| 英国伦理委员会的现状与分析 |
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| 引用本文： | 翁新愚. 英国伦理委员会的现状与分析[J]. 中国新药杂志, 2008, 17(19): 1724-1727 |
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| 作者姓名： | 翁新愚 |
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| 作者单位： | 国家食品药品监督管理局药品安全监管司,北京,100810 |
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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.
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| 关 键 词： | 伦理委员会 分类 申请 审评 |
Current situation and analysis for the UK Research Ethics Committees |
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| WENG Xin-yu. Current situation and analysis for the UK Research Ethics Committees[J]. Chinese Journal of New Drugs, 2008, 17(19): 1724-1727 |
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| Authors: | WENG Xin-yu |
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| Affiliation: | DepartmentofDrugSafetyandInspection,StateFoodandDrugAdministration,Beijing100810,China |
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| Abstract: | 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. |
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| Keywords: | 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. |
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