| 医院药物临床试验机构伦理委员会规范化管理中的问题与对策 |
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| 引用本文： | 王继年,潘荣华,杨芳.医院药物临床试验机构伦理委员会规范化管理中的问题与对策[J].辽宁医学院学报(社会科学版),2014(1):11-14. |
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| 作者姓名： | 王继年 潘荣华 杨芳 |
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| 作者单位： | 安徽医科大学,安徽合肥230032 |
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| 基金项目： | 本文系安徽省2013年度软科学计划项目“安徽省转化医学发展的政策支持体系研究”（编号：1302053048）的研究成果. |
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| 摘 要： | 为保护药物临床试验受试者的合法权益，我国药物临床试验机构伦理委员会规范化建设已取得重要进展，但也暴露了诸多问题。建议加快相关立法，建立政府主导的标准化操作规程，制定伦理委员准入和考核标准，进一步加快其规范化步伐。
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| 关 键 词： | 药物临床试验 伦理委员会 规范化管理 |
On the Standardized Management for the Ethics Committee About Drug Clinical Trial Institutions |
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| Wang Jinian ＆ Pan Ronghua ＆ Yang Fang.On the Standardized Management for the Ethics Committee About Drug Clinical Trial Institutions[J].Journal of Liaoning Medical College:Social Science Edition,2014(1):11-14. |
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| Authors: | Wang Jinian ＆ Pan Ronghua ＆ Yang Fang |
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| Institution: | Wang Jinian ＆ Pan Ronghua ＆ Yang Fang (Anhui Medical University, Hefei Anhui, 230032) |
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| Abstract: | In order to protect the legal rights and interests of drug clinical trial subjects, the ethics committee about drug trial institutions has made a significant standardization progress, but there are also some problems. This paper puts forward some suggestions, such as establishing the relevant legislation, standardizing its operation rules under the government, setting up the assessment criteria for committee members and speeding up its standardiza- tion. |
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| Keywords: | drug clinical trial ethics committee standardized management |
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