涉及人的生命科学和医学研究的伦理审查批准标准及审查要点探讨  

Discussion on ethics review approval criteria and review key points of life science and medical research involving humans

作　　者：张妞[1] 张海洪 ZHANG Niu;ZHANG Haihong(Institutional Review Board,the Affiliated Hospital of Nantong University,Nantong 226001,China;Peking University Health Science Center,Beijing 100191,China)

机构地区：[1]南通大学附属医院伦理委员会,江苏南通226001 [2]北京大学医学部,北京100191

出　　处：《中国医学伦理学》2025年第4期428-433,共6页Chinese Medical Ethics

基　　金：2021年江苏省医院协会“研究型医院背景下医院科研管理与伦理审查协同机制研究”(JSYGY-3-2021-145);2021年江苏省医学会“伦理协同审查机制探索与实践课题”(SYH-330-81-0003);2021年院级管理课题“医联体模式下多中心临床研究项目伦理审查协同机制研究”(TFG2104)。

摘　　要：伦理审查批准标准是伦理审查委员会作出审查决定的依据。充分理解伦理审查批准标准的要求,是保证伦理审查质量的前提。《涉及人的生命科学和医学研究伦理审查办法》对伦理审查批准标准作出重要调整,包括新增对研究者和研究机构资质,以及研究结果的发布等要求的条款。结合《赫尔辛基宣言》2024年版,分析《办法》对伦理审查批准标准的要求,探讨对应的伦理原则及相应的伦理审查要点,以期为规范伦理审查实践、有效提升伦理审查质量提供参考。The ethics review approval criteria are the basis for ethical review committees to make review decisions.A thorough understanding of the requirements of the ethics review approval criteria is a prerequisite for ensuring the quality of ethical reviews.The Measures for the Ethics Review of Life Science and Medical Research Involving Humans made significant adjustments to the ethics review approval criteria,such as new provisions regarding the qualifications of researchers and research institutions,and the release of research results.In combination with the 2024 edition of the Declaration of Helsinki,this paper analyzed the requirements of the Measures for ethics review approval criteria,as well as explored the corresponding ethical principles and corresponding ethical review key points,with a view to providing a reference for standardizing ethics review practice and effectively improving the quality of ethics review.

关 键 词：伦理审查批准标准 科学价值 社会价值 风险控制 知情同意 

分 类 号：R-052[医药卫生]