摘要
从多中心临床研究的现状分析入手,结合最新出台的临床研究管理相关政策和要求,对比美国多中心伦理审查的实践经验,针对我国开展多中心伦理审查的模式提出建议和意见。认为当前我国多中心伦理审查应该采取有条件的“认可”组长单位审查决定的模式,逐步建立单一中心伦理审查的模式,选择最优的主审伦理委员会。区域伦理委员会在多中心伦理审查模式中可以逐步承担起主审伦理的职责,最终为解决完善伦理审查机制、提高伦理审查效率做出贡献。
Based on the analysis of the current situation of multi-center clinical research and the latest policies and requirements, and comparasion with the practical experience of multi-center ethical review in the United States, this paper puts forward suggestions and opinions on the mode of multi-center ethical review in China. It proposes that the multi-center ethical review should adopt the mode of conditional "approval" of the leading site's ethical review decision, gradually establish the mode of single IRB review, and select the best ethical committee. Regional ethics committees can gradually take the responsibility of primary review in the multi-center ethics review model, and ultimately contribute to improving the ethics review mechanism and the efficiency of ethics review.
作者
陆麒
伍蓉
LU Qi;WU Rong(Office of Ethics Committee, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200127, China)
出处
《医学与哲学》
2019年第13期28-31,共4页
Medicine and Philosophy
关键词
多中心伦理审查
协作审查
单一伦理审查
区域伦理委员会
ethical review of multi-center research
cooperative review
single IRB review
regional IRB
