| 我国医疗技术人体试验立法的若干思考 |
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| 引用本文： | 陈小嫦. 我国医疗技术人体试验立法的若干思考[J]. 医学与哲学(人文社会医学版), 2008, 29(10) |
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| 作者姓名： | 陈小嫦 |
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| 作者单位： | 广东医学院,广东东莞523808 |
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| 基金项目： | 教育部2005年人文社会科学研究项目“探索性医疗技术临床准入的法律规制”,项目编号:05JC820042 |
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| 摘 要： | 我国的医疗技术管理立法处于起步阶段。从比较法的角度，提出了我国医疗技术人体试验立法的建议：构建伦理审查委员会审查与行政机关许可的双审制度；国家适度干预伦理审查委员会的设置；主管机关设置与非主管机关设置、外审型与内审型伦理审查委员会建设并行；构建多方位监管模式。
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| 关 键 词： | 医疗技术人体试验 行政许可 监管 |
On Legislation For Medical Technology Research Involving Human Subjects |
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| CHEN Xiao-chang.Guangdong Medical College,Dongguan ,China. On Legislation For Medical Technology Research Involving Human Subjects[J]. Medicine & Philosophy:Humanistic & Social Medicine Edition, 2008, 29(10) |
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| Authors: | CHEN Xiao-chang.Guangdong Medical College Dongguan China |
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| Affiliation: | CHEN Xiao-chang.Guangdong Medical College,Dongguan 523808,China |
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| Abstract: | Legislation of medical technology administration has just begun.On the basis of comparison,to put forward the following suggestions:build two-tiered review system,mode of established by the competent government department and of established by non-governmental department go side by side,so is local Independent Review Board(IRB)and non-local IRB,establish multi-level supervision system. |
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| Keywords: | medical technology research involving human subjects permission supervision |
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