中国科技期刊研究 ›› 2022, Vol. 33 ›› Issue (12): 1655-1662. doi: 10.11946/cjstp.202203310235

• 质量建设 • 上一篇    下一篇

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

曾玲1)()(), 唐宗顺1),*()(), 罗萍1), 冉明会1), 杨丹2)   

  1. 1) 重庆医科大学期刊社,重庆市沙坪坝区大学城中路61号 401331
    2) 重庆医科大学附属儿童医院《儿科药学杂志》编辑部,重庆市渝中区中山二路136号 400014
  • 收稿日期:2022-03-31 修回日期:2022-11-03 出版日期:2022-12-15 发布日期:2023-01-16
  • 通讯作者: 唐宗顺
  • 作者简介:

    曾玲(ORCID:0000-0002-0164-1171),硕士,编辑,E-mail:;

    罗萍,副研究员,硕士生导师;

    冉明会,硕士,编审;

    杨丹,硕士,编辑。

    作者贡献声明: 曾 玲:设计、发放问卷,收集并整理数据,撰写论文; 唐宗顺:审阅与修改论文; 罗 萍:指导研究思路设计; 冉明会:参与问卷预调查,修改论文; 杨 丹:收集和整理数据,修改论文。
  • 基金资助:
    重庆市高校期刊研究会“渝编·仁和基金”资助项目“高校医学期刊编辑的伦理意识现状调查和论文伦理审查的情况研究”(CQYB2020-7)

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

ZENG Ling1)()(), TANG Zongshun1)()(), LUO Ping1), RAN Minghui1), YANG Dan2)   

  1. 1) Periodical Press of Chongqing Medical University, 61 Middle Daxuecheng Road, Shapingba District, Chongqing 401331, China
    2) Editorial Office of Journal of Pediatric Pharmacy, Children's Hospital of Chongqing Medical University, 136 Zhongshan 2nd Road, Yuzhong District, Chongqing 400014, China
  • Received:2022-03-31 Revised:2022-11-03 Online:2022-12-15 Published:2023-01-16
  • Contact: TANG Zongshun

摘要:

【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。

关键词: 医学期刊编辑, 生物医学研究伦理, 伦理审核, 临床试验注册, 动物实验伦理

Abstract:

[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.

Key words: Medical journal editor, Biomedical research ethics, Ethical review, Clinical trial registration, Animal experiment ethics