The damage compensation for participants in clinical trail in USA
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摘要: 目的 为推进我国药物临床试验受试者补偿机制的建立提供参考和意见。 方法 探讨了美国对药物临床试验中的受试者损害责任的认定和补偿方案,并结合从中受到的启示为我国药物临床试验受试者补偿的实际情况提出建议。 结论 在借鉴美国的受试者补偿方案的同时,建立具备我国自身特色的补偿机制,促进我国临床试验质量管理规范的切实实行。Abstract: Objective To give advice and reference for establishment of compensation mechanism of drug clinical trial subjects in China. Methods The drug clinical trials to the subjects' impairment of the determination and compensation scheme liability in USA were discussed. The suggestions to the compensation for participant in China were put forward according to the experiences in USA and the actual situation in China. Conclusion The compensation mechanism in our country must be established in reference to the United States, which could promote the quality control standard for clinical trials the practical implement.
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Key words:
- drug clinical trial /
- subject /
- revelation
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[1] 赫尔辛基宣言. 2008. [2] Lynn BG,Joe KG,Leslie AM.et al.Redesigning a large school-based clinical trial in response to changes in community practice[J]. Clin Trials, 2011, 8(3):311. [3] Gregori D,Foltran F,Verduci E.et al.A genetic perspective on nutritional profiles:do we still need them[J]. J Nutrigenet Nutrigenomics,2011,4(1):25. [4] 李本富.护理伦理学[M].北京:科学出版社,2000:126. [5] 国家食品药品监督管理局.药物临床试验质量管理规范[EB/LO]. http://www.sda.gov.cn/WS01/CL0053/24473.html.2003-08-06. [6] 姜萍,殷正坤.知情同意再探[J]. 中国医学伦理学,2002,15(5):20. [7] Corrigan O.Empty ethics:the problem with informed consent[J]. Sociol Health Illn,2003,25(3):238. [8] 满洪杰.人体试验法律问题研究[D].上海:复旦大学,2009. [9] Paasche-Orlow MK,Brancati FL.Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury[J]. Am J Med,2005,118(2):175. [10] 曹永高. 论完善我国人体药物试验法律制度的几个问题[J]. 法律与医学杂志, 2006, 13(4):276. -
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