国家临床医学研究中心伦理审查互认管理实践国家临床医学研究中心伦理审查互认管理实践  

Management Practices for Mutual Recognition of Ethical Review in National Clinical Research Centers

作　　者：刘明丽 Mingli Liu(National Clinical Research Center for Orthopedics and Sports Rehabilitation,Beijing 100048)

机构地区：[1]国家骨科与运动康复临床医学研究中心,北京100048

出　　处：《现代管理论坛》2025年第1期30-32,共3页

摘　　要：本文聚焦于国家临床医学研究中心伦理联盟在多中心临床研究中推行伦理审查互认的实践。针对多中心研究中伦理审查效率低、标准不统一等问题,国家临床医学研究中心积极响应国家政策,成立伦理联盟并实施伦理审查互认机制。通过对联盟成员单位的调研与实践分析,总结成效。同时,针对互认过程中出现的问题,结合实践经验提出优化路径,包括弥合机构间政策认知差异、规范递交文件格式与内容、强化跨区域伦理委员会协作等。旨在为伦理审查互认模式的优化提供指导,推动我国多中心临床研究的高质量与快速发展。This article focuses on the practical implementation of ethical review mutual recognition by the Ethical Alliance of the National Clinical Medicine Research Center in multicenter clinical studies.In response to issues such as low efficiency and inconsistent standards in ethical review across multicenter studies,the National Clinical Medicine Research Center has actively responded to national policies by establishing the Ethical Alliance and implementing a mechanism for mutual recognition of ethical reviews.Through research and practical analysis of the alliance's member institutions,the article summarizes the results achieved.At the same time,it addresses the problems encountered during the mutual recognition process and,based on practical experience,proposes optimization paths.These include bridging policy awareness gaps between institutions,standardizing submission document formats and content,and strengthening collaboration among ethics committees across regions.The aim is to provide guidance for optimizing the mutual recognition model of ethical review and to promote the high-quality and rapid development of multicenter clinical research in China.

关 键 词：伦理审查互认 伦理联盟管理 国家临床医学研究中心 

分 类 号：R-052[医药卫生]