背景:补充和替代医学(CAM)的医学研究最近有所增加,引发了对CAM道德地位的伦理关注。医学学术期刊负责对手稿进行伦理审查(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,没有对CAM期刊中的ER进行系统分析。本研究旨在评估CAM期刊中道德要求和合规性的现状。
方法:这是一项横断面研究。我们审查了期刊引文报告(2021)(https://jcr)中包含的CAM期刊作者(IFA)的说明。clarivate.com)获取ER的一般信息和要求。我们还浏览了CAM期刊在1月至6月Q1和Q2部分发表的随机对照试验的手稿,2023年,检查道德要求的实际情况。使用描述性统计和Fisher精确检验进行统计分析。
结果:最终纳入了27种期刊和68份手稿。92.6%(25/27)的IFA包含ER的关键字,表明存在道德考虑。然而,CAM不需要特定的ER(n=0)。我们按地理来源对期刊进行分类,JCR部分,电子JCR年,研究的类型,%OAGold探讨可能影响CAM期刊制定一定伦理审查政策的因素。结果表明,在任何分类的期刊中,某些伦理审查政策均无统计学意义(p>0.05)。研究中包含的所有RCT手稿通常符合已发表期刊的伦理审查要求。
结论:所有IFAs讨论的ER,但是内容是分散的,注意力不集中,并且没有关于CAM的特定ER要求。尽管手稿基本上符合期刊的要求,在手稿中不可能更接近ER的过程。为了确保这些政策在未来得到充分执行,CAM期刊应要求作者提供更多详细信息,或形成CAM伦理审查所需的项目清单。
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.