In Ireland, Health Research (see definition below) is governed by the GDPR, the Data Protection Acts 1988 -2018 and the Health Research Regulations 2018 (HRR).
Trinty Roundtable: Amendments to the Health Research Regulations: What Researchers need to know
David Murphy - Putting the Health Research Regulations in the wider Data Protection Context
Professor Louise Gallagher - The Health Research Regulations 2018 - A Research Perspective
Peter Lennon - Amendments to the Health Research Regulations - What researchers need to know
Trinity Masterclass: Amendments to the Health Research Regulations - Exploring Consent
Dr Emily Vereker -Programme Manager, HRCDC Secretariat
Peter Lennon - Examining the Concept of Consent from a Legal Perspective in Health Resesarch
Professor Mary McCarron - Exploring Consent - Perspectives from a Principal Investigator
A Researcher planning to use an individual’s information for health research must obtain the explicit consent of the individual.
Explicit Consent is an additional safeguard under the HRR. Please note that consent should not be used as the legal basis for the use of the participants data under GDPR.
The appropriate legal basis under GDPR is scientific research (Article 9(2)(j)) in the public interest (Article 6(1)(e). Please see here for more information on Research and the Legal Basis.
Consent Declaration in absence of Explicit Consent
It is recognised – as it is in other countries – that sometimes, in limited situations, obtaining consent will not be possible and that the public interest of doing the research significantly outweighs the need for explicit consent.
It is in cases like this that HRCDC has a decision-making role.
The HRB has developed a decision tree to help researchers assess whether they might be eligible to submit an application to the Health Research Consent Declaration Committee (HRCDC) to obtain a consent declaration.
This decision tree also outlines a number of important preliminary steps that must be completed by researchers prior to the submission of any application to the HRCDC.
Health Research Definition
Reg 3(2) of the HRR defines health research as any of the following scientific research for the purpose of human health:
- research with the goal of understanding normal and abnormal functioning, at molecular, cellular, organ system and whole body levels;
- research that is specifically concerned with innovative strategies, devices, products or services for the diagnosis, treatment or prevention of human disease or injury;
- research with the goal of improving the diagnosis and treatment (including the rehabilitation and palliation) of human disease and injury and of improving the health and quality of life of individuals;
- research with the goal of improving the efficiency and effectiveness of health professionals and the health care system;
- research with the goal of improving the health of the population as a whole or any part of the population through a better understanding of the ways in which social, cultural, environmental, occupational and economic factors determine health status;
If you are unsure if your research project falls within the scope of the HRR, please contact the Trinity College Deputy Data Protection Officer (Research) for further assistance: ResearchDPO@tcd.ie.
Further Guidance for Health Researchers
- Health Research Training - prepared by Deputy DPO (Research) – Updated 19.02.2021 - contact firstname.lastname@example.org for further information
- DATA PROTECTION ACT 2018 (SECTION 36(2)) (HEALTH RESEARCH) REGULATIONS 2018, Health Research Regulations (HRR)
- Health Research Board (HRB) HRB Guidance on Health Research Regulation
- HRR Amendments 2021
- Guidance on HRR Amendments
- Guidance on Information Principles for informed consent for the processing of personal data for health research
- Health Research Consent Declaration Committee (HRCDC) website
- Anonymisation and Pseudonymisation - Data Protection Commission Guidance Note