ReviewBritish journal of clinical pharmacology2022
Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.
Review in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Bioethics committee approvals in multicentre laryngology research across Europe: the European Laryngological Society's consensus on legal basis and quality assurance.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026Article
- Adapting research ethics for global health crises: a systematic analysis of COVID-19 pandemic research guidelines and reflections on their post-pandemic implications.BMC medical ethics · 2026Article
- Rethinking ethical reflexivity and oversight in health research through an ecosystem approach: A workshop report.Research ethics · 2026Article
- Approval delays in multi-country COVID-19 trials: the case of COPCOV and the risk of therapeutic inertia.Trials · 2025Article
- Research ethics and integrity challenges in accelerated clinical trials, an interview study.BMC medical ethics · 2025Article
- Ethics review or compliance check? an empirical analysis of 6740 requests for information in Belgian clinical trial evaluations (2017-2024).BMC medical ethics · 2025Article
- Research ethics education needs assessment in Serbian medical researchers.Ethics & behavior · 2025Article
- Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model.BMJ open · 2024Review
- Cross-border data sharing through the lens of research ethics committee members in sub-Saharan Africa.PloS one · 2024Article
- Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries.International journal of environmental research and public health · 2022Article
- Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency.Acta bio-medica : Atenei Parmensis · 2022Article
- Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.British journal of clinical pharmacology · 2022Review
- Exploring perspectives of research ethics committee members on the governance of big data in sub-Saharan Africa.South African journal of scienceArticle
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Research Ethics Committees (RECs)-or Institutional Review Boards (IRBs), as they are known in the US-were created about 50 years ago to independently assess the ethical acceptability of research projects involving human subjects, their fundamental role being the protection of the dignity and rights of research participants. In this paper we develop some critical reflections about the current situation of RECs. Our starting point is the definition of the role they should ideally play, a role that should necessarily include a collaborative approach and the focus on the ethics component of the review. This ideal is unfortunately quite far from reality: inadequacies in the functioning of RECs have been discussed for decades, along with reform proposals. Both in the US and in the European Union (EU), reforms that aim at the centralization of the review process were recently approved. Even though these reforms were needed, they nonetheless raise concerns. We focus on two such concerns, related in particular to Regulation (EU) No 536/2014: the risk of narrowing the scope of the ethics review and that of disregarding the local context. We argue that the COVID-19 pandemic paved the way for the transition towards the centralized model and that an analysis of its impact on the research review process could provide some interesting insights into possible shortcomings of this new model. We conclude by identifying three objectives that define the role of a REC, objectives that any reform should preserve.
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