探索报告准则中的伦理因素:来自一项对研究的研究的结果。

IF 10.7 Q1 ETHICS
Clovis Mariano Faggion, Carla Brigitte Susan Kohl
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引用次数: 0

摘要

背景:报告准则是提高研究透明度和可重复性的关键工具。为了支持负责任的报告,这些指导方针还应涉及道德方面的考虑。然而,这些要素在多大程度上被纳入报告核对表仍不清楚。本研究旨在评估如何将伦理因素纳入这些指导方针。方法:我们确定了在“提高卫生研究质量和透明度(EQUATOR)网络”网站上索引的报告指南。2025年1月30日,从总共657个报告准则和扩展中随机抽取了128个样本。对于每一个,我们检索相关的开发出版物并将数据提取到一个标准化的表中。评估的伦理因素包括COI披露、赞助、作者标准、数据共享指导、方案制定和研究注册。前13项准则的数据提取是独立进行的,一式两份。在达到100%的一致性后,根据“评估系统评价的测量工具”(AMSTAR)-2的建议,由一位作者提取剩余的数据。结果:数据集包括101个原始指南和27个现有指南的扩展。其中一半的指南是在2015年以后发布的,32.0%的指南是在2020年至2024年之间发布的。出版年份中位数为2016年。128个评估指南中约有90个侧重于临床研究。超过70%的指南不包括与利益冲突(COI)或赞助相关的项目。只有8.6%的人将COI和赞助放在一个单独的项目中,而不到9%的人将它们作为两个单独的项目来处理。值得注意的是,只有两个指南(1.6%)提供了使用ICMJE披露表报告潜在利益冲突的说明。近20%的指南提供了研究注册的指导。不到30%的人建议制定研究方案,只有18.8%的人提供了协议共享的指导。此外,不到10%的清单包括作者标准或数据共享的指导。结论:目前的报告准则没有充分考虑道德因素。缺乏关于coi、资助、作者身份和数据共享的标准化项目意味着错失了促进透明度和研究诚信的机会。今后对报告准则的更新应系统地纳入这些要素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Exploring ethical elements in reporting guidelines: results from a research-on-research study.

Background: Reporting guidelines are key tools for enhancing the transparency and reproducibility of research. To support responsible reporting, such guidelines should also address ethical considerations. However, the extent to which these elements are integrated into reporting checklists remains unclear. This study aimed to evaluate how ethical elements are incorporated in these guidelines.

Methods: We identified reporting guidelines indexed on the "Enhancing the Quality and Transparency of Health Research (EQUATOR) Network" website. On 30 January 2025, a random sample of 128 reporting guidelines and extensions was drawn from a total of 657. For each, we retrieved the associated development publication and extracted data into a standardised table. The assessed ethical elements included COI disclosure, sponsorship, authorship criteria, data sharing guidance, and protocol development and study registration. Data extraction for the first 13 guidelines was conducted independently and in duplicate. After achieving 100% agreement, the remaining data were extracted by one author, following "A MeaSurement Tool to Assess Systematic Reviews" (AMSTAR)-2 recommendations.

Results: The dataset comprised 101 original guidelines and 27 extensions of existing guidelines. Half of the included guidelines were published from 2015 onward, with 32.0% published between 2020 and 2024. The median year of publication was 2016. Approximately 90 of the 128 assessed guidelines focused on clinical studies. Over 70% of the guidelines did not include items related to conflicts of interest (COI) or sponsorship. Only 8.6% addressed COI and sponsorship jointly in a single item, while fewer than 9% covered them as two separate items. Notably, only two guidelines (1.6%) provided instructions for using the ICMJE disclosure form to report potential conflicts of interest. Nearly 20% of the guidelines offered guidance on study registration. Fewer than 30% recommended the development of a research protocol, and only 18.8% provided guidance on protocol sharing. Additionally, fewer than 10% of the checklists included guidance on authorship criteria or data sharing.

Conclusion: Ethical considerations are insufficiently addressed in current reporting guidelines. The absence of standardised items on COIs, funding, authorship, and data sharing represents a missed opportunity to promote transparency and research integrity. Future updates to reporting guidelines should systematically incorporate these elements.

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