| 浅谈受试者在药物临床试验中知情同意权的法律保护 |
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| 引用本文： | 田侃,汤扬. 浅谈受试者在药物临床试验中知情同意权的法律保护[J]. 中国药房, 2008, 19(28): 2163-2166 |
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| 作者姓名： | 田侃 汤扬 |
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| 作者单位： | 南京中医药大学经贸管理学院,南京市,210046 |
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| 摘 要： | 目的:为我国药物临床试验相关立法的完善以及受试者人权的保护提供参考。方法:介绍药物临床试验中知情同意权保护的现状,对知情同意权的构成要素进行阐释,并对我国知情同意权保护实践中存在的问题及原因进行分析。结果与结论:我国尚须进一步完善药物临床试验的立法,加强对研究人员的法制教育,加强对违法侵权行为的法律监督。
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| 关 键 词： | 受试者 临床试验 知情同意权 |
Legal Protection of Subjects Informed Consent in Clinical Drug Trials |
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| TIAN Kan,TANG Yang. Legal Protection of Subjects Informed Consent in Clinical Drug Trials[J]. China Pharmacy, 2008, 19(28): 2163-2166 |
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| Authors: | TIAN Kan TANG Yang |
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| Affiliation: | (Economy and Trade Administration School of Nanjing University of TCM, Nanjing 210046, China) |
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| Abstract: | OBJECTIVE： To provide the reference for the improvement of GCP （good clinical practice） regulations and protection of subject＇s human rights. METHODS： The status quo of the protection of subject＇s right of informed consent and the elements for the right of informed consent and the existing problems in its practice in China were analyzed. RESULTS ＆ CONCLUSIONS： China should further promote the legislation of clinical trials, reinforce the legal education of researchers, and emphasize the supervision on the illegal tort act. |
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| Keywords: | Human subject Clinical trial Informed consent |
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