Abstract
This article describes the main changes introduced by the Decree of the Ministry of Health of 26 January 2023 (Identification of 40 territorial ethics committees), against the backdrop of the Italian “long reform” of ethics committees. The article also discusses, with some comparative references, the potential and limits of the Decree in relation to the challenges posed both by the new authorisation procedure for clinical trials under Regulation (EU) 536/2014 and by the most innovative forms of biomedical research. The article concludes with a number of possible measures regarding the composition and functioning of ethics committees, which could better enable them to deal with an increasingly challenging regulatory and research environment. This is also in light of a comparative analysis of several EU Member States.
| Translated title of the contribution | The Italian reform of ethics committees in the European context: Challenges, opportunities, and comparative insights |
|---|---|
| Original language | Italian |
| Pages (from-to) | 103-121 |
| Journal | Rivista italiana di medicina legale e del diritto in campo sanitario |
| Issue number | 1 |
| Publication status | Published - 2023 |
Keywords
- biomedical Research/standards
- clinical trials
- Regulation (EU) 536/2014
- ethics committees