Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.

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.