What GDPR and the Health Research Regulations (HRRs) mean for Ireland: a research perspective

Blanaid Mee,Elisabeth M Connolly,Emma Halpin,Aoife Tanaka,Niamh Clarke,Laura Tier,Ann Cullen,Noel G Mcelvaney,Sarah Mcgarrigle,Ciaran Flanagan,Kathleen Bennett,Lino Manaloto,Eoin Gaffney,Una Gibbons,Richard Flavin,Mary Kirwan

doi:10.1007/s11845-020-02330-3

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.

Highlights

The European Union (EU) General Data Protection Regulation (GDPR) came into effect on May 25, 2018
At a public meeting organised by the Irish Academy of Medical Sciences (IAMS), on November 25, 2019, GDPR
Individuals were invited to provide information via email on any of the following: (a) general understanding of the Health Research Regulations (HRRs), (b) time to obtain Research Ethics Committee (REC) approval, (c) RECs shutting down to become compliant, (d) RECs reluctance to accept external templates due to lack of nationally approved templates, e.g. patient information leaflets, (e) time outlay related to Health Research Consent Declaration Committee (HRCDC) applications and (f) Data Protection Officer (DPO) guidance

Summary

Introduction

The European Union (EU) General Data Protection Regulation (GDPR) came into effect on May 25, 2018. The HRRs introduced additional regulatory requirements for health research in relation to governance, processes and procedures that impacted on several aspects of research [4, 5]. 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 “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. Aims The 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

Objectives

Methods

Results

Conclusion