Royal College of Surgeons in Ireland
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GDPR: an impediment to research?

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journal contribution
posted on 2021-03-06, 10:17 authored by Niamh ClarkeNiamh Clarke, Gillian Vale, Emer ReevesEmer Reeves, Mary KirwanMary Kirwan, David SmithDavid Smith, Michael Farrell, Gerard Hurl, Noel G McElvaneyNoel G McElvaney

Background: The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland's Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland's clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.

Aim: In this article, we explore what exactly is proposed by Europe's GDPR and by Ireland's Health Research Regulations. We look at the challenges presented to clinical researchers, and we highlight those areas, which need clarification by the Department of Health and by the Data Protection Commissioner.

Conclusions: We propose five recommendations, which would ameliorate some of the more restrictive impositions of these regulations. This review was commissioned by the Irish Academy of Medical Science.



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Published Citation

Clarke N, Vale G, Reeves EP, Kirwan M, Smith D, Farrell M, Hurl G, McElvaney NG. GDPR: an impediment to research? Irish Journal of Medical Science. 2019;188(4):1129-1135.

Publication Date

08 February 2019

PubMed ID



  • Beaumont Hospital
  • Medicine
  • General Practice

Research Area

  • Respiratory Medicine


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  • Published Version (Version of Record)