被撤稿的期刊论文中存在的生物医学研究相关伦理问题分析及防范

Analysis and prevention of ethical issues related to biomedical research in retracted journal articles

目的分析期刊论文发表后因生物医学研究相关伦理问题被撤稿的具体原因,并提出相应的防范措施。方法通过生物医学领域的文献数据库PubMed,检索于2021年1月1日至2023年1月1日期间被撤稿的期刊论文,对因伦理相关问题被撤稿的声明进行分析,总结伦理相关具体撤稿原因和类型。结果 2021和2022年度中因伦理相关问题被撤稿的文章分别为77篇和128篇,占同期所有撤稿文章的3.9%和5.4%。具体伦理相关的撤稿原因最主要为无有效伦理批件,在涉及人体试验的伦理问题被撤稿文章中,因无有效伦理批件被撤稿的文章占比由2021年的45.9%升高至2022年的57.0%。在与动物实验相关的因伦理问题被撤稿文章中,其占比从2021年的50.0%升高至2022年的67.3%。此外,其他伦理问题还包括知情同意过程存在问题、伦理批准时间迟于试(实)验开始、伦理批件内容与文章主体内容不符、研究不符合实验动物福利原则等。结论涉及人的医学研究伦理审查及实验动物福利伦理审查均需加强。通过促进机构伦理审查体系建设、鼓励研究者学习伦理相关知识、规范伦理申请及审批、完善知情同意过程及重视实验动物福利,可预防因伦理相关问题而被撤稿的发生。

Objective To analyze the specific reasons for journal articles being retracted due to biomedical research-related ethical issues after publication and propose corresponding preventive measures.Methods Journal articles that were retracted between January 1,2021,and January 1,2023,were retrieved from PubMed,a literature database in the biomedical field.The retraction statements of those articles that were retracted due to ethical-related issues were analyzed with a summarization of detailed reasons and types.Results A total of 77 and 128 articles were retracted due to ethical issues in 2021 and 2022 respectively,accounting for 3.9%and 5.4%of all retracted articles in the same period.The major ethical issue was the lack of valid ethical approval.Among articles retracted for ethical issues related to human trials,the proportion of articles retracted due to lack of valid ethical approval increased from 45.9%in 2021 to 57.0%in 2022,which also increased from 50.0%in 2021 to 67.3%in 2022 among retracted articles related to animal experiments.Other ethical issues included problems in the informed consent process,delay in obtaining ethical approval,inconsistency between ethical approvals and the content of the article,and violation of the principles of laboratory animal welfare.Conclusions The ethical review of medical research involving humans and laboratory animal welfare needs to be strengthened.By promoting the construction of an institutional ethical review system,encouraging researchers to study ethics-related knowledge,standardizing ethical applications and approvals,improving the informed consent process,and attaching importance to the welfare of laboratory animals,the retraction due to ethical issues can be prevented.