医学期刊编辑对生物医学研究伦理问题的处理方式调研及建议

Survey of medical journal editors′ handling of ethical problems in biomedical research and suggestions

【目的】探讨医学期刊编辑处理生物医学研究伦理问题的方式,为推动确立医学期刊伦理审查规范提供参考。【方法】通过问卷星向国内医学期刊编辑发放调查问卷,对审稿时和论文出版后处理医学伦理相关问题的方式展开调研。【结果】共回收问卷230份。调查显示:在审稿阶段,在保护患者隐私方面,英文期刊、中英双语期刊的编辑更注重要求作者提供授权同意相关证明材料;中、英文期刊以及中英双语期刊的编辑对涉及人体试验伦理问题的处理方式都比较规范。但是,对于研究是否获得患者知情同意、动物实验研究是否经过伦理委员会审查、回顾性研究是否需要伦理审查、涉及人的研究是否在临床试验注册中心注册等问题,编辑还需要进一步重视。在论文出版后,编辑发现的医学伦理问题主要是“涉及人的研究未说明是否经过伦理委员会审查”。对论文出版后发现的没有保护患者隐私和没有在临床试验注册中心注册的问题,大部分期刊缺乏相关处理方案。【结论】编辑应加强对论文知情同意、动物实验伦理、回顾性研究伦理的审查,并审查涉及人的研究是否在临床试验注册中心注册,以推动我国医学期刊的高质量发展。

[Purposes] This paper explores how medical journal editors deal with ethical issues in biomedical research, which is expected to lay a basis for medical journals to develop ethical review standards. [Methods] Questionnaires were distributed to editors of domestic medical journals through Sojump to investigate the ways to handle ethical issues in submitted manuscripts or published papers. [Findings] A total of 230 questionnaires are recovered. For the submitted manuscripts, in terms of protecting anonymity and confidentiality of the participants, editors of English journals and bilingual journals generally ask researchers to present informed consent from the participants or other supporting materials. The ethical review involving human body tests by Chinese, English, and bilingual journals is standardized. However, editors should ensure extra efforts to review whether researchers has gain informed consent from participants, to check whether animal experiments have been reviewed by ethics committees, to analyze whether ethical review is necessary for retrospective studies, and to check whether studies involving human test have registered on clinical trial registry. As to published papers, editors find that the major medical ethical problem is that "studies involving human tests fail to mention whether they have been reviewed by an ethics committee". For the ethical problems in published papers, such as no protection of participants′ privacy and no registration on clinical trial registry, most journals lack relevant handling methods. [Conclusions] Editors should strengthen the review on informed consent, animal experiment ethics, retrospective research ethics, and registration of studies involving humans on clinical trial registry, in order to promote the high-quality development of domestic medical journals.