Overview

The purpose of the Health Research Regulations is to support health research and promote public confidence in such research. As well as outlining numerous data protection safeguards when conducting health research, the Regulations make explicit consent the default position for processing personal data for health research. In other words, a health researcher planning to use an individual’s information for health research must obtain the explicit consent of the individual to do so as a required safeguard.

However, it is recognised that sometimes, obtaining consent will not be possible and that the public interest of doing the research significantly outweighs the need for explicit consent.

In such exceptional cases, the Regulations provide that the Health Research Consent Declaration Committee (HRCDC) may make a consent declaration where the public interest in conducting the research significantly outweighs the requirement to obtain explicit consent from research participants.

This consent declaration allows researchers to lawfully process personal data for health research in the absence of explicit consent. Examples of when it may not be practicable or possible to obtain explicit consent includes where the participant may lack decision-making capacity, either temporarily or permanently, or where the participant is lost-to-follow-up or where a researcher wishes to process the personal data of a large number of participants, and it is not practicable to contact each of them in order to obtain their consent.

In everything that we do, the objective of the HRCDC will be to seek to build Transparency, Confidence and Trust.

The Standard Operating Procedures for the Secretariat and HRCDC can be accessed using the link below:

Regarding explicit consent, the Health Research Regulations 2018 maintains the existing situation in law, where explicit consent is the default position for all processing and further processing of personal data for health research purposes (unless the personal data is wholly anonymised or there is specific legal provision authorising the health research in question).

If it is not possible to gain explicit consent, the Regulations provide that the Health Research Consent Declaration Committee (HRCDC) may make a consent declaration where the public interest in conducting the research significantly outweighs the requirement to obtain explicit consent from research participants.

It is important that health researchers engage fully with their Data Protection Officers to understand the law in this area as it affects the processing of personal data for health research in Ireland.

Links to the legalisation, including the Health Research Regulations and subsequent amendments are provided below: