中国医学伦理学2025，Vol.38Issue(1)：46-51,6.DOI:10.12026/j.issn.1001-8565.2025.01.07
简易伦理审查程序在实践中的困境分析
Analysis of the dilemmas of the simplified ethical review procedure in practice
摘要
Abstract
In September 2023,the Measures for Scientific and Technological Ethics Review(Trial Implementation)was issued,revising the provisions related to the simplified procedure for ethical review in Chapter 3,Section 3.This revision of these provisions provides systematic guarantees for further optimizing ethical review work,ensuring that ethical review procedure is well-regulated,and improving scientific research efficiency.The"simplified procedure"does not mean reducing the quality and requirements of the review.Instead,based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations,improving the efficiency of ethical review and subsequent research work,and promoting the development of life sciences and medical research involving humans.In practical work,it introduces numerous new opportunities and challenges for the improvement of ethics review ability,such as new tests on the judgment and decision-making power of ethics committees,how to ensure the reliability and controllability of the conditions related to the simplified review procedure,and how to determine the basic conditions for adopting the simplified review procedure for review.Therefore,to actively respond to the challenges and possible risks brought by the simplified procedure review,efforts should be made to achieve three"unifications",including the unification of researchers'moral autonomy and the heteronomy of supervision implemented by relevant departments;the unification of the standard formulation of the simplified procedure review and the review work in practice;and the unification of ethical responsibility and legal responsibility.关键词
科技伦理/伦理审查/简易程序审查/自律与他律Key words
scientific and technological ethic/ethics review/simplified procedure review/autonomy and heteronomy引用本文复制引用
胡本泽,黄宇虹,谷旭放,郭卫华,胡思源,杨雅清..简易伦理审查程序在实践中的困境分析[J].中国医学伦理学,2025,38(1):46-51,6.基金项目
科技部国家重点研发计划项目(2021YFC1712900) （2021YFC1712900）
