北京市属中医院区域伦理委员会办公室建设与运行的分析与思考  

Construction and Operation of the Regional Ethics Committee Office of Beijing Municipal Hospital of Traditional Chinese Medicine

作　　者：王晶[1] 詹艳华 郭华 刘惠杰 信彬[1] WANG Jing;ZHAN Yanhua;GUO Hua;LIU Huijie;XIN Bin(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Education Department, Beijing Hospital of Traditional Chinese Medicine yanqing Branch,Beijing 102100, China;Research Department,Beijing Hospital of TraditionalChinese Medicine Shunyi Branch,Beijing 101300, China;Beijing Hospital of TraditionalChinese Medicine Ping gu Branch, Beijing 101200, China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京中医医院延庆医院教育处,北京102100 [3]北京中医医院顺义医院科研处,北京101300 [4]北京中医医院平谷医院,北京101200

出　　处：《中国医学伦理学》2020年第3期341-344,共4页Chinese Medical Ethics

基　　金：北京市医院管理中心2018年度(第四批)“青苗”计划专项经费资助项目“基于中医医联体模式的市属中医院区域伦理委员会建设与研究”(QML20181004);陕西省哲学社会科学重点研究基地——陕西省健康文化研究中心课题“一带一路背景下中医药援外培训模式研究”(JKWH2019-Q03);国家“十三五”重大新药创制专项课题“创新药物全过程临床评价示范性技术平台建设”(2019ZX09734001)。

摘　　要：依托于中医医联体建设模式,北京中医医院及其托管的顺义医院、延庆医院、平谷医院、怀柔医院等四家医院,建立了北京市属中医院区域伦理委员会。从落实管理制度指南、优化日常工作流程、搭建工作交流平台、加强人员伦理素养、规范档案信息管理等五个方面,介绍了北京市属中医院区域伦理委员会办公室的建设与运行。优化该区域伦理委员会办公室的管理,可以简化伦理审查流程、加快伦理审查的时效性,提高伦理办公室工作效率,切实保证参与临床试验受试者的利益和安全,尽量减少受试者保护的盲区。Relying on the construction model of the medical alliance of traditional Chinese medicine(TCM),Beijing Hospitd of TCM and its four trusteeship hospitals,which includes Shunyi Hospital,Yanqing traditional Chinese Medicine Hospital,Pinggu Hospital,Huairou Hospital,established the Beijing municipal TCM regional ethics committee.The construction and operation of the regional ethics committee office of Beijing municipal hospital of TMC were introduced from five aspects,including:the implementation of the management system guide,the optimization of daily work processes,the establishment of a work communication platform,the enhancement of personnel ethics and the standardization of archival information management.This study suggested that optimizing the management of the regional ethics committee office can simplify the process of ethical review,speed up the timeliness of ethical review,improve the efficiency of ethical review,effectively ensure the interests and safety of subjects participating in clinical trials,and minimize the blind spot of subject protection.

关 键 词：区域伦理委员会 伦理审查 伦理监管 临床研究 受试者安全 

分 类 号：R-052[医药卫生]