医学期刊中免除伦理审查的实例分析与操作建议  

Case analysis and operational suggestions for exemption from ethical review in medical journals

作　　者：邬加佳[1] 方引超 余菁 王景周 WU Jiajia;FANG Yinchao;YU Jing;WANG Jingzhou(Medical Information Center,the Third Affiliated Hospital of Sun Yat-sen University,510630,Guangzhou,China;不详)

机构地区：[1]中山大学附属第三医院医学情报中心,广州510630 [2]《中山大学学报》编辑部,广州510080

出　　处：《编辑学报》2025年第1期75-78,共4页Acta Editologica

基　　金：广东省科技计划项目(2024B1212070011)。

摘　　要：免除伦理审查是会议审查和简易程序审查之外的另一种医学伦理审查方式,旨在提高审查效率,减轻科研人员的负担,同时确保研究的合法性和道德性。2023年发布的《涉及人的生命科学和医学研究伦理审查办法》新增了“免除伦理审查”的概念。本文基于免除伦理审查的4种情形(公开数据或观察数据、匿名化的信息数据、已有的人的生物样本、生物样本库来源的人源细胞株或细胞系),结合已刊登的实例进行分析并提出实际操作建议,以期加深医学期刊编辑对免除伦理审查的认识,共同优化并完善医学期刊伦理审查操作流程。Exemption from ethical review is another medical ethics review method besides meeting review and simplified procedure review,aimed at improving review efficiency,reducing the burden on researchers,while ensuring the legality and ethics of the research.The“Ethical Review Regulations for Life Sciences and Medical Research Involving Humans”released in 2023 introduced the concept of“waiver of ethical review.”Based on the four situations for exemption from ethical review(publicly available data or observational data,anonymized information data,existing human biological samples,and human cell strains or cell lines from biobanks),this paper analyzes and proposes practical operational suggestions in conjunction with published examples.The aim is to deepen the understanding of medical journal editors regarding the exemption from ethical review and to jointly optimize and improve the operational procedures of ethical review in medical journals.

关 键 词：免除审查 伦理审查 医学伦理 医学期刊 审查流程 

分 类 号：G237.5[文化科学]