多中心临床研究伦理协作审查与管理的思考

Thoughts on Ethical Collaborative Review and Management of Multi-center Clinical Research

对于多中心临床研究,各中心如何通过协作,保证伦理审查质量、提高审查效率,是临床研究管理部门及研究各方探索的重要方向。通过梳理及分析当前国内外多中心伦理审查的现有模式,结合目前中国伦理审查与管理发展的现状,以肿瘤临床研究为切入点,倡导在国内建立由专业学会牵头,在广泛、深入的培训交流及同一平台有效沟通的基础上,进行协作审查,保质提效,充分促进与落实伦理审审“互认”。在此基础上,进一步提出多中心临床研究伦理管理过程的“全程联动”理念,指出研究各方均应厘清职责,提升意识与能力,共同、全面将临床研究者中的受试者保护落到实处。

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.