文章摘要
杨洋,金琦,孙激,鞠翠钰,吴茵杰,程磊,张丽仪.国内医学期刊真实世界研究论文伦理声明著录现状分析与写作建议——以肿瘤学论文为例.编辑学报,2026,38(4):420-426
国内医学期刊真实世界研究论文伦理声明著录现状分析与写作建议——以肿瘤学论文为例
Current status and writing recommendations for ethics statements in real-world study papers published in Chinese medical journals: a case study of oncology papers
  
DOI:10.16811/j.cnki.1001-4314.2026.04.004
中文关键词: 医学期刊  真实世界研究  肿瘤学论文  伦理声明  写作建议
英文关键词: medical journals  real-world study  oncology papers  ethics statements  writing recommendations
基金项目:四川省社会科学重点研究基地四川学术成果分析与应用研究中心资助科研项目“四川期刊发展研究专项”(XSCG21QK-009)
作者单位邮编
杨洋 1)四川大学华西第二医院《中华妇幼临床医学杂志(电子版)》编辑部,出生缺陷与相关妇儿疾病教育部重点实验室,610041,成都 610041
金琦* 2)国家癌症中心,国家肿瘤临床医学研究中心,中国医学科学院北京协和医学院肿瘤医院,100021,北京 100021
孙激 1)四川大学华西第二医院《中华妇幼临床医学杂志(电子版)》编辑部,出生缺陷与相关妇儿疾病教育部重点实验室,610041,成都
3)四川大学华西第二医院《中华医学遗传学杂志》编辑部,出生缺陷与相关妇儿疾病教育部重点实验室,610041,成都 
610041
鞠翠钰 3)四川大学华西第二医院《中华医学遗传学杂志》编辑部,出生缺陷与相关妇儿疾病教育部重点实验室,610041,成都 610041
吴茵杰 4)中国科技出版传媒股份有限公司北京中科期刊出版有限公司,100717,北京 100717
程磊 5)中国科学院生物化学与细胞生物学研究所/分子细胞科学卓越创新中心Cell Research编辑部,200031,上海 200031
张丽仪 6)中山大学肿瘤防治中心Cancer Communications编辑部,510060,广州 510060
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中文摘要:
      真实世界研究论文的学术价值日益受到医学期刊的重视,其伦理声明的规范性问题也随之凸显。文章针对国内医学期刊中真实世界研究论文伦理声明著录不规范的问题,以肿瘤学论文为例,系统分析了伦理审查及批号、患者知情同意、利益冲突声明、临床试验注册号及数据共享声明等核心要素的著录现状。研究显示,当前真实世界研究论文伦理声明存在标注缺失、形式化、内容不完整等问题,在纳入分析的149篇真实世界研究论文中,仅59.7%的论文标注伦理审查信息,38.3%的论文标注知情同意,43.6%的论文标注利益冲突声明,临床试验注册号与数据共享声明的标注率更低。本文基于国际伦理准则和国内政策,从期刊编辑部责任与作者写作规范2方面提出改进建议,构建了适合真实世界研究论文伦理的实质性审查清单,并明确了各伦理要素的标准化写作要点,旨在提升真实世界研究论文的伦理合规性与学术透明度,为医学期刊规范化建设提供参考。
英文摘要:
      Real-world study papers are increasingly valued by medical journals for their academic significance, yet the issue of nonstandard reporting of ethical statements has become increasingly prominent. This study, using oncology papers as an example, addresses the problem of nonstandard reporting of ethical statements in real-world study papers published in domestic medical journals, and systematically analyzes the current status of key ethical elements, including ethical review and approval numbers, patient informed consent, conflict of interest statements, clinical trial registration numbers, and data sharing statements. The study reveals prevalent issues including missing, superficial, and incomplete reporting of ethical statements. Among the 149 real-world study papers analyzed, only 59.7% reported ethical review information, 38.3% documented informed consent, and 43.6% included conflict of interest statements, with even lower reporting rates for clinical trial registration numbers and data sharing statements. Based on international ethical guidelines and domestic policies, this study proposes improvement strategies from the perspectives of journal editorial responsibilities and authors’ writing practices, and clarifies standardized writing recommendations for each ethical element. The study also develops a practical ethical review checklist for real-world study papers. The aim is to enhance the ethical compliance and academic transparency of real-world study papers, providing practical references for the standardization of medical journal publishing.
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