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我国伦理审查法律规范现状及其分析 被引量:6

The Current Situation and Analysis on the Legal Norm of Ethics Review in China
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摘要 本文阐述了我国生物医学伦理审查立法现状以及英国、美国、瑞典三国相关法律情况,着重介绍了我国与伦理审查有关的法规、规章和政策性文件,分析存在的问题并提出建议。 In this paper, the author narrates the legislation status about biomedical ethics review in China, and the related legal issues in Britain, the United States and Sweden as well, focusing on the laws, codes and pol- icy documents about ethics review in China. At last, after analyzing some existing problems, the author puts for- ward some corresponding measures.
作者 滕黎
出处 《医学与法学》 2012年第4期11-14,共4页 Medicine and Jurisprudence
基金 四川川北医学院苗圃基金资助项目"我国伦理委员会组织体系的构建研究"(项目编号:MP-SK-04)的研究成果
关键词 伦理审查 法律规范 现状 分析 ethics review legal norm current situation analysis
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  • 1Directive 2001/20/EC of the European parliament and the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [EB/OL]. (2001 - 05 - 01 ). http://europa. eu/eur-lex/pri/en/oj/dat/2001/1 121/1_ 12120010501 en00340044. pdf.
  • 2Central Office for Research Ethics Committees, Governance atrangements for NHS Research Ethics Committees E EB/OL]. (2001 - 07 -05 ). http ://www. dh. gov. uk/prod_consum_dh/groups/dh_ digitalassets/.
  • 3National Research Ethics Services. Standing Operating Procedures for Research Ethics Committees, Version3.4 [ EB/OL ]. (2007 - 09- 02). http://www, nres. npsa. nhs. uk/news-and-publications/publications/standard-operating-procedures/.

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