What GDPR and the Health Research Regulations (HRRs) mean for Ireland: "explicit consent"-a legal analysis.
Kirwan M; Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland. .
Mee B; Department of Histopathology, St James's Hospital, Dublin, Ireland.
Clarke N; Department of Surgery, School of Medicine, Faculty of Health Sciences, Trinity College Dublin, Dublin, Ireland.
Tanaka A; Department of Histopathology, St James's Hospital, Dublin, Ireland.; Biobank Ireland Trust, Dublin, Ireland.
Manaloto L; School of Biotechnology, Faculty of Science and Health, Dublin City University, Dublin, Ireland.
Halpin E; School of Biotechnology, Faculty of Science and Health, Dublin City University, Dublin, Ireland.
Gibbons U; Department of Histopathology, St James's Hospital, Dublin, Ireland.
Cullen A; Conway Institute of Biomolecular & Biomedical Research, University College Dublin, Dublin, Ireland.
McGarrigle S; Department of Surgery, School of Medicine, Faculty of Health Sciences, Trinity College Dublin, Dublin, Ireland.
Connolly EM; Department of Surgery, St James's Hospital, Dublin, Ireland.
Bennett K; Department of Epidemiology and Public Health Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Gaffney E; Biobank Ireland Trust, Dublin, Ireland.
Flanagan C; Biobank Ireland Trust, Dublin, Ireland.
Tier L; Department of Histopathology, St James's Hospital, Dublin, Ireland.
Flavin R; Department of Histopathology, St James's Hospital, Dublin, Ireland.
McElvaney NG; Department of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland.
Irish journal of medical science [Ir J Med Sci] 2021 May; Vol. 190 (2), pp. 515-521. Date of Electronic Publication: 2020 Jul 30.
Typ publikacji :
Imprint Name(s) :
Original Publication: Dublin : Royal Academy of Medicine of Ireland
MeSH Terms :
Biomedical Research/*legislation & jurisprudence
Computer Security/*legislation & jurisprudence
Informed Consent/*legislation & jurisprudence
Research Design/*legislation & jurisprudence
Female ; Humans ; Ireland ; Male
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Contributed Indexing :
Keywords: Common law; Consent declaration; Explicit consent; GDPR; Health research; Informed consent; Ireland; Irish health regulations; Research
Entry Date(s) :
Date Created: 20200731 Date Completed: 20210430 Latest Revision: 20210430
Update Code :
PubMed Central ID :
Background: Irish 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.
Aims: This 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.
Methods: Legal literature review of academic papers, legal opinion, EU opinion and advice and data protection legislation.
Results: The legal literature review overwhelmingly supports the concerns raised.
Conclusions: Our 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.