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中医药临床研究伦理审查管理实践

     

摘要

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.%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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