...hearing from the patient representatives has provided me with insights about how patients and their carers may view research and the use of their data and reminds me to always keep the patient and their rights at the forefront.
The Committee
The Health Research Consent Declaration Committee (HRCDC) is appointed by and reports to the Minister for Health. It consists of individuals with a diverse range of professional backgrounds and experiences, including critical care medicine and anaesthesiology, data protection and medico-legal expertise, general practice medicine, epidemiology, genomics, social care research, and other areas, thus providing a broad representation of Ireland’s health research community. The Committee’s PPI representative members bring complementary perspectives as members of the public, as carers, and as users of health and social care services in Ireland.
The HRCDC assesses the public interest of each research study. As per Regulation 5(5)of the Health Research Regulations 2018, in order to make a consent declaration, the HRCDC must determine that the public interest in carrying out the health research significantly outweighs the public interest in requiring the explicit consent of the data subject(s).
In carrying out its function, the HRCDC also considers the data safeguards in place for each study in order to ensure that personal data are handled appropriately and according to regulatory requirements.
The HRCDC will consider whether or not a consent declaration should be made on the basis of applications made to it. There is provision for an appeal from the decision of the HRCDC to an independent appeal panel appointed by the Minister.
The Committee may:
- Make a consent declaration
- Make a consent declaration subject to conditions attached
- Not make a consent declaration
- Request further information
- Revoke a consent declaration
- Make a consent declaration
- Make a consent declaration subject to conditions attached
- Not make a consent declaration
- Request further information
- Revoke a consent declaration
Applications for a consent declaration will be assessed by a minimum of seven members of the HRCDC, at least one of whom will be the Chairperson or Deputy Chairperson and one of whom is a public and patient representative.
From time to time, the HRCDC may have vacancies on the committee. If you have an interest in joining the committee, please email the HRCDC Secretariat at secretariat@hrcdc.ie.
Please note that under the Health Research Regulations, appointments to the HRCDC are made by the Minister for Health.