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补充和替代医学期刊作者指南的伦理要求:一项横断面研究。

Ethical requirements of instructions for authors of complementary and alternative medicine journals: a cross-sectional study.

机构信息

Dongzhimen Hospital, Beijing University of Chinese Medicine, 5 Haiyuncang Street, Dongcheng District, Beijing, 100070, China.

Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China.

出版信息

BMC Med Ethics. 2024 Jul 13;25(1):77. doi: 10.1186/s12910-024-01077-1.

Abstract

BACKGROUND

Medical research in complementary and alternative medicine (CAM) has increased recently, raising ethical concerns about the moral status of CAM. Medical academic journals are responsible for conducting ethical review (ER) of manuscripts to protect the interests of human subjects and to make ethical results available before deciding to publish. However, there has been no systematic analysis of the ER in CAM journals. This study is aim to evaluate the current status of ethical requirements and compliance in CAM journals.

METHODS

This is a cross-sectional study. We reviewed instructions for authors (IFAs) of CAM journals included in the Journal Citation Reports (2021) ( https://jcr.clarivate.com ) for general information and requirements for ER. We also browsed the manuscripts regarding randomized controlled trials published by CAM journals in Q1 and Q2 section from January to June, 2023, to check the actual situation of ethical requirement. Descriptive statistics and Fisher's exact test were used for statistical analysis.

RESULTS

27 journals and 68 manuscripts were ultimately included. 92.6% (25/27) IFAs included keywords of ER, indicating the presence of ethical considerations. However, no specific ER was required for CAM (n = 0). We categorized journals by Geographic origin, JCR section, Year of electronic JCR, Types of studies, % of OA Gold to explore the factors that could influence CAM journals to have certain ethical review policies. The results showed there was no statistical significance in certain ethical review policy in any classification of journals (p > 0.05). All RCT manuscripts included in the study generally met the requirements of the published journals for ethical review.

CONCLUSIONS

All IFAs discussed ER, but the content was scattered, unfocused, and there were no specific ER requirements regarding CAM. Although the manuscripts basically met the requirements of the journal, it was not possible to get closer to the process of ER in the manuscript. To ensure full implementation of these policies in the future, CAM journals should require authors to provide more details, or to form a list of items necessary for CAM ethical review.

摘要

背景

补充和替代医学(CAM)的医学研究最近有所增加,这引发了关于 CAM 道德地位的伦理问题。医学学术期刊负责对稿件进行伦理审查(ER),以保护人类受试者的利益,并在决定发表之前提供伦理结果。然而,目前还没有对 CAM 期刊的 ER 进行系统分析。本研究旨在评估 CAM 期刊的伦理要求和合规现状。

方法

这是一项横断面研究。我们查阅了《期刊引证报告》(2021 年)(https://jcr.clarivate.com)中收录的 CAM 期刊的作者指南(IFA),以获取一般信息和 ER 要求。我们还浏览了 2023 年 1 月至 6 月 Q1 和 Q2 部分发表的 CAM 期刊的随机对照试验手稿,以检查伦理要求的实际情况。采用描述性统计和 Fisher 确切检验进行统计学分析。

结果

最终纳入 27 种期刊和 68 篇手稿。92.6%(25/27)的 IFA 包含 ER 的关键词,表明存在伦理考虑。然而,CAM 并没有特定的 ER 要求(n=0)。我们按地理来源、JCR 部分、电子 JCR 年份、研究类型、OA 金比例对期刊进行分类,以探讨可能影响 CAM 期刊制定特定伦理审查政策的因素。结果表明,在任何期刊分类中,特定伦理审查政策均无统计学意义(p>0.05)。研究中纳入的所有 RCT 手稿一般均符合发表期刊对伦理审查的要求。

结论

所有 IFA 均讨论了 ER,但内容分散、不集中,且对 CAM 没有特定的 ER 要求。虽然手稿基本符合期刊要求,但无法更深入地了解手稿的 ER 过程。为了确保未来全面实施这些政策,CAM 期刊应要求作者提供更详细的信息,或形成 CAM 伦理审查所需项目清单。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6142/11245789/f2ffd5e7d0a2/12910_2024_1077_Fig1_HTML.jpg

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