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GDPR: an impediment to research?

Niamh Clarke^1,2, Gillian Vale¹, Emer P Reeves^3,4

¹Beaumont Hospital Ethics (Medical Research) Committee, Beaumont Hospital, Dublin, Ireland.

Irish Journal of Medical Science

|February 9, 2019

Summary

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This summary is machine-generated.

New Irish health research regulations, influenced by Europe's General Data Protection Regulation (GDPR), pose challenges for clinical research. Clarification is needed to ensure patient access to treatments and support the Irish knowledge economy.

Area of Science:

Health Law and Policy
Clinical Research Management
Data Protection in Healthcare

Background:

Recent implementation of Europe's General Data Protection Regulation (GDPR) and Ireland's Health Research Regulations has raised concerns.
Ireland's interpretation creates a unique regulatory environment potentially hindering clinical research and patient access to novel treatments.
These regulations may negatively impact the attractiveness of Ireland for pharmaceutical research and development.

Purpose of the Study:

To examine the specifics of the GDPR and Ireland's Health Research Regulations.
To identify challenges faced by clinical researchers under these new regulations.
To highlight areas requiring clarification from the Department of Health and the Data Protection Commissioner.

Main Methods:

Keywords:

Biobanks/archival material Capacity to consent General Data Protection Regulation Health Research Regulations Retrospective chart reviews

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Review and analysis of European and Irish health research legislation.
Examination of the practical implications for clinical researchers in Ireland.
Identification of ambiguities and areas needing further guidance.

Main Results:

The regulations, as currently applied in Ireland, present significant administrative burdens for clinical researchers.
Potential for researchers and institutions to withdraw from clinical research activities.
Risk of detriment to patient care and the Irish knowledge economy.

Conclusions:

Five recommendations are proposed to mitigate the restrictive aspects of the regulations.
Urgent clarification is needed from regulatory bodies to support clinical research.
Addressing these issues is crucial for maintaining Ireland's position in clinical research and patient welfare.