Exploring ethical elements in reporting guidelines: results from a research-on-research study.

Abstract

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.