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Received:November 08, 2022 Published Online:March 20, 2023
Received:November 08, 2022 Published Online:March 20, 2023
中文摘要: 非实验性临床研究的伦理审查在机构伦理委员会工作中占有重要的地位。本文分析了非实验性临床研究在医院工作的主要类型及非实验性临床研究中受试者权益保护的特点和侧重点。本文提出对于非实验性临床研究工作首先要确定其研究性属性、突出对个人隐私权保护和加强公共告知制度建设的伦理审查工作新思路。并对有关临床科研和教学工作豁免伦理审查和豁免知情同意提出具体的工作措施。
Abstract:The ethical review of non-experimental clinical research plays an important role in the work of the institutional ethics committee. This paper analyzes the main types of non-experimental clinical research in hospitals and the characteristics and emphases of the protection of subjects' rights and interests in non-experimental clinical research. This paper puts forward a new idea of ethical review for non-experimental clinical research work, which should first determine its research nature, highlight the protection of personal privacy and strengthen the construction of public notification system. Specific measures are also proposed for the exemption of ethical review and informed consent in clinical research and teaching.
文章编号: 中图分类号:R-052 文献标志码:B
基金项目:欧盟EDEMTET计划[610211-EPP-1-2019-1-NL-EPPKA2-CBHE-JP(2019-2020/001-001)]
Author Name | Affiliation |
SUN Wei-bin | Institutional Review Board of Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing, Jiangsu 210008, China |
Author Name | Affiliation |
SUN Wei-bin | Institutional Review Board of Nanjing Stomatological Hospital, Medical School of Nanjing University, Nanjing, Jiangsu 210008, China |
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