医疗机构施行免除伦理审查的可行性探析

Exploring the Feasibility of Implementing Exemptions from Ethical Review in Medical Institutions

2023年2月,国家卫健委、教育部、科技部、中医药管理局等四部委联合发布了《涉及人的生命科学和医学研究伦理审查办法》,首次在我国提出“免除伦理审查”的伦理审查方式。结合医疗机构科研伦理审查的实际情况,尝试解读免除伦理审查以及相关的法律法规条文,探讨医疗机构免除伦理审查施行的困难,并尝试讨论医疗机构开展免除伦理审查应做的制度完善和管理优化,旨在为免除伦理审查这一审查方式在医疗机构伦理审查委员会的具体实践提供参考。

In February 2023,the National Health Commission,Ministry of Education,Ministry of Science and Technology,and the National Administration of Traditional Chinese Medicine jointly issued the Measures for Ethical Review of Life Science and Medical Research Involving Human Beings.This marks the first time in China in which the concept of"exemption from ethical review"has been introduced.Based on the actual situation of ethical review in medical institutions'scientific research,this paper attempts to interpret the exemption from ethical review and related legal provisions,explores the challenges in implementing exemption from ethical review in medical institutions,and discusses the necessary institutional improvements and management optimizations.Its aim is to offer reference for the practical application of exemption from ethical review by ethics committees in medical institutions.