ArticleIrish journal of medical science2021
What GDPR and the Health Research Regulations (HRRs) mean for Ireland: a research perspective.
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 6 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Co-designing accessible trial information: lessons from designing an inclusive patient information leaflet in the RaCeR2 study.Research involvement and engagement · 2026Article
- A vision for an academic health science centre: A survey of research engagement and barriers.PloS one · 2026Article
- Research opportunities in precision oncology: perspectives on biospecimen and genomic data sharing from adults with cancer in Ireland.Irish journal of medical science · 2025Article
- Documenting participant Consent in archival records: Aligning yesterday's practices with today's processes.HRB open research · 2025Article
- Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial.HRB open research · 2023Article
- 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 European Union (EU) General Data Protection Regulation (GDPR) in 2018. The HRRs described specific supplementary regulatory requirements for research regarding governance, processes and procedure that impact on several facets of research. The numerous problems that the HRRs and particularly "explicit consent" inadvertently created were presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on November 25, 2019, at the Royal College of Surgeons in Ireland.
aimsThe objective of this review was to obtain feedback and to examine the impact of GDPR and the HRRs on health research in Ireland in order to determine whether the preliminary feedback, presented at the IAMS meetings, was reflected at a national level.
methodsIndividuals from the research community were invited to provide feedback on the impact, if any, of the HRRs on health research. Retrospective patient recruitment and consent outside a hospital setting for a multi-institutional Breast Predict study (funded by the Irish Cancer Society) were also analysed.
resultsFeedback replicated the issues presented at the IAMS with additional concerns identified. Only 20% of the original target population (n = 1987) could be included in the Breast Predict study.
conclusionsOur results confirm that the HRRs have had a significantly negative impact on health research in Ireland. Urgent meaningful engagement between patient advocate groups, the research community and legislators would help ameliorate these impacts.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.