| 舒安琴,徐佳忆,唐晓莲,刘明伟,邹小勇.医学期刊对“涉及人的生命科学和医学研究”伦理审查声明标注的现况调查与分析.编辑学报,2024,36(6):632-636 |
| 医学期刊对“涉及人的生命科学和医学研究”伦理审查声明标注的现况调查与分析 |
| Investigation and analysis of the current status of ethical review statements annotated by medicine journals for “Research Involving Human Life Sciences and Medicine” |
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| DOI：10.16811/j.cnki.1001-4314.2024.06.009 |
| 中文关键词: 伦理审查 伦理委员会 涉及人的生命科学和医学研究 医学期刊 知情同意 |
| 英文关键词: ethical review ethics committee research involving human life sciences and medicine medicine journals informed consent |
| 基金项目:*中国高校科技期刊研究会青年基金课题(CUJS-QN-2023-022);重庆市高校期刊研究会2022年度“渝编·仁和基金”项目(CQYB2022-6) |
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| 中文摘要: |
| 本文以31种综合性医药卫生期刊为调查对象,收集论文中与“涉及人的生命科学和医学研究”伦理审查声明相关的信息,并进行统计学描述和分析。结果显示,669篇论文中共有324篇“涉及人的生命科学和医学研究”(占全部论文的48.4%)。其中210篇(64.8%)标注有伦理审查声明(包括203篇“通过/已获伦理审查”论文和7篇“免除伦理审查”论文),114篇(35.2%)文中“无伦理审查声明”论文。 进一步分析结果显示,期刊对论文是否“涉及人的研究”评判标准不一、审查不严；“伦理审查委员会”的名称表述不统一；伦理审批编号规则不统一、不具有自明性 ；期刊对免除伦理审查要求不一、把握不准；知情同意意识淡薄且知情同意形式多样。可见,学术期刊整体对“涉及人的生命科学和医学研究”伦理审查声明标注情况不容乐观,有必要对论文伦理审查流程和刊出格式进行规范。 |
| 英文摘要: |
| This study investigated 31 comprehensive medical and health journals, collecting and conducting statistical descriptions and analyses of information related to ethical review statements in papers involving “human-related life sciences and medical research.” The results indicated that out of 669 papers, 324(accounting for 48.4% of the total) were categorized as “involving human-related life sciences and medical research.” Among these, 210 papers(64.8%)included ethical review statements(comprising 203 papers with “approved/obtained ethical review” and 7 papers with “exempt from ethical review”), while 114 papers(35.2%)lacked “ethical review statements.” Further analysis revealed that journals had inconsistent criteria for determining whether a paper involved human research and conducted lax reviews; the naming conventions for “Ethics Review Committees” were not unified; the rules for ethical approval numbers were inconsistent and lacked self-explanatory clarity; journals had varying requirements and uncertain understandings regarding exemptions from ethical review; and there was a weak awareness of informed consent, despite diverse forms of informed consent observed. It is evident that the overall situation regarding the labeling of ethical review statements in academic journals for “human-related life sciences and medical research” is not optimistic. There is a need to standardize the ethical review process and publication format for papers. |
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