中国医学伦理学2024，Vol.37Issue(4)：408-414,7.DOI:10.12026/j.issn.1001-8565.2024.04.05
从医疗卫生机构视角探讨免除伦理审查的误区、挑战与对策
Exploration of the misunderstandings,challenges,and countermeasures of exemption from ethical review from the perspective of medical and health institutions
摘要
Abstract
In the implementation of exemption from ethical review,medical institutions equate exemption from ethical review with no ethical review or simple review,misunderstand the scope of exemption from ethical review,confuse the concepts of de-identification and anonymization,and equate privacy with personal information.The implementation faced challenges such as the coordination of conditions for exempt review with other regulations,the lack of clear decision-making subjects for exempting from ethical review,the legality and compliance of using general informed consent for biological samples and information data,as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review.Measures such as improving relevant laws and regulations,perfecting the construction and management of information databases and biological sample libraries,strengthening the project management and process supervision of exemption from ethical review,and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.关键词
医疗卫生机构/免除伦理审查/伦理审查/泛知情同意Key words
medical institutions/exemption from ethical review/ethical review/board consent分类
医药卫生引用本文复制引用
年宏蕾,蒋辉,李继红,刘敏,周吉银..从医疗卫生机构视角探讨免除伦理审查的误区、挑战与对策[J].中国医学伦理学,2024,37(4):408-414,7.基金项目
2022年陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW02) （2022XRW02）
