Analysis of the dilemmas of the simplified ethical review procedure in practice
10.12026/j.issn.1001-8565.2025.01.07
- VernacularTitle:简易伦理审查程序在实践中的困境分析
- Author:
Benze HU
1
;
Yuhong HUANG
1
;
Xufang GU
1
;
Weihua GUO
2
;
Siyuan HU
3
;
Yaqing YANG
4
Author Information
1. Ethics Committee Office， the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine， Tianjin 300250， China
2. School of Marxism， Tianjin Normal University， Tianjin 300382， China
3. Clinical Trial Center， the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine， Tianjin 300193， China
4. School of Medical Humanities， Tianjin Medical University， Tianjin 300070， China
- Publication Type:Journal Article
- Keywords:
scientific and technological ethic;
ethics review;
simplified procedure review;
autonomy and heteronomy
- From:
Chinese Medical Ethics
2025;38(1):46-51
- CountryChina
- Language:Chinese
-
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.
