Reforming Ethical Oversight in Italy: Challenges and Gaps in the Implementation of the New Ethics Committees...

The recent reform of Italian Ethics Committees (ECs), formalized between 2022 and 2023, aimed to streamline ethical oversight in clinical research by transitioning from a fragmented local system to a coordinated national framework. The new structure includes 40 Territorial Ethics Committees (CETs) and three National Committees (CENs), under the supervision of the National Coordination Centre (CCNCE). While the reform aligned Italy with European Regulation (EU) No 536/2014, significant implementation gaps remain. Many CETs face operational delays, non-compliance with legal composition requirements, inconsistent procedures, and limited resources. Technical-Scientific Secretariats (STS)-crucial to committee function-often lack adequate staffing and training, leading to geographic disparities in review efficiency. Financial sustainability is also a major concern, especially for committees handling unfunded non-commercial studies. Furthermore, the limited mandate of ECs excludes a large portion of ethically complex but non-regulated research. The CCNCE's coordinating role is constrained by scarce resources and insufficient authority. To ensure effective, equitable, and independent ethical review, the article calls for regulatory harmonization, organizational investment, financial support, and broader recognition of ECs' roles in all areas of health research.