Ten years after Regulation 536/2014: ethical reflection on the role of Ethics Committees in Italy.

Abstract

Since their institution, Ethics Committees (ECs) dedicated to the ethical evaluation of research protocols have been traditionally entrusted with the role of finding a delicate balance between protecting research participants' rights and avoiding the hampering of scientific progress. In Europe, these bodies have evolved significantly over time, shaped by a dynamic regulatory framework culminating in Regulation (EU) 536/2014, which has been fully applied since 2022. Focusing on the Italian scenario, a decade after the adoption of the Regulation (2014-2024), this paper is aimed at shedding light on the extent to which the evolution of the pertinent normative framework has affected ECs' space for reflection within the ethics review process of clinical trials, essential to protect the rights of research participants. Although focused on the Italian scenario, the analysis holds relevance for the broader European context, since the Regulation is unique and developments in a single Member State may impact the others.