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| 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 |
| Analysis of Current Status and Writing Recommendations for Ethics Statements in Real-World Study Papers in Domestic Medical Journals: an Example from Oncology Papers |
| 投稿时间：2025-11-10 修订日期：2026-08-10 |
| DOI： |
| 中文关键词: 医学期刊 真实世界研究 伦理声明 写作建议 |
| 英文关键词: Medical journals Real-world study 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） |
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| 全文下载次数: 63 |
| 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98篇真实世界研究论文中,仅51.0%的论文标注伦理审查信息,30.6%标注知情同意,25.5%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。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两方面提出改进建议,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 research articles are increasingly valued by medical journals for their academic significance, yet the issue of nonstandard ethical declaration practices has become increasingly prominent. This article addresses the problem of irregular ethical statements in real-world research papers in domestic medical journals, using oncology papers as a case study to systematically analyze the current status of ethical declarations regarding key elements such as ethical review and approval number, patient informed consent, conflict of interest statements, clinical trial registration number, and data sharing statements. The study reveals prevalent issues such as missing, perfunctory, or incomplete ethical declarations. Among the 98 real-world research papers analyzed, only 51.0% reported ethical review information, 30.6% documented informed consent, and 25.5% included conflict of interest statements, with even lower rates for clinical trial registration numbers and data sharing statements. Based on international ethical guidelines and domestic policies, this study proposes improvements from the perspectives of journal editorial department responsibilities and author writing standards, and clarifies standardized writing guidelines for each ethical element. The aim is to enhance the ethical compliance and academic transparency of real-world research papers, providing practical references for the standardization of medical journals. |
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