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中医药临床研究与伦理审查
引用本文:汪秀琴,熊宁宁,王思成.中医药临床研究与伦理审查[J].中国医学伦理学,2010,23(4):82-83.
作者姓名:汪秀琴  熊宁宁  王思成
作者单位:1. 南京中医药大学附属医院GCP中心,江苏,南京,210029
2. 国家中医药管理局科技司,北京,100026
摘    要:在保障研究的科学性和伦理合理性过程中,伦理审查已经成为开展生物医学研究的国际社会通则。此外,作为传统医药的大国,我们有责任也有义务解决中医药临床研究伦理审查的特殊问题,进而制定既能体现国际通行原则、又具有中医药特色的传统医药研究伦理审查的规范和标准。

关 键 词:伦理审查  中医药研究  临床研究  试验风险  医学实践

Clinical Research and Ethics Review of Traditional Chinese Medicine
WANG Xiu-qin,XIONG Ning-ning,WANG Si-cheng.Clinical Research and Ethics Review of Traditional Chinese Medicine[J].Chinese Medical Ethics,2010,23(4):82-83.
Authors:WANG Xiu-qin  XIONG Ning-ning  WANG Si-cheng
Affiliation:WANG Xiu -qin ,XIONG Ning -ning, WANG Si -cheng(1 GCP Center,Affiliated Hospital of Nanfing TCM University,Nanfing 210029,China; 2 Bureau of Technology,State Administration of Traditional Chinese Medicine,Beijing 100026, China)
Abstract:Ethics review has been the general notice of international society in terms of protecting the scientific feature and ethical rationality of biomedical research. As a great power of traditional medicine, China is responsible to solve the specific problems in the ethics review of clinical research of traditional Chinese medicine, and further formulate the regulations and norms of ethics review for clinical research of traditional Chinese medicine which manifest international general notice and embody Chinese characteristics as well.
Keywords:Ethics Review  Research of Traditional Chinese Medicine  Clinical Research  Research Risk  Medical Practice
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