免除伦理审查制度适法性与可操作性探讨  

Discussion on the Legal Applicability and Operability of Exemption Ethical Review

作　　者：赵励彦[1] 张玉梅[2] 刘瑞爽[3] ZHAO Liyan;ZHANG Yumei;LIU Ruishuang(Institutional Review Board,Peking University,Beijing 100191,China;School of Public Health,Peking University,Beijing 100191,China;School of Health Humanities,Peking University,Beijing 100191,China)

机构地区：[1]北京大学生物医学伦理委员会,北京100191 [2]北京大学公共卫生学院,北京100191 [3]北京大学医学人文学院,北京100191

出　　处：《医学与哲学》2024年第2期24-27,共4页Medicine and Philosophy

基　　金：2022年科技部重点研发计划项目(2022YFD2101501);2019年中科院科技战略咨询研究院项目(88037Y0644)。

摘　　要：结合我国现行法律和基本伦理原则,深入分析了免除伦理审查的前置条件和适用情形在适法性与可操作性上可能存在的问题,并在此基础上提出了可行性的建议:第一,明确监管范围,免除伦理审查是一种特殊的审查方式,而非不进行伦理审查;第二,全面评估风险,对研究的风险判断不仅要考虑因研究给个人带来的生理风险,还应考虑其心理、经济、社会以及法律等方面的风险,尤其是对最小风险应明确界定;第三,界定前置条件中的具体概念,以及在此基础上适用情形的判断,制定具体、合理、合法的实施细则,为免除伦理审查的实施提供参考。Based on the current laws and fundamental ethical principles in China,this paper thoroughly analyzes the possible issues in terms of legality and operability.Some feasible suggestions are put forward.Firstly,specify the regulatory scope,emphasizing that exempting ethical review is a distinctive form of review rather than a complete absence of ethical scrutiny.Secondly,comprehensively assess the risk.The risk judgment of research should not only consider the physiological risk brought by the research,but also consider the psychological,economic,social and legal risks,especially to clearly define and comprehensively evaluate the minimum risk.Thirdly,define the specific concepts in the preconditions,and on the basis of the judgment of the application of the situation,formulate specific,reasonable and legal implementation guidelines.It is expected to provide reference for the implementation of exemption ethical review.

关 键 词：免除伦理审查 知情同意 生物样本 个人信息 敏感个人信息 最小风险 

分 类 号：R-05[医药卫生]