The damage compensation for participants in clinical trail in USA

SHEN Yu-hong; ZHANG Zheng-fu; LI Zheng-qi

doi:10.3969/j.issn.1006-0111.2013.04.008

Message Board

Respected readers, authors and reviewers, you can add comments to this page on any questions about the contribution, review, editing and publication of this journal. We will give you an answer as soon as possible. Thank you for your support!

Name

E-mail

Phone

Title

Content

Verification Code

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.

The damage compensation for participants in clinical trail in USA

Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China

Received Date: 2012-06-21

Rev Recd Date: 2013-02-21

Key words:

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.

HTML

Reference (10)

[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.

Message Board

The damage compensation for participants in clinical trail in USA

doi: 10.3969/j.issn.1006-0111.2013.04.008

Abstract

References

Proportional views

通讯作者: 陈斌, [email protected]

Article Metrics

Related

Proportional views