The New Organization of Ethics Committees in Italy: What is the Future of Clinical Ethics?

Abstract

Background: In Italy, clinical ethics is not well institutionalized. On February 7, 2023, the Italian Ministry of Health published four long-awaited decrees regarding the reorganization of ethics committees.

Aim: The aim of this article is twofold: firstly, we aim to briefly summarize the development of clinical ethics in Italy from a legislative point of view; secondly, we aim to examine how Italian regions are implementing the part of the new decrees on the organization of ethics committees that concerns clinical ethics.

Methods: As for the first aim, we conducted a critical interpretive review (CIR). The search was restricted to the opinions offered by the Italian National Bioethics Committee (CNB) and to the major Italian legislative decrees on the topic. Regarding the second aim, we conducted an online search through Regional Official Bulletins of each Italian region.

Results: Our analysis showed that despite the recommendations from the CNB to differentiate Research Ethics Committees (RECs) and Clinical Ethics Committees (CECs), over the years legislative attention has mainly focused on RECs and pharmacological matters. The new decrees allow regions to be flexible in organizing their activities. However, it emerged that only four regions (Veneto, Friuli-Venezia Giulia, Puglia, Emilia-Romagna) have split the roles, while all the other regions have entrusted both roles to a single committee.

Conclusion: The risk for Italy is to take a step backward in the development of clinical ethics. Possible solutions could be either making Local Ethics Committees (CELs) mandatory or institutionalizing Ethics Consultation services (ECSs).