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英国伦理委员会的现状与分析 被引量:15

Current situation and analysis for the UK Research Ethics Committees
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摘要 伦理委员会的主要职责是保护药物临床试验受试者的权益、安全和健康。现对英国伦理委员会的法律、法规、申请及审评程序等进行归纳分析,旨在对规范我国伦理委员会的运作具有参考借鉴作用。 The main responsibility of Research Ethics Committee is to protect the rights, safety and wellbeing of human subjects involved in a clinical trial. This article reviewed the laws & regulations, application and assessment procedure for ethical review of the UK Research Ethics Committees, and this will provide references for the operation of Chinese Research Ethics Committees.
作者 翁新愚
出处 《中国新药杂志》 CAS CSCD 北大核心 2008年第19期1724-1727,共4页 Chinese Journal of New Drugs
关键词 伦理委员会 分类 申请 审评 Research Ethics Committees kinds application review
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参考文献3

  • 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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