摘要
伦理审查是国际通行的研究风险控制的重要手段。医学伦理学在世界各个国家的起步时间不同、发展水平和程度不均,但是,当今世界各国的伦理审查建设都在朝着建设区域伦理委员会的方向发展。我国在建设区域伦理委员会的过程中,面临着探索伦理互认机制、监管伦理持续审查、保护受试者的权益等挑战。本文分享了依托于中医医联体模式建设北京市属中医院区域伦理委员会的探索与实践。在建设市属中医院区域伦理委员会的过程中,通过搭建工作交流平台,达到协作课题伦理审查以及跟踪监管,接受托管医院委托代为伦理审查,逐步扶助托管医院建立伦理审查的目的。本文提出在中国区域伦理委员会建设过程中,需要统一伦理审查标准、形成合理工作程序、提高伦理审查效率。
Ethical review is an important means of risk control of clinical researches internationally. The starting time of medical ethics in various countries in the world is different, and the level and degree of development is uneven, but the construction of ethics review in the world today is moving towards the construction of regional ethics committee(EC).In the process of establishing regional EC in China, we are faced with challenges of exploring the mutual ethics recognition mechanism, continuing examination of supervision ethics and protecting the rights and interests of research subjects. This paper shared the exploration of the regional EC of Beijing municipal hospital based on the model of traditional Chinese medicine(TCM) medical association mode. In the process of establishing the regional EC of municipal TCM hospital, a working communication platform was built to achieve the ethical review and supervise the follow-up collaborative subjects, and to accept the ethical review entrustment of trusteeship hospitals, finally to gradually help the trusteeship hospital to improve their own ethical review system and level. This paper put forward that in the process of constructing regional EC in China,it is necessary to unify the ethical review standards, to form a reasonable working procedure and to improve the ethical review efficiency.
作者
王晶
郭华
詹艳华
刘惠杰
刘清泉
Wang Jing;Guo Hua;Zhan Yanhua;Liu Huijie;Liu Qingquan(Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University,Beijing 100010,China;Office of Academic Research,Shunyi Hospital of Beijing Hospital of Traditional Chinese Medicine,Beijing 101300,China;Office of Educational Administration,Yanqing Hospital of Beijing Hospital of Traditional Chinese Medicine,Beijing 102100,China;Pinggu Hospital of Beijing Hospital of Traditional Chinese Medicine,Beijing 101200,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2019年第12期2690-2694,共5页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家科技部“十三五”重大新药创制专项子课题(2019ZX09734001-003):创新药物临床评价示范性平台建设,负责人:程金莲
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(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
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(JKWH2019-Q03):一带一路背景下中医药援外培训模式研究,负责人:王晶.
关键词
伦理审查
区域伦理委员会
伦理监管
临床研究
医联体
Ethical review
regional ethics committee
ethical supervision
clinical research
medical partnership