What GDPR and the Health Research Regulations (HRRs) mean for Ireland: “explicit consent”—a legal analysis

• DOI: 10.1007/s11845-020-02331-2
• Publication Date: 2020-07-30T00:25:41Z
• Authors: Mary Kirwan; Blanaid Mee; Niamh Clarke; Aoife Tanaka; Lino Manaloto; Emma Halpin; Una Gibbons; Ann Cullen; Sarah McGarrigle; Elisabeth M. Conn...; Kathleen Bennett; Eoin Gaffney; Ciaran Flanagan; Laura Tier; Richard Flavin; Noel G. McElvaney
• Keywords: Legal opinion

Abstract Background Irish Health Research Regulations (HRRs) were introduced following the commencement of General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented under auspices Academy Medical Sciences (IAMS) on April 8 and November 25, 2019 at Royal College Surgeons Ireland welcomed introduction GDPR HRRs. found “explicit consent” by is problematic. call was made to regulate informed consent line with common law as an achievable alternative safeguard, bringing other EU Member States. Aims This article aims review academic papers, opinion, opinion advice data protection relation research explicit consent, order examine burden health determine whether IAMS meetings reflected more widely text. Methods Legal literature legislation. Results overwhelmingly supports concerns raised. Conclusions Our results confirm requirement having had a significantly negative far-reaching impact conduct Ireland. Urgent meaningful engagement between community legislators healthcare required.