Refolo Pietro, Raimondi Costanza, Sacchini Dario, Spagnolo Antonio Gioacchino
Research Center for Clinical Bioethics and Medical Humanities (CRiBCeMH), Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
J Bioeth Inq. 2025 Feb 13. doi: 10.1007/s11673-024-10389-1.
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.
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.
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.
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.
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).
在意大利，临床伦理并未得到很好的制度化。2023年2月7日，意大利卫生部发布了四项期待已久的关于伦理委员会重组的法令。
本文的目的有两个：第一，我们旨在从立法角度简要总结意大利临床伦理的发展；第二，我们旨在研究意大利各地区如何实施新法令中关于伦理委员会组织的涉及临床伦理的部分。
对于第一个目的，我们进行了批判性解释性综述（CIR）。搜索仅限于意大利国家生物伦理委员会（CNB）提供的意见以及意大利关于该主题的主要立法法令。关于第二个目的，我们通过意大利各地区的《地区官方公报》进行了在线搜索。
我们的分析表明，尽管CNB建议区分研究伦理委员会（RECs）和临床伦理委员会（CECs），但多年来立法关注主要集中在RECs和药理学问题上。新法令允许各地区在组织活动方面保持灵活性。然而，结果显示只有四个地区（威尼托、弗留利 - 威尼斯朱利亚、普利亚、艾米利亚 - 罗马涅）进行了角色划分，而所有其他地区都将这两个角色委托给了一个单一委员会。
意大利面临在临床伦理发展方面倒退的风险。可能的解决方案可以是强制设立地方伦理委员会（CELs）或使伦理咨询服务（ECSs）制度化。
