ArticleIrish journal of medical science2021
What GDPR and the Health Research Regulations (HRRs) mean for Ireland: "explicit consent"-a legal analysis.
Article in Irish journal of medical science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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Who cites it
4 citing papers in PubMed.
- Research opportunities in precision oncology: perspectives on biospecimen and genomic data sharing from adults with cancer in Ireland.Irish journal of medical science · 2025Article
- Challenges related to data protection in clinical research before and during the COVID-19 pandemic: An exploratory study.Frontiers in medicine · 2022Article
- Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40.Frontiers in genetics · 2021Article
- Harmonising the human biobanking consent process: an Irish experience.HRB open research · 2021Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIrish Health Research Regulations (HRRs) were introduced following the commencement of the General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on April 8 and November 25, 2019 at the Royal College of Surgeons in Ireland welcomed the introduction of GDPR and the HRRs. The analysis found the GDPR "explicit consent" introduced by the HRRs is problematic. A call was made to regulate informed consent in line with the common law as an achievable alternative safeguard, bringing Ireland in line with other EU Member States.
aimsThis article aims to review academic papers, legal opinion, EU opinion and advice and data protection law in relation to research and explicit consent, in order to examine the legal burden of GDPR and the HRRs on health research in Ireland and to determine whether the analysis presented at the IAMS meetings is reflected more widely in legal text.
methodsLegal literature review of academic papers, legal opinion, EU opinion and advice and data protection legislation.
resultsThe legal literature review overwhelmingly supports the concerns raised.
conclusionsOur results confirm the GDPR explicit consent requirement of the HRRs is having had a significantly negative and far-reaching impact on the conduct of health research in Ireland. Urgent review of the HRRs and meaningful engagement between the health research community and legislators in healthcare is required.
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