The Irish Take - GDPR and Research
The Health Research Regulations (HRRs) were signed into law on the 8th August 2018, and represent the Irish take on GDPR and Research. They have had a significant impact on the conduct of research in Ireland, and a number of articles have been published in relation to difficulties experienced by the research community.
Academic articles have focussed among other matters on the decision to require 'explicit consent for processing of personal data' as a safeguard, as opposed to informed consent to take part in research.
The initial HRRs (August 2018) required 'explicit consent' or a 'consent declaration' from the Health Research Consent Declaration Committee. Amendments (January 2021) provided for some limited exceptions to the requirement for 'explicit consent' or a 'consent declaration' most noticeably for 'low risk, high transparency retrospective chart review studies'.
Links to three academic articles which critique the original HRRs are listed below:
Decisions as to which safeguards to implement in respect of research and GDPR vary across Member States as per recent European Commission Report, link below: