英国伦理委员会的现状与分析

被引:16
作者
翁新愚
机构
[1] 国家食品药品监督管理局药品安全监管司
关键词
伦理委员会; 分类; 申请; 审评;
D O I
暂无
中图分类号
R95 [药事组织];
学科分类号
1007 ;
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。
引用
收藏
页码:1724 / 1727
页数:4
相关论文
共 3 条
[1]  
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[2]  
Governance arrange-ments for NHS Research Ethics Committees. Central Office for Research Ethics Committees. http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/ . 2001
[3]  
Directive 2001/20/EC of the European parliament and the council of 4 April 2001 on the approximation of the laws,regulations andadministrative provisions of Member States relating to the imple-mentation of good clinical practice in the conduct of clinica. http://europa.eu/eur-lex/pri/en/oj/dat/2001/1121/112120010501en00340044.pdf . 2001