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我国临床医学综合期刊病例报告伦理审查与患者知情同意报告现况调查与分析OA北大核心CSTPCD

Investigation and analysis of the current situation of case reporting ethical review and patient informed consent reports in comprehensive journals of clinical medicine in China

中文摘要英文摘要

目的 调查与分析我国临床医学综合类期刊 2022 年发表的病例报告伦理审查与患者知情同意报告情况.方法 根据《2022 年版中国科技期刊引证报告(扩展版)》数据,选择临床医学综合学科分类期刊2022 年发表的病例报告作为研究对象,对符合遴选标准的病例报告进行伦理审查与患者知情同意等信息的提取,采用 Microsoft Excel 2021、SPSS 21.0 对数据进行整理与分析.结果 纳入的 42 本期刊 2022 年共刊载病例报告类型文章 587 篇,其中 36 篇(6.13%)报告了科技伦理和(或)知情同意要求.报告科技伦理审查和(或)知情同意履行的病例报告多来自中国科技核心期刊(88.89%,65.88%),且其所在期刊官网稿约涉及科研伦理的比例也较大(86.11%,63.88%),差异均有统计学意义(P<0.01).结论 临床医学综合学科分类期刊病例报告科技伦理审查和(或)知情同意履行情况报告比例较低.目前,国际上绝大多数期刊要求在发表病例报告前征得患者或法定监护人的知情同意,中国与之相比尚有一定距离,需引起高度重视.

Objective:To investigate and analyze case reporting ethical review and patient informed consent reports published in the comprehensive journals of clinical medicine in China in 2022.Methods:According to the data from the 2022 Edition of the Chinese Science and Technology Journal of the Citation Reports(Extended Version),the case reports published in comprehensive journals of clinical medicine in 2022 were selected as the research objects.The information on ethics and patient informed consent was extracted from the case reports that met the selection criteria,and Microsoft Excel 2021 and SPSS 21.0 were used to sort out and analyze the data.Results:A total of 587 case reporting articles were published in the 42 included journals in 2022,of which 36(6.13%)reported on science and technology ethics and/or informed consent.Case reports reporting on science and technology ethics and/or informed consent mostly came from the key magazine of China technology(88.89%Vs.65.88%),and the proportion of manuscripts involving science and technology ethics on the official website of the journal was relatively high(86.11%Vs.63.88%),and the difference was statistically significant(P<0.01).Conclusion:The proportion of case reports of science and technology ethics and/or informed consent in journals of comprehensive discipline classification of clinical medicine was relatively low.Currently,most international journals are required to obtain the informed consent of patients or legal guardians before publishing case reports.Compared with this,there are still certain gaps in China,which need to be paid great attention to.

曹越;桂裕亮;杨燕;周乐;鲍文琪;周璐敏;钟巧妮;冼静怡;黄笛

武汉大学中南医院中南医学期刊社,湖北 武汉 430071

病例报告伦理审查知情同意报告规范

case reportmedical ethicsinformed consentreporting standard

《中国医学伦理学》 2024 (005)

520-525 / 6

10.12026/j.issn.1001-8565.2024.05.04

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