| 临床研究中知情同意实施过程的要点及建议 |
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| 引用本文： | 柴倩云 费宇彤 王聪聪 夏 芸 韩 梅 刘建平. 临床研究中知情同意实施过程的要点及建议[J]. 世界中医药, 2014, 9(10): 1269-1271 |
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| 作者姓名： | 柴倩云 费宇彤 王聪聪 夏 芸 韩 梅 刘建平 |
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| 作者单位： | [1]北京中医药大学循证医学中心,北京100029; [2]北京中医药大学东方医院科研处,北京100078 |
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| 基金项目： | 基金资助：国家自然科学基金（编号：30901929）;新世纪人才计划（NCET-10-0271）;北京市科技新星项目（2011071）;国家重大新药创制“l临床评价研究标准化操作规程（SOP）”项目[编号：2011ZX09302-006-01-03（5）] |
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| 摘 要： | 随着中医临床研究的开展逐渐增多,伦理问题日渐引起人们的关注,尽管伦理审查中已对知情同意进行严格规定,然而临床实施过程中仍面临各种问题和挑战,文章根据相关法律法规,结合中医临床研究特点,以及专家组访谈结果,对中医临床研究中知情同意实施过程提出几点建议。
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| 关 键 词： | 知情同意 临床研究 伦理 中医药 |
| 收稿时间： | 2014-09-21 |
The key points and suggestions for implementing informed consent in clinical research |
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| Chai Qianyun,Fei Yutong,Wang Congcong,Xia Yun,Han Mei,Liu jianping. The key points and suggestions for implementing informed consent in clinical research[J]. World Chinese Medicine, 2014, 9(10): 1269-1271 |
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| Authors: | Chai Qianyun Fei Yutong Wang Congcong Xia Yun Han Mei Liu jianping |
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| Affiliation: | Chai Qianyun ,Fei Yutong ,Wang Congcong ,Xia Yun ,Han Mei ,Liu jianplng ( 1 Center for Evidence - Based Chinese Medicine ,Beijing University of Chinese Medicine ,Belting 100029, China ; 2 Scientific Research Office ,Donang Hospital, Beijing University of Chinese Medicine ,Beijing 100078, China ) |
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| Abstract: | With the widely development of Chinese medicine clinical research, the ethic issue has been gradually concerned. Although the ethical review has been implemented according to some rules, there are still many problems and challenges on proceeding informed consent. According to the relevant laws and regulations, this article incorporates the characteristics of Chinese medicine clinical research and the findings from an expert panel interview＇, to come up with some suggestions about how to proceed informed consent in Chinese clinical research. |
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| Keywords: | Informed consent Clinical study TCM Ethic |
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