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 papers 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.

Links to three academic articles which critiqued the original HRRs are listed below:

The following presentation was given by the President of the Irish Academy of Medical Science at a meeting of the Irish Health Research Forum:

The Department of Health in the Republic of Ireland has robustly defended its decision in relation to 'explicit consent'.

The following presentation was given by the Department of Health at a meeting of the Irish Academy of Medical Science:

The European Take

Decisions as to which safeguards to implement in respect of scientific research and GDPR vary across EU Member States - see European Commission Report (Feb 2021)(link to European Commission website) and University of Leuven Report (August 2021) (link to EDPB website)

The European Data Protection Board also provided an initial reponse to questions from the European Commission on the consistent application of GDPR focussing on health research- see responses (Feb 2021) (link to EDBP website)

The Irish Take Revisited

Amendments (January 2021) to the Health Research Regulations provided for exemptions to the requirement for 'explicit consent' or a 'consent declaration' most noticeably for {i} pre-screening (subject to conditions) and (ii) 'low risk, high transparency retrospective chart review studies' (subjection to conditions). 'Explicit consent' remains the default position however.

Beaumont Hospital

This GDPR HRR overview table (drafted BH Ethics, updated June 2021) displays the latest exemptions in the overall context of GDPR, and the original Health Research Regulations 2018, and local policy/practice. See also Irish and European Timeline of Events in relation to Consent and Scientific Research (drafted BH Ethics, updated September 2021) and GDPR was always going to be a challenging piece of legislation for researchers (drafted BH Ethics, updated and addendum added 8 August 2021).