| 药物临床试验中不同伦理审查模式的比较 |
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| 引用本文： | 梁伟雄. 药物临床试验中不同伦理审查模式的比较[J]. 中国医学伦理学, 2014, 0(3): 330-332 |
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| 作者姓名： | 梁伟雄 |
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| 作者单位： | 广州中医药大学第二附属医院药物临床试验机构,广东广州510120 |
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| 基金项目： | 国家重大新药创制专项中药新药临床试验技术平台研究（2012ZX09303009-003） |
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| 摘 要： | 分析讨论了机构伦理委员会方便跟踪审查的优势及审批速度迟滞,审批工作不够规范、专业化,难以避免的利益冲突等不足之处;指出了区域伦理委员会审批速度加快,伦理审查水平提高,有利于统一标准的优势及其对研究实施环境不够熟悉,跟踪审查不够方便和及时的不足之处,认为两者可以互为补充。指出要保证区域伦理委员会能够顺利运转,政府主管部门还应配套和完善相应的法规。明确区域伦理委员会的职能和审查范围,完善管理机制。
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| 关 键 词： | 区域伦理委员会 机构伦理委员会 伦理审查 审查模式 |
The Comparison between Different Ethical Review Modes in Clinical Trials |
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| Affiliation: | LIANG Wei - xiong ( Drug Clinical Trial Institution of the Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510120, China) |
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| Abstract: | In the article, the advantages and disadvantages of institutional ethics committee and regional one have been discussed, respectively. And it is believed that these two committees are complementary to each other. Secondly, in order to guarantee the successful operation of the regional ethic committee, corresponding legislation should be implemented by government. The functions and censorship scope of regional ethic committee need to be clarified, with the management system being established sistent and efficient protection on the trial participants. |
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| Keywords: | Regional Ethics Committee Institutional Therefore, the regional ethics committee could offer conEthics Committee Ethical Review Review Mode |
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