The links on this page relate to the processing of personal data in health research including clinical trials in Ireland. These links may be useful to sponsor organisations and co-ordinating groups developing Patient Information Leaflets (PILs) and Informed Consent Forms (ICFs) for submission in Ireland.
Health Research Regulations – Ireland
Explicit consent is required in Irish Law per the Health Research Regulations for data processing in health research. This is a safeguard and is not the same as legal basis for processing personal data.
- DATA PROTECTION ACT 2018 (SECTION 36(2)) (HEALTH RESEARCH) REGULATIONS 2018
- DATA PROTECTION ACT 2018 (SECTION 36(2)) (HEALTH RESEARCH) (AMENDMENT) REGULATIONS 2019
Explicit consent is described in the Article 29 Working Party guidelines.
- ARTICLE 29 WORKING PARTY ON THE PROTECTION OF INDIVIDUALS WITH REGARD TO THE PROCESSING OF PERSONAL DATA
Guidance from the Department of Health and the Health Research Board
- Guidance on Information Principles for informed consent for the processing of personal data for health research (Department of Health)
- GDPR Guidance for Researchers (Health Research Board)
- GDPR Guidance for Researchers & Health Research Regulations 2018 (Health Research Board) – specifically the Health Research Regulations in Ireland
Health Research Consent Declaration Committee (HRCDC)
The Health Research Regulations recognise and provide for a statutory consent declaration process where, 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 such cases, the data controller carrying out health research using personal data may apply for a consent declaration to the HRCDC. More information can be found at the following links.
- About the HRCDC – (includes links to relevant legislation)
- Frequently Asked Questions, Presentations (HRCDC)