中医药临床研究伦理审查管理实践  

Management Practice for Ethical Review of Clinical Research of Traditional Chinese Medicine

作　　者：熊智波[1] 杨舒雯[2] 乔洁[3] 白桦[4] 胡镜清[5] 熊宁宁[6] 徐春波[4] 陈榕虎[7] 王思成 

机构地区：[1]湖北省中医院,武汉430061 [2]湖北省新华医院,武汉430015 [3]中国中医科学院广安门医院,北京100053 [4]世界中医药学会联合会,北京100101 [5]中国中医科学院,北京100700 [6]江苏省中医院,南京210029 [7]福建中医药大学,福州350108 [8]国家中医药管理局科技司,北京100027

出　　处：《世界科学技术-中医药现代化》2014年第4期683-687,共5页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部中国亚太经合组织合作基金项目:传统医药科研伦理评估国际交流研讨会;负责人:熊宁宁;王思成

摘　　要：从我国伦理审查工作现状出发,对我国伦理审查能力发展中存在的问题进行了分析,初步总结了中医药伦理审查能力发展的情况,系统梳理了中医药研究受试者保护体系建设和中医药临床研究伦理审查平台评估工作,并对完善伦理审查制度健全监管体系、完善中医药伦理审查标准和指南、开展伦理审查专业知识培训、推动中医药伦理审查认证认可制度建设等工作以及中医药伦理审查的创新和建设成效进行了客观介绍,就中医药临床研究伦理审查管理实践进行了探讨。From the point of view of ethics review work situation of our country, the existing capacity of our review of ethical problems in development are analyzed, a preliminary summary of the Chinese medicine ethics review ca-pacity development, systematically analyzes the Assessment Human Research Protection System of TCM and Chinese medicine clinical research ethics review platform evaluation work, and to improve the ethical review system to perfect supervision system, improve the medical ethics review standards and guidelines, carrying out the innovation and con-struction of ethical review professional knowledge training, to promote Chinese medicine ethics review certification and accreditation system construction work and Chinese medical ethics review of the clinical research objective, the practice of ethical review management of Chinese medicine are discussed.

关 键 词：伦理审查 中医药 管理实践 临床研究 

分 类 号：R-052[医药卫生]