The constructive engagement and considered approach to decision -making ensures that both the public interest and safeguarding of research participants’ personal health data are at the core of the Committee’s considerations.
Application process
One of the requirements of the Health Research Regulations (HRR) is that explicit consent of the individual to process their personal data in that health research study is required.
However, it is recognised that it may not always be possible to obtain the explicit consent of the study participant to process their personal data in a health research study. In such cases, the HRR provides for a statutory process where the researchers can seek a ‘consent declaration’ for their health research study; applications for a consent declaration are made to the Health Research Consent Declaration Committee (HRCDC). The HRCDC determines whether the health research study that is seeking a consent declaration is of sufficient public interest that it outweighs the requirement to obtain the participant’s explicit consent.
It is not mandatory to apply to the HRCDC. The onus is on the Data Controller of a research study to determine whether an application to seek a declaration is required for health research study. Please refer to the ‘Do I Need to Apply’ section of this website for more information:
The following provides an overview of the consent declaration application process:
Submitting an application
Once a data controller/researcher determines that a consent declaration is required, then they should download and complete the relevant consent declaration application form that is available here:
The application form and necessary accompanying documents must then be submitted by email to secretariat@hrcdc.ie. Scanned copies of the documents should not be submitted.
Valid applications
When received, the Secretariat to the HRCDC will undertake an initial review of the submission to ensure that all the necessary documentation has been provided.
If all the documentation is submitted than a reference ID will be issued, and the application will proceed to the next step.
For an application to be deemed valid and issued with a reference ID, the following must be submitted:
- A fully completed HRCDC application form signed by the data controller(s) of the research study.
- Evidence of research ethics committee (REC) approval i.e., REC approval letter, must accompany the submitted application form. Note: Irish REC approval must be obtained prior to submitting an application to the HRCDC; applications for studies without such REC approval cannot be accepted.
- A data protection impact assessment (DPIA) for the research must be completed.
- Feedback on the DPIA from the data protection officer of the data controller of the study must be submitted.
- Subject to the research in question, study information leaflets and consent/proxy assent forms should also be provided as part of your application.
Secretariat pre-review and HRCDC consideration
When a submission is deemed valid, the application form and accompanying documents will be reviewed by the secretariat. If important information is missing, inconsistent or unclear, the Secretariat will request clarifications or further information from the applicant.
Once the clarifications are submitted, the application and accompanying documents will be prepared for consideration by the HRCDC at its next available HRCDC meeting.
Processing timelines
Applications are pre-reviewed by the Secretariat on a first-come-first-served basis.
Only applications that are deemed ready for HRCDC consideration are forwarded to the HRCDC in advance of a scheduled meeting. Applicants will be informed of the HRCDC meeting where their application will be reviewed.
When an application is tabled for consideration at a HRCDC meeting, the formal decision letter is expected to be issued as soon as possible after the meeting.
Information on the meeting dates and submission deadlines can be found on the Meeting Dates & Submission Deadline webpage.
