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科技与出版  2026, Vol. 45 Issue (4): 111-118    
编辑实务
医学期刊免除伦理审查论文标注的现状调查与分析
邬加佳1,方引超1,余菁2,*,王景周1
1. 中山大学附属第三医院医学情报中心,510630,广州
2. 《中山大学学报》编辑部,510080,广州
Investigation and Analysis of the Annotation Status of Exempt Ethical Review for Papers in Medical Journals
WU Jiajia1,FANG Yinchao1,YU Jing2,*,WANG Jingzhou1
1. Medical Information Center of the Third Affiliated Hospital of Sun Yat-sen University, 510630, Guangzhou, China
2. Journal Editorial Department of Sun Yat-sen University, 510080, Guangzhou, China
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摘要: 

医学期刊实施伦理审查,对于保障研究参与者权益、确保研究科学性、维护学术诚信至关重要。而免除伦理审查的目的是减轻研究者的负担,鼓励信息数据和生物样本的合法利用,加速科技创新和成果转化。文章以《中国科技期刊引证报告(核心版)自然科学卷(2024版)》收录的23种外科学综合类医学期刊为研究对象,收集2025年2月至3月的最新1期期刊,采用回顾性分析涉及人的生命科学和研究(“涉及人的研究”)相关论文,筛选出免除伦理审查论文。采用文献分析法和案例研究法分析免除伦理审查论文的相关信息,包括该文属于免除伦理审查的哪种情形、是否标注伦理审查声明、有无伦理审批号等。结果显示:473篇论文中“涉及人的研究”论文278篇,其中35篇论文属于免除伦理审查范围(30篇没有任何关于伦理审查的说明,3篇标注“不涉及伦理审查”,2篇标注了伦理审查声明且有伦理审查编号)。医学期刊免除伦理审查的决策主体是伦理委员会,而非作者或编辑。医学期刊对“涉及人的研究”免除伦理审查标注总体规范性不足、表述不清、情形分布各异,其原因可能是相关概念不清、引导不足、执行不力,应从加强政策指引、规范流程管理、提升编辑能力等方面入手,提升医学期刊免除伦理审查论文标注规范水平。

关键词 免除伦理审查伦理审查医学伦理医学期刊审查流程    
Abstract

Ethical review by medical journals plays a pivotal role in safeguarding the rights and welfare of research participants, ensuring scientific rigor, and upholding academic integrity. Conversely, exemptions from ethical review are strategically designed to reduce administrative burden on researchers, facilitate the lawful utilization of existing information data and biological samples, and accelerate scientific innovation and translational outcomes. Balancing these dual objectives requires clear guidelines and consistent implementation. This study investigates current practices regarding exemptions from ethical review in Chinese medical journals. We selected 23 medical journals of comprehensive surgery indexed in the China Science and Technology Journal Citation Reports (Core Edition, Natural Sciences Volume, 2024) as our research subjects. The latest issues published between February and March 2025 were systematically collected. Papers involving "human-related life sciences and medical research" (hereafter "human-related research") were retrospectively analyzed to identify studies potentially eligible for exemptions from ethical review according to national regulations. Using literature analysis and case study methodologies, we examined key information, including exemption categories, the presence and wording of ethical review statements, and approval numbers. Among the 473 total papers screened, 278 (58.8%) constituted "human-related research", of which 35 papers (12.6% of "human-related research") fell within recognized exemption from ethical review scopes. Reporting practices among these papers for exemptions from ethical review were highly inconsistent: 30 contained no ethical review statement whatsoever; three stated "not involving ethical review" without further justification; and only two provided both an exemption statement and an official ethics committee reference number. This discrepancy highlights a critical gap between policy intent and practical execution. Crucially, the authority to waive ethical review resides exclusively with institutional ethics committees, rather than authors or journal editors. However, our findings reveal that current labeling practices for exempted "human-related research" remain markedly non-standardized, with expressions lacking clarity or necessary contextual details and diverse categories distribution. Underlying causes include conceptual ambiguity regarding exemption criteria, insufficient explicit guidance from regulatory bodies, and inadequate enforcement mechanisms within editorial processes. To address these deficiencies, multi-faceted interventions are urgently needed. First, strengthened policy guidance from national health and scientific authorities must clarify exemption categories and mandatory reporting standards. Second, standardized process management protocols should be established, and journals are required to implement systematic checks for ethical compliance, even in exempt cases. Third, enhancing editorial capabilities through targeted training programs will empower editors to accurately identify, evaluate, and appropriately label exempted papers. These comprehensive measures can improve the standardization of ethical review annotations in medical journals, thereby reinforcing trust in medical research while supporting efficient scientific progress.

Key wordsexemption from ethical review    ethical review    medical ethics    medical journals    review procedure
出版日期: 2026-05-14
基金资助:广东省科技计划项目(2024B1212070011);广东省科技计划项目(2025A1212150007);广东省科技计划项目(2025A1212150011);中国高校科技期刊研究会-万方数据学术诚信与版权专项基金(CUJS2025-CX-ZZ01);中国高校科技期刊研究会-万方数据学术诚信与版权专项基金(CUJS2025-CX-ZZ16)
通讯作者: 余菁   
Corresponding author: Jing YU   

引用本文:

邬加佳,方引超,余菁,王景周. 医学期刊免除伦理审查论文标注的现状调查与分析[J]. 科技与出版, 2026, 45(4): 111-118.
WU Jiajia,FANG Yinchao,YU Jing,WANG Jingzhou. Investigation and Analysis of the Annotation Status of Exempt Ethical Review for Papers in Medical Journals. Science-Technology & Publication, 2026, 45(4): 111-118.

链接本文:

http://kjycb.tsinghuajournals.com/CN/      或      http://kjycb.tsinghuajournals.com/CN/Y2026/V45/I4/111

图 1  278篇“涉及人的研究”论文的伦理标注情况
图 2  35篇免除伦理审查论文的期刊分布情况
图 3  35篇免除伦理审查情形分布情况
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