Thoughts on Ethical Collaborative Review and Management of Multi-center Clinical Research
10.12026/j.issn.1001-8565.2022.05.09
- VernacularTitle:多中心临床研究伦理协作审查与管理的思考
- Author:
Hongwu LIAO
1
;
Haihong ZHANG
2
;
Jie LI
1
Author Information
1. Medical Ethics Committee of Beijing Cancer Hospital/Beijing Institute for Cancer Prevention and Treatment/Key Laboratory of the Ministry of Education, Cancer Pathogenesis and Transformation Research, Beijing 100142, China
2. Department of Scientific Research, Peking University Health Science Center, Beijing 100191, China
- Publication Type:Journal Article
- Keywords:
Multi-center Clinical Research;
Ethical Review;
Cooperative Review;
Ethical Mutual Recognition;
Ethical Management
- From:
Chinese Medical Ethics
2022;35(5):513-517
- CountryChina
- Language:Chinese
-
Abstract:
For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
