上海市伦理审查地方标准的制定和执行  

Formulation and Implementation of Shanghai Local Standard of Ethical Review

作　　者：曹国英[1] 吴翠云[1] 邹和建[1] 伍蓉[1] CAO Guo-ying;WU Cui-yun;ZOU He-jian(Ethics Committee,Huashan Hospital of Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院伦理委员会,上海200040

出　　处：《医学与哲学（A）》2018年第7期32-33,55,共3页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：2017年国家科技重大新药创制专项(2017ZX09304005)

摘　　要：为使不同机构伦理委员会统一伦理审查标准,缩小审查质量差距,亟需更细化的标准操作规程指导伦理委员会工作。首个《涉及人的生物医学研究伦理审查规范》的上海市地方标准,对伦理审查基本流程、类型等作了详细规定,尤其对伦理审查工作中使用的各种工作用表、模板和文件清单作了规定,为上海市各级医疗机构和科研院校等伦理委员会规范伦理审查工作提供了参考标准,同时也成为了上海市卫生管理部门对伦理委员会督查评估的标准,对地方伦理工作起到了较大的推动作用,规范了流程,提升了审查质量。In order to standardize the procedure of ethical review and improve quality of reviewing among different institutional review boards(IRBs)/ethics committees(ECs),we need more detailed standard operating procedure to guide them.The authors took the lead in formulating the first local standard on“Ethical Review of Biomedical Research Involving Human Subjects”in Shanghai,which includes detailed regulations on the basic procedures and types of ethics review.In particular,the various worksheets,templates and document lists used in the ethical review work are specified in the local standard.It provides reference standards for ethics committee at various hospitals and institutions in Shanghai.At the same time,it has also become the standard for the supervision and evaluation of the ethics committee of the Shanghai Municipal Health Administration,and has played a major role in improving the quality of ethical review.

关 键 词：地方标准 伦理审查 生物医学研究 

分 类 号：R-052[医药卫生]