委托审查的实践与思考  

Practice and Thinking of Entrustment Ethical Review

作　　者：盛艾娟[1] 王美霞[1] 王小琪[1] 金荣华[1] 李玉梅 孙桂珍[1] SHENG Aijuan;WANG Meixia;WANG Xiaoqi;JIN Ronghua;LI Yumei;SUN Guizhen(Ethics Committee,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Office of Party Affairs,Beijing Jishuitan Hospital,Beijing 100035,China)

机构地区：[1]首都医科大学附属北京佑安医院伦理委员会,北京100069 [2]北京积水潭医院党委办公室,北京100035

出　　处：《中国医学伦理学》2020年第11期1345-1348,共4页Chinese Medical Ethics

基　　金：陕西省健康文化研究中心立项资助项目“基于感染及传染性疾病临床研究的伦理委员审查能力评估和准入机制探讨”(JKWH2019-Q01)。

摘　　要：《涉及人的生物医学研究伦理审查办法》规定医疗卫生机构未设立伦理委员会的,不得开展涉及人的生物医学研究工作。目前,国内部分医疗卫生机构特别是基层医疗卫生机构仍未建立伦理委员会,部分医疗卫生机构虽建立了伦理委员会,但是审查能力薄弱,无法保证高质量的伦理审查,无法保护受试者,无法实施部分涉及人的生物医学研究;部分高风险项目的审查建议和/或审查结论存在争议,不能被其他伦理委员会/申办方/研究者认可。委托审查是可行的解决途径。结合委托审查的实践,阐述了委托审查的由来、需求、现状、实践、思考及意义。The Measures for the Ethical Review of Biomedical Research Involving People stipulates that medical and health institutions that have not established an ethics committee can not conduct biomedical research involving people.At present,some domestic medical and health institutions,especially primary medical and health institutions,have not established ethics committees.Although some medical and health institutions have established ethics committees,they have weak review capabilities and cannot guarantee high-quality ethical reviews.They cannot protect subjects and cannot implement some Human biomedical research.The review recommendations and/or review conclusions of some high-risk projects are controversial and cannot be recognized by other ethics committees or sponsors or researchers.Therefore,entrustment ethical review is considered a feasible solution.This research combines the practice of commissioned review to explain the origin,needs,current situation,practice,thinking and significance of commissioned review.

关 键 词：委托审查 伦理审查 伦理委员会 受试者保护 临床研究 

分 类 号：R-052[医药卫生]