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.

Explicit consent is described in the Article 29 Working Party guidelines.

Guidance from the Department of Health and the Health Research Board

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.