| 免除伦理审查制度及其应用实践建议 |
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| 引用本文： | 张海洪. 免除伦理审查制度及其应用实践建议[J]. 医学与哲学, 2023, 44(9): 6-10. doi: 10.12014/j.issn.1002-0772.2023.09.02 |
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| 作者姓名： | 张海洪 |
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| 作者单位： | 北京大学医学部科学研究处 北京 100191 |
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| 基金项目： | 2022年海南省博鳌乐城先行区真实世界研究专项计划项目（HNLC2022RWS009） |
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| 摘 要： | 2023年发布的《涉及人的生命科学和医学研究伦理审查办法》（以下简称《办法》）首次设立了免除伦理审查制度。该制度设计旨在提升伦理审查效率，但也面临一系列的应用实践挑战。从澄清免除伦理审查的概念入手，简要分析免除伦理审查制度设计的初衷和必要性，同时，以美国为例，介绍了免除伦理审查制度的国际进展以及既往实践的经验教训。最后，针对《办法》提出的免除伦理审查相关要求的重点和难点进行了探讨，并就免除伦理审查的决定主体、标准操作程序，以及免除伦理审查的研究的跟踪审查等应用实践细节提出初步建议。
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| 关 键 词： | 免除伦理审查 效率 最小风险 标准操作规程 资质 |
| 收稿时间： | 2023-03-15 |
| 修稿时间： | 2023-03-25 |
Exemption from Ethical Review and Its Application in Practice Proposal |
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| ZHANG Hai-hong. Exemption from Ethical Review and Its Application in Practice Proposal[J]. Medicine & Philosophy, 2023, 44(9): 6-10. doi: 10.12014/j.issn.1002-0772.2023.09.02 |
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| Authors: | ZHANG Hai-hong |
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| Affiliation: | Department of Research, Health Science Center, Peking University, Beijing 100191, China |
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| Abstract: | The first ethical review exemption system was established in 2023. The system is designed to enhance the efficiency of ethical review, but it also faces a series of challenges in practice. Starting from the clarification of the concept, the original intention and necessity of the design of the ethical review exemption system are briefly analyzed, while the international progress of the ethical review exemption system and the lessons learned from past practices are introduced with the example of the United States. Finally, the article discusses the key points and difficulties of the requirements related to the exemption from ethical review proposed by Measures for Ethical Review of Life Sciences and Medical Research Involving Human Subjects, and makes preliminary suggestions on the details of the application practice such as the decision subject of the exemption from ethical review, the standard operating procedure, and the follow-up review of the research exempted from ethical review. |
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| Keywords: | exemption from ethical review efficiency minimal risk standard operating procedures qualification |
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