| 中医药临床研究伦理审查管理实践 |
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| 引用本文： | 熊智波,杨舒雯,乔洁,白桦,胡镜清,熊宁宁,徐春波,陈榕虎,王思成.中医药临床研究伦理审查管理实践[J].世界科学技术-中医药现代化,2014,16(4):683-687. |
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| 作者姓名： | 熊智波 杨舒雯 乔洁 白桦 胡镜清 熊宁宁 徐春波 陈榕虎 王思成 |
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| 作者单位： | 湖北省中医院 武汉 430061;湖北省新华医院 武汉 430015;中国中医科学院广安门医院 北京 100053;世界中医药学会联合会 北京 100101;中国中医科学院 北京 100700;江苏省中医院 南京 210029;世界中医药学会联合会 北京 100101;福建中医药大学 福州 350108;国家中医药管理局科技司 北京 100027 |
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| 基金项目： | 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。 |
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| 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。
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| 关 键 词： | 伦理审查 中医药 管理实践 临床研究 |
| 收稿时间： | 2013/11/8 0:00:00 |
| 修稿时间： | 4/1/2014 12:00:00 AM |
Management Practice for Ethical Review of Clinical Research of Traditional Chinese Medicine |
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| Xiong Zhibo,Yang Shuwen,Qiao Jie,Bai Hu,Hu Jingqing,Xiong Ningning,Xu Chunbo,Chen Ronghu and Wang Sicheng.Management Practice for Ethical Review of Clinical Research of Traditional Chinese Medicine[J].World Science and Technology-Modernization of Traditional Chinese Medicine,2014,16(4):683-687. |
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| Authors: | Xiong Zhibo Yang Shuwen Qiao Jie Bai Hu Hu Jingqing Xiong Ningning Xu Chunbo Chen Ronghu and Wang Sicheng |
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| Institution: | Hubei Provincial Hospital of TCM, Wuhan 430061, China;Xinhua Hospital of Hubei Province, Wuhan 430015, China;Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China;World Federation of Chinese Medicine Societies, Beijing 100101, China;China Academy of Chinese Medical Sciences, Beijing 100700, China;Jiangsu Province Hospital of TCM, Nanjing 210029, China;World Federation of Chinese Medicine Societies, Beijing 100101, China;Fujian University of Traditional Chinese Medicine, Fuzhou 350108, China;Department of Science & Technology of State Administration of Traditional Chinese Medicine of the People's Republic of China, Beijing 100027, China |
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| Abstract: | 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 capacity 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 construction 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. |
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| Keywords: | Ethical review traditional Chinese medicine management practice clinical research |
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