Health Research Regulations, Capacity and the Health Research Consent Declaration Committee

As a consequence of the Health Research Regulations 2018: -

  1. Health Research which involves processing of personal data is defined in Irish law.

  2. Explicit consent of the data subject for processing of personal data for the purposes of health research is mandatory.

  3. -Explicit consent is a legal term related to processing of personal data. It differs from informed consent to take part in a research project, and there are specific conditions which need to be met under GDPR to achieve explicit consent -

  4. Where a research study proposes to involve adults who lack capacity to give explicit consent, an application to the Health Research Consent Declaration Committee or HRCDC applies. This committee was set up in 2019 as a consequence of the Health Research Regulations 2018 and reviews research studies where explicit consent cannot be obtained. It is not a research ethics committee, and hence, researchers apply to the HRCDC after having applied to a research ethics committee.