科研课题临床研究伦理审查的挑战与思考  

Challenges and Reflections on Ethical Review of Clinical Research of Scientific Projects

作　　者：王晶[1] 徐春军[1] 信彬[1] WANG Jing;XU Chunjun;XIN Bin(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

出　　处：《中国医学伦理学》2019年第11期1392-1394,1400,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);2016年度首都医科大学附属北京中医医院院级课题暨两院合作课题项目“中医药临床研究伦理审查平台建设及审查质量提升”(YJ-201710)

摘　　要：伦理委员会的建设和伦理审查制度的完善,可以有效保证涉及人的生物医学研究科学性和伦理性的审查,成为整个受试者保护体系建设中的重要一环。提炼伦理审查的要素,总结伦理初始审查和后期持续审查监管各环节的审查要素,是临床科研伦理审查中值得思考的问题。总结了在科研课题临床研究的伦理审查过程中,项目科学性和伦理性审查方面遇到的挑战。针对科研课题临床研究伦理审查及持续监管进行思考,提出完善培训制度、注重审查细节、加强实地访查等措施,以全方位、多角度的保护参加临床试验受试者的权益。The construction of ethical committee and the improvement of ethical review system can effectively ensure the scientific and ethical review of biomedical research involving human beings, and become an important part of the construction of the whole subject protection system. To refine the elements of ethical review and summarize the elements of review in each link of ethical initial review and subsequent continuous review and supervision are worthy of consideration in the ethical review of clinical scientific research. This paper summarized the challenges faced by the scientific and ethical review of scientific research projects in the process of ethical review of clinical research. Considering the ethical review and continuous supervision of clinical research on scientific projects, the paper put forward some measures, such as improving training system, paying attention to details of review and strengthening field visits, so as to protect the rights and interests of participants in clinical trials with all-round and multi-angle protection.

关 键 词：伦理审查 伦理监管 知情同意 临床研究 科研伦理 

分 类 号：R-052[医药卫生]