In a previous post, we discussed the International Committee of Medical Journal Editors (ICMJE) proposed changes to its decade-old disclosure form. The ICMJE is suggesting these changes in an attempt to eliminate confusion about what exactly constitutes a conflict of interest and what exactly authors should report.
In December 2019, one month before the release of the proposed changes to the widely used disclosure form, the ICMJE released proposed changes to its Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals that also address the conflict of interest reporting problem.
In the proposed revision to the ICMJE Recommendations, the words conflict of interest are often replaced with the words relationships and activities. The ICMJE stance is that authors should disclose all “relationships and activities, directly or topically related to a work.” The organization has eliminated all language that left the decision of what potentially could be viewed as a conflict of interest up to the authors.
Further, the definition of conflict was slightly altered and expanded (revisions are shown in red text):
The potential for a conflict of interest and bias exists when professional judgment concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (such as financial gain). Perceptions of conflict of interest are as important as actual conflicts of interest.
An entirely new paragraph emphasizes the importance of full disclosure:
Individuals may disagree on whether an author’s relationships or activities represent conflicts. Although the presence of a relationship or activity does not always indicate a problematic influence on a paper’s content, perceptions of conflict may erode trust in science as much as actual conflicts of interest. Ultimately, readers must be able to make their own judgments regarding whether an author’s relationships and activities are pertinent to a paper’s content. These judgments require transparent disclosures. An author’s complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the scientific process.
Since its December 2018 revision of the guidelines, the ICMJE has labeled failure of disclosure as scientific misconduct. That was big step. The December 2019 revision upholds that position and further clarifies what needs to be reported:
Scientific misconduct in research and non-research publications includes but is not necessarily limited to data fabrication; data falsification, including deceptive manipulation of images; purposeful failure to disclose relationships and activities (the former wording was conflicts of interest); and plagiarism.
Full disclosure is no joke. Not providing it is scientific misconduct.