三级甲等综合性医院伦理审查体系建设的实践分析  

Practice and Analysis on the Construction of Ethical Review System in A-Level Public Hospital

作　　者：陈梅男 吴晓雯 胡怡然 杭天依 杨春梅 CHEN Meinan;WU Xiaowen;HU Yiran;HANG Tianyi;YANG Chunmei(The First Affiliated Hospital of USTC,Division of Life Sciences and Medicine,University of Science and Technology of China,Hefei,230001,China)

机构地区：[1]中国科学技术大学附属第一医院/安徽省立医院,安徽合肥230001

出　　处：《中国社会医学杂志》2022年第5期491-495,共5页Chinese Journal of Social Medicine

基　　金：“十三五”重大新药创制科技重大专项(2020ZX09201-004);中国科学技术大学附属第一医院(安徽省立医院)教学质量工程项目(2019xjyxm098)。

摘　　要：为提高临床医生开展医学研究的科学性和规范性,中国科学技术大学附属第一医院/安徽省立医院通过明确认证内容和认证程序、构建伦理审查体系组织架构及相关管理制度、系统修订并完善伦理委员会标准操作规程、开展体系相关人员伦理培训、加强利益冲突管理、开展伦理审查体系内部审核等一系列措施,建立了医院伦理审查体系。通过中医药研究伦理审查体系(Chinese Accreditation Program of Ethics Review System for CM Research, CAP)认证,推动了医院涉及人的生物医学研究项目的伦理管理,促进了医院伦理委员会的规范化建设,进而提高了研究项目受试者权益的保护。In order to improve the scientificity and standardability of investigator initiated medical research, the first affiliated hospital of University of Science and Technology of China(USTC)/Anhui provincial hospital established a sophisticated hospital ethical review system certified by the Chinese Accreditation Program of Ethics Review System for CM Research(CAP).Measures used to improve the system includes confirming the accreditation contents and procedures, establishing the organizational structure of hospital ethics review system and related management institutions, systematically revising and consummating the Standard Operation Procedure(SOP),carrying out the ethical training for related personal involving in the ethical review system, defining and reinforce the management of conflict of interest(COI)management, and conducting the internal audit for the hospital ethics review system.Through the CAP certification process, we have managed to promote the ethical management of biomedical research projects involving human, to accelerate the standardization construction of ethics committee in hospital, and to enhance the quality of subject protection in medical researches.

关 键 词：伦理审查体系 中医药研究伦理审查体系认证 医学研究 受试者保护 

分 类 号：R197.32[医药卫生—卫生事业管理]