Hospital with regards this study. Data processing should not commence prior to the necessary agreements/arrangements being in place. [CONDITION MET]","N/A","Condition 1. The outstanding data controller signatures on the HRCDC amendment request form must be submitted as soon as possible and within 1 month. [CONDITION MET]","Condition 1. The outstanding data controller signature from St James’s Hospital on the HRCDC amendment request form must be submitted as soon as possible and within 1 month. \n\nCondition 2. Research ethics approval covering the extension of the study must be obtained for each site (note: the Applicant only provided REC approval from Beaumont Hospital with this amendment request)."]
[null,"Recommendation made","Recommendation 1. For the benefit of the HPO study and future studies, it is recommended that the Applicant undertakes continued public and patient involvement (PPI) activities, including on a project specific basis. [RECOMMENDATIN CONSIDERED]\n\nRecommendation 2. The Applicant is recommended to put in place a data sharing agreement between RCSI and the Children’s Hospital of Philadelphia Research Institute governing the processing of the data and to ensure that the anonymity of participants from Ireland is protected. [UNDER CONSIDERATION]",null,"N/A","N/A","N//A","N//A"]
[null,"Deadline for meeting Conditions","N/A",null,"Condition 1. Data controllership: 10th May ","N/A","Condition 1. Signatures - 10th Aug 2024 [MET]","Condtion 1: REC 14.08.2025"]
[null,"Duration of Declaration ","The Declaration is made commencing 14th June 2022 and shall be valid until 31st January 2023, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner. The consent declaration will not be in effect until Conditions 2 & 4 have been met. AMENDMENT: made commencing 11th July 2025 and shall be valid until 31st July 2026",null,"The approval to the Amendment is made commencing 28th February 2023 and the consent declaration shall be valid until 31st October 2023; this is an extension of the consent declaration made. Amendment is made commencing11th July 2025 and shall be valid until 31st July 2026","The approval to the Amendment is made commencing 22nd August 2023 and shall be valid until 31st July 2024, an extension of the duration of the consent declaration made. Amendment is made commencing 11th July 2025 and shall be valid until 31st July 2026","The approval to the Amendment is made commencing 10th July 2024 and shall be valid until 31st July 2025, an extension of the duration of the consent declaration.Amendment is made commencing 11th July 2025 and shall be valid until 31st July 2026","The approval to the Amendment is made commencing 11th July 2025 and shall be valid until 31st July 2026, an extension of the duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live","Declaration Live","Declaration Live","Declaration Live"]

{"sheet":"22-007-AF1","index":100,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","22-007-AF1"]
[null,"Application Title ","OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly \nHospitalized Patients (OPTIMATE)."]
[null,"Applicant Organisation (Data Controller)","University College Cork"]
[null,"Lead Applicant ","Denis O'Mahony"]
[null,"Research Objective","This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital re-admission and emergency department attendance compared to current usual\nmedication management. The study intervention aims to minimize potentially inappropriate medications in a structured way and involves follow up with patients and GPs. Patients will be allocated equally to (i) standard medication management (control arm) or (ii) trained physician-delivered intervention or (iii)\nclinical pharmacist-delivered intervention."]
[null,"Reason for seeking a Declaration","A consent declaration is requested for the processing of personal data (collection, analysis, storage etc.) for the purpose of the OPTIMATE study where participants lack decision-making capacity due their dementia or the effects of delirium. A consent declaration is requested for both the pilot and main OPTIMATE study. Proxy assent on behalf of the participant will be sought. \nAt the end of the study fully anonymised datasets and results will be made available in data sharing repositories. "]
[null,"HRCDC Meeting Date","12th July 2022"]
[null,"HRCDC Decision Date ","12th July 2022"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. Aligned with the principles of the Assisted Decision-Making Act 2015, it is a condition of this declaration that participant decision making capacity should be determined from a functional perspective and assessment, rather than from a primarily medical perspective. The Applicant is required to report on how decision-making capacity to consent is determined from a functional perspective as part of the Annual Review. [CONDITION MET]\n\nCondition 2. \n- For participants who lack decision making capacity and have been enrolled based on proxy assent, it is a condition of this declaration that their level of decision-making capacity is re\u0002assessed during the study at appropriate points in time.\n- Correspondingly, where it is determined that a participant has regained decision-making  capacity, and can provide explicit consent for the study and the processing of their data, then their deferred consent should be sought. \n- As per Condition 1, participant decision making capacity should be reassessed from a functional perspective. \n- For the avoidance of doubt this condition applies to participants who initially lacked decision\u0002making capacity at the time of their enrolment due to either dementia or delirium. [CONDITION MET]\n\nCondition 3. \n- the Applicant must ensure that that the individual identified to provide proxy assent on behalf \nof an induvial who lacks decision making capacity, is the most appropriate person to understand their will and preferences. \n- where a participant lacks decision-making capacity, the study should continue to engage with the participant to the best extent that is possible, both during the consent/assent process and the study activities.\nThe Applicant is requested to report on both points as part of the Annual Review. [CONDITION MET]","Condition 4. The Applicant is requested to provide confirmation that the study has received \napproval from the full research ethics committee that covers University Hospital Waterford. Evidence that the study has been reviewed and approved by the full research ethics committee for the University Hospital Waterford site must be provided as soon as is practicable and within 2 months of receipt of this consent declaration. For the avoidance of doubt, the consent declaration will not be in effect for the University Hospital Waterford site until this Condition is met.[CONDITION MET]\n\nCondition 5. Appropriate agreements and arrangements governing the sharing and processing of personal data must be in place between the relevant parties in this study, including relevant agreements between the controller UCC and the data processors. Personal data should not be transferred, shared or processed prior to the necessary data agreements being in place. Confirmation should be provided to the HRCDC when the appropriate agreements are in place. [CONDITION MET]\n\n","Condition 6. Separate and specific study information leaflets and consent/assent forms should be used when obtaining (a) consent/deferred consent from the participant and (b) proxy assent from a suitable individual where the participant lacks decision-making capacity. For the avoidance of doubt a single version of the study information leaflet and consent/assent form should not be used. Separate, specific, and tailored study documentation should be utilised when obtaining either participant consent or proxy assent.\nFurther, to ensure clarity and transparency for participants and/or their proxy/relatives, the HRCDC requests that the study information leaflet and assent/consent forms are reviewed and amended. The following observations should be addressed:\n(i) Clear information should be provided to participants and/or their proxy that the OPTIMATE study involves both a pilot phase as well as a main study phase. At the time of obtaining proxy assent or participant consent, individuals should be clearly informed if the participant has been enrolled at the pilot phase. Further, if enrolled at the pilot phase it should be made clear that the participant will continue to be included, and their data processed, in main phase of the OPTIAMTE trial. \n(ii) it should be ensured that the study information leaflets sufficiently and clearly describe the three intervention arms of this study and what the interventions will practically entail for the prescribing of the participant’s medications and their care and treatment.\n(iii) it should be clearly outlined that follow-up data will be sought from the participant’s GP and/or pharmacist. Proxy assent/participant consent should be requested for the collection of this follow-up data within the assent/consent form\n(iv) the information leaflet should inform participants and the proxy that anonymised datasets and results will be made available in data sharing repositories\n(v) the UCC Clinical Studies Data Protection Notice (pgs 5-8 of the study information leaflet) \nshould be provided to the participant and/or proxy as a separate appendix that accompanies the information leaflet and assent/consent from. It should not be incorporated into the main body of the study information leaflet. \n(vi) reference to the processing of racial and ethnicity data should be removed from the UCC Clinical Studies Data Protection Notice, as this data is not collected for this study. More generally the Applicant should ensure that the information leaflet clearly and accurately reflects the data that will be collected and processed for this study.\n(vii) Pg 4 of the information leaflet references that pseudonymised data may be shared/released to third parties if requested. It should be clear in the study documentation that where such pseudonymise data is shared, that the participant’s identify will not disclosed and that the link/master key remains at the hospital site or with UCC. \n(viii) the study information leaflets must provide clear and consistent information with regards withdrawing proxy assent/consent and what will happen the personal data already collected in such a scenario. It should also be clear if there is a point in time where data cannot be deleted or if there is a particular location where data cannot be deleted from. If an explicit request to delete data must be made after assent/consent is withdrawn, then this too must also be clearly outlined in the consenting documents.\nThe study information leaflets, and assent/consent forms must be reviewed and amended as described above prior to the enrolment of participants in the study. [CONDITION MET]"]
[null,"Recommendation made","Recommendation. Aligned with the principle of data minimisation the study should ensure that it \nonly obtains and processes the minimal amount of personal data required for this study. [RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","Condition 4: 18.09.2022 [MET]"]
[null,"Duration of Declaration ","The Declaration is made on 12th July 2022 and is valid until 30th September 2024 and for 15 \nyears thereafter until 30th September 2039, or until the personal data has been destroyed or \nirrevocably anonymised, whichever occurs sooner.\nNOTE: The consent declaration will not be in effect until certain specific conditions are first met."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"22-008-AF1","index":101,"n_rows":15,"n_cols":4,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","22-008-AF1"]
[null,"Application Title ","Evaluation of policies and practices to support safe and appropriate controlled drug \nprescribing"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland "]
[null,"Lead Applicant ","Frank Moriarty"]
[null,"Research Objective","While all medications can pose benefits and risks, some are particularly of concern for reasons of misuse/harm, including opioid medications, used as analgesics to treat pain, and benzodiazepines, used as sedatives to treat sleep troubles and anxiety. The aim of this project is to evaluate prescribing of analgesic and sedative medications. It will examine time trends in volumes and patterns of prescribing in Ireland, to understand how the use of these medications\nhas increased over the last number of years. It will also consider how changes in health policies may have affected prescribing of these medication as well as harm to patients (in the form of drug poisoningsand deaths). Lastly it will examine how much difference there is between regions and GP practices in the level and way they prescribe these medicines, to help understand where and how they may be over- or under-prescribed. Publicly available, non-personal data from NHS England and monthly data from the National Poison Information Centre and the National Drugs Related Deaths Index will also be processed as part of the study’s work packages, including for\ncomparison purposes."]
[null,"Reason for seeking a Declaration","The consent declaration is requested to process the personal data (obtaining, analysing, storing etc.) from the Primary Care Reimbursement Service (PCRS) for the purpose of this research study. The Applicant states that due to the number of participants and for reasons of scientific integrity, it is not feasible to obtain explicit consent."]
[null,"HRCDC Meeting Date","12th July 2022"]
[null,"HRCDC Decision Date ","12th July 2022"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of this consent declaration that robust transparency measures are \nimplemented prior to the commencement of this study. As part of this condition the Applicant is \nrequested to explore what other measures and communication channels can be developed and \nutilised beyond the soon to be established study website that is noted in the HRCDC application \nform. \nThe Applicant must also ensure that the measures implemented clearly outline the aims and \nobjectives of the study, the source of and type of data and the cohort of participants included \n(i.e, PCRS and GMS scheme data), the methods in place to protect the identify of individuals and \nthe comparisons of data with the UK. It should also outline the participant’s data protection \nrights, including any restrictions or derogations to such rights. In this context the limitations to \nwithdrawing data from this study should be clearly highlighted. Such transparency measures \nshould aim to provide information to GPs and pharmacists, as well as the wider public. \nThe Applicant is required to report to the HRCDC on this Condition within 3 months of receipt of \nthis consent declaration. For the avoidance of doubt this consent declaration will not be in effect \nuntil this report is furnished and is considered satisfactory by the HRCDC. [CONDITION MET]\n\nCondition 2. The scope of this consent declaration is made to RCSI for the purpose of this specific \nstudy only, as described in HRCDC application form. The further processing of personal data \nbeyond this scope, including the transfer of pseudonymised data, linkage of the PCRS data with \nother data sources etc. is not covered by this consent declaration and will require the submission \nof an amendment request form or new HRCDC application form for consideration, whichever is \nmost appropriate. [CONDITION MET]\n\nCondition 3. The Applicant must ensure that the appropriate data sharing agreement is in place \nbetween the data controller RCSI and the provider of personal data for this study, the HSE PCRS. \nThe sharing and processing of personal data cannot occur until this condition is met and \nconfirmation should be provided to the HRCDC when the necessary agreement is in place.[CONDITION MET]\n\n","Condition 4. The Applicant must ensure that sufficient security measures, including encryption \nand two-factor authentication, is employed with regards the storage and processing of the data \nin this study. Should the use of OneDrive not provide sufficient encryption, authentication or \nother data security measures, then alternate solutions should be implemented by the study. [CONDITION MET]\n\nCondition 5. The HRCDC notes the following statement in the PCRS Privacy Statement ‘The HSE \nPCRS ensures that you cannot be identified by anonymising the information. If it is not possible to \nanonymise the information, you will be contacted for your consent’. Given that participants may \nnot always be contacted for their consent with regards the use of their PCRS data, the Applicant \nis requested to highlight this section of the Privacy Statement to the PCRS for their consideration \nand amendment in the context of the Health Research Regulations and the consent declaration \nprocess. [CONDITION UNDERWAY]"]
[null,"Recommendation made","Recommendation 1. If not previously undertaken, future PPI activities with representatives \nshould ensure that discussions and engagements are structured in the context of this study, \nincluding that the study has undergone the consent declaration process, the sources and volume \nof data to be used, the participant cohort that is included and other relevant important details \nthat are specific to this particular research. [RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","Condition 1:  18.10.2022 [MET]"]
[null,"Duration of Declaration ","The Declaration is made on 12th July 2022 and is valid for two years until 31st July 2024 and for 5 years of data archiving thereafter until 31st July 2029, or until the personal data has been \ndestroyed or irrevocably anonymised, whichever occurs sooner.\nThe consent declaration will only come into effect when the Applicant has received confirmation from the HRCDC of a satisfactory response to Condition 1."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"22-009-AF1","index":102,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","22-009-AF1",null,"22-009-AF1/AMD1"]
[null,"Application Title ","Linking and harnessing health and population data to improve outcomes in Out-of-Hospital Cardiac Arrest",null,"Linking and harnessing health and population data to improve outcomes in Out-of-HospitalCardiac Arrest"]
[null,"Applicant Organisation (Data Controller)","University College Dublin",null,"University College Dublin"]
[null,"Lead Applicant ","Tomás Barry",null,"Tomás Barry"]
[null,"Research Objective","Out-of-Hospital cardiac arrest (OHCA) affects more than 2,500 people in Ireland every year.Survival remains low at 7%. Treatment is very time sensitive. Survival depends on the actions ofthe community where OHCA occurs and the emergency medical system. The ‘chain of survival’includes early recognition and activation of emergency medical services, care provided bybystanders, dispatched first responders, the ambulance service and hospital.To improve survival this research will study the entire chain of survival from community tohospital for the first time in Ireland. It will link existing national data from first responders,ambulance services, hospitals and the national census. It will explore why different groups ofpatients do or do not survive cardiac arrest and ultimately use this data to develop specific health system interventions that can increase survival in Ireland.A consent declaration is required as individual level consent would be impossible to obtain.",null,"Out-of-Hospital cardiac arrest (OHCA) affects more than 2,500 people in Ireland every year.Survival remains low at 7%. Treatment is very time sensitive. Survival depends on the actions ofthe community where OHCA occurs and the emergency medical system. The ‘chain of survival’\nincludes early recognition and activation of emergency medical services, care provided bybystanders, dispatched first responders, the ambulance service and hospital.To improve survival this research will study the entire chain of survival from community tohospital for the first time in Ireland. It will link existing national data from first responders,\nambulance services, hospitals and the national census. It will explore why different groups ofpatients do or do not survive cardiac arrest and ultimately use this data to develop specifichealth system interventions that can increase survival in Ireland.A consent declaration is required as individual level consent would be impossible to obtain."]
[null,"Reason for seeking a Declaration","A consent declaration is sought for the processing (collection, linkage, analysis, storage) of personal data (coded by study ID) from the OHCAR and HIPE for the purpose of this study. If possible to achieve, the data will be irreversibly anonymised at the end of the study and this data will be made available for future research via a repository. If this is not possible then the data will be stored by UCD for 10 years and then deleted. ",null,"A change in the time period of the personal data to be processed, to now cover 2014 to 2022. "]
[null,"HRCDC Meeting Date","12th July 2022",null,"12th January 2024"]
[null,"HRCDC Decision Date ","12th July 2022",null,"12th January 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of this declaration that the proposed transparency measures (i.e., information on the UCD and other relevant websites) are implemented prior to the commencement of the study. The consent declaration will not be in effect until such measures are in place prior to the study’s commencement. Further, the Applicant is requested to explore and consider what other transparency measures \nand communication channels could be utilised to inform the public about this study, the processing of personal data and their data protection rights, including information on how to withdraw. Examples can include communicating and providing information via other relevant third-party representative organisations such as the Irish Heart Foundation.As part of this Condition, it is also important that the transparency measures implemented are sufficiently publicised and signposted so that the public can be made aware of their presence. [CONDITION MET]\n\nCondition 2. Further to Condition 1, the Applicant is requested to review the content of the privacy notice document that outlines the information to be provided on the UCD and other relevant websites to ensure that it provides information in clear and lay-person’s terms, In this regard, technical terminology such as ‘granular’ and ‘aggregated’ should not be used, and the section describing the data to be processed, including CSO data, should be reviewed and amended where appropriate to ensure that it is clear and concise. [CONDITION MET]\n\nCondition 3. It is noted that should a participant wish to withdraw their data from the study that they should contact the Applicant who will then assist them in liaising with the OHCAR. It is a condition of this declaration that the process for withdrawal is as streamlined as possible from the perspective of the study participant. Correspondingly, where a participant wishes to withdraw their personal data from this study, the steps that need to be taken should not rest with the participant and should be undertaken by the Applicant and the data controller, wherever possible. Only the minimal amount of effort and actions should need to be taken by the participant as part of the withdrawal process.","Condition 4. The Applicant must ensure that the appropriate and necessary data agreements and arrangements are in place between UCD and the relevant parties who will be providing personal data for this study, including the data from HIPE and the OHCAR. Personal data must not be shared, transferred or processed prior to the necessary data agreements being put in place and confirmation should be provided to the HRCDC once the agreements and arrangements have been put in place. The consent declaration will not be in effect until this condition has been met. [CONDITON UNDERWAY]\n\nCondition 5. Where necessary to do so, the Applicant must attain local research ethics committee approval for this study and provide confirmation to the HRCDC when such approval has been obtained. For the avoidance of doubt a consent declaration cannot cover data processing activities that are not covered by the requisite REC approval. \n\nCondition 6. As part of the Annual Review the Applicant is requested to provide updates with regards the potential to irreversibly anonymise the data which is to be explored as part of this study.","N/A"]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to examine and consider the use of Art 9(2)(j) ‘scientific research’ as an appropriate condition for the proposed processing of personal data in this study. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. Should the Applicant submit a future application to the HRCDC, it is recommended that further detailed information on the PPI engagement undertaken is outlined in the HRCDC application form. General statements outlining that PPI engagement has been undertaken should be avoided.  [RECOMMENDATION CONSIDERED]",null,"N/A"]
[null,"Deadline for meeting Conditions","N/A",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made on 12th July 2022 and is valid until 30th September 2025 and for 10 years of data archiving thereafter until 30th September 2035, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner.\nNOTE: in line with the principle of data minimisation, the duration of the consent declaration may be amended should the personal data be irreversibly anonymised. \nNOTE: as per the attached conditions, the consent declaration will not be in place prior to meeting certain conditions.",null,"The approval to the Amendment is made commencing 12th January 2024 and shall be valid until 30th September 2025 and for 10 years of data archiving thereafter until 30th September 2035, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live"]

{"sheet":"22-010-AF1","index":103,"n_rows":16,"n_cols":3,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","22-010-AF1"]
[null,"Application Title ","Blockchain and AI Enabled Stratified Trials System (BESTS): A pilot study"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland University of Medical and Health \nSciences (RCSI)\nBeaumont Hospital\nSt James’s Hospital "]
[null,"Lead Applicant ","Gianpiero Cavalleri"]
[null,"Research Objective","Blockchain and Artificial Intelligence (AI) Enabled Stratified Trials System (BESTS) is a newly \ndeveloped technology that aims to match people to relevant clinical trials, using their health data. Health data is information about a person’s medical condition and their genetics. Blockchain is a highly secure IT infrastructure that protects health data entered into the system from outside cyberattacks. Artificial intelligence (AI) uses a person’s health data to match them to relevant clinical trials.\nThis pilot research study is to test prototypes of BESTS with potential users including patients, care-partners, decision makers and healthcare providers. Understanding from a user perspective what they like, what they would change, how easy it is to use and how it can be improved, will allow researchers develop a system to empower patients and care-partners to seek out ongoing clinical trials in a safe, transparent, trustworthy manner. \nThe overall objective is to test and validate the functionality, technical performance, standard operating procedures and user experience of a prototype version of the BESTS (Blockchain and AI-Enabled Stratified Trial System) platform. This study will examine the usability and utility of the BESTS platform, how it works in controlled practice and its effectiveness in enhancing the care pathway for patients, their families and healthcare professionals alike before approving for wider use."]
[null,"Reason for seeking a Declaration","In some cases, participants will lack decision-making capacity due to the impact of their intellectual disabilities. A consent declaration is requested for the processing of personal data of this cohort for the purpose of this specific trial/pilot of the BEST study."]
[null,"HRCDC Meeting Date #1","6th September 2022"]
[null,"HRCDC Meeting Date #2","4th October 2022"]
[null,"HRCDC Decision Date ","4th October 2022"]
[null,"HRCDC Decision","No Declaration"]
[null,"Specific Conditions attached ","N/A"]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","N/A"]
[null,"Status of Declaration","N/A"]

{"sheet":"22-011-AF1","index":104,"n_rows":15,"n_cols":6,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","22-011-AF1",null,null,"22-011-AF1/AMD1"]
[null,"Application Title ","SENSE-Cog Residential Care: A feasibility study of hearing and vision support to improve quality of life in care home residents with dementia",null,null,"SENSE-Cog Residential Care: A feasibility study of hearing and vision support to improve quality of life in care home residents with dementia"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin",null,null,"Trinity College Dublin"]
[null,"Lead Applicant ","Iracema Lero",null,null,"Iracema Lero"]
[null,"Research Objective","SENSE-Cog Residential Care will compare our Sensory Support Intervention for Residential Care (SSI\u0002RC) to Care as Usual (CaU) in Residents with Dementia (RwD) with hearing and/or visual impairment.The study will ascertain feasibility, acceptability, and tolerability of the intervention. It will explore whether the intervention may be effective in improving quality of life and other outcomes and\nevaluate cost-effectiveness. Approximately 10 homes will participate, 5 will receive the intervention and 5 will receive CaU. RwD in the intervention arm will receive hearing and vision assessments and aids to assist. Staff in the intervention nursing homes will receive general training in sensory cognitive health. Selected staff, Sensory Champions, will receive further training and deliver the SSI-RC. SSI-RC has four levels: Resident, Staff, environment, and referral pathway. Assessment will be carried out in several ways including semi-structured interviews and questionnaires. at the beginning of the study, after 3-months and again after 6-months. ",null,null,"SENSE-Cog Residential Care will compare our Sensory Support Intervention for Residential Care (SSI\u0002RC) to Care as Usual (CaU) in Residents with Dementia (RwD) with hearing and/or visual impairment.The study will ascertain feasibility, acceptability, and tolerability of the intervention. It will explore whether the intervention may be effective in improving quality of life and other outcomes andevaluate cost-effectiveness. Approximately 10 homes will participate, 5 will receive the intervention and 5 will receive CaU. RwD in the intervention arm will receive hearing and vision assessments and aids to assist. Staff in the intervention nursing homes will receive general training in sensory cognitive health. Selected staff, Sensory Champions, will receive further training and deliver the SSI-RC. SSI-RC has four levels: Resident, Staff, environment, and referral pathway. Assessment will be carried out in several ways including semi-structured interviews and questionnaires. at the beginning of the study, after 3-months and again after 6-months. "]
[null,"Reason for seeking a Declaration","A consent declaration is required to process the personal data of residents with dementia (i.e., participants who lack decision-making capacity) for the purpose of this specific research study (i.e., collection, transfer, analysis, storage etc.).",null,null,"The amendment is requested to (i) add 3 further sites to the study and (ii) to extend the duration of the consent declaration to November 2031."]
[null,"HRCDC Meeting Date","13th December 2022",null,null,"13th June 2023"]
[null,"HRCDC Decision Date ","13th December 2022",null,null,"13th June 2023"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to further enhance the level of PPI engagement within this study; specifically, the Applicant is requested to undertake engagement and discussions with, and seek feedback from, the residents with dementia who will be recruited to the study. This engagement with residents should consider discussions and seek feedback on the development and delivery of the study, the assent/consent process, transparency measures and the dissemination of findings and other relevant matters. PPI engagement with residents with dementia should also discuss support for and the development of a larger future study that may follow this feasibility study. [CONDITION MET]\n\nCondition 2. It is a condition of this declaration that proxy assent on behalf of a resident who lacks decision-making capacity is sought and obtained from an individual who understands the resident’s will and preferences. Further, should the capacity of the resident fluctuate over the course of the study, the study must seek to obtain their deferred consent to continue to process their data. Deferred consent, if the resident regains capacity, should be sought at an appropriate point in time that does not cause undue stress to the resident. [CONDITION MET]\n\nCondition 3. Appropriate data agreements and arrangements must be in place between the relevant parties prior to the processing of personal data for this study. The consent declaration will not be in effect until this condition is met. [CONDITION MET]\n\nCondition 4. The Applicant is requested to seek confirmation that the REC approval obtained from TCD is sufficient to conduct the study at that nursing home. Where local REC approval is required from the nursing home this must be obtained. Confirmation that TCD REC approval is sufficient, or that local REC approval is required and has been obtained, should be provided to the HRCDC as soon as practicable. For the avoidance of doubt, the consent declaration will not be in effect for the nursing home sites where local REC approval is required but has not been obtained, until REC approval is in place. [CONDITION MET]","Condition 5. With regards the study information leaflets and assent/consent forms and withdrawing from the study, the following should be addressed by the Applicant:\n(i) The current information leaflets state ‘You can change your mind about your relative taking part in the study and opt out at any time even if the study has started’ or ‘You can decide to take part or not each time we visit. If you choose not to take part, this will not affect your care or treatment’. It must be clearly outlined to both the resident providing assent/consent and the person providing proxy assent where they lack decision making capacity, what will happen the personal data if their assent/consent or proxy assent is withdrawn, i.e., aligned with the \nresponse from the applicant, the data collected will continue to be processed subject to their agreement and it will be deleted if they do not agree. Information should also be provided whether there is a point in time where personal data cannot be deleted/removed.\n(ii) Further to point (i), where a participant wishes to withdraw from the study and/or exercise their data rights, a contact within the nursing home, not just the Trinity College research team, should be clearly provided in the information leaflets for both the participant and their proxy. This contact in the nursing home can then liaise and engage with the Trinity College contact. [CONDITION MET]\n\nCondition 6. The Applicant is requested to review and strengthen the security of the data collected for this study, in particular the security of the physical copies of data and the methods of data \ntransfer, to ensure they are suitably robust; where practicable, the transfer of physical or hard\u0002copy data from the nursing home sites to the research team in Trinity College Dublin should be avoided and data transferred by secure electronic methods only. The Applicant is requested to reply to this condition and provide details on the robust security of the data as soon as possible \nand within 2 months. The consent declaration will not be effect until a satisfactory response is provided to the condition by the requested deadline. [CONDITON MET]","Condition 7. Aligned with the principle of data minimisation, the Applicant should ensure that only the minimal level of personal data is collected, processed, transferred and stored for the purpose of this study. Consideration should also be given on whether the data can be anonymised or destroyed sooner than November 2027.\n\nCondition 8. The study information leaflets and the consent/assent forms for residents with dementia and those providing proxy assent should be reviewed to ensure that they are written in the correct perspective. For example, the statement ‘Do I have to take part’ in the information leaflet for the relative/proxy should be rephrased as ‘Does my relative have to take part’. [CONDITION MET]\n\nCondition 9. The Applicant is requested to provide updates on the number of residents with dementia recruited to this study as part of the Annual Review. [CONDITION MET]","Condition 1. Further to Condition 1 that was attached to the original consent declaration, the Applicant is also requested to undertake PPI engagement with relevant representative groups such as \nthe Alzheimer’s Association of Ireland. [CONDITION MET]"]
[null,"Recommendation made","Recommendation. With regards the study information leaflet and assent/consent and proxy assent forms, the Applicant is recommended to ask the residents with dementia and their relative/proxy, if they would also wish to be included and have their data processed in a larger future study that may follow form this feasibility study. [RECOMMENDATION CONSIDERED]",null,null,"Recommendation 1. It is noted that the ‘Demonstration of Capacity’ checklist document includes a section detailing the Mental Capacity Act 2005. The HRCDC recommends that this section is amended to align with the latest legislation in this area, namely the Assisted Decision-Making Act \n2015. [CONSIDERATION UNDERWAY]"]
[null,"Deadline for meeting Conditions","Condition 6: 22.02.2023 [MET]",null,null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 13th December 2022 and shall be valid until 30th November 2027 or upon confirmation that the personal data have been rendered anonymised or destroyed, or whichever occurs sooner.AMENDMENT UPDATED - The approval to the Amendment is made commencing 13th June 2023 and shall be valid until 30th November 2031 ",null,null,"The approval to the Amendment is made commencing 13th June 2023 and shall be valid until 30th November 2031 [This is an extension of the original consent declaration]."]
[null,"Status of Declaration","Declaration Live",null,null,"Declaration Live"]

{"sheet":"22-012-AF1","index":105,"n_rows":15,"n_cols":4,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","22-012-AF1"]
[null,"Application Title ","Targeted Review and Amalgamation of Unmapped Major Trauma and Ambulance Data in Ireland: TRAUMA Study"]
[null,"Applicant Organisation (Data Controller)","National Office of Clinical Audit (NOCA) and Health Service Executive (HSE) National Ambulance Service (NAS)"]
[null,"Lead Applicant ","Professor Frank Doyle"]
[null,"Research Objective","This study aims to support the development of the national trauma care system in Ireland by combining, anonymising, and then analysing two currently separated datasets. These are, the National Ambulance Service (NAS) electronic Patient Care Record (ePCR) and the Major Trauma Audit (MTA). As this data concerns trauma  patients, informed consent was not possible and given the size of the dataset it is considered that retrospective consent to process the data is not feasible. Therefore, the Applicant is applying for a consent declaration to process the data for the purposes of linking and anonymising the datasets. They plan to analyse the anonymised data to map the patient journey from the scene of the incident to discharge from hospital and to identify characteristics that determine the need to bring patients to major trauma centres. "]
[null,"Reason for seeking a Declaration","The declaration is required for the transfer and merging of two personal datasets (the National Ambulance Service (NAS) electronic Patient Care Record (ePCR) & the Major Trauma Audit (MTA)). Once merged the data will be anonymised and transferred for analysis to RCSI. The pseudonymised audit and NAS data obtained for this study by the data controllers will be retained for 5 years after the study concludes. "]
[null,"HRCDC Meeting Date","8th November 2022"]
[null,"HRCDC Decision Date ","8th November 2022"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is a condition of this declaration that the study website is launched and adequately promoted prior to the transfer and processing of participant data between the parties, and that there is a sufficient timeframe between the launch of the website and when the transfer of data occurs; for the avoidance of doubt participant data (whether personal/pseudonymised or anonymised data) cannot be transferred between the NAS, NOCA and/or RCSI before the launch of the website. Further to this, the website should provide clear information on the aims and objectives of the study, the data to be processed and clearly outline the participant’s data protection rights, including the right to withdraw and how to exercise such rights. The website should also outline any derogations or limitations to data protection rights, if applicable, including at what point data cannot be withdrawn from the study if this is requested by the participant \nIn addition to the study website, the Applicant is also requested to explore what other transparency measures and communications activities could be implemented. (Please see Condition 2 and Recommendation 1)\nNote: While the transfer of ‘real-world’ participant data cannot occur before this condition is met, it does not prevent the transfer of the ‘dummy dataset’ that will be used in the pilot of this study. [CONDITON MET]   \n\nCondition 2. Further to Condition 1, where a participant wishes to withdraw their data from this study then their data should be withdrawn where this is possible to do so, in the context of GDPR derogations and the feasibility of withdrawing the data at that point of the study. When considering a participant’s request to withdraw their data, all the joint data controllers (NOCA, NAS, RCSI) should therefore have due consideration on the feasible and practicable steps that can reasonably be taken to remove the participant’s data at that stage of the study. [CONDITON MET]   \n","Condition 3. The Applicant is requested to ensure that PPI engagement continues during the study and that those engaged are participant representatives who can provide the perspective and views of the study’s patient cohort (i.e., trauma patients). The PPI engagement undertaken is a reporting requirement of the Annual Review. [CONDITON MET]   \n\nCondition 4. When obtained, confirmation of final and full research ethics committee approval must be provided to the HRCDC. The consent declaration will not be in effect until this condition has been met. [CONDITON MET]   \n\nCondition 5. An authorised signature on the consent declaration application form, and data protection officer feedback on the DPIA, on behalf of RCSI must be submitted to the HRCDC as soon as practicable and no later than 2 months from the date of this declaration. The consent declaration will not be in effect until this condition has been met. [CONDITON MET]   \n\nCondition 6. It is a condition of this declaration that the necessary agreements/arrangements governing the transfer and use of the data for this study are in place between the relevant parties. This includes relevant data sharing agreements and joint controller arrangements. No transfer of data can occur prior to the required agreements/arrangements being in place. [CONDITON MET]   "]
[null,"Recommendation made","Recommendation 1. Further to study website and the withdrawal of data, the Applicant should ensure that a clear protocol is in place with regards participant withdrawal. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The Applicant is requested to inform the HRCDC of the results of the pilot study using the ‘dummy dataset’ as part of the Annual Review. As part of this the Applicant is requested to inform the HRCDC of the changes, if any, that have made regarding the data used in this study that may arise from the pilot, including whether the study requires the inclusion of additional participant data. In addition, the Applicant is requested to adhere to the data minimisation principle and ensure that only the necessary data is processed for the purpose of this study.  [RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","Condition 5: Signature & Dpia - 22nd January 2023 [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 8th November 2022 and shall be valid until 31st July 2030(5 years after the study has concluded) or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"22-013-AF1","index":106,"n_rows":15,"n_cols":6,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","22-013-AF1"]
[null,"Application Title ","Maximising equity and accessibility of acute stroke care pathways in Ireland (Part C): Patient outcome and experience"]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons in Ireland University of Medicine and Health Sciences"]
[null,"Lead Applicant ","David Williams"]
[null,"Research Objective","This study aims to understand what happens to individual patients around the time of their stroke. By understanding the individual factors that help or hinder people from seeking or receiving care quickly we hope to understand how best to plan and organise stroke services in the future. Some strokes are relatively mild and some very severe and life-changing and so this study hopes to include patients with a variety of experiences so we can better learn from the experience of all."]
[null,"Reason for seeking a Declaration","The consent declaration is sought to process the personal data of stroke patients who lack decision-making capacity (i.e., collection, transfer, analysis, storage etc.). The personal data will be obtained from in-patient survey, qualitative interviews and medical chart review. Where a patient lacks decision-making capacity, proxy assent from a relative will be sought and deferred consent obtained where possible. The relative/proxy will complete the survey/interview on behalf of participant who lacks capacity. If deemed suitable and appropriate fully anonymised data will be made available in a public repository.  "]
[null,"HRCDC Meeting Date","25th January 2023"]
[null,"HRCDC Decision Date ","25th January 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to revisit the designation of the roles and responsibilities within this study to ensure that the designation of RCSI as the data controller of the study, and Beaumont Hospital as a data processor, is correct. Please discuss this matter with the relevant data protection officers (DPOs) and respond to the HRCDC within 2 months of the date of thisdeclaration. Should the data controllership arrangement subsequently change you should consult the Secretariat on whether an amendment is required. [CONDITON MET]\n\nCondition 2. Once obtained, the Applicant is requested to submit confirmation of full research ethics committee approval from the Beaumont Hospital REC. Confirmation should be provided as soon as practicable and within 2 months of receipt of this letter. [CONDITON MET]\n\nCondition 3. The Applicant should ensure that the required data agreements/arrangements are in place with the relevant parties for the purpose of this study. [CONDITON MET]\n\nCondition 4. The Applicant is requested to review the personal data to be collected and \notherwise processed for the purpose of this study to ensure that only the minimum data required is processed. The HRCDC is of the view that serious consideration should be given as to whether Eircode and exact date of birth (as opposed to age only) should be used. [CONDITON MET]\n\nCondition 5. Where the patient has been discharged from hospital, it is noted that the patient’s general practitioner (GP) may be contacted by the study for their opinion on the appropriateness of approaching the patient for recruitment to the 3-month interview and as part of reassessing capacity. In advance of contacting GPs, the study should examine how it will ensure that the GPs are appropriately informed about this study and that they will be asked for information, including that the patient’s relative has provided assent for this. Aligned with Condition 3, the Applicant must also ensure that any required agreements or arrangements are put in place with GPs should they be necessary to authorising the sharing of information on the patient. The Applicant should \ndiscuss this matter with their DPO. ","Condition 6. With regards the proxy assent and consent process and study activities the Applicant is requested to undertake the following: \n• Ensure that the relative who provides proxy assent on behalf of the patient who lacks decision-making capacity is the most appropriate to understand the patient’s will and preferences.\n• Decision-making capacity of the patient should be determined from a functional assessment at the initial assessment and recruitment phase, and at subsequent appropriate points during the course of study.\n• The Applicant must ensure that a clear process is in place on when and how decision-making capacity will be re-assessed from a functional perspective for all patients following their initial recruitment, and up until the 3-month follow-up interview for those invited to complete the interview. Strong consideration should be given as to whether capacity can be appropriately re-assessed, and patient consent obtained, at each point of study contact. On approaching the GP of patients who lacked decision-capacity at the survey stage and who are invited to \nparticipate in the 3-month interview, the role of and protocol for contacting the GP and how they will be involved in practice in the process of re-assessing decision-making capacity from a functional perspective, should be clearly outlined in this process. \n• Further to the patient’s relative, where they lack decision making capacity, the patient should be involved to the greatest extent possible in (i) the assent/consent process during the course of the study and (ii) the study activities. The Applicant is requested to report on this process as part of the Annual Review, including the \nnumber of participants recruited to the study who have not been able to provide explicit consent.  [CONDITON MET]","Condition 7. Where a patient regains decision-making capacity during the study, the survey responses provided on their behalf by their relative should always be provided to the patient as a standard process. The study should also consider and take on board any comments or edits/changes that the patient may have to their relative’s survey responses, where this is deemed suitable and appropriate.  [CONDITON MET]\n\nCondition 8. As part of the Annual Review, the Applicant must inform the HRCDC whether fully anonymised data is to be made available in a public repository at the end of the study or if the data will be deleted. The Applicant must also ensure that any data made available in a public \nrepository is fully, irrevocably anonymised; in this context no audio or video recordings should be made available. \n\nCondition 9. With regards the surveys/interviews and the audio/video recordings, the HRCDC requests the following; \n• Any audio or video recordings must be stored in a secure environment and held for the minimum period that is necessary. \n• Steps should be taken to prevent directly identifiable data being recorded or otherwise provided to the transcription service provider.","Condition 10. To ensure clarity and transparency for participants and/or their relatives, the HRCDC requests that the following observations are addressed regarding the study information leaflets and assent/consent forms for patients and their relative: \n(i) The term ‘consent’ should not be used when referring to seeking permission from a relative \non behalf of a patient who lacks decision-making capacity to provide consent for data \nprocessing; the term ‘proxy assent’ should instead be used when referring to permission \nfrom a relative. Accordingly, the inaccurate use of ‘consent’ from a relative in both the \nrelative and patient information leaflets and assent/consent forms should be amended. \n(ii) The study information leaflets and corresponding proxy assent an consent forms should outline that fully anonymised data may be made available in a public repository and to request specific permission for this from the relative and/or patient. \n(iii) Where a patient regains decision-making capacity and is requested to provide deferred consent, the study information leaflet and deferred consent form should request their deferred consent for the continued retention and processing of their personal data that was collected for the study when they lacked decision-making capacity. \n(iv) All versions of the study information leaflets for the relative and the patient should be consistent on the Art 6 and Art 9 bases for processing personal data and on the duration of data retention. The versions submitted to the HRCDC refer to either Art 6(1)(e) or Art 6(1)(f) and state different data retention periods of either 5 years or until April 2025. Of note the responses to the HRCDC state that the legal basis is Art 6(1)(e) and that the data will be \nretained until April 2025. \n(v) The study information leaflets should provide clear information on the secure storage and retention of the interview recordings. \n(vi) All the study information leaflets should note that the recordings will be transcribed by a third party, \n(vii) The study information leaflets should provide more clear information on what will happen the personal data collected if proxy assent from the relative is withdrawn and/or if the patient wants to withdraw from the study or does not provide deferred consent i.e., information that aligns with the responses provided to the HRCDC. Details should be provided in the study information leaflets on the options that will be given to the individual on what will happen their data in such circumstances, including that data can be removed \nfrom the study and deleted, and at what point it would not be possible to withdraw their \ndata from the study. \n(viii) To avoid potential confusion about the role of the HRCDC, the reference to the HRCDC in the \nstudy information leaflets should be removed or otherwise amended to simply outline that a \nconsent declaration has been made for this study.  [CONDITON MET]"]
[null,"Recommendation made","Recommendation 1. The study is recommended to ensure that all efforts are made to protect patient confidentiality and privacy. This includes ensuring that confidential patient information obtained during the study is not inadvertently passed on to or shared with family members, and that efforts are made to protect patient privacy if the study survey and/or interviews are not conducted in a wholly private setting, for example if they are conducted in a hospital ward.[RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","Condition 1: Data controller/data processor. \nCondition 2: REC approval \n03.04.2023\n[CONDITIONS MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 25th January 2023 and shall be valid until 30th April 2025 or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"23-001-AF1","index":107,"n_rows":15,"n_cols":6,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-001-AF1"]
[null,"Application Title ","EUROPA T-DXd - EUropean Real-world experience Of Previously treated advanced/metastatic HER2-positive breast cancer patients Accessing trastuzumab deruxtecan through a named patient program"]
[null,"Applicant Organisation (Data Controller)","Daiichi Sankyo Europe GmbH"]
[null,"Lead Applicant ","Prof Janice Walshe"]
[null,"Research Objective","EUROPA is an observational real-world data collection (RWDC) project related with trastuzumab deruxtecan (T-DXd) for advanced metastatic breast cancer. Patients were treated with T-DXd within a Named Patient Programme (NPP), which will be the basis for the RWDC project. \nThe RWDC project is to be carried out in Ireland, as well as Spain and Italy, to evaluate T-DXd’s treatment outcomes from evidence sourced in an observational, real-world clinical setting. Such early insights, along with other relevant evidence, may assist the Sponsor in informing appropriate treatment protocols for the benefit of future patients."]
[null,"Reason for seeking a Declaration","This study involves both retrospective patients and those who are currently being treated with T-DWd as part of the Named Patient Programme (NPP), which is the basis for this real-world data collection study.\nThe study will seek the explicit consent of eligible patients for EUROPA; however, a consent declaration is required for patients whom the study is unable to contact and who are therefore considered to be lost to follow-up. The data processing activities includes collection, transfer, analysis, storage of personal data taken from patient’s medical records held at site that were completed within the NPP. Anonymised data will also be shared with a third party, AstraZeneca who is a collaborator on the development of T-DXd. "]
[null,"HRCDC Meeting Date","28th February 2023"]
[null,"HRCDC Decision Date ","28th February 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to extend the proposed 8-week timeframe of the contact process to provide potential participants with more time to respond. In addition, the following should also be undertaken:\n(i) A standard and consistent process across the Irish sites must be designed and implemented with regards contacting potential participants; accordingly standard materials must also be employed as part of this process and used by the Irish sites (e.g., a standard contact letter or other correspondence should be used). As part of this contact process, the Irish sites must also inform the potential participant about what will happen if they do not reply i.e., the individual must be informed that they will be considered lost to follow up and will be included in the study and have their personal data processed. The potential participants must also be informed about \ntheir data protection rights, any limitations to those rights, how to exercise their rights and be provided with a clear point of contact for the study in Ireland. Participants should also be informed if there is a point in the study where their data cannot be deleted. \n(ii) When contacting participants, the study information leaflet and consent form must also be sent. [CONDITION MET]\n\nCondition 2. Further to Condition 1, should a participant respond to the contact process after the extended timeframe has concluded (i.e., they have already been deemed lost to follow-up), it remains that the study must still consider and respect the participant’s wishes, including if they reply that they do not consent to be included in this study and to have their personal data processed. If a scenario arises where the participant who was deemed lost to follow-up is later in contact with the hospital site for other reasons, then the Applicant should seek to obtain their consent for this study if the opportunity arises.  [CONDITION MET]","Condition 3. The Irish hospital sites must, alongside the joint data controllers, be responsible for implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland if the participant has queries or otherwise wishes to exercise their rights. \n\nCondition 4. The Applicant must ensure that the required data agreements and arrangements are in place for this study, including data transfer agreements, joint controller arrangements and necessary agreements covering the transfer and processing of data outside the EEA. [CONDITION MET]\n\nCondition 5. It is a condition of this declaration that the data to be transferred to AstraZeneca is anonymised data only. [CONDITION MET]\n\nCondition 6. The Applicant is requested to enhance the transparency measures to be implemented in this study, beyond the provision of study information leaflets. The Applicant is requested to enhance transparency via the websites of the Irish hospital sites and other appropriate platforms that may be available. The information provided on the websites should outline the purpose of the study, the processing of personal data and the data protection rights of participants, including any limitations to those rights and how to exercise those rights. Consideration should also be given to enhancing transparency methods by way of dissemination of study findings. \n\n","Condition 7. Only on-site access to identifiable data for the purpose of study audits must be undertaken; remote audits and access to identifiable data should not occur. [CONDITION MET]\n\nCondition 8. Data protection training must be completed by all personnel involved in this study.  [CONDITION MET]\n\n","Condition 9. The study information leaflets, and consent forms should be reviewed and amended as follows to ensure clarity and consistency of information for potential participants:\n(i) The joint controllership of this research study must be clearly noted i.e., the US Sponsor and its European Affiliate must be named as joint data controllers of the study,\n(ii) It must be outlined that anonymised data will be transferred/shared with AstraZeneca as part of this study,\n(iii) The time period of the data covered by this study must be clear,\n(iv) It must be outlined what will happen the personal data if a participant wishes to withdraw from the study (i.e., no further data will be collected) and to clearly note their rights with regards the erasure/deletion of data if the participant wishes to exercise their rights. Any derogations to the participant’s right to withdraw and to have their data deleted should also be outlined, as should any point in the study where it may not be possible to delete their personal data if requested (please also refer to the note for context for Conditions 1-2 – for letter only)\n(v) The signature of section for the legal representative should be removed as participants who lack decision-making capacity are not included in this study. [CONDITION MET]\n\nCondition 10. Please submit a signature on the HRCDC application form from the Irish Principal Investigator, Prof Janice Walshe, as soon as practicable and within 2 months for receipt of this consent declaration. [CONDTION MET]"]
[null,"Recommendation made","Recommendation 1. The Applicant is recommended to review the study information leaflets and where possible make simpler and shorten the document for the benefit of participants. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The Applicant is recommended to undertake engagement with public and patient (PPI) representatives about this study, for example engagement with cancer patient groups. Matters of discussion with PPI representatives should include informing representatives about the study, seeking their views on the study as well as engaging with representatives on the language, length and readability of the study information leaflets. PPI engagement should also examine how to enhance other transparency measures such as via the hospitals or other websites and platforms. [UNDER CONSIDERATION]"]
[null,"Deadline for meeting Conditions","Condition 10. 10th May 2023 [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 28th February 2023 and shall be valid for 10 years until 30th April 2033 or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner."]
[null,"Status of Declaration","Declaration No Longer Required"]

{"sheet":"23-002-AF1","index":108,"n_rows":15,"n_cols":10,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,null,"AMENDMENT #1","AMENDMENT #2","AMENDMENT #3","AMENDMENT #4"]
[null,"Application Ref ID","23-002-AF1",null,null,null,"23-002-AF1/AMD1","23-002-AF1/AMD2","23-002-AF1/AMD3","23-002-AF1/AMD4"]
[null,"Application Title ","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.",null,null,null,"Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations.","Development and Establishment of the Epilepsy-Associated Gene-Ready Register (EAGER) – A Register of Patients with Epilepsy caused by Pathogenic Mutations."]
[null,"Applicant Organisation (Data Controller)","Royal College of Surgeons Ireland",null,null,null,"Royal College of Surgeons Ireland","Royal College of Surgeons Ireland","Royal College of Surgeons Ireland","Royal College of Surgeons Ireland"]
[null,"Lead Applicant ","Norman Delanty",null,null,null,"Norman Delanty","Norman Delanty","Norman Delanty","Norman Delanty"]
[null,"Research Objective","The aim of this study is to set up an Irish register of patients with epilepsy due to known genetic mutations. This will allow researchers to identify patients who may be suitable for new treatments or clinical trials developed in the future to target particular types of genetic epilepsies (known as precision or targeted therapies). The patient will only ever be contacted by the Consultant, or the Research Nurse assigned to work on this register and will never be contacted by a third party.",null,null,null,"The aim of this study is to set up an Irish register of patients with epilepsy due to known genetic mutations. This will allow researchers to identify patients who may be suitable for new treatments or clinical trials developed in the future to target particular types of genetic epilepsies (known as precision or targeted therapies). The patient will only ever be contacted by the Consultant, or the Research Nurse assigned to work on this register and will never be contacted by a third party.","The aim of this study is to set up an Irish register of patients with epilepsy due to known genetic mutations. This will allow researchers to identify patients who may be suitable for new treatments or clinical trials developed in the future to target particular types of genetic epilepsies (known as precision or targeted therapies). The patient will only ever be contacted by the Consultant, or the Research Nurse assigned to work on this register and will never be contacted by a third party.","The aim of this study is to set up an Irish register of patients with epilepsy due to known genetic mutations. This will allow researchers to identify patients who may be suitable for new treatments or clinical trials developed in the future to target particular types of genetic epilepsies (known as precision or targeted therapies). The patient will only ever be contacted by the Consultant, or the Research Nurse assigned to work on this register and will never be contacted by a third party.","The aim of this study is to set up an Irish register of patients with epilepsy due to known genetic mutations. This will allow researchers to identify patients who may be suitable for new treatments or clinical trials developed in the future to target particular types of genetic epilepsies (known as precision or targeted therapies). The patient will only ever be contacted by the Consultant, or the Research Nurse assigned to work on this register and will never be contacted by a third party."]
[null,"Reason for seeking a Declaration","Consent will be obtained from participants who have decision-making capacity. The consent declaration is requested to process the personal data of those who lack decision-making capacity to provide explicit consent; for this cohort, proxy assent will be obtained on their behalf. \nThe scope of the consent declaration is for the collection, transfer and storage of data to and by the data controller RCSI - personal data for the register will be collected from participating hospital medical records. The declaration also covers the processing of the personal data in the register for pre-screening purposes by the data controller of the Register, RCSI, for future studies, including RCSI informing participants about future trials. The declaration would not cover the further processing of the personal data beyond this scope, including the sharing or disclosure of personal data with any third parties. ",null,null,null,"A change in the data controllership of the study to include Beaumont Hospital.","An extension of the consent declaration by 1-year. ","An extension of the consent declaration by 2 years","To add the Mater as an additional site (and data processor) to this study. It is also noted that study will use of RedCap instead of Excel."]
[null,"HRCDC Meeting Date","29th March 2023",null,null,null,"22nd August 2023","3rd April 2024","31st March 2025","16th September 2025"]
[null,"HRCDC Decision Date ","29th March 2023",null,null,null,"22nd August 2023","3rd April 2024","31st March 2025","16th September 2025"]
[null,"HRCDC Decision","Conditional Declaration",null,null,null,"Amendment Approved","Amendment Approved","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to enhance the transparency measures so that researchers may be informed about the Register, it’s purpose and how it can be utilised for pre-screening. Enhanced transparency measures should consider the data controller and hospital websites as well as considering if information can be provided on other appropriate third-party sites. [CONDITION UNDERWAY]\n\nCondition 2: It is a condition of this declaration that public and patient engagement activities are strengthened, including engagement with patients with epilepsy and/or other representative groups such as Epilepsy Ireland. Matters for PPI discussions could include the consent/proxy assent process and information leaflets, transparency measures and the overall development of the Register. [CONDITION UNDERWAY]\n\nCondition 3. The Applicant should review the data to be collected for the Register and ensure that it will only collect the data that is necessary for the purpose of the Register, considering both the principle of data minimisation and to ensure the ‘legitimate purpose’ legal basis that the data controller is relying on can apply. [CONDITION MET]\n\nCondition 4. \n-\tThe Applicant is requested to ensure that it is not automatically assumed that patients with epilepsy – who the Applicant describes as ‘vulnerable’ - would lack decision-making capacity to consent to this register and that decision-making capacity is therefore always determined from a functional perspective, which aligns with the principles of the Assisted Decision-Making Act. \n-\tThe patient with epilepsy should also be involved, to the best extent possible, in the decision-making process with regards inclusion in the Register and for their views to be taken on board. Where a participant who lacks decision-making capacity is enrolled in the Register, then the Applicant is further requested to revisit if they can provide consent at a later date as capacity can fluctuate over time.\n-\tIt was also not fully clear to the HRCDC what was meant by obtaining permission from a ‘legal representative’ in the context of this study as there is no concept of a ‘legal representative’ being able to provide permission for data processing purposes – however it is noted that the term is used in the context of clinical trials. The HRCDC regards obtaining proxy assent from someone who understands the participant’s will and preferences as a suitable safeguard and therefore the Applicant should ensure that the person providing proxy assent on behalf of the participant who lacks decision making capacity, understands the participant’s will and preferences.\n-\tThe Applicant is requested to report on determining capacity from a functional perspective and who provides proxy assent on the participant’s behalf as part of the Annual Report.   [CONDITION UNDERWAY]","Condition 5. Confirmation of full, research ethics committee approvals from all three hospital sites must be submitted to the HRCDC as soon as possible and within 3 months of receipt of this letter. A consent declaration cannot cover data processing where the required REC approval is not in place. [CONDITION MET]\n\nCondition 6. The required data agreements and arrangements must be in place between the parties prior to data being transferred. Data cannot be transferred before such agreements and arrangements are in place.[CONDITION MET]\n\nCondition 7. The Applicant is requested to explore and consider if an alternative platform to an excel database can be used by the Register, in the context of both data security and the practical and effective use of the data for the purpose of pre-screening. The Applicant is also requested to ensure that the data is securely encrypted when transferred from the hospital sites.  ","Condition 8. To ensure clarity and consistency of information for the participants and those providing proxy assent on their behalf, the study information leaflets and consent/assent forms should be reviewed and amended as follows prior to recruiting participants:\n(i)\tAligned with the responses provided to one of the research ethics committees, the study information leaflets should outline that consent/proxy assent can be provided on the day of request or that a time interval can be provided to consider the study documents and provide consent/proxy assent at a later date. \n(ii)\tAs the data is being processed for the purpose of a pre-screening Register and will not be shared with third parties or processed as part of specific study analysis, the documents should be amended to remove references to ‘research’ and ‘study’ and make it fully clear that this is a ‘Register for pre-screening’ and on how the data will be used now and how it may be used in the future.\n(iii)\tthe study information leaflets for the legal representative refers to approaching both the legal representative and the epilepsy patient about this Register, while the legal representative is also asked to provide permission for the researcher to access the patient’s records. For clarity the information leaflets should make it clear that the legal representative is being asked to provide ‘proxy assent’ on behalf of the patient who lacks decision-making capacity. \n(iv)\tFurther to point (iii) the term ‘proxy assent’, not ‘consent’ should be used when referring to seeking permission from a suitable individual to process the personal data of a patient with epilepsy who lacks decision-making capacity. \n(v)\tThe study information should make it clear what will happen the participant’s personal data in the Register if consent or proxy assent is withdrawn i.e., the personal data will be deleted.\n(vi)\tThe names of all the hospital sites and that a data breach is a potential risk should be outlined in the information leaflets.\n(vii)\tThe leaflets should outline whether the Principal Investigator of the Register, Prof Delanty, who is managing the Register and would be doing the pre-screening activities for future studies, has a relationship with commercial organisations who may be involved in such future studies.\n(viii)\tFurther to Condition 4, the term ‘legal representative’ should be amended, with reference instead made to ‘a person who understands the participant’s will and preference’ and/or family member, carer, guardian [CONDITION MET]","Condition 9. Please submit written signatures on the HRCDC application form from the PI of the Register within 3 months of receipt of this decision letter (only typed signatures have been submitted to date).[CONDITON MET]","Condition 1. It must be ensured that there is an appropriate joint data controller arrangement between RCSI and Beaumont Hospital and that such arrangement covers this study, including roles and responsibilities. [CONDITION MET]\n\nCondition 2. Signature on the amendment request form on behalf of Beaumont Hospital is outstanding and should be submitted as soon as practicable, and within 1 month of the date of the HRCDC’s decision letter. [CONDITION MET]","N/A","N/A","Condition 1. Full REC approval from MMUH must be in place. (Note: it is noted that the MMUH REC correspondence requests evidence of approval from the HRCDC for the site's PILs and assent/consent forms. It has been clarified to the Applicant that the HRCDC does not provide studies with formal approval or sign-off of such proxy or patient facing documents.)"]
[null,"Recommendation made","N/A",null,null,null,"N/A","N/A","N/A","N/A"]
[null,"Deadline for meeting Conditions","Condition 5 (full REC) [MET] and Condition 9 (sigantures [met]) : 6th July 2023 (i.e., 3 months)",null,null,null,"Condition 1: Signautres - 5th Oct 2023 [MET]","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 29th March 2023 and shall\nbe valid for 1 year until 31st March 2024 (The Applicant can request an extension of the duration of the declaration by submitting an amendment request form for consideration) -Amendment made until 31st March 2027)",null,null,null,"The approval to the Amendment is made commencing 22nd August 2023 and shall be valid until 31st March 2024 in line with the duration of the consent declaration made (The Applicant can request an extension of the duration of the declaration by submitting an amendment request form for consideration) -Amendment made until 31st March 2027)","The approval to the Amendment is made commencing 3 rd April 2024 and shall be valid until 31st March 2025, an extension of the duration of the original consent declaration.-Amendment made until 31st March 2027)","The approval to the Amendment is made commencing 31st March 2025 and shall be valid until 31st March 2027, an extension of the duration of the original consent declaration.","The approval to the Amendment is made commencing 31st March 2025 and shall be valid until 31st March 2027, in line with current duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live",null,null,null,"Declaration Live","Declaration Live","Declaration Live","Declaration Live"]

{"sheet":"23-003-AF1","index":109,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-003-AF1",null,"23-003-AF1"]
[null,"Application Title ","CADY Sub-study 1: Biomarker and Major Adverse Cardiovascular Events (MACE) data Analysis.",null,"CADY Sub-study 1: Biomarker and Major Adverse Cardiovascular Events (MACE) data Analysis."]
[null,"Applicant Organisation (Data Controller)","Cancer Trials Ireland (CTI)\nAbbott Laboratories",null,"Cancer Trials Ireland (CTI)\nAbbott Laboratories"]
[null,"Lead Applicant ","Ray McDermott",null,"Ray McDermott"]
[null,"Research Objective","Between 2008 and 2014, 483 patients enrolled in the CADY study to test if cardiac blood biomarkers could predict heart problems in women treated with Trastuzumab (Herceptin) for breast cancer. They were at greater risk from death from cardiovascular causes. If those at higher risk were identified earlier and treated, such adverse outcomes may be preventable. \nCardiac biomarkers are produced and released into the blood when the heart is under strain. Blood samples from enrolled patients have been tested and results are available. This sub-study includes a repetition of the biomarker testing on leftover blood samples including an additional biomarker and the collection of survival and major adverse cardiovascular events data. Through a collaboration with Abbott Laboratories these data together with already available data will be used to develop a predictive tool for cardiotoxicity using a Machine Learning approach.",null,"Between 2008 and 2014, 483 patients enrolled in the CADY study to test if cardiac blood biomarkers could predict heart problems in women treated with Trastuzumab (Herceptin) for breast cancer. They were at greater risk from death from cardiovascular causes. If those at higher risk were identified earlier and treated, such adverse outcomes may be preventable. \nCardiac biomarkers are produced and released into the blood when the heart is under strain. Blood samples from enrolled patients have been tested and results are available. This sub-study includes a repetition of the biomarker testing on leftover blood samples including an additional biomarker and the collection of survival and major adverse cardiovascular events data. Through a collaboration with Abbott Laboratories these data together with already available data will be used to develop a predictive tool for cardiotoxicity using a Machine Learning approach."]
[null,"Reason for seeking a Declaration","The Applicant states that while consent was obtained from participants for the main, original CADY study, the consent obtained does not cover this new sub-study. The Applicant also outlines why it is not considered feasible to seek participant re-consent for this new sub-study. \nThe scope of the consent declaration is for the purpose of this new CADY sub-study only, involving the further processing of personal data that was obtained from the original main CADY study and the collection and further processing of new patient data obtained from a chart review (i.e., updated survival and major adverse cardiovascular event data). Data processing includes collection, transfer, analysis, storage etc of the personal data. Data and associated samples will be transferred between the joint data controllers and named data processors; the Applicant stated that the data received by the US based joint controller, Abbott Labs, is considered to have been anonymised.",null,"To extend the duration of the consent declaration to 31st December 2032 (study to now conclude by 31st December 2025 and an extension of the data archiving period from 5 to 7 years)"]
[null,"HRCDC Meeting Date","29th March 2023",null,"30th May 2025"]
[null,"HRCDC Decision Date ","29th March 2023",null,"30th May 2025"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The consent declaration covers the processing of personal data for the purpose of this CADY sub-study only; it does not cover the processing of personal data with regards the original, main CADY study. In addition, the consent declaration does not cover the processing of personal data (i) where the participant has already withdrawn their consent and (ii) where consent for future research was not provided by the participant. [CONDITION MET]\n\nCondition 2. A consent declaration cannot cover data processing where research ethics committee approval is not in place. The consent declaration therefore does not come into effect for St Vincent’s University Hospital and St James’s Hospital & Tallaght University Hospital, until confirmation of full research ethics committee approvals for these sites is in place and evidence of such has been submitted to the HRCDC. Further, for the other additional sites that were named in the HRCDC application form for which REC approval had yet to be sought, the declaration also does not cover these hospitals until confirmation of full and final approval for these sites is in place and submitted to the HRCDC. [CONDITION MET]\n\nCondition 3. The Applicant is requested to enhance the level of transparency for this study. Information on this sub-study, the processing of personal data and data protection rights, including the right to withdraw, how to exercise such rights and any derogations to such rights, should be provided on other appropriate communication channels and platforms that are likely to be frequented or seen by participants and the public; examples include providing information via cancer patient group websites and appropriate social media channels. The Applicant is requested to report on this condition as part of the Annual Review.  [CONDITION MET]\n\nCondition 4. The Applicant is requested to undertake public and patient involvement (PPI) activities prior to the study commencing; the consent declaration will not come into operation until PPI engagement has occurred with Cancer Trials Ireland’s Patient Consultant Committee (PCC) as was outlined in the HRCDC application form and that the project has taken account of this feedback The Applicant is requested to report to the HRCDC on the PPI engagement that has occurred within 3 months of receipt of this decision. Engagement with PPI representatives should consider the important topics of reconsenting participants and enhancing transparency measures (please see Condition 3 and Recommendation 1). [CONDITION MET]","Condition 5. It is a condition of this declaration that the required data agreements and arrangements are in place between the relevant parties for the purpose of this sub-study, including agreements between the joint data controllers, the hospital sites, data processors and the transfer of data outside of the EEA. In this regard, the Applicant is also requested to revisit the roles and responsibilities that have been designated to each of the parties to ensure they are correct and that the correct agreements/ arrangements are put in place (i.e., data controllership, data processors, third party data controller etc.). The transfer of data should not occur prior to this condition being met. [CONDITION UNDERWAY]\n\nCondition 6. Where a participant wishes to withdraw from the sub-study then this wish should be respected, and their data removed from the study where possible to do so, taking into consideration any GDPR derogations that may apply. It this context, it is noted that the Applicant states that a participant’s data cannot be deleted or removed from the study once it has been anonymised for transfer to Abbott Laboratories; the Applicant should ensure that it is not reasonably possible to have the participant’s data deleted or removed from the study if they withdraw post-anonymisation (i.e., ensure that reasonable steps are taken to determine if their data can be identified and removed from the study post-anonymisation and transfer to Abbott Laboratories). \nNote: the HRCDC re-emphasises the importance that the participant’s data protection rights are respected, including where a participant wishes to withdraw their data from the study; in such a situation the data controller should respect their decision and remove their data from the study where this is reasonably practicable, taking into consideration any GDPR derogations that may apply. [CONDITION UNDERWAY]\n\nCondition 7. It must be ensured that the data transferred between the parties is securely encrypted. [CONDITION MET]\n\nCondition 8. Data protection officer feedback from Abbott Laboratories on the data protection impact assessment must be submitted to the HRCDC as soon as practicable and within 2 months of receipt of this letter. No transfer of data to Abbott Laboratories can occur until this condition is met. [CONDITON MET]","Condition 1. The Applicant must submit the data controller signatures that are outstanding on the amendment form as soon as possible and within 2 months.[CONDITION MET]"]
[null,"Recommendation made","Recommendation. The Applicant is strongly recommended to make reasonable efforts to obtain the reconsent of living participants where such opportunities arise and where this is practicable, in particular where the participant maybe attending the hospital during the study’s lifetime. Where reconsenting a participant is not practicable, then the Applicant is also strongly recommended to make efforts to provide the participant with direct information about the study, the processing of personal data and their data protection rights, for example via sending them an information leaflet or requesting that their GP informs them about the study. [RECOMMENDATION CONSIDERED]",null,"N/A"]
[null,"Deadline for meeting Conditions","Condition 4 (PPI report): 6th July 2023 (i.e., 3 months)\nCondition 8 (DPO feedback [MET]): 6th June 2023",null,"Condition 1: Signatures 30th July 2025 [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 29th March 2023 and shall be valid until May 2025 and for 5 years archiving thereafter, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner. [AMENDMENT - The approval to the Amendment is made commencing 30th May 2025 and shall be valid until 31st\nDecember 2032; this is an extension of the duration of the consent declaration made.]",null,"The approval to the Amendment is made commencing 30th May 2025 and shall be valid until 31st December 2032; this is an extension of the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live"]

{"sheet":"23-004-AF1","index":110,"n_rows":15,"n_cols":6,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-004-AF1",null,null,"23-004-AF1/AMD1"]
[null,"Application Title ","Individualised Blood Pressure Targets versus Standard Care among Critically Ill patients with Shock - A Multicentre Randomised Controlled Trial(REACT Shock RCT)",null,null,"Individualised Blood Pressure Targets versus Standard Care among Critically Ill patients with Shock - A Multicentre Randomised Controlled Trial(REACT Shock RCT)"]
[null,"Applicant Organisation (Data Controller)","University of Newcastle, Australia.",null,null,"University of Newcastle, Australia."]
[null,"Lead Applicant ","Bairbre McNicholas",null,null,"Bairbre McNicholas"]
[null,"Research Objective","Blood pressure (BP) is a vital parameter and maintaining an adequate BP is one of the most fundamental tenets of management of shock. It is a decision that ICU clinicians make every time they assess such patients and it is plausible that their decisions regarding BP targets may directly impact on outcomes of those patients. Conventional practice often results in a varying degree of untreated relative hypotension that is inadvertently accepted in real world setting. Minimizing such variation by targeting a patient’s own basal BP can be a simple strategy or a management approach that can potentially improve outcomes. Although it has been suggested by the guidelines, this approach has never been tested in an RCT among ICU patients with shock. Therefore, high-quality evidence from a well-designed RCT is needed to influence strength of recommendations regarding choice of BP targets for vasopressor support.\nThis study will compare standard care to a strategy of targeting patients' usual pre-illness blood pressure (BP) during management of shock in ICU. 1260 eligible patients will be randomly assigned to either standard care (control) or a strategy of individualized BP target (intervention).\nThe intervention and the BP monitoring in the study will last until a patient is not requiring breathing support or does not require invasive BP monitoring catheters. The choice and the dose of BP-titrating medication will be at the discretion of the treating clinician. Data will be collected on the degree of untreated BP deficit, peak rise in serum creatinine and serum cystatin levels, protocol compliance, recruitment rate, death, and major adverse kidney events (MAKE) during the first 14 days.\nThe study will also collect information on hospital mortality and incidence of any major complications. These clinical outcomes and the data on achieved-BP will be compared in between the two groups to assess efficacy of the intervention in relation to the standard care.",null,null,"Blood pressure (BP) is a vital parameter and maintaining an adequate BP is one of the most fundamental tenets of management of shock. It is a decision that ICU clinicians make every time they assess such patients and it is plausible that their decisions regarding BP targets may directly impact on outcomes of those patients. Conventional practice often results in a varying degree of untreated relative hypotension that is inadvertently accepted in real world setting. Minimizing such variation by targeting a patient’s own basal BP can be a simple strategy or a management approach that can potentially improve outcomes. Although it has been suggested by the guidelines, this approach has never been tested in an RCT among ICU patients with shock. Therefore, high-quality evidence from a well-designed RCT is needed to influence strength of recommendations regarding choice of BP targets for vasopressor support.\nThis study will compare standard care to a strategy of targeting patients' usual pre-illness blood pressure (BP) during management of shock in ICU. 1260 eligible patients will be randomly assigned to either standard care (control) or a strategy of individualized BP target (intervention).\nThe intervention and the BP monitoring in the study will last until a patient is not requiring breathing support or does not require invasive BP monitoring catheters. The choice and the dose of BP-titrating medication will be at the discretion of the treating clinician. Data will be collected on the degree of untreated BP deficit, peak rise in serum creatinine and serum cystatin levels, protocol compliance, recruitment rate, death, and major adverse kidney events (MAKE) during the first 14 days.\nThe study will also collect information on hospital mortality and incidence of any major complications. These clinical outcomes and the data on achieved-BP will be compared in between the two groups to assess efficacy of the intervention in relation to the standard care."]
[null,"Reason for seeking a Declaration","Patients with shock frequently present emergently and obtaining \ninformed consent is not possible or practical. The consent declaration is requested to process the personal data of participants who lack decision-making capacity to provide explicit consent due to the nature of their medical condition. Data \nprocessing includes access, collection, analysis, and storage of the personal data of participants in Ireland for the purpose of the REACT-SHOCK RCT only, which includes follow-up data. Data sources include the local hospital records and GPs as well as data generated from the study intervention.Where a participant lacks decision-making capacity proxy assent will be requested followed by a consent to continue once the patient has capacity.",null,null,"The amendment is requested to change/update the data controller of the study from the Hunter New England Local Health District to the University of Newcastle, Australia."]
[null,"HRCDC Meeting Date","22nd August 2023",null,null,"29th January 2024"]
[null,"HRCDC Decision Date ","22nd August 2023",null,null,"29th January 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Irish hospital sites must, alongside the data controller Hunter New England Health Local Health District, be responsible for the implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participant if a participant has queries or otherwise wishes to exercise their rights.\n\nCondition 2. It is a condition that the protocol for assessing or re-assessing participant decision\u0002making capacity is consistent throughout the course of this study, whether this assessment occurs within the hospital or post-hospital discharge and whether it is undertaken by the hospital staff and/or by or with the support of GPs; this should include the provision of necessary information \nand guidelines for those involved in this process. Please provide an update on this condition within 3 months. (Please also see Recommendation 1). [CONDITION UNDERWAY]\n\nCondition 3. The required data agreements and arrangements must be in place for this study, including agreements between the data controller of the study, the Irish sites, and the other named data processor in Australia. Data agreements/arrangements should also be in place if off-site back\u0002up data is held by another third party. Further, the necessary agreements/arrangements must be \nimplemented for transferring data outside the EEA (e.g., Standard Contractual Clauses) and a Transfer Impact Assessment must also be completed. Please also discuss these matters with the relevant data protection officer. The transfer of data between parties cannot occur prior to the necessary agreements being in place and required assessments being undertaken. [CONDITION MET]","Condition 4. Confirmation that research ethical approval was ratified by the full Galway REC should be submitted to the HRCDC as soon as possible. Feedback from the data controller of the study, Hunter New England Health Local Health District, must also be provided as soon as possible and within 1 month. The consent declaration will not cover data processing at the Galway site or data transfer to Australia prior to this condition being met. \n\nCondition 5. It is noted that where a proxy or participant wishes to withdraw from the study that either permission to continue to process the personal data already collected will be requested or, if this is not granted, ‘all efforts’ to remove the personal data will be made. It is a condition of this declaration that if a proxy or participant wishes to withdraw and have the data removed then the personal data must be deleted up until the point where this cannot be done (i.e., publication of the findings or if other GDPR derogations may apply). If the study wishes to continue to process data after withdrawal, then specific, clear and separate proxy assent/participant consent should be obtained and recorded for this continued post-withdrawal processing. Where the proxy withdraws and provides assent for the data to continue to be processed then it remains that consent to continue for this processing must still be obtained from the participant if they regain capacity.","Condition 6. There are references in the study information leaflets on sharing/disclosing data with the HSE and other third parties that may include but are not limited to ‘industry bodies’, ‘external professional advisors’ and ‘others where it is permitted by law or where we have your consent/assent’. It is not clear who or what is meant by ‘these parties and for what purpose personal data may be shared with the HSE and other such third parties. Therefore, the study information leaflets must provide more precise and granular informaiton on what is meant by ‘industry bodies’, ‘external professional advisors’ and ‘others where it is permitted by law or where we have your consent/assent’ and outline what personal data may be shared with such third parties and the reasons for this sharing in the context of this study. In addition to amending the information leaflets as described above, the accompanying proxy assent and participant consent forms should also include clear options on sharing/disclosing data to third parties that aligns with the amended information leaflets. References and options to processing/using data in future research studies beyond this specific study should also be amended or removed in the documentation for the proxy, given that the scope of the declaration cannot cover future research studies and is limited to storage only for future research. This condition is to be addressed for the documents across all the Irish sites and the amendments made prior to the recruitment of participants. Please provide an update on this condition within 3 months.","Condition 1. The required data agreements and arrangements must be in place for this study, including agreements between the new data controller of the study (University of Newcastle), the Irish sites, and the other named data processors. Data agreements/arrangements should also be in place if off-site back-up data is held by another third party. Further, the necessary agreements/arrangements must be implemented for transferring data outside the EEA (e.g., Standard Contractual Clauses) and a Transfer Impact Assessment must also be completed. Please discuss these matters with the relevant data protection officer.\nThe transfer of data between parties cannot occur prior to the necessary data agreements/arrangements being in place and required assessments being undertaken. [This condition aligns with Condition 3 of the original declaration]  [CONDITION MET]\n\nCondition 2. Feedback from the new data controller of the study, the University of Newcastle, Australia, must be submitted as soon as possible and within 1 month. The consent declaration will not cover data processing or data transfer to Australia prior to this condition being met. [This is an update to Condition 4 attached to the original declaration].  [CONDITION MET]\n\nCondition 3. Research ethics approval for the change in data controller of this study has been submitted for the Galway site, however equivalent approval remains pending for Tallaght University Hospital and St Vincent’s University Hospital. Research ethics approval for the change in data controllership must be obtained from all sites and evidence of this submitted to the HRCDC as soon as practicable or within 2 months. The amendment request will not cover the change in data controller, and therefore data processing, at these sites until the requisite REC approval is in place. [This is an update to Condition 4 attached to the original consent declaration]. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. Aligned with the Assisted Decision-Making Act, the study is requested to have regards to assessing decision-making capacity from a functional assessment, where appropriate. \n\nRecommendation 2. The Applicant is requested to undertake further PPI engagement for the benefit of this study, including engaging with PPI representatives on the study information leaflets.\n\nRecommendation 3. When seeking verbal proxy assent or participant consent, it should be ensured that the individual fully understands all elements of the study and data activities, for example by reading out the full study information leaflet and providing a copy of the leaflet provided to the individual.","Recommendation 4. the Applicant is requested to address the following in the study information leaflets across all sites to ensure clarify and transparency of information:\no Not all versions of the proxy study information leaflet clearly refer to monitoring by the Hunter Research Institute. Further the Hunter Research Institute is also not clearly noted as acting on behalf of the sponsor in the consent to continue information leaflets for the Galway site. \no All versions of the site information leaflets should be consistent to state that ‘pseudonymised data’, not ‘anonymised data’ recorded up the point of withdrawal will be included in the study subject to the proxy/participant’s permission being granted. A description of what is meant by the term ‘pseudonymised’ should also be provided. The Applicant may also wish to consider the use of the term ‘coded data’, instead of ‘pseudonymised data’. \no It must be clearly outlined in all versions of the study documentation on the data that will be collected from the GP (this was addressed in the information leaflets for the pilot but is outstanding in the leaflets for this main trial). \no Statements that data protection rights are limited should be refined to provide further context of why rights may be limited.",null,"n/a"]
[null,"Deadline for meeting Conditions","Condition 2: Study Protocol 5th Dec 2023 [IN PROGRESS]\nCondition 4: REC 5th Oct 2023\nCondition 6: PILs 5th Dec 2023 [MET]",null,null,"Condtion 2: Feedback 6th Feb 2024 [MET]\nCondtion 3:  REC 6th April 2024 [MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 22nd August 2023 and shall be valid until 30th September 2027 and 10 years of data archiving thereafter (i.e., 30th September 2037), or until the personal data has been anonymised or deleted. \nNote: The HRCDC discussed the request for a declaration of 19 years, consisting of 4 years for the study and 15 years of data archiving. It was commented that it may be appropriate to make a declaration of a shorter period and that the Applicant can request an extension by submitting an amendment request form (if required).",null,null,"The approval to the Amendment is made commencing 29th January 2024 and shall be valid until 30th September 2027 and for 10 years of data archiving thereafter until 30th September 2037, or until the personal data has been destroyed or irrevocably anonymised, whichever occurs sooner, in line with the duration of the original consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,null,"Declaration Live"]

{"sheet":"23-005-AF1","index":111,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-005-AF1"]
[null,"Application Title ","The journey from wardship to supported decision-making: An examination of the process and the experiences of people leaving wardship"]
[null,"Applicant Organisation (Data Controller)","National Disability Authority"]
[null,"Lead Applicant ","Caroline O’Nolan"]
[null,"Research Objective","The process of dismantling wardship and moving to a system of supported decision-making commenced on 26th April 2023. The new system of supported decision-making is aligned with Article 12 (Equal Recognition before the Law) of the United Nations Convention on the Rights of Persons with a Disability (UNCRPD). This change will mean that people will no longer be deemed to be unable to exercise legal capacity and appropriate and dynamic decision-making supports will instead be provided.This research will critically assess the process of transition from wardship. A mixed methods approach will be adopted and will include interviews with a range of participants and observations of court hearings . The inclusion of people who are Wards of Court is a fundamental part of this research. Participants will include Wards of Court and the Committees that act on their behalf and key informants that have knowledge of or experience regarding wardship or the Decision Support Service."]
[null,"Reason for seeking a Declaration","It will be assumed that all participants (i.e., those who are or who \nwere wards of court) will have decision-making capacity from the \noutset, however it is expected that an unknown proportion may not \nhave decision-making capacity to provide consent for this specific \nstudy. The Court Service has also provided permission/consent \nfor the participation of the wards of court in this study. While this \nmeans there are no legal barriers from the court, the \nApplicant/data controller is of the view that this permission from\nthe Court does not meet the requirements of HRR explicit consent \ne.g., the court permission/consent does not note the names of the \nwards.\nThe consent declaration is therefore requested to process the \npersonal data of participants who are or who were wards of court \nbut who lack decision-making capacity to provide explicit consent \nfor this study. Data processing includes personal data processed \nfor the expression for the interest phase and the main study \nphase."]
[null,"HRCDC Meeting Date","22nd August 2023"]
[null,"HRCDC Decision Date ","22nd August 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. It is important to ensure that the study and the study information leaflets clearly outline that data can be removed before the referenced 3-month time limit is reached, and also to outline the reasons why it is not possible for data to be removed after this time limit, for example if it will then not be possible to remove that participant’s qualitative response from the analysis and why. It should also be detailed if this time limit is applicable to some or to all of the study data e.g., does it apply to the transcribed quantitative interview responses only or is there is other personal data held by the researchers that could still be deleted after 3-months, if requested. Further, please note that it remains that if data can still be deleted/removed after 3 months then it should be deleted if requested, subject to relevant derogations that may apply; a consent \ndeclaration does not override the data rights of participants.[CONDITION MET]\n\nCondition 2. Personal data collected from the expression of interest process on participants who were not selected for inclusion in this study should be deleted as soon as practicable. In line with the principle of data minimisation, only the minimum amount of personal data required for the study should be deleted. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. It was noted that the DPIA responses did not tick yes to processing data on criminal records, however it is also stated in the DPIA that data on criminal records may be disclosed during the interviews. Accordingly, the Applicant is requested to amend this section of the DPIA.[RECOMMENDATION CONSIDERED]\n\nRecommendation 2. All references to the use of an external transcriber should be removed from the study information leaflets, given that it is not proposed to use one [RECOMMENDATION CONSIDERED]\n\nRecommendation 3. The HRCDC was of the view that the GDPR statement document submitted was not as accessible when compared to the study information leaflets and consent forms. Therefore, the Applicant is requested to revise this GDPR statement so that its accessibility aligns more closely with the other study documentation.  [RECOMMENDATION CONSIDERED]"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The consent declaration is made on 22nd August 2023 and is valid until 30th September 2036 (a period of 3 years for the study and 10 years of data archiving)."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"23-006-AF1","index":112,"n_rows":16,"n_cols":4,"rows_kept":16,"cut":false,"hidden":false,"merged":[]}
[]
[]
[null,"Application Ref ID","23-006-AF1"]
[null,"Application Title ","COST2CARE: Addressing the economic and human cost of hospital acquired and nursing\u0002sensitive adverse events in older patients through optimal use of routine discharge data and measurement of missed nursing care."]
[null,"Applicant Organisation (Data Controller)","Dublin City University"]
[null,"Lead Applicant ","Marcia Kirwan"]
[null,"Research Objective","Older patients make up the largest proportion of acute hospital inpatient populations. Pneumonia, delirium, urinary tract infections and pressure injuries are four common adverse events that occur in older patients, known collectively as ‘Failure to Maintain (F2M)’ events. These are nursing-sensitive patient outcomes, predominantly affected by the quality of nursing care provided, that contribute to higher healthcare costs, lower quality care, and less satisfactory patient experiences.In this study, we will determine how these nurse sensitive outcomes are currently represented in routinely available national discharge data in Ireland. These data are collected as Hospital In\u0002Patient Enquiry data and known as HIPE data. A structured chart review will be conducted in one hospital to validate the rates of nursing-sensitive events available in the HIPE data. The cost of these events to the Irish health service will be calculated using ICD10 data, length of stay, and other variables associated with Cost of Illness calculations. Through nurse and patient-reported surveys, the human costs of missed care will be further examined."]
[null,"Reason for seeking a Declaration","The activities for which a consent declaration is requested are as follows:\n(i)\tReceiving and processing personal data from the HPO to identify the sample of charts from the Mater Hospital.\n(ii)\tAccessing the patients charts and extracting data variables onto a spreadsheet i.e., retrospective chart review activity. (Note: once this is completed, the unencrypted MRN and admission and discharge date data will be deleted from the spreadsheet to anonymise the data in the spreadsheet).\n(iii)\tFollowing the chart review and the removal of the unencrypted MRN by DCU, the Healthcare Pricing Office will disclose further pseudonymised clinical data to DCU; this will be linked via a separate encrypted MRN; the Applicant states that this data is considered anonymised when received by DCU as they cannot and will not reverse the encrypted MRN.\nA consent declaration is not requested for other study activities i.e., surveys or data analysis. For the points outlined above, informed consent will not be obtained from the patients whose charts will be reviewed. The Applicant outlines the reasons for this including the large sample size of patient charts needed to conduct the chart review."]
[null,"HRCDC Meeting Date","13th June 2023"]
[null,"HRCDC Decision Date ","13th June 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant is requested to ensure that strong transparency measures are \nimplemented for this study; specifically, and as detailed in the responses provided by the Applicant, \ntransparency measures should include the placing of clear and informative notices in the public \nareas of the Mater Hospital and on the project website. Transparency measures should inform \nparticipants about this study, the processing of their personal data and their data protection rights, \nincluding the right to withdraw and how to exercise their rights. Measures should also outline at \nwhat point in the study that data cannot be removed. \nThe Applicant is requested to provide an update on the implementation of these transparency \nmeasures as soon as practical and within 3 months of the date of this consent declaration; \naccordingly, a copy of the notice to be provided in the hospital and a link to the project’s website \nshould be provided. The study should not commence prior to these transparency measures being \nin place. [CONDITION MET]\n\nCondition 2. Linked to condition 1, a clear process for withdrawing from the study and deleting \npersonal data from the study must be in place, should a participant wish to exercise their rights. \nBased on the information provided by the Applicant, the Healthcare Pricing Office and the Mater \nHospital should therefore be involved in this process. [CONDITION MET]\n\nCondition 3. Full ethics approval from the research ethics committee of the Mater Hospital must \nbe in place, and confirmation of this approval must be submitted to the HRCDC. The consent \ndeclaration will not be effect until full REC approval has been obtained.  [CONDITION MET]\n\nCondition 4. It is a condition of the consent declaration that the required data \nagreements/arrangements (e.g., data sharing agreements) are in place between the DCU and the \nproviders of personal data, including agreements with the HPO and the Mater Hospital. Data \nshould not be transferred or processed without the required agreements being put in place. [CONDITION MET]","Condition 5. To protect the data, the laptops and devices used by the researchers in this study \nshould be appropriately encrypted.\n\nCondition 6. With regards the anonymisation of the data by DCU (i.e., the removal of the \nunencrypted MRN and other variables), the data controller should ensure that the required \nvariables to anonymise the data have been removed/deleted and such data is not being retained. It is the responsibility of the data controller, DCU, to determine and ensure that the data has been anonymised.\n\nCondition 7. The data controller must ensure that any data shared with the health economist for \nthe purpose of this study is fully anonymised and that measures are in place to protect the \nparticipant’s anonymity."]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","Condition 1: Transparency - 30th September 2023 [MET]"]
[null,"Duration of Declaration "," The Declaration is made commencing 13th June 2023 and shall be valid until 31st July 2024 to \nenable the completion of the chart review and for the final disclosure of data from the HPO to DCU."]
[null,"Status of Declaration","Declaration No Longer Required"]

{"sheet":"23-008-AF1","index":113,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-008-AF1"]
[null,"Application Title ","ARISE FLUIDS"]
[null,"Applicant Organisation (Data Controller)","Monash University"]
[null,"Lead Applicant ","Alistair Nichol"]
[null,"Research Objective","This trial will investigate if giving a smaller amount of initial IV fluid with earlier commencement of a medication drip (\"vasopressors\") to improve blood pressure leads to better patient outcomes than the conventional approach of giving a larger amount of fluid and starting medication later (\"fluids\"). Patients eligible for the trial who have suspected septic shock in the ED will be randomly allocated to receive treatment according to one of these treatment regimens. We will follow patients up and assess their progress. The main outcome we will measure is the number of days the patient has survived out of hospital at 90 days after entering the trial. This outcome measure has been chosen in consultation with consumers as being a patient-centred measure which captures survival as well as being associated with severity of illness and quality of life."]
[null,"Reason for seeking a Declaration","Due to the nature of the trial and severity of illness participants will lack capacity to give informed consent on enrolment in the trial due to infection, delirium and sedation. Due to the critical nature of septic shock, treatment needs to be commenced rapidly under emergency conditions and is part of life-saving care. The consent declaration is requested to process personal data of participants who lack decision-making capacity to provide explicit consent. In such circumstances deferred proxy assent followed by \nconsent to continue will be obtained. Data processing activities includes collection, transfer, analysis and storage of personal/pseudonymised data – this includes transfer of such data to Monash University, Australia. "]
[null,"HRCDC Meeting Date","22nd August 2023"]
[null,"HRCDC Decision Date ","22nd August 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Irish hospital sites must, alongside the data controller Monash University, be responsible for implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participant if a participant. [CONDITION MET]\n\nCondition 2. The required data agreements and arrangements must be in place for this study. Further, the necessary agreements/arrangements must be implemented for transferring data outside the EEA (e.g., Standard Contractual Clauses) and a Transfer Impact Assessment must also be completed. Please see Chapter V of the GDPR and the 2021 decision of CJEU on Transfer Impact Assessments. Please also discuss these matters with the relevant data protection officer. The transfer of data between parties cannot occur prior to the necessary agreements being in place and required assessments being undertaken.  [CONDITION MET]\n\nCondition 3. Feedback on the DPIA from Monash University’s Data Protection Officer must be submitted as soon as practicable and within 1 month of receipt of this decision letter. No data can be transferred to Monash prior to the submission of this DPO feedback. [CONDITION MET]\n\nCondition 4. Due to the nature of this study, proxy assent will be deferred, including telephone assent. It is a condition of this declaration that the personal data of the participant should be deleted if deferred proxy assent is not obtained after a reasonable timeframe\n\nCondition 5. Individuals withdrawing from the study should not be asked for permission to continue to collect and process follow-up data after withdrawal.","Condition 6. The following points should also be addressed in the study information leaflets and assent/consent forms:\no Amend the inaccurate reference to joint data controller. \no There are references in the study information leaflets on sharing/disclosing data with the HSE and other third parties that may include but are not limited to ‘industry bodies’, ‘external \nprofessional advisors’ and ‘others where it is permitted by law or where we have your consent/assent’. It is not clear who or what is meant by these parties and why data may be shared with them in the context of this study. The study information leaflets must provide more precise and granular informaiton on what is meant by ‘industry bodies’, ‘external professional advisors’ and ‘others where it is permitted by law or where we have your consent/assent’ and outline what personal data may be shared with such third parties and the reasons for this sharing in the context of this study. The accompanying proxy assent and participant consent forms should also include clear options on sharing/disclosing data to third parties that aligns with the amended information leaflets.\no References to processing/using data in future research studies beyond ARISE FLUIDS should be amended or removed in the documentation for the proxy; proxy assent is limited to storage of the data only for use in potential future studies.\nNote: Clear information should be provided on who and why data may be shared with third parties in the context of this specific study. In addition, the scope of the consent declaration does cover processing of personal data by other third parties beyond those noted in the HRCDC application \n(i.e., SVUH and the Australian Data Controller, Monash University). Proxy assent and the consent declaration also does not cover future unknown research purposes. For the participant informaiton leaflet, if seeking consent to process data for future studies beyond the ARISE FLUID Trial, it is responsibility of the data controller to ensure that sufficient information is provided to the participants with capacity and that any such consent obtained is compliant.\no The Applicant must also ensure that is clear and transparent in the study information leaflets that the data to be processed, including shared and analysed by Monash, is pseudonymised data, not anonymised data, and that the statement that pseudonymised data will be kept indefinitely is corrected i.e., such data is retained for 15 years and then deleted. [CONDITION MET]","Condition 7. Further to Condition 5, where an individual withdraws from the study and the researchers wish to continue to process the personal data already obtained, then permission for this must be obtained from the proxy and recorded. In addition, consent to continue from the participant when they regain decision-making capacity should also be obtained for this continued processing."]
[null,"Recommendation made","Recommendation 1. The Applicant to requested to review and amend the study information leaflets and assent/consent forms to ensure transparency and consistency of information, with the following points to be addressed:\no The term ‘I know of no known objections’ should also be positively re-phrased to ask whether the participant would wish to be included in this study.\no The information leaflets outline that other hospitals, rehabilitation hospitals or nursing homes, may be contacted as part of the follow-up process to verify discharge dates provided by the participant. The assent/consent form should provide an option to agree to this. \no The proxy assent documents request the proxy to state ‘yes’ or ‘no’ to questions that they may not know the answer to, for example ‘has your relative written down his or her views in a “living will?”’. A ‘don’t know’ option should be included as some proxies may not know the answer to each of these types of questions. \no There are some inaccurate references noted in the study information leaflets and the proxy assent forms on patient samples/materials, for example withdrawing samples and storing material for future studies. As no samples are collected for this study these references should be amended. \no The reference to making data available in anonymised repositories should be removed as the Applicant has clarified this will not occur.\no Where appropriate, the Applicant is requested to utilise more lay-person language in the study documentation, for example amend the sentence ‘within the spectrum of accepted usual care’","Recommendation 2. Where the participant continues to lack capacity for a prolonged period time, proxy assent should be re-affirmed at an appropriate point in the study."]
[null,"Deadline for meeting Conditions","Condition 3: DPIA 5th Oct 2023 [met]"]
[null,"Duration of Declaration ","The declaration is made on 22nd August 2023 and is valid until 31st August 2027 and for 15 years archiving thereafter (until 31st August 2042), after which the pseudonymised data will be deleted."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"23-009-AF1","index":114,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-009-AF1"]
[null,"Application Title ","Anaemia management with red Blood Cell transfusion to improve post intensive caredisability- a randomised controlled trial – (The ABC post-intensive care trial)"]
[null,"Applicant Organisation (Data Controller)","University of Edinburgh"]
[null,"Lead Applicant ","Alistair Nichol"]
[null,"Research Objective","People who are discharged from intensive care (ICU) are often anaemic, due to their severeillness impacting their body’s ability to produce new blood cells. This usually does not causeissues for the patient, and therefore is generally not treated when they are in ICU, or after.However, it can sometimes take months for the body to recover from this anaemia. Peopletypically feel tired in the weeks and months after ICU discharge, which is a symptom ofanaemia. We don’t yet know if treating post intensive care anaemia will help with thistiredness. This trial will aim to find out if treating the anaemia while patients are in ICU with ablood transfusion helps with these symptoms. A consent declaration is being sought for thisresearch as patients may not be able to consent upon their ICU discharge, due to delirium,severe tiredness, and impaired short term memory."]
[null,"Reason for seeking a Declaration","Due to the nature of the trial and severity of illness participants, some will lack capacity to give informed consent on enrolment in the trial due to delirium, severe fatigue, and cognitive impairment impacting short-term memory common in those being discharged from ICU. The consent declaration is therefore requested to process the personal data for those who lack decision-making capacity to provide explicit consent. \nNote: participants under 18-years of age will not be recruited at SVUH. In addition, the Irish sites will not be involved in the sub-study, only the main ABC trial and the scope of the declaration only includes data on SVUH participants (other sites and/or data sources e.g., HIPE) are not covered."]
[null,"HRCDC Meeting Date","19th September 2023"]
[null,"HRCDC Decision Date ","19th September 2023 "]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. Research ethics committee approval for an extension to the study must be obtained and a copy of this approval submitted to the Secretariat. The consent declaration does not cover this study if valid REC approval is not in place or has expired. \n\nCondition 2. The study should comply with the principle of data minimisation, for example can age, rather than date of birth, be collected and processed. \n\nCondition 3. The necessary data agreements and arrangements must be in place between the study parties, including a data controller to data processor agreement between University of Edinburgh and St Vincent’s University Hospital, prior to the transfer of data occurring. Further to this, it is noted that the study protocol states the following: ‘If a participant is discharged to another acute care hospital from the enrolling hospital as part of the same hospitalization, the randomization allocation will be maintained wherever possible until discharge from that acute hospital. The site study team will attempt to provide advice to the hospital to which the patient is discharged and obtain relevant study assessment data’. Where this occurs then data agreements must also be in place with the other acute hospital.","Condition 4. The Applicant/data controller is requested to review and amend the study information leaflets and assent/consent documentation to ensure clarity and consistency of information. Specifically, the following points must be addressed prior to the study commencing: \n• The study information leaflets should clearly outline what samples and data will be collected and processed from Irish participants, including following-up data and samples. In addition, references to the sub-study, sharing data/samples with Oxford University and 5-year follow-up and data linkage should be removed from the documents used in Ireland, as it has been confirmed that these activities are not applicable to Ireland. \n• References to requesting permission to use personal data in other future research studies should not be included in the documentation provided to the proxy; proxy assent and the consent declaration cannot cover data processing for future research studies. The consent declaration can only cover storage only for future studies. \n• The statement in the information leaflet that ‘you may have rights’ should be amended to confirm that individuals do have rights. Linked to this, the data protection rights should also be clearly listed i.e., right of access, right to erasure etc. \n• It must be ensured that the study documentation, and the request to withdraw form, provide clear and concise information on withdrawing from the study and what will happen the personal data if a request is made to withdraw, including clear information on the options that will be provided. \n• Aligned with the information provided to the HRCDC, it must be clearly outlined to individuals why data that is removed from the study analysis is still retained by the data controller for reasons of data validity, study safety etc. In this context the statement ‘If you do decide to stop being part of the study at any time, the University of Edinburgh and NHS Lothian, as co-- sponsors, will keep information about you that we already have. The University of Edinburgh and NHS Lothian need to manage your records in specific ways for the research to be reliable….’ should be amended to clarify and reassure individuals why data will still be retained.","Condition 5. Where proxy assent/participant consent is withdrawn and the study wishes to continue to process the data already collected and/or continue to collect and process follow-up data, then permission for this must be obtained and recorded from the proxy or participant, whichever is relevant. Please note: if such permission is obtained from the proxy on behalf of a participant who lacks decision-making capacity, then participant consent to continue must also be obtained for this continued data processing when they regain decision-making capacity. \n\nCondition 6. As part of the Annual Review the Applicant/data controller is requested to report on the number of participants recruited to this study from the Irish site and to also report on the numbers who have provided consent to continue."]
[null,"Recommendation made","Recommendation. Consideration should be given to including ‘Don’t know’ options in the assent form for relevant questions. For example, the point in the assent form asking about a participant’s living will."]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 19th September 2023 and shall be valid until 31st August 2025 and 5 years thereafter (until 31st August 2030), or until the personal data is deleted or fully anonymised, whichever occurs first."]
[null,"Status of Declaration","Declaration No Longer Required"]

{"sheet":"23-010-AF1","index":115,"n_rows":15,"n_cols":9,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-010-AF1",null,null,null,"23-010-AF1/AMD1"]
[null,"Application Title ","ESsCAPE",null,null,null,"ESsCAPE"]
[null,"Applicant Organisation (Data Controller)","Biotest AG",null,null,null,"Biotest AG"]
[null,"Lead Applicant ","Biotest AG",null,null,null,"Biotest AG"]
[null,"Research Objective","This ESsCAPE study is a randomised, double-blind, multi-centre, phase III trial that will evaluate the safety and efficacy of trimodulin compared to placebo as an additional therapy to standard of care treatments for adult patients with severe community acquired pneumonia (sCAP), who are hospitalised and require ventilation to breathe. sCAP is a life-threatening disease, as patients may suffer from complications such as \nsepsis and multiple organ failure. As this represents an unmet need for these patients the primary goal is to improve patient’s outcomes and the quality of life with trimodulin.\nTrimodulin is an immunoglobulin preparation which contains antibodies directed against a wide range of infectious pathogens. The hope is that trimodulin will augment the standard of care therapies, strengthening the body’s immune responses to prevent further worsening of the disease and ultimately reduce the symptoms of sCAP, allowing patients to recover from the disease.Trimodulin will be compared with a placebo and administered intravenously. Study participants will be randomised by chance, by a computer on a 1:1 basis to receive trimodulin or placebo in addition to the standard of care treatment and medication usually given in this indication. This means participants will have an equal chance of receiving either trimodulin or placebo. Exposure to placebo is deemed necessary to allow reliable evaluation of the beneficial effect of trimodulin, as well as of the adverse events observed with trimodulin and compared with those observed with the inactive placebo.\nThe study will run in 4 phases: Screening (up to 2 days), Treatment period (5 days), Follow-Up Period (up to 24 days) and Extended Follow-Up period (up to 72 days).Study duration for each participant will be approximately 103 days (15 weeks). The Sponsor of this study is Biotest AG.",null,null,null,"This ESsCAPE study is a randomised, double-blind, multi-centre, phase III trial that will evaluate the safety and efficacy of trimodulin compared to placebo as an additional therapy to standard of care treatments for adult patients with severe community acquired pneumonia (sCAP), who are hospitalised and require ventilation to breathe. sCAP is a life-threatening disease, as patients may suffer from complications such as \nsepsis and multiple organ failure. As this represents an unmet need for these patients the primary goal is to improve patient’s outcomes and the quality of life with trimodulin.\nTrimodulin is an immunoglobulin preparation which contains antibodies directed against a wide range of infectious pathogens. The hope is that trimodulin will augment the standard of care therapies, strengthening the body’s immune responses to prevent further worsening of the disease and ultimately reduce the symptoms of sCAP, allowing patients to recover from the disease.Trimodulin will be compared with a placebo and administered intravenously. Study participants will be randomised by chance, by a computer on a 1:1 basis to receive trimodulin or placebo in addition to the standard of care treatment and medication usually given in this indication. This means participants will have an equal chance of receiving either trimodulin or placebo. Exposure to placebo is deemed necessary to allow reliable evaluation of the beneficial effect of trimodulin, as well as of the adverse events observed with trimodulin and compared with those observed with the inactive placebo.\nThe study will run in 4 phases: Screening (up to 2 days), Treatment period (5 days), Follow-Up Period (up to 24 days) and Extended Follow-Up period (up to 72 days).Study duration for each participant will be approximately 103 days (15 weeks). The Sponsor of this study is Biotest AG."]
[null,"Reason for seeking a Declaration","This study involves patients suffering with severe community acquired pneumonia and requiring the use of invasive mechanical ventilation for breathing. Consent may not be possible to obtain as these patients will either feel very unwell and weak or using the \nventilator. The consent declaration is therefore requested to process the personal data of participants who lack decision-making capacity to provide explicit consent. Where they lack decision\u0002making capacity, then proxy assent will be obtained from a legally \nappointed representative and deferred consent to continued obtained as soon as possible. The data processing activities includes collection, transfer, analysis, storage of personal/pseudonymised data (including data associated with samples) for the purpose of (i) the main ESsCAPE clinical trial and (ii) the optional PK sub-study. GP data may also be used for pre-screening/eligibility and therefore this may also need to be covered. Future research will require an amendment or new application to be submitted.",null,null,null,"To cover the inclusion of independent doctor assent in scenarios where proxy assent from a relative/friend cannot be obtained in the first instance at the point of enrolment. In making this amendment, Condition 2 attached to the original declaration is no longer applicable."]
[null,"HRCDC Meeting Date","22nd August 2023",null,null,null,"10th December 2024"]
[null,"HRCDC Decision Date ","22nd August 2023",null,null,null,"10th December 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,null,null,"Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Irish hospital sites must, alongside the data controller BioTest AG, be responsible for implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participant if a participant has queries or otherwise wishes to exercise their rights. [CONDITION MET]\n\nCondition 2. It is a condition of this declaration that proxy assent on behalf of a participant should only be obtained from a relative or friend who understands the participant’s will and preference. \n\nCondition 3. The Applicant must ensure that data agreements/arrangements are in place between all the parties involved in this study; this includes agreements with the named data processors, Irish sites, the named laboratory service providers and with GPs, if GP data is provided for this study. The transfer of data, including data associated with samples, cannot occur prior to appropriate data agreements being in place.  [CONDITION MET]\n\nCondition 4. The Applicant is requested to undertake PPI engagement activities with relevant individuals or representative groups, for example ICUSteps. Consideration should be given to discussing/exploring matters such as the assent/consent process and study documentation with the PPI representatives. At the time of the first Annual Review, the Applicant/data controller is expected to report on the PPI activities that have been undertaken.  [CONDITION MET]","Condition 5. Where the proxy or participant withdraws from the study, the data and associated samples should be destroyed unless there is a legal or regulatory obligation to retain it, or it is no longer possible to have it destroyed (e.g., after the publication of findings or other applicable GDPR derogation). This applies to the main study, sub-study and samples/data for future studies. Individuals should be provided with clear information that as to why this is the case, for example for regulatory reasons; if there is a legal obligation or other valid derogation to retain the data and not delete it, then this must be made clear in the study informaiton leaflets. Lastly, the separate withdrawal of assent/consent form only requests a signature but does not provide information on what will now happen the data and samples for the main study, sub-study and future studies. Information on what will happen the data and associated samples should also be included in this separate withdrawal document.","Condition 6. The Applicant/data controller is requested to address the following in the study information leaflets and assent/consent forms with regards sharing of data: o The consent forms include a separate section outlining that data ‘may be transferred outside my country’ and states ‘I cannot participate’ or ‘data cannot be processed….’ if permission/consent is not provided for this transfer, with the individual asked to tick a box to expressly consent to this. It is the view of the HRCDC that the wording of this separate section is quite technical and legalistic and may cause undue pressure on the participant or proxy to agree to transfer of their data outside of their country. The HRCDC requests that this section is reviewed and amended to provide clarification on what data might be shared, with whom and for what purpose in the context of this study. o The table in the consent form includes the following request: ‘I give permission for my coded data to be: if required, transferred to any country where laws protecting my personal information may be different to those in my own country’. The HRCDC is of the view that this is a relatively broad statement, and that more information and corresponding, granular/layered consent options should be provided on what coded data may be shared, with whom and for what purpose in the context of this specific trial i.e., sharing with external laboratories for the purpose of this specific trial. o References to sharing data with third parties for future research studies beyond this specific study (and sub-study) do not apply where proxy assent is obtained; proxy assent and a consent declaration cannot cover sharing or processing of data for future unknown research studies. Therefore, such references in the main study information leaflets provided to the proxy should be removed/amended; the declaration can only cover storage only of the personal data for future research. The specific consent documentation for future studies provided to the proxy should also be amended to reflect that assent for future studies is for storage of data only for future research. Please also refer to Condition 5 on PPI.  [CONDITION MET]","Condition 7. the Applicant/data controller is requested to further review and amend the study information leaflets and assent/consent forms as follows: o Incorrect references to sharing personal data with health insurers should be removed. o While the study information leaflets refer to destroying leftover samples or storing them for up to 6 months after the end of the study, it was not clear if this applies to all the laboratories including the specifically named external laboratory service providers that are covered by this declaration. Participants should be clearly informed if their samples will be deleted, stored or returned by the external labs. o There are no ‘yes/no’ boxes provided in the assent/consent form – please include ‘yes/no’ boxes for each of the options in the assent/consent forms. Initials alone should not be used in the assent/consent forms. Individuals should be asked for their permission via ‘yes/no’ boxes.  [CONDITION MET]","Condition 1. With regards data processing, seeking proxy assent from a relative/friend in the first instance must continue to be the default. Where this is not possible and independent doctor permission is therefore obtained in the first instance, then the study should continue to make reasonable efforts to obtain proxy assent from a relative/friend or, if they regain decision-making capacity, the participant’s consent to continue. The personal/ pseudonymised data collected for the study where only independent doctor assent has been obtained and where the participant continues to lack capacity, should not be uploaded/transferred from the hospital site until sufficient efforts are made to obtain proxy assent from the relative. For clarity, if proxy assent from a relative/friend cannot be obtained after sufficient efforts are made, then the data can be transferred from the hospital site and analysed for this study. As part of the Annual Review, the Applicant is requested to report on the number of participants in Ireland (as a proportion of total participants in Ireland) where data processing is taking place on the basis of independent doctor assent in the absence of deferred assent from the participant relative/friend proxy assent.\n\nCondition 2. A clear and consistent process for identifying an independent doctor should be in \nplace and implemented at the local Irish sites if proxy assent from a relative/friend cannot be \nobtained."]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to amend the study information leaflets as follows:\no It should be ensured that clear and correct document headings are provided on all the study documentation for proxies and participants; for example, a clear heading should be provided on the consent for future research form. \no the reference in the study information leaflets for the proxy/participant to check with the private medical insurance company about this study should be made more prominent within the document. [RECOMMENDATION CONSIDERED]",null,null,null,"Recommendation 1. The following references are made regarding the transfer of data outside the EU or EEA in the study information leaflet and assent/consent form for the independent doctor: o ‘The provision of your personal data is voluntary. However, you cannot participate in this study without your express consent to the processing of your data’. o ‘Your coded data can only be transferred to these countries if you have expressly consented to this. Without your explicit consent to the transfer of your data to countries without an adequacy decision and appropriate safeguards, you cannot participate in this clinical research study’. The following references are also made towards the end of the study information leaflet and assent/consent form for the independent doctor, in the section entitled ‘Data protection consent’ under point 2, followed by ‘tick-boxes’ and the signature section. o ‘I have been informed that my data may also be transferred to people and organizations outside my country and the European Union (EU) or the European Economic Area (EEA), where personal data protection laws may be less constraining than those in my own country or in the EU or EEA. I have been informed that I cannot participate in this study without my consent to the transfer of my data to these countries’ o ‘I expressly consent to the transfer of my data to countries outside my country and the European Union and the European Economic Area where the protection of my data cannot be guaranteed in a comparable manner. I am aware of the considerable personal disadvantages that such a transfer of data may entail’ o ‘I understand I cannot participate in this study, or my data cannot be processed if my permission/consent is not provided for this transfer’ It is important that the independent doctor is informed that data will be transferred to other counties/parties and that there may be risks; however the wording of the above references suggest that the independent doctor is being asked to agree to ‘waive’ the data rights and protections of the participant who lacks decision-making capacity with regards the transfer of their data to third countries outside the EEA - a data subject’s rights and protections cannot be waived by an independent doctor. The Applicant is therefore requested, at the next available opportunity, to amend the study document for the independent doctor so that they are not asked to waive the data rights and protections\n\n","Recommendation 2. The independent doctor/relative/friend study documents use the term ‘consent’ rather than ‘assent’ when referring to seeking permission from the relative/friend or independent doctor with regards data processing The term ‘consent’ is accurate with regards the relative/friend or independent doctor providing permission to enrol a participant onto the trial, although it is not ‘consent’ for the data processing but proxy ‘assent’ as a data safeguard. It was commented that the use of ‘assent’ rather than consent could be reviewed and considered by the Applicant to avoid confusion.\n\n","Recommendation 3. The study withdrawal from provided, outlines that the data and associated samples collected to date will continue to be used in this study unless the participant requests for them to be deleted/destroyed; however, it is noted that the withdrawal form does not provide an actual option for the participant to confirm if they want their data and samples deleted/destroyed; this should be considered"]
[null,"Deadline for meeting Conditions","N/A",null,null,null,"N/A"]
[null,"Duration of Declaration ","The consent declaration is made on 22nd August 2023 and is valid until 31st December 2024 and for 25 years of data archiving thereafter (until 31st December 2049), or until the personal data has been destroyed or irrevocably anonymised.",null,null,null,"The approval to the Amendment is made commencing 10th December 2024 and shall be valid until 31st December 2049, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,null,null,"Declaration Live"]

{"sheet":"23-011-AF1","index":116,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-011-AF1"]
[null,"Application Title ","Building Circles of Support for People with Intellectual Disabilities"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin, The University of Dublin"]
[null,"Lead Applicant ","Mary Mc Carron"]
[null,"Research Objective","The overall aim of the project is research findings to develop resources to enhance the Circles of Support (COS) for adults with intellectual disabilities (ID) that can be used in person-centred planning processes. Person-centred planning puts the individual with intellectual disability at the centre of the process, and builds supports around that person meeting their individual strengths, needs, wishes and goals. The Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA) data strongly supports individualised COS as necessary to enhance inclusion and participation. This project will translate published IDS-TILDA findings from four completed Waves into new resources: \n1. A COS Blueprint with Guidelines for service providers to promote COS, with specific measures to identify, recruit, support and sustain these Circles. \n2. A COS Workbook for people with intellectual disabilities and their carers to better understand how to integrate COS into plans. This will include an easy-read and plain\u0002language Handbook with accompanying video. \nProject outputs will include testimonial case studies of six individuals with intellectual disabilities and their COS, who will be recruited from project partner Stewarts Care.\n• Interviews/focus groups will take place with participants and their COS. These sessions will be audio recorded and notes will also be taken by the researcher. The output of these sessions will support production of accessible written and video content (short video vignettes) of the series of case studies in good practice in COS."]
[null,"Reason for seeking a Declaration","Explicit consent will be sought from all project participants, in line with the assumption of capacity outlined in The Assisted Decision\u0002Making (Capacity) (Amendment) Act 2022. However, given the aim to include perspectives of participants with mixed levels of intellectual disability, there are likely to be some participants who will lack the capacity to provide explicit consent. The consent \ndeclaration is requested to cover the processing of personal data for those participants with ID who are unable to provide explicit consent. The Applicant/data controller requests that the consent declaration cover (i) the interviews/focus groups and (ii) the recording and publication of the case study video content; the videos will identify the participants."]
[null,"HRCDC Meeting Date","22nd August 2023"]
[null,"HRCDC Decision Date ","22nd August 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The study information leaflets should inform the participants that there may be a risk that the video recordings may be misused by other people after they are uploaded online. In addition, while the consent forms state that the videos will almost be impossible to delete once they are uploaded, this is not clearly mentioned in the information leaflets; information that the videos are impossible to fully delete should be included in both the consent form and the information leaflets. \n\nCondition 2. It is noted that the same document is used when requesting either participant consent or proxy assent i.e., there is a section for the participant or their support person to sign. The HRCDC is of the view that the proxy should be asked to sign a form that is separate to the form provided to the participant with an intellectual disability i.e., a single combined assent/consent signature \nform for both the participant and the proxy should not be used. (Please note that this condition requests separate assent/consent signature forms – it does not apply to the study information leaflets that are used).\n\nCondition 3. The personal data obtained from the expression of interest process of participants who subsequently not selected for this study should be deleted as soon as practicable. In line with the principle of data minimisation, personal data should not be processed for longer than is necessary.\n\nCondition 4. Appropriate data agreements must be in place with the data processor involved in the video recordings."]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The consent declaration is made on 22nd August 2023. With regards the video recordings the declaration will remain valid indefinitely. For the other personal data (i.e., demographic data, audio recordings, transcripts etc.) the declaration is in place until 30th November 2024; after this point the non-video personal data collected for this study should be deleted or fully anonymised."]
[null,"Status of Declaration","Declaration No Longer Required"]

{"sheet":"23-012-AF1","index":117,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,null,"Application Ref ID","23-012-AF1","23-012-AF1/AMD1"]
[null,null,"Application Title ","Research Use of Diagnostic Genomic Testing Data for Epilepsy","Research Use of Diagnostic Genomic Testing Data for Epilepsy"]
[null,null,"Applicant Organisation (Data Controller)","Beaumont Hospital\nRoyal College of Surgeons in Ireland","Beaumont Hospital\nRoyal College of Surgeons in Ireland"]
[null,null,"Lead Applicant ","Norman Delanty","Norman Delanty"]
[null,null,"Research Objective","Our understanding of the genetic factors that contribute to epilepsy comes from the research domain. Such findings are translated to the clinical setting, to the point that today, genetic testing is a relatively standard diagnostic test in the epilepsy clinic. \n\nA result of genetics being used routinely in the clinic is that significant volumes of genetic data are now produced in the clinical setting. But such data is being wasted as it is typically not used beyond the initial attempt to make a genetic diagnosis. This study proposes to bring those data in to the research domain, to enable further discovery which can then help clinicians to treat and inform their patients.\n\nStudy aims and objectives:\nTo identify monogenic genetic causes of epilepsy\nTo identify genetic modifiers of epilepsy\nTo identify genetic risk factors of epilepsy\nTo identify genetic factors that influence treatment of the epilepsy (e.g. predictors of adverse reactions).","Our understanding of the genetic factors that contribute to epilepsy comes from the research domain. Such findings are translated to the clinical setting, to the point that today, genetic testing is a relatively standard diagnostic test in the epilepsy clinic. \n\nA result of genetics being used routinely in the clinic is that significant volumes of genetic data are now produced in the clinical setting. But such data is being wasted as it is typically not used beyond the initial attempt to make a genetic diagnosis. This study proposes to bring those data in to the research domain, to enable further discovery which can then help clinicians to treat and inform their patients.\n\nStudy aims and objectives:\nTo identify monogenic genetic causes of epilepsy\nTo identify genetic modifiers of epilepsy\nTo identify genetic risk factors of epilepsy\nTo identify genetic factors that influence treatment of the epilepsy (e.g. predictors of adverse reactions)."]
[null,null,"Reason for seeking a Declaration","A high proportion of epilepsy sufferers are persons who have a lack of decision-making capacity, often due to the nature of their disease or as a related co-morbid condition. They would most likely fail any functional test of capacity. Every effort will be made to support the patients, but it is more than probable that there will be individuals who will not have capacity to give explicit consent. \nThe consent declaration is therefore requested to process the personal data of those who lack decision-making capacity to provide consent for the purpose of this study. Processing includes collection, analysing and storing data, including follow-up data. Data to be processed includes demographic and clinical data, including images, and already generated genetic data.","To add Cork University Hospital as an additional site to this study."]
[null,null,"HRCDC Meeting Date","12th December 2023","30th May 2025"]
[null,null,"HRCDC Decision Date ","12th December 2023","30th May 2025"]
[null,null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,null,"Specific Conditions attached ","Condition 1. As part of the Annual Review, the Applicant is requested to report on the number of \nparticipants recruited to this study who lack-decision making capacity. [CONDITION MET]\n\nCondition 2. The study should employ separate and specific proxy information leaflets and proxy \nassent forms aimed at the relative/friend providing proxy assent who may not be in a legal role \nsuch as a ‘Decision Making Representative’ or ‘Legal Representative’. These separate, specific \ndocuments should use the term ‘participant representative’ when referring to the proxy individual and make it clear that the study is seeking the suitable individual’s ‘proxy assent’ (rather than their ‘consent’) for data processing. \nIn addition, the wording of this sperate proxy documentation should be clearly aimed at the proxy; accordingly, the document should not be written in the first-person that refers to ‘your data’, ‘your samples’, ‘your healthcare’ etc. [CONDITION MET]\n\nCondition 3. The required data agreements and arrangements must be in place between the \nparties for this study prior to data being transferred. [CONDITION MET]\n\nCondition 4. Feedback from the RCSI data protection officer on the study DPIA, and the outstanding signature from Beaumont Hospital on the HRCDC application form should be submitted as soon as practicable and within 2 months. Data processing cannot commence until these are submitted. [CONDITION MET]\n\nCondition 5. Confirmation of full REC approval should be submitted as soon as practicable and \nwithin 2 months. [CONDITION MET]","N/A"]
[null,null,"Recommendation made","Recommendation 1. Based on the information provided, it was not fully clear to the HRCDC \nwhether the PPI engagement to date included dialogue to capture the views of those who have \nreduced decision-making capacity. The Applicant/data controllers are requested to undertake PPI engagement to capture the views and perspectives of those with reduced capacity. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. It should be ensured that the documents provided to the proxy and/or \nparticipants, include clear transparent information on how the biosamples and data are \ntransferred, including how the bio samples are sent to the external laboratory for the purpose of \nthe clinically indicated DNA testing. It should also be clear that CeGaT Laboratories are the only \nexternal laboratory where samples/data are sent; therefore, the broad references to ‘outside \nlaboratories’ should be amended. [RECOMMENDATION CONSIDERED]\n\nRecommendation 3. The participants/proxy should be provided with an explicit option in the \nconsent/assent form on whether they wish to be notified of incidental findings. [RECOMMENDATION CONSIDERED]","N/A"]
[null,null,"Deadline for meeting Conditions","Condition 4: DPO feedback - 19th Feb 2024 [MET]\nCondition 5: REC approval - 19th Feb 2024 [MET]","N/A"]
[null,null,"Duration of Declaration ","The Declaration is made commencing 12th December 2023 and shall be valid until 31st December 2028, or until the personal data is deleted or fully anonymised or participant consent is obtained, whichever occurs first.","The approval to the Amendment is made commencing 30th May 2025 and shall be valid until 31st December 2028, in line with the original duration of the consent declaration made."]
[null,null,"Status of Declaration","Declaration Live","Declaration Live"]

{"sheet":"23-013-AF1","index":118,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-013-AF1"]
[null,"Application Title ","The Prevalence of Primary Tauopathies in Ireland; a Clinically-Defined Population Study in the Province of Leinster"]
[null,"Applicant Organisation (Data Controller)","Tallaght University Hospital\nMater Misericordiae University Hospital"]
[null,"Lead Applicant ","Sean O’Dowd"]
[null,"Research Objective","Primary tauopathies are a group of neurodegenerative diseases primarily comprising progressive supranuclear palsy (PSP) and Corticobasal Degeneration (CBD). PSP is a rare neurological disorder within the neurodegenerative disease family. There is currently very limited information on the prevalence and incidence of PSP and CBS in Ireland.\nThe aim of this study is to identify as many people as possible living within the Leinster region who have a possible diagnosis of PSP or CBS. Participants in the study will be asked to complete a number of questionnaires, alone or with the help of a carer/informant, and consent to a neurological examination. This study aims to help understand more about the number of people with PSP/CBS in Ireland, the particular challenges people with PSP/CBS face, and the natural history of these diseases.\nThe study includes provision for blood and spinal fluid sampling to create a biobank of serum, DNA, and spinal fluid of people with PSP and CBS; however, this is not applicable to those with impaired ability to consent."]
[null,"Reason for seeking a Declaration","The majority of participants in this study will be able to provide consent. However, it is anticipated that a minority (estimate 10%) will be unable to provide consent due to lack of decisionmaking capacity. \nThe consent declaration is therefore requested to process (i.e., access, collection, analysis, storage) the personal data of those who lack decision-making capacity for the purpose of this specific study (i.e., data from medical records, questionnaires/interviews/assessments, pre-existing clinical images, HIPE data). For those who lack capacity, proxy assent will be obtained.\nNote: the consent declaration will not cover (i) processing of personal data with regards the biobank element of this study, (ii) processing of personal data of family as Applicant confirms personal data is not processed on family and (iii) use of video recordings."]
[null,"HRCDC Meeting Date","12th December 2023"]
[null,"HRCDC Decision Date ","12th December 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The required data agreements and arrangements must be in place prior to the transfer \nof personal data. This includes agreements with and between the 5 hospital sites, joint controller \narrangements, as well as agreements with HIPE. \n\nCondition 2. before referring potential participants to the study, clinicians who are making referrals \nshould record permission from the proxy/participant to refer them to the research team and to \nshare their data for this referral. \n\nCondition 3. The following statement was provided to the HRCDC ‘If participants do not wish to\ncomplete an interview, but wish to participate in the study, they can consent to a review of their \nclinical notes’. Where this occurs then clear assent/consent for the review of clinical notes only, \nshould be obtained.\n\nCondition 4. As part of the Annual Review, the Applicant is requested to report on the number of \nparticipants recruited to this study who lack-decision making capacity. \n\nCondition 5. Where proxy assent/participant consent is withdrawn or is refused and the study \nwishes to continue to process the data already collected, then permission for this must be obtained \nand recorded from the proxy or participant, whichever is relevant."]
[null,"Recommendation made","Recommendation 1. With regards the study information leaflets and assent/consent forms, the \nApplicant is requested to consider the following:\no the terms ‘next-of-kin’ and ‘legal representative’ should not be used in the documentation used to \nobtain proxy assent on behalf of a participant who lacks decision-making capacity. Instead, \n‘participant representative’ should be used as it is considered more appropriate. \no It should be clearly outlined where the clinical data is obtained from i.e., the medical records of the 5 named hospital sites. In addition, the references to obtaining scans and data from records ‘held by other healthcare providers who have been involved in the participant’s care’ that are not the 5 named sites should be amended as this won’t occur. \no It was noted that the information leaflet for the proxy refers to seeking ‘consent’ from the proxy, in \nsome places. The term ‘proxy assent’, not ‘consent’, should be used when referring to seeking \npermission for data processing from a relative. \no It was commented that the phrase ‘Your/your family member’s doctor will not be upset if you decide not to take part and it will not affect the any aspect of your medical care’ should be revised; the word ‘upset’ should be avoided. The points above should be addressed as soon as practicable or by the next ethics amendment.\n \nRecommendation 2. Data minimisation is an important principle that should be adhered to. In this \ncontext the study should ensure that only the minimum data is collected and processed for this study; for example, are date of birth and age both needed.\n\nRecommendation 3. It was noted that the DPIA refers to digitised pseudonymised data being retained indefinitely, which is not in line with the duration noted to the HRCDC and accordingly the duration of the consent declaration that has been made. The Applicant is requested to revisit the DPIA and amend this."]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 12th December 2023 and shall be valid until 31st January 2031, or until the personal data is deleted or fully anonymised, whichever occurs first."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"23-014-AF1","index":119,"n_rows":15,"n_cols":4,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-014-AF1"]
[null,"Application Title ","Adolescent and Young Adult (AYA) Cancer Epidemiology in Ireland – a retrospective review of National Cancer Registry Ireland (NCRI) data from 2002 to 2018"]
[null,"Applicant Organisation (Data Controller)","Trinity College Dublin"]
[null,"Lead Applicant ","Owen Smith"]
[null,"Research Objective","This study involves the collection and analysis of retrospective data to advance our knowledge of the epidemiology of adolescent and young adult cancer in Ireland. Data collected will include incidence rates, age at diagnosis, geographical location, disease type and survival of all patients aged 16-24 +364 days diagnosed with cancer between the years of 2002 to 2018 in the Republic of Ireland. Existing pseudonymised data collected by the NCRI will be used for the study."]
[null,"Reason for seeking a Declaration","The consent declaration is requested to process the personal data (which is considered pseudonymised data) provided by the National Cancer Registry of Ireland for the purpose of this study. The Applicant outlines the reasons for not seeking consent, including the number of participants involved (approx. 2500). "]
[null,"HRCDC Meeting Date","19th September 2023"]
[null,"HRCDC Decision Date ","19th September 2023"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The Applicant/data controller is requested to strengthen the level of public and patient involvement (PPI) with regards this specific research study. Accordingly, the study should engage with representative groups from the area of adolescent and young people’s cancer. Consideration should be given to engaging with PPI representatives on matters such as transparency measures. The Applicant is requested to report on PPI engagement within 3 months. [CONDITION MET]\n\nCondition 2. Measures to inform participants and the public about this study must be in place prior to the commencement of this research i.e., providing information on the NCRI and TCD websites; data processing cannot commence until adequate transparency measures are in place. Transparency measures should also include clear information on the participant’s data protection rights, including how to exercise such rights and provide a point of contact. The right of the participants to withdraw from the study and have their data removed should be clearly outlined in the transparency measures. The point at which data can no longer to deleted/removed should also be clearly highlighted. Further to providing such information on the NCRI and TCD websites, the Applicant/data controller is also requested to consider other methods of enhancing transparency \nsuch as links with relevant groups or networks. The Applicant is requested to report on this condition within 3 months. [CONDITION MET]\n\nCondition 3. A clear process to enable participants to request to withdraw from the study and have their data removed should be in place between NCRI and TCD, with responsibilities for this process clearly documented. [CONDITION MET]","Condition 4. The appropriate data sharing agreements must be in place between the parties. Data cannot be transferred prior to the data agreements being in place. [CONDITION MET]\n\nCondition 5. It is noted that ‘geographical location’ will be collected, however it is not clear what this is specifically referring to e.g., a county, town, electoral district etc. Given that geographical data will be collected and in the context of the nature of this study, the Applicant/data controller should ensure steps are taken to prevent participant re-identification using geographical and the other data variables that will be collected. More generally, the study should take on board and comply with the principle of data minimisation. Lastly, the Applicant is requested to report on what is specifically meant by ‘geographical data’ within 3 months.[CONDITION MET]"]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","Condition 1: PPI - 3rd Jan 2024 [MET]\nCondition 2: Transparency - 3rd Jan 2024[MET]\nCondition 5: Data Minimisation - 3rd Jan 2024[MET]"]
[null,"Duration of Declaration ","The Declaration is made commencing 19th September 2023 and shall be valid until 31st December 2027, or until the data is deleted or fully anonymised, whichever occurs first."]
[null,"Status of Declaration","Declaration Live"]

{"sheet":"23-015-AF1","index":120,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-015-AF1",null,"23-015-AF1/AMD1"]
[null,"Application Title ","Investigation into the use of IL-1β, I-CAM1 and/or E-Selectin in identifying the effects of infection in placental tissue.",null,"Investigation into the use of IL-1β, I-CAM1 and/or E-Selectin in identifying the effects of infection in placental tissue."]
[null,"Applicant Organisation (Data Controller)","Cork University Hospital\nCork University Maternity Hospital",null,"Cork University Hospital\nCork University Maternity Hospital"]
[null,"Lead Applicant ","Brendan Fitzgerald",null,"Brendan Fitzgerald"]
[null,"Research Objective","Chorioamnionitis is a bacterial infection unique to pregnancy, associated with complications in preterm babies such as infection (e.g., meningitis or pneumonia), severe neonatal brain injuries, and in some cases, death. Testing will be carried out on chorioamnionitis affected placental tissue, previously submitted to for histological analysis immediately following birth. Immunohistochemical staining with IL-1β, I-CAM1 and E-Selectin antibodies is hypothesised to identify endothelial cell activation as part of an inflammatory response to infection, the severity of which may be determined by the level of antibody expression present once stained. Correlation may be identified between the grade of infection assigned to the patient cases upon H&E analysis, and the level of antibody expression observed. This may hold diagnostic value for the identification of neonatal sepsis through placental tissue evaluation and expanded in the future to other tissue types for the purpose of identifying sepsis related deaths in both adults and infants.",null,"Chorioamnionitis is a bacterial infection unique to pregnancy, associated with complications in preterm babies such as infection (e.g., meningitis or pneumonia), severe neonatal brain injuries, and in some cases, death. Testing will be carried out on chorioamnionitis affected placental tissue, previously submitted to for histological analysis immediately following birth. Immunohistochemical staining with IL-1β, I-CAM1 and E-Selectin antibodies is hypothesised to identify endothelial cell activation as part of an inflammatory response to infection, the severity of which may be determined by the level of antibody expression present once stained. Correlation may be identified between the grade of infection assigned to the patient cases upon H&E analysis, and the level of antibody expression observed. This may hold diagnostic value for the identification of neonatal sepsis through placental tissue evaluation and expanded in the future to other tissue types for the purpose of identifying sepsis related deaths in both adults and infants."]
[null,"Reason for seeking a Declaration","The study will undertake pre-screening activities (i.e., identifying the suitable tissue samples) in line with the pre-screening amendment to the Health Research Regulations. \nFollowing the identification of the participant samples after pre-screening, the samples and the relevant Lab Accession Numbers will be extracted and the samples then pseudonymised using another number and linked to the master list; this limited pseudonymised data will be retained while the samples are prepared for staining (i.e., cutting and slicing) and to return them to the patient’s file. Once the selected samples are prepared and returned, they will be anonymised i.e., the master list will be deleted and therefore no pseudonymised data will continue to be processed. \nThe consent declaration is therefore requested for the processing of the limited pseudonymised data (i.e., Lab accession number and study sample code and master list) during the preparation of the samples for staining. ",null,"Change in data controller of the study to the South/South West Hospital Group under the HSE (and subsequent removal of Condition 3 on joint controller arrangements that was attached to the original consent declaration). \n\nExtension of the duration of the consent declaration by 3 months to 31st July 2024. "]
[null,"HRCDC Meeting Date","19th September 2023",null,"3rd April 2024"]
[null,"HRCDC Decision Date ","19th September 2023",null,"3rd April 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The Applicant/data controller must implement the transparency measures prior to the study commencing i.e., the study information posters and study information leaflets). With regards the transparency measures the Applicant/data controller is also required to review and amend these documents as follows: \n• The information poster to be provided in the hospital waiting rooms should include specific information on withdrawing from the study, including how to withdraw and the point at which it may no longer be possible to withdraw. Linked to this, the phrase in the poster ‘We will be able to inform you if you have been selected as a participant while this information is available’ should be amended to outline that an individual can contact the study if they any questions on their potential inclusion in the study and would wish to withdraw. \n• It was the view of the HRCDC that language used in the separate study information leaflet was overly technical (e.g., use of scientific terms such as ‘Histopathology’ and the description of the study) and that it could be made more reader friendly. In addition, it should be outlined that 40 participants, not 30, will be included in this study. [CONDITION MET]","Condition 2. The Applicant/data controller should undertake some public and patient engagement with regards to this study before study commencement, including on the study transparency measures i.e., posters and information leaflets. While it is noted that there may not be a PPI group in this specific area, and while the HRCDC is not requesting the Applicant to set up a specific PPI group, it is considered that there are other groups in the broader areas of maternal and infant health who may be able to provide input into the study and who could be contacted for some engagement. Such groups that could be considered to provide input may include PPI groups from the UCC INFANT centre (the study sponsor) and/or other patient Advocacy groups. The Applicant is requested to provide an update on this condition prior to the study commencing. [CONDITION MET]\n\nCondition 3. It must be ensured that the data agreements/ arrangements to be put in place \nbetween CUH and CUMH also meet the requirement of a joint data controller arrangement and cover this specific study.","Condition 1. It is unclear whether the extension of the duration of the study to 31st July 2024 requires further/additional approval from the research ethics committee (REC). When confirming acceptance of this amendment, the Applicant/data controller is requested to also confirm if extended REC approval is required, or if the REC approval already obtained covers the extended study duration. If REC approval is required for the extension of the study, the Applicant must obtain this approval and submit evidence of it to the HRCDC as soon as practicable. [CONDITION MET]"]
[null,"Recommendation made","N/A",null,"N/A"]
[null,"Deadline for meeting Conditions","N/A",null,"N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 19th September 2023 and shall be valid until 30th April 2024, or once the personal data has been fully anonymised or deleted, whichever occurs first. - (Amendment is made valid until 31st July 2024)",null,"The approval to the Amendment is made commencing 3 rd April 2024 and shall be valid until 31st July 2024, an extension of the duration of the consent declaration originally made."]
[null,"Status of Declaration","Declaration No Longer Required",null,"Declaration No Longer Required"]

{"sheet":"23-016-AF1","index":121,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref ID","23-016-AF1","23-016-AF1/AMD1","23-016-AF1/AMD2"]
[null,"Application Title ","Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS).","Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS).","Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome (PEGASUS)."]
[null,"Applicant Organisation (Data Controller)","Amsterdam University Medical Centers","Amsterdam University Medical Centers","Amsterdam University Medical Centers"]
[null,"Lead Applicant ","Lieuwe J. Bos","Lieuwe J. Bos","Lieuwe J. Bos"]
[null,"Research Objective","Acute respiratory distress syndrome (ARDS) is a frequent cause of severe acute respiratory failure and has a mortality rate of approximately 30%. The identification of patients with different subtypes (termed ‘phenotypes’) of ARDS, based on whether the changes in their lungs are localized (‘focal’) or spread across the lungs (‘diffuse), may be helpful to better target mechanical ventilation strategies. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish ‘focal’ from ‘diffuse’ ARDS subtypes. This study will test the hypothesis that LUS-guided personalized mechanical ventilation will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation in ARDS patients. This study will include 538 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with moderate or severe ARDS. There will be a predefined feasibility and safety evaluation after inclusion of the first 80 patients. Patients will receive a LUS exam within 12 hours after diagnosis of ARDS to classify lung morphology as focal or non-focal ARDS. Immediately after the LUS exam patients will be randomly assigned to the intervention group, with personalized mechanical ventilation, or the control group, in which patients will receive standard care.","Acute respiratory distress syndrome (ARDS) is a frequent cause of severe acute respiratory failure and has a mortality rate of approximately 30%. The identification of patients with different subtypes (termed ‘phenotypes’) of ARDS, based on whether the changes in their lungs are localized (‘focal’) or spread across the lungs (‘diffuse), may be helpful to better target mechanical ventilation strategies. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish ‘focal’ from ‘diffuse’ ARDS subtypes. This study will test the hypothesis that LUS-guided personalized mechanical ventilation will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation in ARDS patients. This study will include 538 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with moderate or severe ARDS. There will be a predefined feasibility and safety evaluation after inclusion of the first 80 patients. Patients will receive a LUS exam within 12 hours after diagnosis of ARDS to classify lung morphology as focal or non-focal ARDS. Immediately after the LUS exam patients will be randomly assigned to the intervention group, with personalized mechanical ventilation, or the control group, in which patients will receive standard care.","Acute respiratory distress syndrome (ARDS) is a frequent cause of severe acute respiratory failure and has a mortality rate of approximately 30%. The identification of patients with different subtypes (termed ‘phenotypes’) of ARDS, based on whether the changes in their lungs are localized (‘focal’) or spread across the lungs (‘diffuse), may be helpful to better target mechanical ventilation strategies. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish ‘focal’ from ‘diffuse’ ARDS subtypes. This study will test the hypothesis that LUS-guided personalized mechanical ventilation will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation in ARDS patients. This study will include 538 consecutively admitted invasively ventilated adult intensive care unit (ICU) patients with moderate or severe ARDS. There will be a predefined feasibility and safety evaluation after inclusion of the first 80 patients. Patients will receive a LUS exam within 12 hours after diagnosis of ARDS to classify lung morphology as focal or non-focal ARDS. Immediately after the LUS exam patients will be randomly assigned to the intervention group, with personalized mechanical ventilation, or the control group, in which patients will receive standard care."]
[null,"Reason for seeking a Declaration","The consent declaration is requested to process the personal data of participants who lack decision making capacity due to the nature of their critical condition (collection, transfer, analysis, storage etc.). In such circumstances deferred proxy assent will be obtained on their behalf, and consent to continue sought when the participant regains decision-making capacity.","To add the Mater Misericordiae University Hospital as a study site and, correspondingly, as a data processor.","a. To include Tallaght University Hospital as a site; \nb. To include a PEGASUS sub-study, IMPROVE-LM, within this consent declaration; \nc. To extend the consent declaration until 31st December 2027 to facilitate patient recruitment, and for 15 years thereafter to enable data archiving (until 31st December 2042)."]
[null,"HRCDC Meeting Date","17th October 2023","19th February 2024","9th July 2025"]
[null,"HRCDC Decision Date ","17th October 2023","19th February 2024","9th July 2025"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The required data agreements/arrangements must be in place between the parties prior to personal data being transferred and processed. In this context, the data controller must ensure that the data agreements/arrangements meet the necessary GDPR requirements. [CONDITION MET]\n\nCondition 2: Where an individual wishes to withdraw from the study and the study wishes to continue to process the existing personal data already collected up to that point, then permission for this should be sought from the proxy or participant, whoever is relevant, and appropriately recorded. If this permission to continue to process data after withdrawal is provided by the proxy, then consent to continue to process the data already collected should also still be obtained from the \nparticipant if they regain decision-making capacity. Where an individual requests that the personal data is deleted following withdrawal then it should be deleted up until the point where this is no longer practicable i.e., data lock. As part of the Annual Review, the Applicant/data controller is also requested to provide information on when the data lock will occur i.e., if it is after all participants \nhave been recruited to study. [CONDITION UNDERWAY]\n\nCondition 3. The consent declaration does not cover data processing in a situation where deferred proxy assent is not provided; if proxy assent is not obtained in a short period after the 72hrs, then data deletion should occur. [CONDITION UNDERWAY]","Condition 1. Full Research Ethics Committee approval must be obtained for the inclusion of the Mater Hospital as a new site and confirmation of this approval should be submitted to the HRCDC/Secretariat once it is obtained. Data processing cannot commence at the Mater site until this condition is met. [CONDITION MET]\n\nCondition 2. The necessary data agreements/arrangements must be in place between the data controller of the study and the Mater hospital. Data processing cannot commence at the Mater site \nuntil this condition is met. [CONDITION MET]","Condition 1. The updates made to the Galway and the Mater PILs that adds details on the IMPROVE\u0002LM sub-study must be approved by the relevant research ethics committees prior to the enrolment of patients into the sub-study. \n\nCondition 2. The necessary data agreements/arrangements must be in place with regards the new site, Tallaght University Hospital."]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to review and amend the study information leaflets and assent/consent forms as follows:\n(i) Parts of the documents refer to ‘90’ and not ’90 days’.\n(ii) The proxy assent form should be titled ‘deferred proxy assent form’ as opposed to only ‘proxy assent form’.\n(iii) Linked to point (ii), it should be fully clear in the proxy information leaflets and assent form that the proxy is being asked to provide permission for the participant’s continued participation and data processing. For example, the proxy assent form should state 'I assent to my relative/friend continuing to take part in this research study having been fully informed of the risks, benefits and alternatives’. [RECOMMENDATION CONSIDERED]\n\nHRCDC Comment: Lastly, The HRCDC noted the response on what PPI engagement has been undertaken for this study i.e., discussed at the February 2023 meeting. It is assumed that PPI meetings will continue periodically, and that the PEGASUS study will be discussed again at relevant points. The HRCDC encourages the Applicant/data controller to undertake continued PPI engagement during this study, and in this context to consider engagement with PPI representatives on the dissemination of the study findings, among other matters. The Applicant is asked to provide an update on PPI engagement in the relevant section of the Annual Review","N/A","Recommendation 1. The GUH Proxy Assent form submitted with the amendment form includes two options for future research; it is recommended that the Applicant amends the text on the options for future research outlined to the proxy in the assent form to also include ‘subject to HRCDC approval, where applicable’, in addition to subject to REC approval."]
[null,"Deadline for meeting Conditions","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 17th October 2023 and shall be valid until 31st October 2025and for 15 years thereafter (until 31st October 2040), or until the personal data has been irrevocably anonymised or destroyed.AMENDMENT: shall be valid until 31st December 2027 and for 15 years thereafter (until 31st December 2042), or until the personal data has been irrevocably anonymised or destroyed; this is an extension of the duration of the consent declaration.","The approval of this amendment is made commencing 19th February 2024 and shall be valid until 31st October 2025 and for 15 years thereafter (until 31st October 2040), or until the personal data has been irrevocably anonymised or destroyed, in line with the duration of the consent declaration made. AMENDMENT: shall be valid until 31st December 2027 and for 15 years thereafter (until 31st December 2042), or until the personal data has been irrevocably anonymised or destroyed; this is an extension of the duration of the consent declaration.","The approval of this amendment is made commencing 9th July 2025 and shall be valid until 31st December 2027 and for 15 years thereafter (until 31st December 2042), or until the personal data has been irrevocably anonymised or destroyed; this is an extension of the duration of the consent declaration."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live"]

{"sheet":"23-017-AF1","index":122,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-017-AF1",null,"23-017-AF1/AMD1"]
[null,"Application Title ","Preventing caRdiovascular collapsE with VasoprEssors duriNg Tracheal IntubatiON: The PREVENTION Randomized Controlled Trial",null,"Preventing caRdiovascular collapsE with VasoprEssors duriNg Tracheal IntubatiON: The PREVENTION Randomized Controlled Trial"]
[null,"Applicant Organisation (Data Controller)","University of Torino",null,"University of Torino"]
[null,"Lead Applicant ","University of Torino",null,"University of Torino"]
[null,"Research Objective","Tracheal intubation is the most commonly performed procedure in critically ill patients and is essential to facilitate invasive ventilation, or ‘life support’. It is a high risk procedure, with severe complications seen in 45% of patients, in the recent INTUBE study. These adverse events appear to have long-term consequences, with patients experiencing at least one major peri-intubation event at higher risk of dying. Hemodynamic complications such as low blood pressure (i.e. shock) is the commonest severe complication seen, and even a short period of shock may lead to harm, and even cause death. Studies show that the need to deeply sedate patients to reduce discomfort from the procedure may play a key role in these complications. This randomized controlled clinical trial will investigate whether pre-emptively starting medications to maintain blood pressure (termed ‘vasopressors’) in patients undergoing tracheal intubation can reduce the risk of hemodynamic complications inpatients requiring urgent/emergent tracheal intubation compared to standard care.",null,"Tracheal intubation is the most commonly performed procedure in critically ill patients and is essential to facilitate invasive ventilation, or ‘life support’. It is a high risk procedure, with severe complications seen in 45% of patients, in the recent INTUBE study. These adverse events appear to have long-term consequences, with patients experiencing at least one major peri-intubation event at higher risk of dying. Hemodynamic complications such as low blood pressure (i.e. shock) is the commonest severe complication seen, and even a short period of shock may lead to harm, and even cause death. Studies show that the need to deeply sedate patients to reduce discomfort from the procedure may play a key role in these complications. This randomized controlled clinical trial will investigate whether pre-emptively starting medications to maintain blood pressure (termed ‘vasopressors’) in patients undergoing tracheal intubation can reduce the risk of hemodynamic complications inpatients requiring urgent/emergent tracheal intubation compared to standard care."]
[null,"Reason for seeking a Declaration","The consent declaration is requested to process the personal data of participants who lack decision making capacity due to the nature of their critical condition (collection, transfer, analysis, storage etc.). In such circumstances deferred proxy assent will be obtained on their behalf, and consent to continue sought when the participant regains decision-making capacity.",null,"Scope of amendment(s): To add the following three sites to the study (these new sites are also data processors): \n- Tallaght University Hospital, Dublin, \n- Mater Misericordiae University Hospital, Dublin \n- Beaumont Hospital, Dublin"]
[null,"HRCDC Meeting Date","17th October 2023",null,"1st May 2025"]
[null,"HRCDC Decision Date ","17th October 2023",null,"1st May 2025"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The required data agreements/arrangements must be in place between the parties prior to personal data being transferred and processed. In this context, the data controller must ensure that the data agreements/arrangements meet the necessary GDPR requirements. [CONDITION MET]\n\nCondition 2. Where an individual wishes to withdraw from the study and the study wishes to continue to process the existing personal data already collected up to that point, then permission for this should be sought from the proxy or participant, whoever is relevant, and this permission should be appropriately recorded. If this permission to continue to process data after withdrawal is provided by the proxy, then consent to continue to process the data already collected should also still be obtained from the participant if they regain decision-making capacity. Where an individual requests that the personal data is deleted following withdrawal then it should be deleted up until the point where this is no longer practicable i.e., data lock. As part of the Annual Review, the Applicant/data controller is also requested to provide information on when the data lock will occur i.e., if it is after all participants have been recruited to study.","Condition 3. The Applicant/data controller is requested to amend the study information leaflets and assent/consent forms, as per the replies provided to the Secretariat query letter and to address other points highlighted by the HRCDC: \n(i) Remove references to collecting and using bio-samples \n(ii) It must be made clear who the data controller of the study is, i.e., University of Torino, and that personal/pseudonymised data will be shared with this controller in Italy (Note: the responses provided states that PILs have been updated to reflect that data in ‘an anonymised format’ will be transferred. Based on the information provided the data is not fully anonymised but remains pseudonymised) \n(iii) Aligned with the scope of the consent declaration, remove references to future research, sub\u0002studies etc from the proxy information leaflet and assent forms. \n(iv) Ensure consistency of information in the study information leaflets and assent/consent forms confirming that data is held for 10 years, and not 15 or 25 years as referenced in some sections. Note: The Applicant’s responses to the Secretariat query letter stated a few of the above changes had been made, however the HRCDC did not receive a copy of the update documents that reflect these changes, therefore it is important that the above amendments are made. Confirmation that the above changes have been made is acceptable; the HRCDC do not need to receive copies of the updated leaflets. [CONDITION MET]\n\nCondition 4. The consent declaration does not cover data processing in a situation where deferred proxy assent is not provided; if proxy assent is not obtained in a short period after the 48hrs, then data deletion should occur.","Condition 1: The necessary data agreements/arrangements must be in place between the data controller of the study and the new hospital sites/data processors"]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to review and amend the study information leaflets and assent/consent forms as follows:\n(i) It should be fully clear in the proxy information leaflets and assent form that the proxy is being asked to provide permission for the participant’s continued participation and data processing. For example, the proxy assent form should state 'I assent to my relative/friend continuing to take part in this research study having been fully informed of the risks, benefits and alternatives’.\n(ii) The statement ‘If a study has been published that included data linked to you/your relative, it may not be possible to alter this result’ may be confusing to the individual reading the document. You are asked to look at this phrase to make it clear to the subject. [RECOMMENDATION CONSIDERED]\n\nHRCDC Comment: Lastly, the HRCDC noted the response on what PPI engagement has been undertaken for this study i.e., discussed at the February 2023 meeting. It is assumed that PPI meetings will continue periodically, and that the PREVENTION study will be discussed again at relevant points. \nThe HRCDC encourages the Applicant/data controller to undertake continued PPI engagement during the course of this study, and in this context to consider engagement with PPI representatives on the dissemination of the study findings, among other matters. The Applicant is asked to provide an update \non PPI engagement in the relevant section of the Annual Review. \nThe HRCDC also noted that a primary and secondary research outcome outlined in the HRCDC application form were identical. The Applicant is requested to review this. ",null,"Recommendation 1. The DPO of Data Controller, University of Torino, should review the DPIA that covers the inclusion of these additional hospital sites."]
[null,"Deadline for meeting Conditions","N/A",null,"N/A"]
[null,"Duration of Declaration ","The consent declaration is made on 17th October 2023 and is valid until 30th November 2025 and for 10 years thereafter (Until 30th November 2035), or until the personal data has been irrevocably anonymised or destroyed.",null,"The approval to the Amendment is made commencing 1st May 2025 and shall be valid until 30th November 2035, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live"]

{"sheet":"23-019-AF1","index":123,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-019-AF1",null,"23-019-AF1/AMD1"]
[null,"Application Title ","Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3)",null,"Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3)"]
[null,"Applicant Organisation (Data Controller)","University of Nottingham",null,"University of Nottingham"]
[null,"Lead Applicant ","Ronan Collins",null,"Ronan Collins"]
[null,"Research Objective","TICH-3 is a randomised clinical trial investigating the efficacy of tranexamic acid in treating hyperacute spontaneous intracerebral haemorrhage. This condition involves sudden bleeding within the brain, which can lead to severe health complications or death. The trial aims to determine if tranexamic acid can provide a beneficial treatment option for patients experiencing this type of haemorrhage.",null,"TICH-3 is a randomised clinical trial investigating the efficacy of tranexamic acid in treating hyperacute spontaneous intracerebral haemorrhage. This condition involves sudden bleeding within the brain, which can lead to severe health complications or death. The trial aims to determine if tranexamic acid can provide a beneficial treatment option for patients experiencing this type of haemorrhage."]
[null,"Reason for seeking a Declaration","The study involves emergency treatment for stroke patient. Wherever possible the study will obtain participant explicit consent prior to their recruitment to the study, however the consent declaration is requested to process the personal data of those who lack decision-making capacity to provide explicit consent upon recruitment due to the nature of their condition. If a patient does not have decision-making capacity, then proxy assent will be obtained on their behalf from a relative or from an independent doctor. ",null,"Where the participant lacks decision-making capacity, the original consent declaration application outlined an assent/consent process that involves independent doctor permission followed by family/friend deferred proxy assent.  Following the making of the consent declaration, the Applicant/data controller noted that there may be rare cases where it is not possible to obtain such deferred proxy assent and where the participant does not regain decision-making capacity. If this rare situation occurs, only the initial permission from the independent doctor permission would be obtained.  It is requested that the scope of the consent declaration would cover the continued processing of personal data for this study in the rare situation where proxy assent from a relative/friend is not obtained despite adequate efforts being made, and only the initial permission for enrolment from the independent doctor is in place. The processing of personal data in such a scenario was not outlined in the original HRCDC application form. "]
[null,"HRCDC Meeting Date","17th October 2023",null,"26th March 2024"]
[null,"HRCDC Decision Date ","17th October 2023",null,"26th March 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The process of completing the follow up at day 180 for each participant will be co\u0002ordinated and undertaken by the National co-ordinator (i.e., TUH under the supervision of Ronan Collins), if it is not done by personnel form the local site. A secure process for transfer of data between the hospital sites to enable this follow up must be therefore documented and in place prior to the commencement of the study e.g., transfer of data via the secure hospital systems such as HEANet. The Applicant is asked to provide details to the committee on this secure process within three months of receipt of this letter.[CONDITION MET]\n\nCondition 2. References to the processing of personal data should be removed from the assent documentation provided to the independent doctor who may provide initial permission at study enrolment if no other suitable person is available i.e., from a relative/friend. Proxy assent as a safeguard for data processing should be sought from a suitable relative/friend. [CONDITION MET]\n\nCondition 3. The necessary data agreements/arrangements must be in place between the relevant parties prior to data being transferred. This includes agreements/arrangements between the University of Nottingham and the Irish hospital sites including Standard Contractual Clauses if applicable, agreements for the transfer of personal data between the sites (e.g., local hospital and \nco-ordinating centre) and agreements with GP, if necessary. Data cannot be transferred prior to the necessary agreements/arrangements being in place. [CONDITION MET]","Condition 4. It is noted that local personnel on the study delegation log can set-up an account to enable them to access the study’s designated web portal/electronic case report form. It must be Page 3 of 5 ensured that the local researcher set-up is appropriately overseen and authorised and done in a secure manner. [CONDITION MET]\n\nCondition 5. Where the study wishes to collect the 180- day follow-up data after an individual withdraws, then clear permission for this should be obtained and appropriately recorded, whether from the relative/friend or the participant. If this permission to continue to process data after withdrawal is provided by the proxy, then consent to continue to collect this follow-up data should also still be obtained from the participant if they regain decision-making capacity. The study information leaflets should therefore also be amended to reflect and provide clarity on this potential permission for follow-up data collection i.e., amend the statement/section ‘If you withdraw, we will no longer collect any information about you or from you but we will keep the information about you that we have already obtained…’ Further, while it is acknowledged that the data collected to date cannot be deleted upon a request to withdraw from the study, it remains that data should be deleted where it is practicable and possible, subject to any GDPR derogations that may apply. For example, if all the data isn’t needed post-withdrawal, then the data that can be deleted should be deleted. [CONDITION MET]","Condition 1. The Applicant/data controller must make every reasonable effort to obtain participant consent to continue if they regain decision-making capacity and make every reasonable effort to obtain deferred proxy assent where they have not yet regained capacity. Accordingly, a clear process outlining the efforts that will be made to obtain participant consent to continue/deferred proxy assent must be in place; as part of this process, the participant’s social worker or family doctor should be contacted to identify and determine if there is a suitable relative who can provide proxy assent on behalf of the participant who lacks capacity. Efforts made to determine if the participant has regained capacity and efforts to then seek participant consent to continue, as well as efforts made to obtain deferred proxy assent, must be tracked by the Applicant/data controller, and appropriately documented. The Applicant/data controller must also report in the Annual Review on the number of participants recruited to the study in Ireland where participant consent to continue or deferred proxy assent has not been obtained. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. Where initial permission is provided by the independent doctor, the response to the HRCDC stated that ‘the study will still always seek to obtain written proxy assent from a suitable relative/friend as soon as possible if the participant continues to lack capacity, and this proxy assent will be done as soon as possible'. In seeking subsequent assent from the relative/friend as soon as practicable, if after a reasonable period of time post enrolment (a couple of days) the relative/friend cannot be reached in-person then proxy assent should be obtained from them by telephone, subject to REC approval. A significant period should not lapse between initial doctor assent and deferred relative/friend assent. The HRCDC is agreeable that an amendment is not required for telephone assent (if implemented) and accordingly this would be covered by scope of the declaration made. The Applicant is also requested to report at the first Annual Review on the time it has generally taken to obtain deferred relative/friend assent. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The committee recommend that PPI groups in Ireland are consulted also on the study, the documentation, consent / assent process etc. An update on this activity in this area can be provided at the annual review. [RECOMMENDATION CONSIDERED]\n\n","Recommendation 3. The Applicant is requested to review and amend the study information leaflets as follows:\n• aligned with the duration of the consent declaration, it should be made clear in the study information leaflets that the personal data will be fully anonymised 1 year after the study concludes (note: the current versions state ‘After this time your personal data will be disposed of securely’ this could be misunderstood that all data will be destroyed as opposed to anonymising the personal data). \n• Ensure the following is corrected in the information leaflet for the relative: ‘The study will also involve giving you a drip for 8 hours’. \n• More broadly, ensure that the documents are adapted for an Irish context i.e., relates to research and data processing of Irish based participants, does not refer to NHS data sources etc. [RECOMMENDATION CONSIDERED]","N/A"]
[null,"Deadline for meeting Conditions","Conditon 1: Data security  23rd Jan 2024 [MET]",null,"N/A"]
[null,"Duration of Declaration ","The Consent Declaration is made on 17th October 2023 and is valid until 1st April 2029 (i.e., 87 months following commencement of study on 1st January 2022) and for 1 year thereafter (until 1st April 2030), or until the personal data has been irrevocably anonymised or destroyed.",null,"The approval to the Amendment is made commencing 27th March 2024 and shall be valid until 1st April 2029 (i.e., 87 months following commencement of study on 1st January 2022) and for 1 year thereafter (until 1st April 2030), in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live"]

{"sheet":"23-020-AF1","index":124,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Application Ref ID","23-020-AF1","23-020-AF1/AMD1","23-020-AF1/AMD2"]
[null,"Application Title ","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opioid Use in Ireland (2020 – 2022)","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opioid Use in Ireland (2020 – 2022)","A Capture-Recapture Study to Estimate the Prevalence of Problem-Opioid Use in Ireland (2020 – 2022)"]
[null,"Applicant Organisation (Data Controller)","University College Cork","University College Cork","University College Cork"]
[null,"Lead Applicant ","Seán Millar","Seán Millar","Seán Millar"]
[null,"Research Objective","This research project aims to estimate the number of problem-opioid drug users in the Republic of Ireland from 2020 – 2022. Problematic opioid use is a significant problem in Ireland and across the globe. Opioids include drugs such as heroin, morphine, methadone, codeine, hydrocodone, fentanyl and tramadol. While some of these have valid medical purposes, their misuse as “street drugs” can lead to many health and social issues for users and society. This data will be used to compare trends in opioid use over time and inform government and policy makers regarding the scale of the problem. As measuring the prevalence of drug users is difficult, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) recommend the use of indirect methods such as the capture-recapture method to estimate the prevalence of high-risk drug users.","This research project aims to estimate the number of problem-opioid drug users in the Republic of Ireland from 2020 – 2022. Problematic opioid use is a significant problem in Ireland and across the globe. Opioids include drugs such as heroin, morphine, methadone, codeine, hydrocodone, fentanyl and tramadol. While some of these have valid medical purposes, their misuse as “street drugs” can lead to many health and social issues for users and society. This data will be used to compare trends in opioid use over time and inform government and policy makers regarding the scale of the problem. As measuring the prevalence of drug users is difficult, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) recommend the use of indirect methods such as the capture-recapture method to estimate the prevalence of high-risk drug users.","This research project aims to estimate the number of problem-opioid drug users in the Republic of Ireland from 2020 – 2022. Problematic opioid use is a significant problem in Ireland and across the globe. Opioids include drugs such as heroin, morphine, methadone, codeine, hydrocodone, fentanyl and tramadol. While some of these have valid medical purposes, their misuse as “street drugs” can lead to many health and social issues for users and society. This data will be used to compare trends in opioid use over time and inform government and policy makers regarding the scale of the problem. As measuring the prevalence of drug users is difficult, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) recommend the use of indirect methods such as the capture-recapture method to estimate the prevalence of high-risk drug users."]
[null,"Reason for seeking a Declaration","This is a retrospective observational study, using data previously collected by other agencies to perform statistical analysis and estimate the number of problematic opiate users in Ireland. The data collected includes demographic data such as participant name and date-of-birth which is required to match cases between the different registries and databases. \nA declaration is requested for UCC to obtain, match, consolidate the personal data. The personal data is subsequently fully anonymised before it is analysed. The consent declaration is requested as it is not considered feasible/practicable to obtain the explicit consent of participants for several reasons. The Applicant also stated that the nature of the capture-recapture method requires all individuals to be included.","To extend the duration of the consent declaration by 6 months to 31st December 2024","To extend the duration of the consent declaration by 10 yearsto 31st December 2034 to cover future waves/cohorts for the ‘Capture-Recapture study’."]
[null,"HRCDC Meeting Date","14th November 2024","20th May 2024","18th November 2024"]
[null,"HRCDC Decision Date ","14th November 2024","20th May 2024","18th November 2024"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. The transparency measures and PPI activities for this latest cohort study (i.e., 2020-2022 cohort) that have been outlined in the HRCDC application form, should be implemented/undertaken as soon as practicable and prior to the study commencing. With regards to the transparency measures to be implemented, they should clearly outline the rights of participants, including that their right to withdraw from this study is limited and why it is limited. [CONDITION MET]\n\nCondition 2. It is a condition that this declaration is not in effect until confirmation has been received by the HRCDC that the required data transfer agreements are in place between UCC (the data controller of the study) and the providers of the personal data. Linked to this full approval from the research ethics committee must also be in place and confirmation of this provided to the HRCDC. For the avoidance of doubt, no transfer of personal data can occur until the appropriate agreements and full REC approval are in place. [CONDITION MET]","N/A","Condition 1. The requisite data agreements/arrangements must be implemented prior to the transfer of data between the parties. Linked to this, full approval from the research ethics committee must also be in place for any future study waves/cohorts. Confirmation that agreements and REC approvals are in place for any future waves/cohorts is a reporting \nrequirement of the Annual Review; the consent declaration will not cover future waves if agreements and REC approval are not in place. \n\nCondition 2. Aligned with the original consent declaration, transparency measures are to be implemented for any future study waves/cohorts. Such measures should clearly outline the rights of participants, including that their right to withdraw from this study is limited and why it is limited. "]
[null,"Recommendation made","Recommendation 1. The Applicant/data controller is requested to review the security of the data transfer and storage methods to ensure they are sufficiently secure. [RECOMMENDATION CONSIDERED]\n\nRecommendation 2. The HRCDC positively notes the transparency measures that have been undertaken to date and the proposed measures that are to be undertaken. To further strengthen transparency for this study, the HRCDC recommends that the Applicant should explore the use ofadditional suitable transparency measures to inform participants and the public about this study and to enhance signposting to the study’s web pages on the UCC and drugsandalcohol.ie websites. For example, consideration should be given to utilising the social media platforms/websites of the data controller (UCC) as well as the Probation Service and the HSE. The Applicant is requested to report on this at the Annual Review.[RECOMMENDATION CONSIDERED]","N/A","N/A"]
[null,"Deadline for meeting Conditions","N/A","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made on 14th November 2023 and shall be valid for 6 months (until 31st May 2024) when the personal data is to be fully anonymised.\n(Note: If this study maybe repeated for future cohorts, the Applicant may submit an amendment request for consideration prior to the consent declaration expiring) (Amendment 31.12.2024)  Amendment until 31st December 2034","The approval to the Amendment is made commencing 20th May 2024 and shall be valid until 31st December 2024, an extension of the consent declaration previously made. - Amendment until 31st December 2034","The approval to the Amendment is made commencing 31st December 2024 and shall be valid until 31st December 2034, an extension of the consent declaration previously made. Note: The Applicant can apply for a future amendment to extend the duration of the consent declaration, prior to this declaration expiring on 31st December 2034."]
[null,"Status of Declaration","Declaration Live","Declaration Live","Declaration Live"]

{"sheet":"23-021-AF1","index":125,"n_rows":15,"n_cols":3,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Application Ref ID","23-021-AF1"]
[null,"Application Title ","Patient-Reported Outcomes in Cemented and Uncemented Total Hip \nReplacements"]
[null,"Applicant Organisation (Data Controller)","National Orthopaedic Hospital Cappagh (NOHC)\nNational Office for Clinical Audit (NOCA) @ RCSI"]
[null,"Lead Applicant ","James Cashman"]
[null,"Research Objective","The researchers aim to do a retrospective study looking at the Patient Related Outcome Measures (PROMs) in those that have undergone a hip replacement and compare the results between those who had a cemented implant vs those with a cement less implant. It seeks to use data that has been uploaded to the Irish National Orthopaedic Register (INOR). INOR uses two internationally recognised PROMs scoring tools. The Oxford Hip, which measures the pain and physical functioning, associated with the joint and the EQ5DL, which is a quality of life measurement-scoring tool. "]
[null,"Reason for seeking a Declaration","The data processing activities for this study is limited to extracting and fully anonymising the pre-existing register data for this study as follows:\n•\tNOCA, as the owners of the Irish National Orthopaedic Register (INOR) will extract the data required for this study from this register i.e., data of NOHC patients included in the register from whom their register consent is already provided. \n•\tNOCA will fully, irrevocably anonymise the extracted dataset. The extracted, fully anonymised dataset will then be transferred to NOHC for study analysis. The timeline of patient data to be extracted is from June 2019 to 31st December 2023.\nData on implants/patients from the National Orthopaedic Hospital Cappagh has been included on the register (INOR) since June 2019; patients have provided explicit consent with regards their personal data on the register. However, this register consent did not cover consent for research, including anonymising the data for research.\nSince 2022 all new implant patients have been asked for their separate consent to use their register data for research purposes. A process is also underway to seek retrospective research consent from those pre-existing patients who provided register consent between June 2019 to 2022.\nThe declaration is requested to cover patients from Cappagh Hospital who provided register consent between June 2019 to 2022, but where their research consent is not yet obtained (n= 3170). The Applicant outlines that it will not be possible or practicable to obtain the research consent of all these pre-existing patients prior to commencing this specific research study.\nIn addition, the Applicant notes that there may be rare cases where it is not possible to obtain research consent from a very small number of newly treated patients in Nov – Dec 2023 who are admitted outside the normal treatment pathway and therefore who may not yet provide their research consent prior to the study commencing (i.e., their research consent would be collected at the post-opt stage). The declaration is therefore also requested to cover these rare cases in November-December 2023."]
[null,"HRCDC Meeting Date","14th November 2024"]
[null,"HRCDC Decision Date ","14th November 2024"]
[null,"HRCDC Decision","Conditional Declaration"]
[null,"Specific Conditions attached ","Condition 1. The transparency measures outlined to the HRCDC should be implemented as soon \nas practicable and prior to the data being extracted and fully anonymised. It is important to ensure that the transparency measures provide clear information on the purpose of the study, data protection rights and how a participant can request to withdraw/opt-out from the study. It is also important to ensure that participants are given sufficient opportunity to withdraw/opt-out. \n\nCondition 2. Up until the point where the extraction and anonymisation of the data occurs in early 2024, the Applicant/data controllers should ensure (i) that research consent of the 2019-2022 patients who may be attending clinical follow-up during this period should still be sought and (ii) strong efforts should be made to obtain the post-opt research consent of the Nov-Dec 2023 patient cohort. On point (ii) the Applicant/data controller is also requested to report on the numbers within this November – December 2023 cohort whose consent for research was and was not obtained at the annual review."]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 14th November 2023 and shall be valid until 29\nth February 2024, when the anonymisation is expected to be fully completed."]
[null,"Status of Declaration","Declaration Expired"]

{"sheet":"23-023-AF1","index":126,"n_rows":15,"n_cols":4,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-023-AF1","23-023-AF1/AMD1"]
[null,"Application Title ","Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation – the STEPCARE trial","Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation – the STEPCARE trial"]
[null,"Applicant Organisation (Data Controller)","Helsingborg Hospital","Helsingborg Hospital"]
[null,"Lead Applicant ","Alistair Nichol","Alistair Nichol"]
[null,"Research Objective","Cardiac arrests (where a person’s heart stops beating) outside of hospital affect around 300,000 people each year in Europe. Patients who are in ICU after a cardiac arrest will have many of the normal functions of their body managed by doctors, aiming to keep their measurements within a certain range. However, we don’t know exactly what these measurements should be. This trial aims to test how best to control three important measurements in ICU to decide which is best for patients. These are: 1. How deeply the participant is kept asleep (sedated) 2. How warm or cold they should be 3. What their blood pressure should be The study will be open to unconscious ICU adult patients who have had an out-of-hospital cardiac arrest, and their heart has started pumping again. Eligible patients will be allocated at random to receive care which will test a combination of these 3 factors.","Cardiac arrests (where a person’s heart stops beating) outside of hospital affect around 300,000 people each year in Europe. Patients who are in ICU after a cardiac arrest will have many of the normal functions of their body managed by doctors, aiming to keep their measurements within a certain range. However, we don’t know exactly what these measurements should be. This trial aims to test how best to control three important measurements in ICU to decide which is best for patients. These are: 1. How deeply the participant is kept asleep (sedated) 2. How warm or cold they should be 3. What their blood pressure should be The study will be open to unconscious ICU adult patients who have had an out-of-hospital cardiac arrest, and their heart has started pumping again. Eligible patients will be allocated at random to receive care which will test a combination of these 3 factors."]
[null,"Reason for seeking a Declaration","The consent declaration is sought to process the personal data ofparticipants who will lack decision-making capacity to provide consent due to the nature of their illness for the purpose of the main STEPCARE study (processing includes collection, transfer, \nanalysis, storage of data). Deferred proxy assent will be obtained in such circumstances, including deferred assent by telephone.The study also seeks to collect bio samples and associated data for future bio-marker sub-studies. In addition, to data processing for the \nmain STEPCARE trial, the scope of the declaration will cover thesubsequent storage of data, including storage of data only for future biomarker sub-studies; however, the declaration will not extend to further processing of those who lack capacity for bio-marker sub\u0002studies; an amendment request or new application will be required.","1. A change to the study protocol involving the collection and storage of additional blood samples and the associated data for the optional biomarker sub-study. These additional samples and associated data will be collected from those who are consented/assented into the optional biomarker sub-study. Note: the additional samples are limited to blood samples only. \n2. A change in what may happen with regards continued processing of data if proxy assent is withdrawn, subject to the what is selected by the proxy i.e. there is a new withdrawal form which provides new options on what will happen the data if the proxy/participant withdraws – this includes continuing to collect further follow-up data post-withdrawal, as well as continuing to process the data already collected."]
[null,"HRCDC Meeting Date","12th December 2023","17th April 2025"]
[null,"HRCDC Decision Date ","12th December 2023","17th April 2025"]
[null,"HRCDC Decision","Conditional Declaration","Amendment Approved"]
[null,"Specific Conditions attached ","Condition 1. Where proxy assent/participant consent is withdrawn or is refused and the study wishes to continue to process the data already collected, then permission for this must be obtained and recorded from the proxy or participant, whichever is relevant. If such permission is obtained from the proxy on behalf of a participant who lacks decision-making capacity, then participant consent to continue must also be obtained for this continued data processing when they regain decision-making capacity.\n\nCondition 2. The Applicant is requested to report in the Annual Review on the PPI activities to beundertaken. It is noted that the responses provided to the HRCDC stated ‘this study will be discussed with the ICC CTN PPI group at their meeting’.","N/A"]
[null,"Recommendation made","Recommendation 1. The terms in the study documents ‘If there is no known objection by your relative being in this study’ and ‘Do you have any objection to your relative taking part…’ should be amended to be more positively phrased to ask the person providing proxy assent if they thought the participant would like to or be willing to be included in this research. The Applicant is requested to amend these terms in the study documentation at the earliest opportunity.","N/A"]
[null,"Deadline for meeting Conditions","N/A","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 12th December 2023 and shall be valid until 31st January 2028 and for 15 years thereafter until 31st January 2043 or until the personal data is deleted or fully anonymised or participant consent is obtained, whichever occurs first.","The approval to the Amendment is made commencing 17th April 2025 and shall be valid until 31st January 2043, in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live","Declaration Live"]

{"sheet":"23-024-AF1","index":127,"n_rows":15,"n_cols":5,"rows_kept":15,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Application Ref ID","23-024-AF1",null,"23-024-AF1/AMD1"]
[null,"Application Title ","Platform of Randomized Adaptive Clinical Trials in Critical Illness (PRACTICAL) Randomized Controlled Trial",null,"Platform of Randomized Adaptive Clinical Trials in Critical Illness (PRACTICAL) Randomized Controlled Trial"]
[null,"Applicant Organisation (Data Controller)","University Health Network",null,"University Health Network"]
[null,"Lead Applicant ","Alistair Nichol",null,"Alistair Nichol"]
[null,"Research Objective","Acute hypoxemic respiratory failure (AHRF) is a type of lung failure, usually caused by problems with heart and lung conditions preventing the lungs from working as they should. AHRF is a common, life-threatening condition associated with significant risk of death and disability. Patients who develop AHRF usually need machines to support their lungs, including mechanical ventilation where a machine is breathing for the patient. Mechanical ventilation and intensive care treatment can itself cause lung problems and infections. Doctors are interested in more effective ways to treat AHRF. In this study, multiple different potential treatments will be tested, to investigate the best strategy to treat people with this disorder. This will include different mechanical ventilation settings, which may reduce the damage this process can have on the patient and help them recover quicker.",null,"Acute hypoxemic respiratory failure (AHRF) is a type of lung failure, usually caused by problems with heart and lung conditions preventing the lungs from working as they should. AHRF is a common, life-threatening condition associated with significant risk of death and disability. Patients who develop AHRF usually need machines to support their lungs, including mechanical ventilation where a machine is breathing for the patient. Mechanical ventilation and intensive care treatment can itself cause lung problems and infections. Doctors are interested in more effective ways to treat AHRF. In this study, multiple different potential treatments will be tested, to investigate the best strategy to treat people with this disorder. This will include different mechanical ventilation settings, which may reduce the damage this process can have on the patient and help them recover quicker."]
[null,"Reason for seeking a Declaration","The consent declaration is requested for the processing of personal data of those who lack decision-making capacity. Data processing includes access, collection, transfer, analysis, storage. Data in Ireland will be transferred to parties outside the state, including the Sponsor and other named data processors.",null,"To add the Mater Hospital as a new site/data processor to the study"]
[null,"HRCDC Meeting Date","30th January 2024",null,"31st October 2024"]
[null,"HRCDC Decision Date ","30th January 2024",null,"31st October 2024"]
[null,"HRCDC Decision","Conditional Declaration",null,"Amendment approved"]
[null,"Specific Conditions attached ","Condition 1. St Vincent’s Hospital must, alongside the data controller, the University Health Network, be responsible for the implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participant if a participant has queries or otherwise wishes to exercise their rights.\n\nCondition 2. The necessary data agreements and arrangements must be in place between the parties involved in the study prior to the sharing/transfer/disclosure of personal data. This includes the necessary data controller/data processor agreements in addition to the necessary agreements that need to be in place to share personal data to parties outside the EEA. [CONDITION UNDERWAY]\n\nCondition 3. The responses from the Applicant stated that the data will be fully anonymised after 20 years but also states ‘where under sponsor’s instructions the data will be destroyed’. It is not clear if this statement on destroying the data under the sponsor’s instructions means (i) destroying personal identifiable data to fully anonymise the dataset (ii) destroying all the data such that no data is archived or (iii) destroying the anonymised data at a later point in time. The Applicant is requested to provide clarity on this matter when confirming acceptance or otherwise of this consent declaration. [CONDITION MET]\n\nCondition 4. The feedback from the data controller’s data protection officer on the DPIA is to be submitted as soon as practicable and within 2 months. The transfer of personal/pseudonymised data cannot commence until the DPO feedback has been provided. In addition, it is noted that the DPIA submitted identified data protection risks but did not include corresponding mitigating actions. This section of the DPIA should be addressed and an update also provided within 2 months. [CONDITION MET]\n\n","Condition 5. It is acknowledged that PPI engagement is pending, with the study to be discussed with the ICC-CTN PPI group at the next meeting. The study is requested to report on this PPI engagement as part of the Annual Review, including on the feedback that was received and how it was taken on board. [CONDITION UNDERWAY]\n\nCondition 6. Where proxy assent/participant consent is withdrawn or is refused and the study wishes to continue to process the data already collected, then permission for this must be obtained and recorded from the proxy or participant, whichever is relevant. If such permission is obtained from the proxy on behalf of a participant who lacks decision-making capacity, then participant consent to continue must also be obtained for this continued data processing when they regain decision-making capacity. It should also be outlined to individuals when it may no longer be possible to remove the data (i.e., not possible to remove it from interim analysis but can be removed from future analysis). [CONDITION UNDERWAY]\n\nCondition 7. The Applicant is requested to amend the study information leaflets and assent/consent forms as follows, at the earliest opportunity:\noThe study information leaflets should clearly outline the parties involved in this study who are involved in the processing of data and their role in this research, including those based outside of Ireland (i.e., the data controller/sponsor and the data processors who were named as part of the HRCDC application and named in the scope section of the decision letter)\noThe section in the information leaflets on sharing/disclosing data with the HSE ‘other third parties’ should be reviewed and amended to provide clearer information on who or what is meant by these very broad categories of third parties (i.e., ‘relevant industry bodies’, ‘external professional advisors’, others were permitted by law’ etc.) and why personal data may be shared with them, whether the third party is involved in statutory oversight or regulation of the study, or another separate matter. The accompanying proxy assent and participant consent forms should also include clearer options on sharing/disclosing data with other such third parties that aligns with the amended information leaflets. [CONDITION UNDERWAY]","Condition 1. It is noted that Condition 7 attached to the original consent declaration on changes/amendments to the PILs has not yet been fully addressed. The outstanding changes to the study documents outlined in Condition 7 for both the Mater Hospital and St Vincent University Hospital sites must be fully implemented by 31st January 2025 i.e., the due date of the Annual Review.\n\nCondition 2. The requisite data agreements/arrangements between the data controller and the Mater Hospital must be in place prior to any data transfer/processing occurring from this site. "]
[null,"Recommendation made","Recommendation 1. The lawful basis for processing personal data that is referenced in the DPIA does not align with the basis noted to the HRCDC (i.e., ‘public interest’ and ‘scientific research’). The Applicant is asked to address this inconsistency in the DPIA.\n\nRecommendation 2. The Applicant is requested to amend the study information leaflets and assent/consent forms as follows at the earliest opportunity:\noThe proxy assent documents use both ‘relative’ and ‘person responsible’ as interchangeable terms. The document should be consistent in the terms used and therefore use only one term.\noThe statement ‘If there is no known objection by your relative to be included’ should be more positively rephrased to ask if they thought the participant would wish to be included in this research study.\noPermission to use the personal data in future research studies is requested (e.g., participant consent form). The study documents should provide the individual with sufficient information and options to understand how the personal data might be used for future research. Please refer to Section 2.3. of the HSE Consent Policy for Health and Social Care Research that provides information to researchers when seeking broad consent for future research. As a general point, researchers need to ensure that any consent obtained for the future use of data from is compliant with data protection legislation.\n(Note: the proxy assent form also refers to data processing for future research purposes. As has been noted previously, proxy assent and a consent declaration does not cover data processing in future research but can cover the storage only of the personal data for potential future research).",null,"N/A"]
[null,"Deadline for meeting Conditions","Condition 4: DPO Feedback 7th April 2024 [MET]",null,"Condition 1. 31st Jan 2025"]
[null,"Duration of Declaration ","The Declaration is made commencing 30th January 2024 and shall be valid until 31st January 2046 (i.e., for the duration of the study plus 20 years archiving), or until the personal data is fully anonymised or deleted, or explicit consent is obtained from all participants.",null,"The approval to the Amendment is made commencing 31st October 2024 and shall be valid until 31st January 2046 (i.e., for the duration of the study plus 20 years archiving), in line with the duration of the consent declaration made."]
[null,"Status of Declaration","Declaration Live",null,"Declaration Live"]

{"sheet":"24-001-AF1","index":128,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Research Objective","Using a pre-existing platform, the MALDI-TOF MS, which is widely available and used by many laboratories for identifying microorganisms, we intend to investigate its ability to identify toxin producing strains of S.aureus (a common skin organism that can cause severe and invasive infections), and then correlate this with patient demographics, site of infection and outcome, principally mortality.","Using a pre-existing platform, the MALDI-TOF MS, which is widely available and used by many laboratories for identifying microorganisms, we intend to investigate its ability to identify toxin producing strains of S.aureus (a common skin organism that can cause severe and invasive infections), and then correlate this with patient demographics, site of infection and outcome, principally mortality."]
[null,"Reason for seeking a Declaration","The consent declaration is requested for the processing of personal data (collection, transfer, analysis etc) without the explicit consent of the participant for the duration of the study; the data is confirmed as pseudonymised during the study. \nThe personal data to be processed has already been collected as part of patient care and treatment and includes data associated with/generated from the bio samples/isolates that were also collected as part of patient care and treatment. The study will involve the data of up to 300 patients. ","To extend the duration of the consent declaration by 2 months i.e., 31st August 2024."]
[null,"Specific Conditions attached ","Condition 1. \n• Engagement with public, patient and carer involvement (PPI) representatives must occur prior to the commencement of this study. PPI engagement should discuss and seek feedback on matters that may arise given this study will not seek to obtain participant consent. Importantly, PPI engagement should also discuss and seek feedback on how transparency measures for this study can be best developed so that participants who may be included in the study can be informed about this research, the use of their data and samples and how they can request to be withdrawn from the study. For example, the Applicant is requested to discuss other transparency measures with the PPI representatives that are beyond the hospital posters to include other methods such as the CUH website, social media accounts etc. Information provided on the transparency measures should be presented in a lay person language.\n• The transparency measures, including those beyond the hospital posters, must be in place prior to the study commencing. \nThe Applicant is requested to report on the PPI engagement activities within 2 months, including on what other transparency measures will be undertaken.\n\nCondition 2. Where a participant contacts the researchers and wishes to have their data deleted from the study, then this should occur wherever this is possible and practicable, subject to any GDPR derogations that may apply. A consent declaration cannot override the decision of a particiapnt to withdraw from the study.\n\nCondition 3. Appropriate data agreements must be in place between the data controller of the study (CUH) and the data processor (UCC) with regards this study. Data cannot be transferred between these parties prior to the necessary agreements being in place.","N/A"]
[null,"Recommendation made","N/A","N/A"]

{"sheet":"24-002-AF1","index":129,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Research Objective","Brain injury which occurs due to trauma is a leading cause of death/disability and particularly affects young people. After the primary brain injury, additional brain damage often occurs, which can significantly affect patient survival/disability. The brain requires a continuous adequate supply of oxygen. Patients who die/have significant disability after a traumatic brain injury often have had low levels of oxygen in the brain. There are common interventions that can normalise the brain oxygen levels. However, none of the standard monitoring devices routinely used in the intensive care unit (ICU) measure brain oxygen levels. In the BONANZA study patients’ brain oxygen levels are monitored and when a low level of oxygen is detected, we provide treatments in an attempt to bring the brain oxygen levels back to normal. We believe this close monitoring and ICU intervention to improve brain oxygen levels will reduce the amount of death/disability 6 months after injury.","Brain injury which occurs due to trauma is a leading cause of death/disability and particularly affects young people. After the primary brain injury, additional brain damage often occurs, which can significantly affect patient survival/disability. The brain requires a continuous adequate supply of oxygen. Patients who die/have significant disability after a traumatic brain injury often have had low levels of oxygen in the brain. There are common interventions that can normalise the brain oxygen levels. However, none of the standard monitoring devices routinely used in the intensive care unit (ICU) measure brain oxygen levels. In the BONANZA study patients’ brain oxygen levels are monitored and when a low level of oxygen is detected, we provide treatments in an attempt to bring the brain oxygen levels back to normal. We believe this close monitoring and ICU intervention to improve brain oxygen levels will reduce the amount of death/disability 6 months after injury."]
[null,"Reason for seeking a Declaration","The consent declaration is requested for the processing of personal data for this specific study (i.e., collection, transfer, analysis, storage) of the participants as they will lack decision-making capacity. The patient population for BONANZA are those who have suffered a severe traumatic brain injury, and as such will lack capacity to give informed consent on enrolment into the trial due to injury sustained. \nA process of deferred proxy assent will be implemented; due to the emergency nature of the study, it will not be possible to obtain proxy assent before study enrolment/data processing. Deferred proxy assent will be obtained as soon as possible and consent to continue will be sought from the participant if they regain capacity.","To add UCD as a data processor to the study. UCD will now be providing study support; specifically, UCD will now be undertaking the outcome assessments which were originally to be undertaken by the Irish site, Beaumont Hospital. \n\nAn additional option on what may may happen further data processing upon withdrawal from the study; specifically, that follow-up data could still be collected and processed after study withdrawal. (Note: This new option to continue collecting follow-up data after a participant is withdrawn is only covered if proxy assent is provided for this via the withdrawal form. Where proxy assent is provided for this, then, where practicable, participant consent should also be sought for this if they regain capacity)."]
[null,"Specific Conditions attached ","Condition 1. The Irish hospital sites, Beaumont Hospital, with the data controller Monash \nUniversity, are responsible for the implementation of and compliance with the consent declaration \nand data protection requirements; there should also be a point of contact in Ireland for participant \nif a participant has queries or otherwise wishes to exercise their rights.\n\nCondition 2. The required data agreements and arrangements must be in place for this study. \nFurther, the necessary agreements/arrangements must be implemented for transferring data \noutside the EEA (e.g., Standard Contractual Clauses) and a Transfer Impact Assessment must also \nbe completed. Please also discuss these matters with the relevant data protection officer. The \ntransfer of data between parties cannot occur prior to the necessary agreements being in place \nand required assessments being undertaken. [CONDITION MET]\n\nCondition 3. If deferred proxy assent and/or participant consent to continue is refused or \nwithdrawn, then permission must still be sought from the proxy or participant to continue to \nprocess the personal/pseudonymised data already collected. If such permission is provided by the \nproxy, then consent should still be sought form the participant if they regain decision-making \ncapacity.\n\nCondition 4. The Applicant is requested to inform the HRCDC in the Annual Review on whether \nnormal clinical practice within Beaumont Hospital changes i.e., the percentage of patients receiving \nbrain oxygen monitoring as part of normal care changes.","Condition 1. Appropriate data agreements/arrangements must be in place with UCD."]
[null,"Recommendation made","Recommendation. The HRCDC requests that the study information leaflets, and assent/consent \nforms are reviewed and amended as follows:\no It should be made clear to the participant whether their treatment has already been completed \nby the time they are asked to provide consent.\no Consider whether further information on the personal data to be processed for this study can \nbe outlined. \no The legal basis outlined for processing personal data is confusing and appears to combine two \nseparate legal bases: the PILs currently state ‘Legitimate public interest’ which appears to \ncombine the ‘public interest’ and ‘legitimate interest’ bases. \no The phrase ‘are you aware of any objections your relative had to being included…’, should be \nmore positively rephrased to ask the proxy if they believed the individual would wish to be \nincluded in this study.\no The proxy information documents refer to seeking assent from the proxy to for their relative to \nbe contacted by the researchers as part of this research study. Relative assent should not be \nrequired for the study to contact the participant and therefore such references should be \nremoved.\no The use of the terms ‘optimisation; and ‘standard’ strategy in the study documentation to \ndescribe the two different intervention groups may cause confusion for the proxy and \nparticipant and should be amended to use more lay-person language. \no References to brain oxygen monitoring being part of normal or standard patient care in \nBeaumont Hospital should be removed or amended considering the information provided to \nthe HRCDC by the Applicant on this issue. [RECOMMENDATION CONSIDERED]","N/A"]

{"sheet":"24-003-AF1","index":130,"n_rows":5,"n_cols":5,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Most ICU patients who need a breathing machine (ventilator) to help them breathe require sedation with one or more sedative (calming) drugs, given as continuous drip into a vein. Currently, there is no agreement amongst doctors around the world about the best choice of sedative drug or the best way to manage sedation. Many of the commonly used sedative drugs have side effects and are thought to be associated with longer time on the ventilator, longer stay in the ICU, leading to delirium (a confused state often including hallucinations) and decreased mental awareness after recovery from critical illness. Dexmedetomidine is a commonly used sedative drugs that can be used alone or in combination, to keep ICU patients comfortable while on a ventilator. The purpose of this study is to evaluate dexmedetomidine, which might improve survival and recovery for older patients who require sedation in ICU."]
[null,"Reason for seeking a Declaration","The patient population for SPICE IV are those who are experiencing critical illness and are unconscious, and as such will lack capacity to give informed consent on enrolment into the trial. All patients who will be eligible for participation will be unconscious and receiving ICU treatment and will be unable to participate in the informed consent process. \nThe consent declaration is therefore requested to process the personal data (collection, transfer, analysis, storage etc.) of participants recruited to SPICE IV who lack capacity, for the purpose of this specific study. "]
[null,"Specific Conditions attached ","Condition 1. The Irish hospital sites must, together with the data controller Monash University,\nbe responsible for the implementation of and compliance with the consent declaration and data \nprotection requirements; there should also be a point of contact in Ireland for participant if a \nparticipant has queries or otherwise wishes to exercise their rights.\n\nCondition 2. The required data agreements and arrangements must be in place for this study. \nFurther, the necessary agreements/arrangements must be implemented for transferring data \noutside the EEA (e.g., Standard Contractual Clauses) and a Transfer Impact Assessment must also \nbe completed. The transfer of data between parties cannot occur prior to the necessary \nagreements being in place and required assessments being undertaken.","Condition 3. \n• On the references to future research included in the proxy assent documentation, the current text outlined in the documentation should be amended to the following: ‘If my relative does not regain decision-making capacity, I give assent for my relative’s material/data to be stored/used for XXX years for possible future research only related to the current study without further assent being required but only if the research is approved by a Research Ethics Committee and the Health Regulation Consent Declaration Committee (HRCDC) if required’. \n• The participant study information leaflet refers to obtaining personal data from the patient’s Fit Bit device, however no other references to this are made in the HRCDC application form or in the proxy information leaflet. The Applicant should review the study information leaflets to ensure they are aligned on whether Fit Bit data is used or not. If it is not used, then this reference should be deleted. \n• The Applicant should re-visit the relevant conditions attached to consent declarations made in the previous year for their other similar ICU studies to identify changes to PILs that are also applicable to the SPICE IV study. These changes include the following: \no More positively rephase text such as ‘if there is no known objection’ or ‘are you aware of any objections…’ to more positively to ask the proxy if they believed the individual would wish to be included in this study. \no References in the study documentation on sharing/disclosing personal data (including pseudonymised data) to third parties such as relevant industry bodies should be reviewed and amended to provide clearer information on who or what is meant by these third-party categories, what personal data may be shared with them and the reasons why. Where personal data is shared with third parties such as industry bodies, the accompanying proxy assent and participant consent forms should also include clear options on sharing/disclosing personal/pseudonymised data to third parties. \nThe changes to the study documentation should be made as soon as possible in advance of the study commencing. The applicant is requested to report on this condition within 3 months.\n\n","Condition 4. Where an individual withdraws from the study and the researchers wish to continue to process the personal data already obtained, then permission for this must be obtained from the proxy and recorded. In addition, consent to continue from the participant when they regain decision-making capacity should also be obtained for this continued processing (Please also see Recommendation 1)."]
[null,"Recommendation made","Recommendation. The text in section 11 of the study information leaflets on study withdrawal, does not fully align with the replies provided to the HRCDC on study withdrawal and the deletion of data i.e., it is not fully clear that where there is a request to withdraw, that the study will discuss options with the proxy/ participant and ask their will and preferences on what they wish to happen to the data already collected. It was also commented by the HRCDC that the language used in this section of the PIL is quite legalistic. It is important to ensure that the individual clearly understands that the personal data can still be deleted prior to analysis and that options on what will happen the data will be discussed with them 1 The amendment request application form and accompanying guidance (including examples when an amendment should be submitted) can be found at: https://hrcdc.ie/apply/#b-3. Applicants are also encouraged to contact the Secretariat prior to submitting an amendment request for HRCDC consideration. Page 4 of 4 at the point of withdrawal. The Applicant is therefore requested to review and amend the above text in the study information leaflet, to ensure that it is clear."]

{"sheet":"24-004-AF1","index":131,"n_rows":5,"n_cols":5,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Research Objective","Acral melanoma including acral lentiginous melanoma (ALM) is an aggressive subtype of cutaneous melanoma arising on the palms, soles or around the nails. It is the least common subtype of melanoma diagnosed overall, accounting for 2–3% of melanoma diagnoses. Compared with other subtypes of melanoma, most studies suggest that acral melanoma has a poorer prognosis, with diagnosis often occurring at a more advanced clinical stage. Many factors contribute to this including the propensity of this subtype of melanoma to affect areas not commonly examined by the patient or doctor and lesions mis-diagnosed as another pathology such as trauma, fungal infection or vascular ulcer. Furthermore, ALM has a disproportionately higher incidence in non-white patients compared to other melanoma subtypes. Reduced awareness of melanoma risk in non-white populations contributes to delayed diagnosis. This study aims to examine patient characteristics, tumour features, disease course and survival patterns of patients diagnosed with this rare and aggressive subtype of melanoma.",null,"Acral melanoma including acral lentiginous melanoma (ALM) is an aggressive subtype of cutaneous melanoma arising on the palms, soles or around the nails. It is the least common subtype of melanoma diagnosed overall, accounting for 2–3% of melanoma diagnoses. Compared with other subtypes of melanoma, most studies suggest that acral melanoma has a poorer prognosis, with diagnosis often occurring at a more advanced clinical stage. Many factors contribute to this including the propensity of this subtype of melanoma to affect areas not commonly examined by the patient or doctor and lesions mis-diagnosed as another pathology such as trauma, fungal infection or vascular ulcer. Furthermore, ALM has a disproportionately higher incidence in non-white patients compared to other melanoma subtypes. Reduced awareness of melanoma risk in non-white populations contributes to delayed diagnosis. This study aims to examine patient characteristics, tumour features, disease course and survival patterns of patients diagnosed with this rare and aggressive subtype of melanoma."]
[null,"Reason for seeking a Declaration","To process personal data provided by the National Cancer Registry Ireland (NCRI) of patients from 1994-2022 for this specific study (i.e., obtaining, sharing, analysis etc.) \nPatients include those diagnosed with acral melanoma and those diagnosed with other subtypes of melanoma The Applicant states that given the significant time period being studied, it will not be possible or practical to obtain explicit consent from all data subjects. The dataset requested from NCRI is considered pseudonymised.",null,"An extension of the consent declaration to 31st March 2025."]
[null,"Specific Conditions attached ","Condition 1. The study must ensure that it logs all the personnel who will be accessing the \npseudonymised data for this study. In addition, it was discussed that study personnel, such as the \nPrincipal Investigator may not be permanent staff at UHL; therefore, the study team and data \ncontroller need to have responsibilities defined, should the PI not be available to destroy or return \nthe personal data once the study ends. \n\nCondition 2. The necessary data sharing agreements must be in place between UHL and NCRI; the agreement should also set out the roles and responsibilities of each party with regards the process for withdrawing a participant from the study. Data cannot be transferred prior to the agreement being in place.","Condition 3. The Applicant/data controller is requested to strengthen the level of public and patient involvement for this study through discussions with relevant cancer patient and cancer research groups. PPI discussions should consider matters such as the study transparency measures. PPI engagement should occur prior to the study commencing. Please report on this condition within 2 months.\n\nCondition 4. The transparency measures outlined by the Applicant should be implemented prior \nto the study commencing. The transparency measures must also make it fully clear on how \nparticipants can request to be withdrawn from the study and have their data removed, including \ncontact details. It should also be outlined at what point in the study participant withdrawal would \nno longer be possible. Please provide an update on this condition within 2 months. \n\n\nCondition 5. In the Annual Review, the Applicant is requested to report on the total number of \nparticipants included in this study from the time period covered by this study; this includes those \nwith Acral Melanoma and the comparator/matching cohort of patients. It should also be reported \nwhether the personal/pseudonymised data was destroyed or returned to NCRI after the end of this \nstudy.","n/a"]
[null,"Recommendation made","N/A",null,"n/a"]

{"sheet":"24-005-AF1","index":132,"n_rows":5,"n_cols":5,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1"]
[null,"Research Objective","This clinical pilot aims to test the feasibility of lung cancer screening in Ireland. Current/former smokers aged 55-74 years old, are at greater risk of developing lung cancer (LC). In Ireland, ~2,690 people are diagnosed with LC every year, of which 2/3 will die of the disease. As 8/10 are diagnosed with advanced LC, the goal of this study is to identify lung cancer early, in people without symptoms. Participant selection is based on age, smoking history, and relevant medical history. Participants will have a ‘lung health check’ including: a breathing test, low-dose chest CT scan, and smoking cessation education. The purpose of the chest CT is to pick up lung cancer at an early stage. Earlier detection of lung cancer improves survival, and likelihood of treatment. The lung health check pilot will be delivered by community-based mobile unit in North Dublin/North East, in line with international recommendations.",null,"This clinical pilot aims to test the feasibility of lung cancer screening in Ireland. Current/former smokers aged 55-74 years old, are at greater risk of developing lung cancer (LC). In Ireland, ~2,690 people are diagnosed with LC every year, of which 2/3 will die of the disease. As 8/10 are diagnosed with advanced LC, the goal of this study is to identify lung cancer early, in people without symptoms. Participant selection is based on age, smoking history, and relevant medical history. Participants will have a ‘lung health check’ including: a breathing test, low-dose chest CT scan, and smoking cessation education. The purpose of the chest CT is to pick up lung cancer at an early stage. Earlier detection of lung cancer improves survival, and likelihood of treatment. The lung health check pilot will be delivered by community-based mobile unit in North Dublin/North East, in line with international recommendations."]
[null,"Reason for seeking a Declaration","To meet the target of 2138 participant lung checks in this pilot, 30,000 patients aged between 55-74 years from Centric Health Network GP practices will need to be contacted to determine their eligibility. Given this high number of potential participants who will need to be contacted, an external vendor with the requisite staffing and infrastructure will be employed to do this contact and pre-screening work; the sharing and processing of personal data (i.e., contact information) to and by this external vendor to contact patients will be undertaken without initial patient consent. \nThe consent declaration is therefore requested to only cover obtaining and using personal data from the GP records to contact potential participants to assess their suitability for participation in this pilot",null,"An extension of the declaration until December 2026."]
[null,"Specific Conditions attached ","Condition 1. In the interest of transparency, the invitation letter should be amended to make it fully clear that this invite is being issued by the named 3rd party contractor on behalf of (or in collaboration with) the patient’s GP; accordingly, the details and role of the 3rd party contractor should be clearly noted in the letter. The invitation letterhead must be amended to include the third-party contractor and, if also useful, consider including the research team and Centric Health. [CONDITION MET]\n\nCondition 2. It is noted that while a potentially eligible patient may invite a family member or friend to support them during the pre-screening and verbal consent call, the study must ensure that the patient has decision making capacity and that verbal consent is provided by them at the point of the pre-screening call. Verbal consent should not be provided by a relative or friend on behalf of a patient who lacks decision-making capacity. If there is a question on the patient’s capacity at the point of seeking verbal consent, then verbal consent should not be obtained from the patient. It should be ensured there are processes in place to ensure that verbal consent is obtained from the patient.  [CONDITION MET]\n\nCondition 3. The documentation used to obtain written consent from the patient for the lung health screening when they attend the screening unit, should remove the references to providing optional samples/data for a separate biorepository for future research. This must be implemented prior to the start of the lung health check screening and confirmation of this provided to the HRCDC.  [CONDITION MET]","Condition 4. The Lung Health Check script notes the following under ‘verbal consent’: ‘Can I check you are happy to proceed and give your consent for me to collect the answers to the questions and record them as part of the study’. The Applicant is requested to review and amend the verbal consent script so that it provides much more detailed information on what the patient is being asked to consent to, and to ensure informed verbal consent is being obtained for the applicable study activities; i.e., the participant is being asked to provide verbal consent for the pre-screening/eligibility assessment and the associated processing of their personal data for this activity. Linked to this, it is noted that the verbal consent script does not provide any information on data sharing with SOLACE and therefore this must also be addressed as part of this condition when amending the verbal consent script, so that informed verbal consent for this activity is also obtained. The verbal consent script must be amended as above prior to the pre-screening phone calls commencing.  [CONDITION MET]\n\nCondition 5. The required data agreements and arrangements must be in place between the parties involved in this pilot screening study; this includes agreements with the 3rd party contractor. The patient contact information that is the subject of this declaration, should also not be retained by the 3rd party contractor beyond the period needed to contact patients to determine \ntheir eligibility for the pilot screening; the data agreement/arrangements between the data controllers of the study and the 3rd party contractor should therefore cover the return of or destruction of this data.   [CONDITION MET]\n\nCondition 6. An authorised signature on the HRCDC application and data protection officer feedback on the DPIA from RCSI must be submitted before the study commences, or at minimum within 2 months. A signature and DPO feedback are required from each joint data controller of the study  [CONDITION MET]","Condition 1: REC approval must be in place if the study wishes to contact the entire cohort."]
[null,"Recommendation made","Recommendation 1. To help potentially improve the take-up of the calls by patients, the letter could provide patients with the phone number that will be contacting them to conduct the pre\u0002screening call.\n\nRecommendation 2. The study should record whether a patient is being supported by a relative or friend during the verbal consent process and pre-screening phone call.",null,"N/A"]

{"sheet":"24-006-AF1","index":133,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Pregnancy-associated blood clots, also called venous thromboembolism (VTE), are the leading cause of direct maternal death in Ireland and the UK. Current clinical guidelines recommend that women who have an elevated risk of VTE during pregnancy or after childbirth should receive anticoagulant medication. Achieving universal VTE risk assessment is a challenge in busy postnatal environments. Despite the terrible impact of VTE, compliance with VTE prevention strategies in Irish maternity units was shown to be sub-optimal. There was a clear demand for a more streamlined approach to VTE prevention at a national level. In 2014, a multidisciplinary team in the Rotunda Hospital developed an electronic risk assessment tool called ‘Thrombocalc’ which calculates a simple risk score and makes recommendations on thromboprophylaxis based on each woman’s individual VTE risk factors. Thrombocalc is a tangible solution to a common problem. Through collaborative research and quality improvement, Thrombocalc was embedded in routine care. Through this research the Applicant wants to find out exactly how much the electronic tool, Thrombocalc, reduces the number of people who develop a blood clot after pregnancy. They also want to refine the current tool to ensure they are using the best way to estimate a person’s risk of developing a blood clot in the 6 weeks after pregnancy. This information will help show how best to prevent blood clots after a baby is born. To do this the study needs to compare how many women had a blood clot before Thrombocalc was introduced into the Rotunda Hospital and how many women had a blood clot after Thrombocalc was introduced. To do the second, the study needs to look at all of the risk factors that each woman had, and to use this data to build a good “model” using statistical techniques that will allow them to predict her risk of a blood clot. This will be the first time that this will have been done with such high-quality data. It is often difficult to find out exactly how many women get blood clots after they leave the hospital with their baby. This research will use 3 ways of finding out this information; (1) Using scan results which were used to diagnose the blood clot, (2) Using records collected by the hospital called Hospital In-patient Enquiry (HIPE) records, which are reported to the Health Service Executive (HSE) and (3) Using the patient’s individual medical chart.  The findings from this research will be used to deliver the right treatment to the right patient, preventing dangerous blood clots in those who are at risk and avoiding unnecessary blood thinner injections in those who don’t need it."]
[null,"Reason for seeking a Declaration","A consent declaration is requested due to the large number of patients involved in this study, estimated at >70,000 and the time period that is covered; the Applicant outlined that it is not practicable or feasible to obtain the explicit consent of the participants for these reasons. "]
[null,"Specific Conditions attached ","Condition 1. The required data agreements and arrangements for the transfer and processing of \npersonal/pseudonymised data must be in place; data cannot be transferred until such \nagreements/arrangements are in place.\n\nCondition 2. The transparency measures should be in place prior to the study commencing.\n\nCondition 3. The Applicant must report in the Annual Review if data is obtained from medical \nrecords from other hospitals in Leinster, beyond the Rotunda and the Mater, and confirm that \nthe required data agreements with those hospitals are in place.\n"]
[null,"Recommendation made","Recommendation 1. The information posters/notices on this study should be reviewed and \namended to ensure that it provides details in lay-person language; for example, the title of the \nstudy poster should be revisited. The poster should also provide further details on withdrawing \nfrom the study and the deletion of the data, including providing a phone number as well as the \nemail address. As part of this process to improve readability, it is also recommended to have the \nrevised study information poster reviewed by suitable public and patient representatives.\n\nRecommendation 2. There should be a webpage for this study that includes details on the \nparticipants data rights, including right to withdraw, and that the link to this website should be \nshared with the advocacy groups to provide on their own websites, along with the poster."]

{"sheet":"24-007-AF1","index":134,"n_rows":6,"n_cols":4,"rows_kept":6,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","More than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. The safe management of the airway remains a major challenge in these patients, while complications arising from these procedures can be very severe, and can include, low blood pressure, low oxygen levels, leading to cardiac arrest, severe brain injury and even death.   We do not have robust data on the frequency of major complications arising from management of the airway in people undergoing major surgical procedures. ‐intubation complications The primary aim of the STARGATE study is to assess the current incidence of major adverse events during advanced airway management in anaesthesia in patients undergoing planned or emergency surgery performed in the operating room (OR) or in other locations within the hospital (such as radiologic suites, and the emergency room).  The secondary aim of STARGATE isto assessthe current practice of airway management during anaesthesia worldwide."]
[null,"Reason for seeking a Declaration","This study involves the processing of personal data of prospective patients who will be treated in the hospital. The Applicant outlines why it is not considered feasible or appropriate to obtain explicit consent for this study which includes the practical challenges to obtain consent given that eligible participants will be identified and enrolled at multiple different locations in the hospital and also due to concerns relating to scientific value and potential study bias.   "]
[null,"Specific Conditions attached ","Condition 1. \n• It is a condition of this consent declaration that the study must develop a process for obtaining deferred consent from participants who are enrolled into this study; this process should be developed with the aim of seeking to obtain deferred consent from as many of the 50 study participants as possible. It is expected that the process for seeking deferred consentwill be the default procedure undertaken by this study; only where deferred consent cannot \nbe obtained from a participant should the study then provide the individual with an option to opt-out of the study (please see bullet point below).\n• For those participants whose deferred consent cannot be obtained, then the study must implement a clear opt-out mechanism, providing everyone whose deferred consent could not be obtained with an option to opt-out of the study and have their personal data deleted. The suggested timeline of 7 days for the participant to opt-out, as outlined by the Applicant’s responses, must be 7 days, or longer wherever possible, from the date the participant is informed of their ability to opt-out and not 7 days, or longer wherever possible, from their enrolment in the study. The collected data cannot be transferred from the Irish hospital site to \nthe data controller of the study before this minimum 7-day period lapses. \n• The Applicant must submit a detailed protocol for seeking deferred consent and for the direct opt-out process to the HRCDC; in addition, relevant documents such as the deferred consent information leaflet and consent forms and the opt-out documents for the participant, including study informaiton leaflets, must also be submitted. ","Condition 2. The Irish hospital sites must, together with the data controller University of Torino, be responsible for the implementation of and compliance with the consent declaration and data protection requirements; there should also be a point of contact in Ireland for participants if a participant has queries or otherwise wishes to exercise their rights. \n\nCondition 3. The required data agreements and arrangements must be in place for this study. The transfer of data between parties cannot occur prior to the necessary agreements being in place. "]
[null,"Recommendation made","N/A"]
[null,"Duration of Declaration ","The Declaration is made commencing 25th June 2024 and shall be valid until 31st July 2030, or until the personal/pseudonymised data has been deleted or fully anonymised."]

{"sheet":"24-008-AF1","index":135,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The Irish population is ageing and this is leading to an increase in the use of medications. Older adults are at significant risk of experiencing an adverse drug event/reaction (ADE/ADR) (an \nevent/reaction that is harmful or unpleasant and unintended and which occurs at normal doses). Approximately 10% of hospital admissions in those aged over 65 years are ADR-related and 70% of all these admissions are preventable or avoidable. However, there is a lack of valid and reliable \nmethods or tools for physicians to detect and predict ADRs and this study is being performed to ensure a newly developed risk prediction tool is valid and reliable. The tool will use participant information such as age, gender, medications, medical conditions, use of walking aids, help with \ndaily activities among others. The study will be conducted to test the tool in real world settings to ensure it is reliable and valid and user-friendly. "]
[null,"Reason for seeking a Declaration","The consent declaration is requested to process the personal data of participants who lack decision-making capacity. Within the study there is a sub-group of people with dementia resulting in loss of decision-making capacity and people who may have intellectual disability that separately or in combination has resulted in lack of decision-making capacity. Additionally, older adults presenting acutely to the hospital may have a delirium which can impact on the participants’ ability to consent, but these patients may regain capacity to consent, and they will be given the time to recover in order to optimise their capacity. "]
[null,"Specific Conditions attached ","Condition 1. Full research ethics committee approval must be obtained for each site. The consent declaration is not in effect where REC approval is not in place. Confirmation of REC approval should be submitted, when available. [CONDITION MET]\n\nCondition 2. The required data agreements and arrangements must be in place prior to thetransfer and processing of data for this study. [CONDITION MET]\n\n","Condition 3. \n(a) The versions of the study information leaflets and the family member proxy assent/participant consent forms are quite technical in nature, with language such as ‘risk prediction algorithm’ impacting the readability of these documents. Accordingly, the Applicant/data controller should review and amend these documents, ensuring that they use more lay-person language to help improve their overall readability to help participants and/or their family member better understand the study and the processing of data. Once amended, the updated documents should be reviewed by appropriate public and patient representative(s) to help ensure readability. (See websites such as NALA.ie as an example when working to improved document readability).\n(b) The family member documentation should ask them to consider the participant’s will and preferences on whether they would wish to be included in this study.\n(c) the HRCDC notes that there are inconsistencies and errors within study documentation that should be addressed. Examples include:\n- The family member proxy study documentation is worded in various places as if the \nproxy providing assent on behalf of the participant who lacks capacity, is the individual \nwho is enrolled into the study and having their data processed, for example by referring \nto ‘my participation’ and ‘my name and address’ as well as ‘my data’.\n- The term ‘assent’, not ‘consent’, should be used when referring to seeking permission \nfrom the family member to process personal data on behalf of the participant who lacks \ndecision-making capacity \n- The family member proxy assent form submitted, provides an option to assent to linking \nthe participants GMS medical card to the prescription dispensing information collected \nby the PCRS as well as reference to a questionnaire. The Applicant has already confirmed \nto the HRCDC that this is an error and so this should be deleted. \n- The patient re-consent form includes a section with wording that refers to the HRCDC \npreviously providing ‘consent’ for the study; this wording should be removed as the \nHRCDC does not provide consent on behalf of the participant.\n- On what will happen the data at the end of the study, the replies to the HRCDC state \nthat the data processed under the consent declaration for those who lack decision\u0002making capacity will be deleted after the study ends in July 2025, while it will be anonymised and used in the future for those who provide consent. For information, \nplease note that the Applicant/data controller can choose to fully anonymise the personal/pseudonymised data of those covered by the consent declaration at the end of the study as the exit strategy, instead of deleting it. \n- All three versions of the documents submitted to the HRCDC also separately refer to storing and using coded electronic data for future further research for 7 years, which is inconsistent with the replies to the HRCDC that data will be deleted or anonymised. \n- The information and options on data archiving, future use and anonymisation/deletion \noutlined in all the versions of the study documents need to be reviewed and amended \nto provide clear and consistent information. \n- As proxy assent and a consent declaration cannot cover the processing of \npersonal/pseudonymised data in other future studies, there should be no references to \nthe further future use of personal/pseudonymised data in the family member proxy \ndocumentation. \n- With regards participant consent to store and further use personal data in future \nresearch, it is the responsibility of the Applicant to ensure they have obtained valid \nconsent for this. [CONDITION MET]"]
[null,"Recommendation made","Recommendation. The study findings should be disseminated beyond medical journals to include patient groups. [RECOMMENDATION CONSIDERED]"]

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[null,null,null,"AMENDMENT #1"]
[null,"Research Objective","We know that social exclusion, such as that experienced by homeless people, people with substance use disorders, prisoners and certain minorities (Travellers, aboriginal people) has a profound effect on health. We know that people in these frequently overlapping groups often have experienced severe psychological trauma in childhood and/or adulthood, and that this affects their mental health and behaviour. They have more chronic illnesses and a much shorter life\u0002expectancy than others, and frequently have contact with multiple health and social care services across their life-span. In Ireland at present, there is no method of identifying people who are socially excluded in national-level health databases and therefore we are not able to track their use of health and social services. We will create a database unifying many different sources that will enable us to identify people who are socially excluded and see where services should be targeted to improve their health outcomes.","We know that social exclusion, such as that experienced by homeless people, people with substance use disorders, prisoners and certain minorities (Travellers, aboriginal people) has a profound effect on health. We know that people in these frequently overlapping groups often have experienced severe psychological trauma in childhood and/or adulthood, and that this affects their mental health and behaviour. They have more chronic illnesses and a much shorter life\u0002expectancy than others, and frequently have contact with multiple health and social care services across their life-span. In Ireland at present, there is no method of identifying people who are socially excluded in national-level health databases and therefore we are not able to track their use of health and social services. We will create a database unifying many different sources that will enable us to identify people who are socially excluded and see where services should be targeted to improve their health outcomes."]
[null,"Reason for seeking a Declaration","The study will be analysing existing datasets from the period 2010-2019 retrospectively and the number of individuals in the dataset is estimated at 100,000-140,000. The population group of interest in this study is also inherently transient and often do not have longstanding contact information (e.g. regular phone number and/or address) so it is considered impractical to attempt to contact people and request their consent to take part. The consent declaration is therefore requested to process the personal/pseudonymised data obtained from defined datasets without the explicit consent of the participants for the purpose of the INCLUDE study. ","The amendment is for the following changes to the data time periods covered by the declaration:\n- 2024 HIPE data from SJH and the Mater.\n- 2015-2024 data from the HSE Central Treatment List, PASS data from the Dublin Regional \nHomeless executive and data from the Irish Prison Service."]
[null,"Specific Conditions attached ","Condition 1. It was noted that the study poster submitted to the HRCDC provides information on who to contact if an individual thinks they may be included in this study and if they want more informaiton or if they wish to withdraw. However, it was noted that the website does not outline that an individual can contact the study if they want to withdraw; this difference should be \naddressed and transparency measures implemented prior to the study commencing so that participants may have adequate time to withdraw from the study before withdrawal is no longer possible.\n\nCondition 2. The necessary data agreements and arrangements need to be in place prior to data processing and data transfer commencing, this includes data agreements with the providers of the data for this study.\n\nCondition 3. The Applicant should explore if additional transparency measures could be implemented, including dissemination of information via the Irish Prison Service or Probation Service in particular, as well as disseminating posters in locations that participants may be attending such as clinics and homeless services. More generally, transparency measures should be clear on the data sources to be used in this study and how to withdraw from the study.","Condition 1. The transparency measures for this study should be updated to reflect the changes in the data time periods covered by this amendment."]
[null,"Recommendation made","N/A","N/A"]

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[]
[null,"Research Objective","This study is a Non-Interventional, Multicentre, Observational, Uncontrolled and Prospective \nResearch. The study focus on patient admitted in Intensive care Unit (ICU) after an Out of Hospital Cardiac \nArrest (OOHCA).The main complication for a patient after a cardiac arrest is the anoxo-ischemic encephalopathy that could induce a sever neurological disability or vegetative state.\nThe main goal of the study is to determine the diagnostic performance and the clinical utility of \nvarious prognostication score after an OOHCA in ICU to prognosis the neurological outcome. The \nstudy is also design to describe the epidemiological characteristic of the patients included in the study.\nThe practices of the centres will not be modified; the doctors in charge of the patients will collect \nclinical and biological data on a daily basis. These data are already collected in all OHCA coming in ICU. The outcome and neurological outcome will be also collected after the ICU stay."]
[null,"Reason for seeking a Declaration","Participants enrolled onto this study will be in a coma upon enrolment due to their out-of-hospital cardiac arrest, and therefore it will not be possible to obtain their explicit consent. The consent declaration is therefore requested to process their personal data without their explicit consent (i.e., collection, transfer, analysis). "]
[null,"Specific Conditions attached ","Condition 1. The required data agreements and arrangements must be in place between the relevant parties prior to the sharing of data. \n\nCondition 2. With regards the response from the Applicant that the personal/pseudonymised data from St James’s Hospital will be anonymised soon after the study ends, the Applicant must ensure that if REC approval is needed for this change in data retention, that it has been obtained. The consent declaration will not be in effect until the requisite REC approval is in place.\n\nCondition 3. The proxy assent and consent form include the following broad statement on sharing \ndata with third parties for the purpose of the AfterROSC-2 study:\n‘I agree to allow personal information about my relative to be shared with third parties including, \nnational and international hospitals, and academic research institutions for the purposes of completing the research as laid out in this information leaflet’. Based on the responses provided by the Applicant, the only parties processing personal/pseudonymised data from Ireland for this study are St James’s Hospital and the \nAssociation AfterROSC. The Applicant is therefore requested to revise/amend the above option in \nthe proxy assent and consent forms to outline that personal data is only shared with Association \nAfterROSC."]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to consider reviewing and amending the following points with regards the proxy assent and participant consent documentation: \no The study information leaflets reference that patients participating in studies have better outcomes than those not participating in research. The HRCDC discussed if this wording could unintentionally pressurise the proxy or the participant to agree to enrol in the study. The Applicant is therefore asked to review the wording of this statement and consider including that the patient’s treatment will not be affected if they don’t participate in the study. \no The term ‘consent’, rather than ‘assent’, is used in some parts of the proxy assent documentation; ‘assent’ rather than ‘consent’ should be used when referring to permission from a proxy to process the participant’s personal data for health research. \n\nRecommendation 2. The Applicant is requested to consider including if transparency measures for this study can be further enhanced; for example, by providing information on this study on relevant websites or sharing information with relevant groups. In addition, the Applicant is requested to consider if public and patient engagement can also be enhanced during this study."]

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[]
[null,"Research Objective","This project evaluates the feasibility of a new bone health assessment system called Echolight for people with intellectual disabilities, which uses advanced technology to measure bone density without radiation. Unlike the conventional DXA scanning, Echolight is portable, more comfortable for patients and it doesn’t require them to lie in an exact position for long periods of time. Our study will involve 80 participants with varying levels of intellectual disabilities inclusive of mild, moderate, severe and profound. Inclusion of all levels of ability is critical to see how well this new method works for all individuals within the intellectual disability population and to achieve a comprehensive demographic analysis which aims to understand the correlation between intellectual disability levels and bone health issues, providing nuanced insights into the specific needs of various subgroups within the intellectual disability population. By exploring the feasibility of this technology, we aim to improve access to early bone health assessments and promote inclusivity in healthcare. It is anticipated that approximately 20 individuals ( the purpose of this application) from Wexford Residential Intellectual Disability Service (HSE service provider), with a severe/profound level of intellectual disability will be invited to participate in the project, whom by nature of their diagnosis may not have the capacity to consent to participate independently. To allow for such occurrences, the application of the consent declaration would be required for this specific population cohort."]
[null,"Reason for seeking a Declaration","The study involves the processing of personal data of participants with intellectual  disability recruited from multiple sites in Ireland (mild, moderate, severe and  profound disability). It is anticipated that approximately 20 individuals with a severe/profound level of intellectual disability will be invited to participate in the  project, whom by nature of their diagnosis may not have the capacity to consent to  participate independently. The consent declaration is limited to processing the personal data (collection, transfer, analysis, storage.) of approximately 20 individuals with a severe/profound level of intellectual disability who will be unable to provide explicit consent.  "]
[null,"Specific Conditions attached ","Condition 1. The Applicant must submit the research ethics committee approval for the Wexford site, once available. The consent declaration will not cover the Wexford site untilsuch REC approval has been obtained.\n\nCondition 2. The required data agreements/arrangements must be in place prior to the transfer of data between the parties."]
[null,"Recommendation made","Recommendation 1. Further to condition 2, the Applicant is recommended to ensure that the data \nagreements/arrangements for this study covers the collection and processing of data obtained \nfrom the participants medical records held by the residential service (i.e., previous DXA scan \nresults).\n\nRecommendation 2. In cases where a key or support worker is providing proxy assent, the project team is asked to consider if the signature from a second appropriate person might be sought as a further potential safeguard."]
[null,"Deadline for meeting Conditions","N/A"]

{"sheet":"24-012-AF1","index":139,"n_rows":6,"n_cols":3,"rows_kept":6,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Platelet transfusions are commonly given in Intensive Care Units (ICU) as patients in ICU often have fewer platelets in their blood than healthy people. In ICUs, platelet transfusions are mainly given to try and prevent bleeding, for example during a procedure. However, platelet transfusions also have risks, such as allergic reactions. We do not know to what level the platelet count should fall (the best transfusion threshold) before the benefits of giving platelet transfusions outweigh the risks. Therefore, we intend to carry out a large clinical trial to find out the best transfusion threshold below which platelet transfusions should be given to patients who need an invasive procedure in ICU. Patients will become eligible for the study during a time critical intervention and are likely to lack capacity at the time of randomisation, therefore, a consent declaration is sought."]
[null,"Reason for seeking a Declaration","Participants are likely to lack decision-making capacity to provide explicit consent at the point of enrolment. Accordingly, a consent declaration is requested to process the personal/pseudonymised data (collection, transfer, analysis, storage) of participants who lack capacity. ."]
[null,"Specific Conditions attached ","Condition. The required data agreements/arrangements must be in place with the parties prior to the transfer/sharing of the data."]
[null,"Recommendation made","N/A"]
[null,"Deadline for meeting Conditions","N/A"]

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[]
[null,"Research Objective","The Health Service Executive (HSE) is seeking to optimise its learning function from incident reporting. Since the revision of the Incident Management Framework (IMF) in 2018, the HSE has further broadened its scope in terms of investigative tools. In particular, the HSE strives to better understand how, and how well the learning is extracted and applied from the incident management review process. Thus, the revisedThe IMF (2020) defines a 6-step incident management process. Step 6 focuses on the “Improvement Planning and Monitoring”, that involves developing and monitoring an action plan and sharing learning within and across the service. The  purpose of the study is to evaluate the effectiveness of the different incident review methods in embedding the 6 principles of the IMF, explore staff, patient/service user and family/ carers experiences in incident reviews and to evaluate and improve the human factors  analysis ( e.g. fatigue, poor procedures, understaffing etc.  that contributed to an incident),  in a systematic and comprehensive way. In addition, to evaluate and improve the recommendation generation in incident reviews to determine whether recommendations are clearly based on the contributory factors that have been identified and address them effectively."]
[null,"Reason for seeking a Declaration","Consent will be obtained for the personal data obtained via the participant survey and interview stages; however, consent will not be obtained for Stage C of the study i.e., processing personal data from the incidence reports. 200 incident reviews/reports will be extracted from NIMS and each report could involve the data of at least 6 people including the patient, staff, family members and others. The applicant outlines the reasons why consent cannot be obtained including the number of individuals involved. "]
[null,"Specific Conditions attached ","Condition 1. Based on the information provided, it is the HRCDC’s understanding that all individuals from the extracted NIMS report will be contacted and asked if they wish to complete the study survey and that individuals will have the ability to withdraw such data from this research. It is a condition of this declaration that (i) the individuals must be clearly told in the initial contact about the study survey that their information contained in the extracted NIMS report will be used in this study, including transferred to Trinity College, and (ii) that they can withdraw their NIMS data from the study; this includes clearly outlining who to contact to request this and outline what limits there could be to such rights e.g., is there a point where they can no longer request their \nNIMS data to be excluded from the study. \n\nCondition 2. As this study involves the processing of data relating to health service personnel, and given the sensitive nature of this research, it is important that there is also engagement with health service staff about this study. Matters that should be considered for discussion with staff include their views of the study, the study design as well as transparency measures and dissemination of findings. It is a condition that engagement with health service personnel is undertaken prior to the \nstudy undertaking the surveys, interviews and review of NIMS reports. The Applicant is requested to report on the progress of engagement with health service personnel (and with patients) within 4 months.\nConsideration should also be given to continue to undertake public and patient engagement during the study, where practicable, such as those who complete the study interviews. [CONDITION MET]","Condition 3. As part of the Annual Review, the Applicant must inform the HRCDC of the security arrangements in place with regards the use of Sharepoint, including considering the potential risks to the data, of human error such as sharing the data with the wrong individuals via this platform.\n\nCondition 4. The required data agreements and arrangements must be in place between the study parties. Data cannot be transferred prior to such agreements being implemented."]
[null,"Recommendation made","Recommendation 1. It is noted that the data would be pseudonymised before it is transferred to Trinity College, including the NIMS reports. However, it was also noted that even after pseudonymisation, the reports may be identifiable due to the nature of their content. The applicant is asked to consider having a ‘gatekeeper’ to check the data before it is transferred to ensure it is pseudonymised to be best extent possible and to limit the risk that the information may be identifiable.\n\nRecommendation 2. Consideration should be given to exploring if a consent mechanism could be added to future NIMS reports to allow individuals to consent for the use of their NIMS data in future health studies"]

{"sheet":"24-014-AF1","index":141,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","AIRWAYS-3 is being conducted to find out whether insertion of a supraglottic airway device is more effective than tracheal intubation for adults who have suffered a cardiac arrest in hospital. We do not know the best way for hospital staff to provide rescue breathing (airway management) during an in-hospital cardiac arrest, and will be comparing the traditionally used tracheal intubation, placing a breathing tube in the windpipe, to the newer alternative a supraglottic airway device, which is placed just above the voice box. Patients involved in the study be allocated to one of these two types of airway management in a process called randomisation. We will then measure and compare the degree of disability, survival, quality of life, use of NHS resources for every patient included in the trial during their hospital stay and at 3 and 6 months after the cardiac arrest."]
[null,"Reason for seeking a Declaration","Due to the nature of the medical emergency, participants will not have the capacity to provide consent; a consent declaration is requested to process their personal/pseudonymised data for the purpose of this study (i.e., collection, transfer, analysis, storage)"]
[null,"Specific Conditions attached ","Condition 1. The required data agreements and arrangements, including joint controller arrangement, must be in place between the relevant parties prior to the sharing of data. \n\nCondition 2. The Applicant is requested to undertake PPI engagement in Ireland with regards the AIRWAYS-3 study and to provide information about this activity, including details on the PPI feedback that was received, prior to the study commencing. The Applicant is requested to respond to this condition as soon as possible and within 2 months.\n\nCondition 3. With regards the study information leaflets and assent/consent documents, the \nfollowing points must be addressed prior to the study commencing:\n- The deferred proxy and participant consent to continue information leaflets notes that the \nproxy or participant does not have to agree for the participant to continue to take part in the \nstudy and that they can withdraw at any time; however, it was noted that the leaflets do not \nreference what will happen the data already collected if they do not provide assent or consent \nor later decide to withdraw. It should be outlined in the PILs what will happen if assent or \nconsent is refused or is later withdrawn i.e., that options will be provided including the option \nto delete the data already collected, where possible. \n- On the references to future research included in the proxy assent documentation, the current \ntext outlined in the documentation should be amended to the following: ‘If my relative does \nnot regain decision-making capacity, I give assent for my relative’s material/data to be \nstored/used for XXX years for possible future research only related to the current study without \nfurther assent being required but only if the research is approved by a Research Ethics \nCommittee and the Health Regulation Consent Declaration Committee (HRCDC) if required’.\n\nCondition 4. The submitted consent declaration application form has been signed on behalf of the \nUniversity of Warwick. It is a condition that the outstanding signature on the application form from \nthe other joint data controller, the University Hospitals Bristol and Weston NHS Foundation Trust, \nis submitted prior to the study starting."]
[null,"Recommendation made","Recommendation 1. \no The HRCDC commented that the section of the study information leaflets relating to data protection (i.e., Section 5), uses quite technical and legalistic language. The Applicant is asked to consider if this text can be reviewed and revised to provide such information in more-lay person language, where possible. Consideration should be given to engaging with public and patient groups or individuals on this matter. \no The proxy assent form includes the statement: ‘Do you believe your friend/relative would wish to take part in this study?’; however, the accompanying proxy information leaflet refers to the participant being included ‘If there is no known objection by your relative/friend’. It was commented that this statement in the proxy study informaiton leaflet should be reframed more positively to ask whether the relative/friend would wish to be included in this study. \n\nRecommendation 2. On the separate study withdrawal form, it is the view of the HRCDC that the options on the second page with regards to what will happen the data already collected and the potential continued collection of data post-withdrawal, do not fully correspond with the options on page 1, and this may be confusing. The Applicant is therefore requested to review and amend the options provided on the second page to ensure they fully correspond with the first page of the withdrawal form."]

{"sheet":"24-015-AF1","index":142,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","This study will investigate the impact of brain frailty, marked by brain atrophy (shrinkage) on imaging, on the recovery ofstroke patients undergoing thrombectomy—a procedure to remove blood clots and restore blood flow in acute ischemic stroke patients. Using AI to analyze brain images,the study aimsto better predict outcomes by including brain atrophy as a frailty marker. \n\nKey findings include: \n• Frail patients before a stroke are more likely to die or remain dependent 90 days post\u0002thrombectomy, with a lower chance of regaining independence. \n• Brain atrophy is linked to poorer recovery and higher mortality after thrombectomy. \n• Frail patients show less neurological improvement and face a higher risk of early neurological decline. \n• Frailty is a stronger predictor of early death than age. \n\nBy incorporating AI-driven analysis of brain atrophy in prediction models, this study could lead to more personalized treatment and improved outcomes for stroke patients."]
[null,"Reason for seeking a Declaration","TBC [To be updated when HRCDC decision is made- take info from approved minutes]"]
[null,"Specific Conditions attached ","TBC"]
[null,"Recommendation made","TBC"]

{"sheet":"25-001-AF1","index":143,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The AKI-EPI 2 Study is an international, multicentre observational research project aimed at understanding the occurrence, severity, and outcomes of acute kidney injury (AKI) in critically ill patients admitted to intensive care units (ICSs) worldwide. AKI is a common yet severe complication that significantly impacts patient outcomes. By collecting and analyzing data from up to 10,000 patients across diverse global regions, this study seeks to update the understanding of AKI's epidemiology and investigate factors such as the timing of AKI, the use of renal replacement therapy (RRT), and disparities in outcomes based on geographical and healthcare system differences. The research will inform better care pratices and guide future clinical trials focusecd on AKI in critically ill populations. No experimental interventions will be undertaken, and all data will be anonymized to protect the patient privacy. "]
[null,"Reason for seeking a Declaration","The study involves two parts:\n•\tThe processing of data generated from care and treatment of all sequential critically ill patients who are newly admitted to ICU after the date the study starts at the Irish site. Data up to the first 7-days in ICU, or until ICU discharge will be processed, as will hospital outcome data. The recruitment target is 60 patients. \n•\tFor all these patients who survive, the study will collect 3 & 12 month follow-up data (e.g., quality of life questionnaires); updated kidney function test results will also be sought from the GP. \nThose with and without acute kidney injury (AKI), up to the target of 60 patients, will be included in both part 1 and part 2 of the study. The consent declaration is requested as the participants will lack decision-making capacity as they are critically ill and have been admitted to ICU. Consent to continue for patients who survive will be sought at the point of the patient’s ICU discharge; proxy assent will be sought if the patient lacks decision-making capacity at the point of ICU discharge. \nThe first 7 days ICU data will be collected by the research study after the 7-day ICU period has passed; this data will be collected in the days or weeks following the patient’s first 7-day ICU period as it is subject to the resources available; the patient may still be in the ICU or may have been discharged from ICU when this data is collected. "]
[null,"Specific Conditions attached ","Condition 1. The necessary data agreements and arrangements (i.e., data sharing agreements, data controller to data processor agreements etc.) must be in place prior to data processing and data transfer commencing, this includes relevant data agreements with GPs if they provide follow\u0002up kidney function blood results. \n\nCondition 2. The Applicant originally submitted study information leaflets in advance of the HRCDC meeting that did not reference the follow-up data collection and processing. Draft updated study information leaflets, that included highlighted changes for additional text on the 3- and 12-month follow-up and GP data, were later submitted and were reviewed by the HRCDC; however, these documents were pending REC approval. To ensure that proxy assent/consent to continue is obtained for surviving patients for both parts of this study, as was confirmed by the Applicant in their replies to the HRCDC, the updated information leaflets submitted must be approved by the relevant research ethics committee prior to the study commencing. \n\nCondition 3. - A clear and consistent process for approaching and informing GPs about this study and that they may be requested to provide updated blood results of their patient must be in place. There must also be secure transfer process in place to forward the follow-up data form the GP to the AKI-EPI 2 study. - It should be made clear in the study information leaflets that follow-up data will be collected from GPs with regards both AKI and non-AKI patients, where applicable. In addition, a specific yes/no option to collect and use this GP data for this study should be included in the proxy assent and participant consent forms. \n\nCondition 4. With regards the study information leaflets, the Applicant is also required to address the following prior to the study commencing: - The DPIA references that the anonymised dataset will be held by Ghent University Hospital for future research purposes; while anonymised data falls outside the GDPR and Health Research Regulations, the study information leaflets for the proxy and the participant must clearly outline that anonymised data will be held by this data controller for future research. - The Applicant’s responses to the HRCDC outlines that if a participant is withdrawn, new data will no longer be collected for the study, and permission will be sought to continue to process the data already collected; if permission for this is not provided by the proxy or participant then the data already collected will be fully deleted, except for where the data is already published. The study information leaflets for the proxy and participants must provide clear and consistent informaiton on this matter. If the participant is withdrawn and the study wishes to continue to process the data already collected, then permission for this needs to be obtained from the proxy or participant and appropriately recorded."]
[null,"Recommendation made","N/A"]

{"sheet":"25-002-AF1-CSO","index":144,"n_rows":6,"n_cols":3,"rows_kept":6,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The Irish Traveller community suffer from higher rates of respiratory disease compared to the general population in Ireland. There is some evidence that they were particularly affected by outbreaks of COVID-19 during the pandemic. But we do not know the full extent of the pandemic’s effect on Traveller health or the underlying reasons why they may have been at greater risk from COVID-19. This limits our ability to design measures to protect Travellers in advance of future pandemics. To address this, we propose to research anonymised data collected in Ireland to determine the level of COVID-19 illness that occurred in the Irish Traveller community, and to understand the underlying factors that placed Travellers at risk from COVID-19. Our work will be in line with the National Traveller Health Action Plan (2022-2027) from the Health Service Executive (HSE) “to minimise the impact of COVID-19 and other communicable diseases on Travellers”."]
[null,"Reason for seeking a Declaration","To access and process pseudonymised data (research microdata files) from the CSO Health \nResearch Data Centre, hosted by the Central Statistics Office, for the purpose of the study ‘An \nepidemiological study of COVID-19 in the Irish Traveller population’."]
[null,"Specific Conditions attached ","Condition 1. It is a condition of this consent declaration that transparency measures should be further enhanced to better inform the traveller community about this study and the processing of data. Transparency measures should therefore be enhanced beyond the dissemination of findings and Pavee Point, to include wider Traveller networks and other suitable transparency measures for this cohort, with measures enhanced at the commencement of the study and duration the life of the research.In addition, given that data of the non-traveller community will be processed, consideration should be given to reaching out to this cohort more generally via enhanced transparency measures. \n\nCondition 2. Data agreements/arrangements must be in place between the data controller, DCU, and Trinity College Dublin as the data processor.\n\nCondition 3. It is a condition that this consent declaration is not effective until final approval to access the Health Research Data Centre has been granted by the CSO."]
[null,"Recommendation made","Recommendation 1. Linked to condition 1, further PPI engagement with traveller representatives should be considered to help determine and design further appropriate transparency measures for this community."]
[null,"Deadline for meeting Conditions","N/A"]

{"sheet":"25-003-AF1","index":145,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","In patients with liver cirrhosis, acute kidney dysfunction (named acute kidney injury (AKI)) may occur. Various causes may explain these kidney dysfunction episodes, and specific management exists for some of them. However, clarification of the right diagnosis is sometimes difficult in this population, and is associated with delayed diagnosis and associated management. Our objective is to evaluate the ability of novel urinary biomarkers (proteins in the urine) to predict response/progression of acute kidney injury in patients with liver disease, using urine samples at the time of diagnosis. These discoveries could help us to discriminate (more quickly) between various kidney injuries and therefore optimize the treatment and outcomes in this patient population."]
[null,"Reason for seeking a Declaration","To process the personal data of participants who lack decision-making capacity due to their medical condition; for those who lack decision making capacity, deferred proxy assent will be obtained within 48hrs"]
[null,"Specific Conditions attached ","Condition 1. An amendment to the research ethics approval from Wexford must be obtained to cover participants who lack decision-making capacity. This consent declaration will not cover data processing at the Wexford since until the requisite REC approval has been obtained. \n\nCondition 2. In addition to assessing decision-making capacity during the hospital admission to determine if consent to continue could be obtained from the participant, decision-making capacity should also be re-assessed at the 3 month and 1 year follow-up points, where practicable, and consent to continue sought if they have regained capacity. \n\nCondition 3. The Applicant is asked to report on the numbers of participants recruited to the study who continue to lack decision-making capacity as part of the Annual Review.\n\nCondition 4. The required data agreements and arrangements must be in place between the parties involved in this study; this includes joint data controller arrangements, data controller – data processor agreements and data transfer agreements with GPs where patient’s GP data is transferred for the purpose of this study. In addition, the study should ensure that the transfer or sharing of data/information from the GP to the study team is secure","Condition 5. The following points are to be addressed with regards the study information and assent/consent forms: - The SVUH proxy PILs do not outline that if a participant doesn’t regain capacity that they will continue to be included in the study based on the proxy assent obtained; this should be amended. - The study documents across all sites should provide consistent information on the participants data rights, including that the personal/pseudonymised data and samples will be destroyed upon withdrawal; it was noted that the SVUH information leaflets do not refer to destroying the data and samples upon withdrawal. - The feedback/comments provided by the UCD data protection officer on the study information leaflets should be addressed for all sites e.g., providing a ‘no consent’ option for participants/proxy on using GP data; the information provided on, and seeking assent/consent for, the biobank etc. - The SVUH PILs references that data may be disclosed/shared with ‘relevant industry bodies’, and the documentation for the other sites refer to sharing data and/or samples with other parties for the purpose of the Cirrhosis-Acute Kidney Injury Cohort Study e.g., ‘I agree for my relative’s biological samples to be shared with commercial/biopharmaceutical companies for this study’. The references to sharing data/samples with industry bodies and other parties for this specfic study should be amended/removed; the Applicant has confirmed that only UCD will be involved in processing the samples and data for the purpose of the Cirrhosis-AcuteKidney Injury Cohort Study. (Please note that this point does not apply to references made on sharing data/samples with other parties with regards other future studies – please see recommendation 4 below) \nThe HRCDC acknowledged that the SVUH documentation was developed and used in the years \nprior to extending the study to the other sites, however, the Committee noted that the study \ndocuments used at the Mater, Galway and Wexford seemed to provide clearer information on \nmatters such as details about the study, data processing activities and other areas. In addition to \nthe points noted above, consideration should be given to aligning the SVUH documents more \nwith the documents from the three other hospital sites. "]
[null,"Recommendation made","Recommendation 1. The Applicant is requested to consider storing the contact details of the participant’s GP in a separate location from the participant’s pseudonymised study data to help prevent the risk of disclosure of the participant’s identity. \n\nRecommendation 2. The phrase in the study information leaflets ‘If there is no known objection by your relative to being included’ should be more positively rephrased to ask whether the proxy believes the participant would wish to be included in this study. \n\nRecommendation 3. PPI engagement should be further enhanced through engagement with appropriate patient organisations such as the Irish Kidney Association, the Irish Liver Foundation or other similar bodies. Enhanced PPI engagement could include disseminating study findings or outcomes to relevant organisations and also requesting PPI feedback on the study information leaflets and assent/consent forms (please see Condition 5).\n\n","Recommendation 4. It is noted the study information leaflets and assent/consent documentation used at the sites refer to processing the personal/pseudonymised data and samples in future research that may involve commercial or for-profit companies or others. The Applicant should ensure that any participant consent for future research is compliant, including that the details on potentially sharing data/samples with other third parties including commercial companies, is clear and sufficient. The HRCDC also recommends that it would be beneficial to provide additional detail within the PILs on the type of future research that may be undertaken in the future (Note: Researchers can seek broad participant consent for future research, however it is the responsibility of the researchers/data controllers to ensure that any broad consent from participants for future research is compliant and valid). \n\nRecommendation 5. The Applicant is requested to ensure that an appropriate ‘transport security protocol’ is in place with regards the transfer of health data from the hospital to the RedCap database."]

{"sheet":"25-004-AF1-CSO","index":146,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","This project aims to analyse the prevalence and impact of co-morbidities in people with diabetes in Ireland. It will use data from the PCRS, 2016 and 2022 Census, and death registrations. The study will examine individuals with diabetes from the 2016 Census and assess their health and economic status over time, using prescription data to determine if they have, or develop other conditions. The 2016 Census data will help examine the risk factors for developing other conditions, while the 2022 Census data will assess changes in self-reported health and economic status. Mortality rates will be calculated rates for people with diabetes, with and without other conditions. The confidentiality of the people included in the study will be protected and no data that could be used to identify a specfic person will be published. The results of the project till be published in an open-access journal, making the findings freely available. "]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and process pseudonymised data (research microdata files) from Health RDC hosted by the Central Statistics Office. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the Health RDC, a consent declaration is required. "]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the Health Research Data Centre has been granted by the CSO. In addition, the approval from the CSO must cover the datasets that the Applicant wishes to process i.e., Census, PCRS, death registrations and Health Ireland survey data."]
[null,"Recommendation made","N/A"]

{"sheet":"25-005-AF1","index":147,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Since the Russian Invasion of Ukraine in 2022, Ireland has hosted an estimate of over 100,00 beneficiaries of temporary protection (BOTP). A variety of medical specialties have noted increased subscription to their services, requiring ongoing restructuring of services to best serve this vulnerable population. This is particularly true of infectious diseases services, owing to the increased prevalence of a variety of infectious diseases among the Ukrainian population, including tuberculosis, hepatitis C, hepatitis B, and HIV.     \nThanks to access to early testing, well-tolerated medications, and outpatient clinics, the majority of people living with HIV (PLWH) attending Irish HIV services have evidence of suppression of replicating of their HIV virus (“virally suppressed”, “virological suppression”) and evidence of good immune function (i.e. exhibiting a high CD4 T lymphocyte count).    \nBy contrast, an increased proportion of patients presenting from Ukraine are not virally suppressed, have evidence of immunosuppression exhibit a greater burden of co-morbidities; through poorer access to testing (and later diagnoses), more-frequent co-infections, and interruptions to treatment through forced migration. Such patients also exhibit greater prevalence of resistance-associated mutations (RAMs) in their HIV virus samples which have the potential to make their virus not treatable by commonly-used antiviral agents, complicating their care. This has been demonstrated in cohort studies performed in other host countries.\nAnecdotally, many Ukrainian beneficiaries of temporary protection living with HIV (UBOTPLH) in Ireland have little control over where they are deployed for accommodation. Frequently, their allocated location is in rural areas with limited access to public transport. This complicates their ability to attend clinics for regular, in-person follow up. Language barriers are also frequently observed. To date, no such studies have described the cohort of UBOTPLH in Munster. This study aims to describe the characteristics of the population of UBOTPLH attending Cork University Hospital’s HIV service. This is expected to inform health services regarding the increasing complexity clinicians face through increased attendance in HIV clinics, capture the service utilization (i.e. ED attendances, admissions) of such patients and difficulties experienced by them in seeking HIV care (distance travelled, language barrier), in order to explore means of improving their experience and access to care"]
[null,"Reason for seeking a Declaration","To process personal data (access, collection, analysis, storage) for the purpose of this specfic study. The Applicant outlines that it is not considered possible or feasible to obtain consent due to challenges in contacting participants and language barriers. "]
[null,"Specific Conditions attached ","Condition 1. The Applicant must undertake PPI engagement activities to discuss with, and receive feedback from patients, with regards this specfic study; examples of PPI that could be considered include engagement with PPI Ignite and/or a small number of potential participants who are attending the clinic in CUH. Such engagement must commence prior to the study commencing and the Applicant is to provide an update on this by 30th September 2025. Areas to discuss with the person/people from a patient perspective can include the poster and other transparency measures, among others [CONDITON MET]\n\nCondition 2. With regards the study poster, the Applicant is requested to address the following:\n• It was noted that the study poster submitted references that written consent is not required for this research. This reference to consent not being required does not seem appropriate given that the applicant has decided that the retrospective chart review amendment of the Health Research Regulations does not apply. This reference should be deleted or amended, for example by instead referencing, if needed, that a consent declaration has been made.\n• The poster further includes a statement ‘if you wish to discuss your consent being withdrawn for this research, please contact…’. It is a condition that the poster needs to explicitly state that participants have the right to request to be withdrawn from the study, not just to contact \nthe researchers to discuss their withdrawal. The term consent should also not be used as consent has not been sought for this study. Further the above and linked to Condition 1, the Applicant should also take on board relevant feedback on the posters that arises from the PPI engagement.\n\n","Condition 3. The consent declaration will not be in effect until full REC approval has been obtained. The Applicant should submit a copy of the full REC approval to the HRCDC, when available. [CONDITON MET]\n\nCondition 4. The Applicant should ensure that a clear process is in place to withdraw a participant form the study, and delete their data, if requested to do so by the participant, subject to any derogations that may apply."]
[null,"Recommendation made","Recommendation 1. In addition to undertaking PPI engagement as per condition 1, the Applicant is also asked to consider wider contact and communications with other groups such as HIV Ireland and Ukrainian refugee support groups to enhance communications about the purpose of this study and the dissemination of the study’s findings.\n\nRecommendation 2. Where a potential participant in the study (i.e., those who meet the study criteria) attends the clinic prior to and during the study, the study leaflet should be provided directly to the patient during their clinic visit."]

{"sheet":"25-006-AF1","index":148,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Acute brain injury as a result of trauma or haemorrhagic stroke (including subarachnoid haemorrhage and intracranial haemorrhage) can have devastating consequences at both a personal and societal level. These patients are at risk of disorders in blood clotting after brain injury. This can result in extension of the bleed if a coagulopathy develops or venous thromboembolism and multiorgan failure if a prothrombotic state ensues. These consequences are associated with worse outcomes for patients. There are few targeted therapies to improve patient outcomes in this population. Extracellular vesicles (EVs) are nano-metre sized particles that are released from virtually all cell and carry a cargo containing lipids, proteins and nucleic acids. One of their most well described roles is their contribution to coagulation in health and disease. There is evidence to suggest that EVs are released after brain injury. Our hypothesis is that brain derived EVs are elevated after acute brain injury and that they contribute to disorders on blood clotting, organ failure and worse outcomes. This would be a potential mechanism to identify patients at risk of bleeding or thrombosis and organ injury following acute brain injury and possibly to develop targeted therapies for future use."]
[null,"Reason for seeking a Declaration","The consent declaration is requested to process the data of participants who lack decision-making capacity to consent. This study can only be carried out in an ICU setting as it is aiming to investigate extracellular vesicles in patients with moderate to severe brain injury. By nature of their illness and the treatments they are receiving, including sedation and mechanical ventilation, a significant proportion will lack the capacity to consent to research on recruitment. "]
[null,"Specific Conditions attached ","Condition 1. The necessary data agreements and arrangements must be in place between the parties prior to the processing of personal data commencing; this includes joint data controller arrangements and data transfer agreements. \n\nCondition 2. Full REC approval, not just provisional approval, must be obtained from each relevant REC. \n\nCondition 3. The outstanding data protection officer feedback on the DPIA from the joint data controller, RCSI, must be submitted as soon as possible and within 2 months and before the start of the study. [CONDITION MET]\n\nCondition 4. It is noted that personal data would be captured on a spreadsheet and transferred to the researchers in UCD via secure email of an encrypted file. The Applicant is asked to explore if alternative more secure methods of data recording and transfer could be implemented for this study, including methods that also provide for a log/audit of the personnel who are accessing the data. In addition to the personal data, it should be ensured that the pseudonymised samples that are linked to the data are securely transferred and stored during the course of the study. The Applicant is asked to report on this condition as part of the Annual Review.","Condition 5. It is a condition that the following points are addressed in the study information leaflets and assent/consent forms for all the sites: \n- parts of the proxy information leaflet and assent form refers to the use of ‘my samples’ or ‘my data’ rather than the participant’s samples or data. \n- the study information leaflets note a start date that has already passed; the PILs should note an accurate start date. \n- Beaumont Hospital is not referenced as a joint data controller in the versions of the leaflets and assent/consent forms submitted to the HRCDC; all the PILs should provide clear details on all the joint data controllers of the study. \n- The proxy information leaflet will need to provide the same level of detail as the participant’s leaflet on what will happen the data and samples upon withdrawal, including that data and samples can be destroyed; all versions of the PILs should provide the same clear information on the right to withdraw and the destruction of samples and data. [CONDITION MET]"]
[null,"Recommendation made","Recommendation 1. The HRCDC requests the applicant to undertake further PPI engagement during this study. Enhanced PPI engagement could include discussions with enrolled participants and their proxies about this study and its potential benefits, as well as disseminating the outcomes/findings of this study to participants, their families and the public."]

{"sheet":"25-007-AF1","index":149,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[null,null,null,"AMENDMENT #1"]
[null,"Research Objective","Novus Diagnostics is conducting a proof-of-concept study on SepTec- a new bedside device that detects bloodstream infection (BSI) rapidly - a leading cause of sepsis. Sepsis is a life-threatening condition where early and accurate diagnosis is critical. Unlike traditional blood cultures that can take 1–3 days, SepTec delivers results within 15 minutes, classifying pathogens as gram-positive, gram-negative, or fungal. Rapid detection will enable clinicians to initiate targeted antimicrobial treatments promptly, which is particularly vital in intensive care units where timely intervention can save lives. Targeted treatment will also help reduce the use of broad-spectrum antibiotics, mitigating antimicrobial resistance. In this study, whole blood samples from suspected BSI patients will be analyzed using SepTec (results will not influence patient care decisions). The primary aim is to evaluate SepTec's clinical feasibility and effectiveness, generating data to support development and future integration into clinical practice for improved management of life-threatening infections.","Novus Diagnostics is conducting a proof-of-concept study on SepTec- a new bedside device that detects bloodstream infection (BSI) rapidly - a leading cause of sepsis. Sepsis is a life-threatening condition where early and accurate diagnosis is critical. Unlike traditional blood cultures that can take 1–3 days, SepTec delivers results within 15 minutes, classifying pathogens as gram-positive, gram-negative, or fungal. Rapid detection will enable clinicians to initiate targeted antimicrobial treatments promptly, which is particularly vital in intensive care units where timely intervention can save lives. Targeted treatment will also help reduce the use of broad-spectrum antibiotics, mitigating antimicrobial resistance. In this study, whole blood samples from suspected BSI patients will be analyzed using SepTec (results will not influence patient care decisions). The primary aim is to evaluate SepTec's clinical feasibility and effectiveness, generating data to support development and future integration into clinical practice for improved management of life-threatening infections."]
[null,"Reason for seeking a Declaration","To process the personal/pseudonymised data of participants who lack decision-making capacity due to the nature of their illness, for the purpose of this study. A process of deferred proxy assent, followed by participant consent to continue will be implemented. ","The inclusion of MMUH as an additional study site and data processor."]
[null,"Specific Conditions attached ","Condition 1. The necessary data agreements and arrangements must be in place between the parties prior to the processing of personal data commencing. \n\nCondition 2. Full REC approval, not just provisional approval, must be obtained. \n\nCondition 3. It is a condition that the following points are addressed in the study information leaflets and assent/consent forms: - The study information leaflets reference that data would be stored for 10 years; this should be corrected to align with the replies to the HRCDC that data and samples will be destroyed by March 2028. - On withdrawing from the study, the Applicant confirmed that the samples collected would be destroyed and the default position is that the pseudonymised data would be deleted unless this is no longer possible to do so. The study information leaflets should explicitly outline that personal/pseudonymised data will not be retained, but will be destroyed, if proxy assent or participant consent is withdrawn, subject to GDPR derogations that may apply. (please note that the consent declaration does not override an individual’s decision to withdraw from the study and to have their data deleted) - It is the view of the HRCDC that more detailed information on the role of Novus Diagnostics, beyond their funding the study and receiving some data, is outlined in the information leaflets; the study information leaflets must therefore provide more specfic detail on the role of Novus Diagnostics in this study, including that they are the data controller of the study and that they will be receiving and processing, including analysing, personal/pseudonymised data and the associated samples. It should also be clear in the study information leaflets that Novus is a commercial entity. - The term ‘consent’ or ‘explicit consent’ is inaccurately used in the proxy information leaflet and assent form, for example ‘I give informed explicit consent…’; the term ‘proxy assent’, not ‘consent’ should be used when referring to seeking permission from the proxy. - The proxy assent documents are titled ‘Next of Kin information leaflet and deferred assent form’ and the participant consent to continue reference the patient’s ‘Legal Representative’. The use of these terms is not appropriate and therefore should be corrected, for example by using the term ‘proxy’. - The PILs for all cohorts should outline that the results of the SepTec device in this study will not have a direct impact on the participant’s clinical care.","Condition 1. The necessary data agreements and arrangements must be in place between Novus and MMUH prior to the processing of personal data commencing."]
[null,"Recommendation made","Recommendation 1. Transparency notices about this study within the hospital should be implemented before the study commences. \n\nRecommendation 2. It is recommended that the PPI groups/representatives who have been engaged with should be kept up to date about this study. In addition, it is recommended that PPI engagement going forward notes that this proof-of-concept study on SepTec is a follow-on from previous research involving SepTec. \n\nRecommendation 3. Further to Recommendation 2, PPI engagement should also note that data and samples may still be included in the research if deferred proxy assent cannot be obtained.","n/a"]

{"sheet":"25-008-AF1","index":150,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","This research aims to improve the prediction and management of Acute Kidney Injury (AKI) using artificial intelligence (AI). AKI is a sudden decline in kidney function that affects one in five hospital patients and can lead to severe complications. The project will develop a secure research environment at St. James’s Hospital to test and refine AI models, ensuring they work effectively with local patient data. Researchers will use historical, pseudonymised health records (2018–2023) to assess AI’s ability to predict AKI early, helping doctors make better treatment decisions in the future. A consent declaration is needed because the study involves past patient data, and obtaining individual consent from thousands of patients is not feasible. To protect privacy, all data will be pseudonymised, securely stored, and used only for research. This study will contribute to safer, more effective AI tools for healthcare without affecting patient care directly."]
[null,"Reason for seeking a Declaration","The declaration made is for GENAKI study to cover the processing (collection, storage, analysis) of the pseudonymised data within a secure Trusted Research Environment (TRE), where access is strictly controlled, and no data can be extracted by researchers, for the purpose of testing/assessing/validating/developing AI models within the TRE."]
[null,"Specific Conditions attached ","Condition 1. Research ethics committee approval must be in place for the reduced number of participants i.e., the reduction of 100,000 participants to no more than 30,000. \n\nCondition 2. The HRCDC notes the detailed PPI engagement activities that are planned for this study, with the Applicant having noted that this is subject to funding. It is a condition of this declaration that appropriate PPI engagement must be undertaken prior to the study commencing.\n\nCondition 3. It is of the view of the HRCDC that only providing information to participants via the St James’s Hospital and Trinity College websites is insufficient; accordingly, it is a condition that the study’s transparency measures are enhanced to include study specfic notices/posters within relevant areas of the hospital. It is also a condition of this declaration that all transparency measures implemented (i.e., websites, posters etc.) include clear information on the participant’s data rights including the right to withdraw and have their data deleted, and a clear point of contact on who to contact to exercise this right. Enhanced transparency measures must be in place prior to the study commencing."]
[null,"Recommendation made","Recommendation 1. Further to Condition 2, the Applicant is requested to consider undertaking PPI activities with the standing PPI group from St James’s Hospital. \n\nRecommendation 2. The Applicant should explore how the findings from this study could be disseminated to participants and the public and not just made available to the research community via peer-reviewed journals and conferences. This could also be discussed as part of PPI engagement."]

{"sheet":"25-010-AF1","index":151,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Many cancers in the human body, including oral cancers have been found to be infected with bacteria. Research suggests that cancers that are heavily infected are more likely to spread and may not respond as well to chemotherapy. Although full-blown cancers have been studied for bacterial infection, no research has been carried out to examine if very early stage diseases are infected. These diseases include oral leukoplakia, which can develop into oral cancer in about 10% of cases. We wish to examine if early stage diseases such as oral leukoplakia are infected as this might be a factor which could be involved in their malignant transformation. We believe that this could be translated into therapies to prevent the malignant transformation of these diseases."]
[null,"Reason for seeking a Declaration","TBC [To be updated when HRCDC decision is made- take info from approved minutes]"]
[null,"Specific Conditions attached ","TBC"]
[null,"Recommendation made","TBC"]

{"sheet":"25-011-AF1","index":152,"n_rows":5,"n_cols":6,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[null,null,null,null,"AMENDMENT #1","AMENDMENT #2"]
[null,"Research Objective","The EXTUBE study is an international research project investigating complications that can occur when a breathing tube is removed (extubation) after surgery or critical illness. While this is a routine medical procedure, extubation can sometimes lead to serious issues such as breathing difficulties, low oxygen levels, or the need for emergency airway support. Despite its importance, extubation has not been as thoroughly studied as intubation (placing the breathing tube). This study will collect data from hospitals worldwide to understand the frequency, risk factors, and best practices for safe extubation. The findings will help improve patient safety by identifying ways to reduce complications and develop better guidelines for healthcare providers. By studying extubation in a large, diverse group of patients, this research aims to enhance outcomes and support safer airway management in both surgical and intensive care settings.",null,"The EXTUBE study is an international research project investigating complications that can occur when a breathing tube is removed (extubation) after surgery or critical illness. While this is a routine medical procedure, extubation can sometimes lead to serious issues such as breathing difficulties, low oxygen levels, or the need for emergency airway support. Despite its importance, extubation has not been as thoroughly studied as intubation (placing the breathing tube). This study will collect data from hospitals worldwide to understand the frequency, risk factors, and best practices for safe extubation. The findings will help improve patient safety by identifying ways to reduce complications and develop better guidelines for healthcare providers. By studying extubation in a large, diverse group of patients, this research aims to enhance outcomes and support safer airway management in both surgical and intensive care settings.","The EXTUBE study is an international research project investigating complications that can occur when a breathing tube is removed (extubation) after surgery or critical illness. While this is a routine medical procedure, extubation can sometimes lead to serious issues such as breathing difficulties, low oxygen levels, or the need for emergency airway support. Despite its importance, extubation has not been as thoroughly studied as intubation (placing the breathing tube). This study will collect data from hospitals worldwide to understand the frequency, risk factors, and best practices for safe extubation. The findings will help improve patient safety by identifying ways to reduce complications and develop better guidelines for healthcare providers. By studying extubation in a large, diverse group of patients, this research aims to enhance outcomes and support safer airway management in both surgical and intensive care settings."]
[null,"Reason for seeking a Declaration","The study outlines that seeking and requiring consent would impact the scientific validity of the study and introduce selection bias. The Applicant also notes that the study protocol requires sites to have a ‘consent waiver’ in order to participate in this research. ",null,"To add Tallaght University Hospital, Dublin and Mayo University Hospital wish as sites and data processors in this study.","To add Mater Misericordiae University Hospital, Dublin and Cork University Hospital as sites and data processors in this study."]
[null,"Specific Conditions attached ","Condition 1. Further to providing the participant with the study information leaflet, it is a condition of this declaration that, where the participant continues to lack capacity, the information leaflet detailing the study and how to withdraw should also be provided to a suitable proxy who understands the will and preference of the participant, and that the proxy should be able to withdraw the participant who lacks capacity from the research and have their data deleted. \n\nCondition 2. The following must be addressed within the information leaflet that will be provided to the participant or the proxy: - It should be made clear that this is an international study with Galway as one of sites involved.It should be clear that the study data controller is the University Health Network, Canada and that personal/pseudonymised data will be transferred to and analysed by the controller in Canada for the purpose of this study. In addition, it should clear whether the University Health Network will have access to non-coded/identifiable data, including if they will have access to the \nparticipant’s medical records for the purpose of auditing or quality assurance. - It should be outlined that participant and/or the proxy can withdraw from the study and have the data deleted up until the point the database is locked for analysis which is expected to occur within 6 months of enrolment being completed, not just requesting withdrawal within 2 weeks of leaving the hospital (As per the information provided to the HRCDC). [CONDITON MET]\n\n\n","Condition 3. The necessary data processing arrangements must be in place between GUH and the\nUniversity Health Network prior to the study commencing; this includes required \nagreements/arrangements for transfer of data outside the EEA, for example Standard \nContractual Clauses and conducting a Transfer Impact Assessment.","Condition 1. The required data agreements must be in place between these new sites and the data controller of the study prior to the transfer of data.","Condition 1. The required data agreements must be in place between these new sites and the data controller of the study prior to the transfer of data."]
[null,"Recommendation made","N/A",null,"N/A","N/A"]

{"sheet":"25-012-AF1-CSO","index":153,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The study is a part of the RECONNECT project, which is directed at optimising use of data in the Irish healthcare system, with an initial focus on diabetes. RECONNECT aims to develop approaches to integrate healthcare data systems pertinent to chronic disease, for population health planning, health service policy and patient care, while prioritizing data privacy and governance. This case study aims to examine trends in medications prescribed for diabetes across age, sex, and social deprivation to describe current inequalities in diabetes care. The results from the study will provide insights and guide policy on developing systems for equitable care delivery for diabetes in Ireland. A consent declaration is sought for the analysis of CSO’s research microdata files (pseudonymised PCRS dataset) for this study. Explicit participant consent is not available to use the personal data for research purposes."]
[null,"Reason for seeking a Declaration","The Applicant is seeking to access and obtained pseudonymised data (research microdata files) from the CSO Health RDC. As the data being accessed is pseudonymised data and that it is not feasible to seek consent from individuals whose data is held by the CSO within the Health RDC, a consent declaration is required."]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the Health Research Data Centre has been granted by the CSO."]
[null,"Recommendation made","N/A"]

{"sheet":"25-013-AF1","index":154,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","People with intellectual disabilities and autism often experience poorer oral health due to challenges in daily mouthcare and inconsistent support. Keep My Teeth introduces a co\u0002designed, multicomponent oral health intervention targeting staff, clients, and families in residential and day services. It compares two delivery models—Platinum and Diamond—that include policy development, training, personalised care plans, and local champions. The Diamond model adds sustained dental professional support. Delivered in partnership with St Michael’s House and the National Federation of Voluntary Service Providers, the study uses a cluster randomised design and mixed-methods evaluation. It aims to improve oral health outcomes, promote inclusive care, and inform a scalable national model."]
[null,"Reason for seeking a Declaration","Some participants are adults with intellectual disabilities who lack decision-making capacity to provide explicit consent for research participation, including data processing. Many do not have formal decision supporters (e.g. decision-making representatives) under the Assisted Decision-Making (Capacity) Act (ADMA). A consent declaration is therefore needed to allow inclusion of this underrepresented population; proxy assent will be obtained on their behalf. "]
[null,"Specific Conditions attached ","Condition 1. The following points on the study assent/consent documentation should be addressed: - It is noted that different email addresses for the same researcher/study email were provided in the client, staff and family documents and that this should be addressed (i.e., the PILs note caoimhin.macgiollaphadraig@dental.tcd.ie, macgiolla@dental.tcd.ie and KeepMyTeeth@dental.tcd.ie) - The study information leaflets should make it clear that data can be removed/deleted from the study up until the point it is anonymised\n\nCondition 2. Following the co-design activities with PPI representatives, the final versions of study information leaflets and consent/assent forms must be approved by the relevant REC and submitted to the HRCDC secretariat for noting.\n\nCondition 3. The Study website that is referenced by the Applicant should be in place prior to the \nstudy commencing.\n"]
[null,"Recommendation made","Recommendation 1. It is recommended that the information leaflets provided to the staff and family members reference the relevant GDPR Art.6 and Art.9 bases for processing personal data in this study.\n\nRecommendation 2. It is noted that the DPIA submitted refers to ‘participant initials or assigned codes’ for pseudonymisation; in the interest of data security, use of participant initials would not be seen as good practice as a pseudonymisation measure."]

{"sheet":"25-014-AF1","index":155,"n_rows":5,"n_cols":4,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The In-Touch study is a research project aiming to improve palliative care for nursing home residents with advanced dementia. It will test a new approach combining daily sensory-based activities, with family meetings to support decision-making and care planning. The study will assess whether In-Touch improves residents’ comfort, agitation, and quality of life, while also benefiting families (satisfaction with care) and staff (job satisfaction & well-being). The trial will take place in nursing homes across Europe, including eight in Ireland, involving residents, family members, and staff. Nursing homes will be randomly assigned to either the In-Touch programme or standard care. Researchers will collect data over 12 months from health records, staff surveys, family interviews, and observations. The study will also examine costs and participant experiences. Findings will guide better dementia care in nursing homes. Results will be shared with healthcare professionals, policymakers, and families through publications, training materials, and public engagement."]
[null,"Reason for seeking a Declaration","To process the personal/pseudonymised data of participants with dementia who lack decision making capacity to provide consent for the purpose of the In-Touch study – for these participants, proxy assent will be obtained on their behalf."]
[null,"Specific Conditions attached ","Condition 1. The data held on the US cloud server should be deleted from their server as soon as possible, once the data has been downloaded by UCC. The US service provider is storing data only and will not be processing the data any further. \n\nCondition 2. The required data agreements and arrangements must be in place prior to the data processing or sharing commencing. This includes required data agreements with the selected Irish nursing homes, the joint data controller and data transfer agreements between the In-Touch consortium members (i.e., the joint data controllers) and data agreements with US service provider. In addition, the required arrangements/legal basis for transfer of data outside the EEA must also be in place, including for example, standard contractual clauses with regards data to be stored in the US. \n\nCondition 3. The applicant is requested to address the following points with regards both the control and intervention resident proxy assent documents and the resident consent documents: - The study information leaflets for the residents should provide an estimated timeline for when the data is expected to be fully anonymised and therefore the point up to which it can be requested to have the participant’s data removed from this study. Further, as data will be fully anonymised by June 2028, incorrect references that ‘The personal data collected in the study will be kept for a period of 15 years as per the research partners’ Code of Research Conduct after the end of the study’ should be corrected. - The leaflets and assent/consent forms should make it clear that pseudonymised data is being stored in the US – not fully anonymised data.","Condition 4. The Applicant is required to report in the Annual Review which of the nursing homes noted in the HRCDC application have been selected to participate in this study."]
[null,"Recommendation made","Recommendation 1. For the benefit of participants and those providing proxy assent on their behalf, the proxy and resident study information leaflets could provide additional lay-person information that clarifies that the nursing home, and not the individual residents, have been selected and randomised to be either an intervention site or a control site in this study. In addition, to avoid potential confusion, the individual should be informed early in the information leaflet that they are part of either the control site or the intervention site and therefore whether they will be receiving the In-Touch intervention or not."]

{"sheet":"25-015-AF1-CSO","index":156,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","This research is part of a PhD project looking at how we find the people who may benefit \nmost from having their medicines reviewed by a pharmacist in a GP practice. To implement this service, more evidence is needed to inform the prioritisation of patient groups, such as those living with long term conditions. Several pieces of research are planned to achieve this. Some involve looking at data on medicine prescribing to understand how many people use multiple medicines (e.g. more than 5 or more than 10 \nmedicines) or have other issues with their medicines such as drugs interacting with a \nperson’s disease or condition. This will feed into later parts of the research which will gather the views from experts (including research, health professionals, patients and the public) on how to best identify patients who may benefit most from a medicines review by a pharmacist in the community setting."]
[null,"Reason for seeking a Declaration","For accessing and processing pseudonymised data (research microdata files) from the Health Research Data Centre (HRDC), hosted by the Central Statistics Office (CSO). Primary Care Reimbursement Services (PCRS) and Irish Healthy Survey data is to be processed within the CSO HRDC."]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the Health Research Data Centre has been granted by the CSO. \n\nCondition 2. The study webpage that was referenced by the Applicant in their replies to the HRCDC must be put in place before the study commences."]
[null,"Recommendation made","N/A"]

{"sheet":"25-016-AF1","index":157,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","This study is a retrospective review of sports-related spinal cord injuries (SR-SCIs) managed at the Mater Misericordiae University Hospital (MMUH) between 2015 and 2024, with corresponding rehabilitation data from the National Rehabilitation Hospital (NRH). SR-SCIs, caused by sports such as rugby, diving, and cycling, are relatively uncommon but can result in significant long-term disability. Using pseudonymised hospital records, the study will describe the sports involved, types and severity of injuries (using ASIA Impairment Scale), surgical management, and rehabilitation outcomes ( SCIM III ). It will also document length of stay and complications where available. With this review, the study aims to provide a descriptive overview of SR-SCIs in Ireland, contributing to a better understanding of patient trajectories within this population."]
[null,"Reason for seeking a Declaration","TBC [To be updated when HRCDC decision is made- take info from approved minutes]"]
[null,"Specific Conditions attached ","TBC"]
[null,"Recommendation made","TBC"]

{"sheet":"25-017-AF1-CSO","index":158,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Smoking imposes a significant health and economic burden on individuals and society. Smokers are more likely to develop chronic illnesses and die earlier than non-smokers costing the economy and themselves in terms of lower productivity and increased healthcare expenditure. Smoking is the leading cause of preventable death and preventable cancers in Ireland (and globally). The impact of smoking varies by socio-economic class with smoking exerting a greater toll on those in lower socio-economic groups. This research project aims to investigate the impact of smoking on the Irish population. The prevalence of smoking by socio-economic group and health status will be examined. The impact of smoking on mortality (both all-cause and by major cause of death) will be modelled and the contribution of smoking to socio-economic differences in mortality will be analysed."]
[null,"Reason for seeking a Declaration","For accessing and processing pseudonymised data (research microdata files) from the Health Research Data Centre (HRDC), hosted by the Central Statistics Office (CSO). Census 2022 data will be processed in this study, alongside death registration data."]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the Health Research Data Centre has been granted by the CSO."]
[null,"Recommendation made","Recommendation 1. The Applicant is strongly recommended to strengthen the level of PPI engagement with regards this study, including, for example, by engaging with relevant advocacy groups to increase awareness of this study and to disseminate the study findings. In addition, to further increase awareness of this study among patients and the public, the Applicant should consider strengthening the proposed transparency measures beyond social media, for example by considering press releases, inclusion in newsletters and to explore if a designated study webpage can be put in place."]

{"sheet":"25-018-AF1","index":159,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Metformin as a treatment is used in pregnant women with obesity (OB), gestational diabetes (GDM) and polycystic ovary syndrome (PCOS). A number of expensive randomized controlled trials have been conducted, each answering one clinical question. Each trial has also collected additional data which has not been used to its full potential. The MiPS study proposes to pool data from completed randomized trials conducted worldwide and re-analyse a new combined dataset to examine unanswered clinical questions. Using data already collected to answer unanswered clinical questions is a faster and more financially acceptable proposition than setting up further new expensive randomized trials. Answering these additional clinical questions will facilitate the delivery of more patient focused care globally with metformin as a treatment option. Answering these additional clinical questions will facilitate upgrades to global policy and guidelines on the use of metformin in pregnancy. The University of Galway was/is the sponsor of the EMERGE randomized trial of metformin vs placebo for the treatment of GDM. The trial was completed and published in October 2023 (JAMA. 2023 Oct 24;330(16):1547-1556. doi: 10.1001/jama.2023.19869). Monash University Melbourne Australia are the sponsor of the proposed MiPS study (BMJ Open 2020;10:e036981.doi:10.1136/bmjopen-2020-036981). I as PI of EMERGE, and the University of Galway as sponsor have been invited to participate in this MiPS collaboration and I am seeking from this committee authorization/consent to use specific pseudo-anonymized data points from EMERGE as set out in the MiPS protocol. In this regard I/University of Galway am/are not a data controller for MiPS as I/we did not contribute to the design of the MiPS protocol. I /we will be the Docusign Envelope ID: C928FF97-CB5C-4864-89CD-EA6AA7E224D3 Version 6 – June 2025 - Page 3 of 21 processor of the EMERGE data for the MiPS study. My application will expand on the need for this collaboration (processor to controller arrangement)."]
[null,"Reason for seeking a Declaration","The consent declaration covers the processing of data from the Irish EMERGE Trial for the purpose of the MiPS study as described in the HRCDC application form i.e., the analysis/study papers specifically outlined by the Applicant."]
[null,"Specific Conditions attached ","Condition 1. The necessary data agreements and arrangements, including for transfer of data outside of the EEA, need to be in place prior to the transfer of data from Ireland. \n\nCondition 2. It is noted that the research ethics approval letter from Monash University submitted to the HRCDC, expired on 23rd June 2025. The Applicant/data controller must address this issue as soon as possible and ensure that REC approval from Monash remains in place and is valid for the MiPS study."]
[null,"Recommendation made","Recommendation 1. For the benefit of participants and the study, it is recommended that the findings from the MiPS study are disseminated to the EMERGE participants/PPI group. In addition, further to the informal engagement that has occurred to date with two EMERGE study 1 The amendment request application form and accompanying guidance (including examples when an amendment should be submitted) can be found at: https://hrcdc.ie/apply/#b-3. Applicants are also encouraged to contact the Secretariat prior to submitting an amendment request for HRCDC consideration.  participants on the MiPS study, consideration should be given to undertaking further PPI engagement, including at an earlier stage of the study so that participants can be made aware of the research sooner.\n\nRecommendation 2. The transparency measures referenced by the Applicant, including via social media, should be aimed at the participants from Ireland and be implemented as early as possible to allow sufficient time for participants to withdraw from the MiPS study, if they wish to do so. The transparency measures should inform participants that their EMERGE data is being transferred to Monash University for use in the MiPS study and outline their data protection rights and how to exercise such rights, including how to request the withdrawal of their data."]

{"sheet":"25-019-AF1","index":160,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The IPOS study is a nationwide research project in Ireland examining how older patients with multiple health conditions fare after major urgent or planned surgeries. As advances allow more complex operations in older, sicker patients, they still face a higher risk of complications. Ireland currently lacks detailed data on surgery risks, complications, and healthcare resources used for these patients. Thisstudy will observe patients across multiple centresto measure their health risks, identify common complications, and find factors that can be changed to improve outcomes. It will also look at Ireland’s ability to provide timely and high‐quality surgical and critical care. The results will help guide healthcare planning and policies to improve safety and fairness in surgical care for high‐risk patients nationwide."]
[null,"Reason for seeking a Declaration","TBC [To be updated when HRCDC decision is made- take info from approved minutes]"]
[null,"Specific Conditions attached ","TBC"]
[null,"Recommendation made","TBC"]

{"sheet":"25-020-AF1","index":161,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","People living with kidney failure, whether on dialysis or after a kidney transplant, are far more likely to experience a stroke compared to the general population. Several risk factors have been identified internationally, but little is known about the specific situation in Ireland.\n\nThis project will link information from the national kidney disease system (KDCPMS) with stroke data collected by the National Office of Clinical Audit (NOCA) to explore what causes stroke among people with kidney failure. The goal is to improve prevention, care, and recovery for these patients in Ireland. The research is a national collaboration between the HSE, universities, and patient organisations and will directly inform future stroke prevention policies."]
[null,"Reason for seeking a Declaration","TBC [To be updated when HRCDC decision is made- take info from approved minutes]"]
[null,"Specific Conditions attached ","TBC"]
[null,"Recommendation made","TBC"]

{"sheet":"25-021-AF1","index":162,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","Nearly every person with Down syndrome develops Alzheimer’s disease (AD) during their lifetime. Despite urgent clinical need, people with Down syndrome have historically been excluded from AD clinical trials. The Bio-MinDS study aims to identify reliable biomarkers to improve early detection, diagnosis, and monitoring of AD in this population. Adults with, and without Down syndrome will attend annual visits at Tallaght University Hospital, where they will complete health checks, memory and thinking tests, and provide blood samples. Samples and data will also be shared with trusted academic collaborators in Sweden and the United Kingdom. The findings will guide future clinical trials and contribute to better treatments, as well as deepen understanding of healthy brain ageing. Docusign Envelope ID: 5094CF1F-B235-43DE-BD4E-D8CDB9BEEA6A Version 6 – June 2025 - Page 3 of 35 C This study seeks to improve care for people with Down syndrome and reduce health inequalities."]
[null,"Reason for seeking a Declaration","The consent declaration covers the processing of personal/pseudonymised data of those who lack decision-making capacity, and where proxy assent is obtained, for the purpose of the Bio-MinDS study."]
[null,"Specific Conditions attached ","Condition 1. Data Controller to data processor agreements, as per the GDPR, must be in place between TCD/TUH and the processors UCL and University of Gothenburg, prior to the sharing of data and associated samples.\n\nCondition 2. The outstanding data protection officer feedback from Tallaght University Hospital on the DPIA must be submitted before the study starts.\n \nCondition 3. The Applicant is requested to address the following within the study information leaflet prior to the study commencing:\n- It should be clear and consistent that participant data can be fully deleted if requested, not just their contact details, and it should be clear up to what point their data can be fully deleted from this study (note: pg 14 of the study information leaflet only notes that contact details can be deleted, however the replies provided to the HRCDC said data can be fully deleted). \n- Reference to the inclusion of a Lumbar puncture should be removed from the information leaflets as the Applicant has confirmed that CSF samples will not be used in this study."]
[null,"Recommendation made","Recommendation 1. The Applicant should consider informing participants within the study information leaflet that there may be risks to sharing data with ‘third countries’ i.e., those outside the EEA and who do not have an adequacy decision in place. It is recognised that this must be done in an appropriate manner for the overall style of the information leaflet"]

{"sheet":"25-022-AF1-CSO","index":163,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","This study aims to examine the patterns and quality of respiratory medication prescribing in Ireland before and after the implementation of the GP-led structured Chronic Disease Management (CDM) programme in Ireland. Respiratory conditions include asthma and Chronic Obstructive Pulmonary Disease (COPD)This study will provide an overview of real\u0002world prescribing practices that can inform strategies to optimise prescribing quality and improve patient care. This study will use data on prescriptions for adults who are eligible for free GP care (have a medical card) over a 10-year period in Ireland."]
[null,"Reason for seeking a Declaration","For accessing and processing pseudonymised data (research microdata files) from the Health Research Data Centre, hosted by the Central Statistics Office, for the purpose of this specific study."]
[null,"Specific Conditions attached ","Condition 1. It is a condition that this consent declaration is not effective until final approval to access the Health Research Data Centre has been granted by the CSO and until full REC approval is in place."]
[null,"Recommendation made","Recommendation 1. Applicant could consider exploring PPI engagement with relevant asthma groups or representatives, in addition to the COPD groups who have been contacted to date."]

{"sheet":"25-023-AF1","index":164,"n_rows":5,"n_cols":3,"rows_kept":5,"cut":false,"hidden":false,"merged":[]}
[]
[null,"Research Objective","The SMART-FLOW study aims to improve how fluid is removed from critically ill patients in intensive care who require continuous kidney support. Decisions about fluid removal currently vary between clinicians and can affect patient safety. Using routinely collected ICU data from Galway University Hospital  and other ICUs where local ethics have agreed to involvement from 2019 to 2024, this study will develop a secure, research-grade database and apply machine learning and advanced text analysis to better understand factors linked to harmful drops in blood pressure during fluid removal. The project will also include interviews with ICU staff to explore how fluid decisions are made and recorded. All patient information will be carefully  and irrevocably anonymised before analysis, and no identifiable data will be shared outside the hospital environment.  The goal is to support the future development of safer, more consistent and evidence-based approaches to fluid management in critically ill patients."]
[null,"Reason for seeking a Declaration","TBC [To be updated when HRCDC decision is made- take info from approved minutes]"]
[null,"Specific Conditions attached ","TBC"]
[null,"Recommendation made","TBC"]