中医药伦理审查的特色与对策探讨  

Discussion on Characteristics and Countermeasures of Traditional Chinese Medicine Ethical Review

作　　者：王晶[1] 信彬[1] Wang Jing;Xin Bin(Ethics Committee Office, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital MedicalUniversity,Beijing 100010,China;Ethics Committee, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院伦理委员会办公室

出　　处：《世界科学技术-中医药现代化》2019年第4期708-714,共7页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：北京市医院管理局2018年度(第四批)“青苗”计划专项经费资助项目(QML20181004):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,负责人:王晶;首都医科大学附属北京中医医院2016年度院级课题暨两院合作课题项目(YJ-201710):中医药临床研究伦理审查平台建设及审查质量提升,负责人:王晶

摘　　要：中医药是我国医药宝库中的重要组成部分,在世界范围内产生越来越深刻的影响。目前,涉及中医药的临床研究越来越多。任何涉及人的医学研究都不可避免地会给参加研究的受试者带来风险。因此,伦理委员会对中医药相关项目的审查和监督就显得尤为重要。本文简要回顾了中医药伦理审查的建设历程。中医药伦理审查具有其自身特色的,这其中包括中医理论,中草药复方制剂等药物疗法,针灸、拔罐、推拿等非药物疗法等干预方式,以及试验设计、疗效评价、风险与受益等中医药临床研究中的实际问题。针对中医药研究的自身特色,本文提出落实并完善伦理审查制度和程序、提升委员审查能力、优化日常工作流程、提高主要研究者的伦理意识、运用外部认证估推动伦理工作发展等几点对策,不断提升中医药伦理审查的水平,完善受试者保护体系。Traditional Chinese medicine(TCM) is an important part of traditional medicine in China. It has a profound impact around the world. At present, more and more clinical researches on TCM have been carried on. Any medical research that involves people will inevitably bring risks to subjects participating in the study. Therefore, ethical review and supervision on TCM related projects by the ethical committee are particularly important. This paper briefly reviewed the construction history of TCM ethical review. Characteristics of TCM ethical review including TCM basic theories;intervention methods which contain drug therapy such as Chinese herbs and TCM compound medication, and non-drug therapies such as acupuncture, cupping, massage;as well as experimental design, therapeutic evaluation, risk and benefit in TCM clinical studies. According to TCM characteristics, this paper suggest several countermeasures to constantly improve the ethical review standard of TCM, which included to implement and improve the ethical review systems and procedures, to enhance the review ability of ethical committee members, to optimize daily work processes, to improve the ethical awareness of principal investigator(PI), to use external authentication in the promotion of ethical review development as well as to improve the system of the subjects’ protection.

关 键 词：临床研究 伦理审查 医学伦理 中医药研究 医学伦理委员会 

分 类 号：R211[医药卫生—中医学]