期刊文献+

完善我国药物临床试验损害补偿体系建议 被引量:1

下载PDF
导出
摘要 随着我国药物临床试验事业的蓬勃发展,药物临床试验损害作为一种新的损害情形在赔偿诉讼中尚存司法定性争议。作为对赔偿制度的补充,药物临床试验损害补偿体系已在英美建立。相较之下,《药物临床试验质量管理规范》只较为笼统地规定了我国药物临床试验损害补偿的大体模式。因此,将系统整理英美药物临床试验损害补偿模式,以期为完善我国模式提供参考。
作者 郑澜 邵蓉
出处 《现代商贸工业》 2013年第12期137-139,共3页 Modern Business Trade Industry
  • 相关文献

参考文献8

  • 1Steinbrook, R. Compensation for injured research sub]ects[J].New England Journal of Medicine, 2006,354 : 1871-1873.
  • 2Human Subject Division,University of Washington. The office ofsponsored programs has released an important reminder up-date about industry-sponsored clinical trials [EB/OL]. http://www. Washington, edu/research/hsd/announcements/. q = 264.2008-12-8/2013-3-1.
  • 3Scott,L. D. Research-related injury: problems and solutions[J].Journal of Law,Medicines Ethics,2003,31(3) : 419-428.
  • 4Child,C.,etc. Cost benefits of an institutionally-based subject in-jury treatment and management program [ EB/OL]. https://www. rmis. ucsf. edu, 2013-3-1.
  • 5Workshop and Commissioned Papers. Women and health re-search: ethical and legal issues of including women in clinicalstudies[C]. 1999,volume 2.
  • 6Hockhauser,M. Paying for research related injuries in the US[J].British Medical Journal.2006 ,332 (7541) : 610.
  • 7Guest, S. Compensation for subjects of medical research [J] . themoral rights of patients and the power of research ethics commit-tees. Journal of Medical Ethics,1997, (23) : 181-185.
  • 8Association of the British Pharmaceutical Industry. Guidelines forphase 1 clinical trials (2012 edition)[EB/OL]. http://www. ab-pi. org. uk/our-work/library/guidelines/Pages/default. aspx,2013-3-1.

同被引文献10

引证文献1

二级引证文献12

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部