Avoiding Pitfalls in Conflict of Interest Disclosures

Conflict of interest (COI) disclosures should be used to avoid any doubt about the integrity of published works.
Avoiding Pitfalls in Conflict of Interest Disclosures
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Concerns about ethics in publishing are not new. Surprisingly, even experienced authors find themselves making ethical errors in their manuscript submissions. One area of debate in the literature is conflict of interest (COI) disclosure, as some authors consider the requirement to disclose extensive details of financial and other relationships to be very intrusive and unnecessary for judging the merits of published papers.1 Others believe that COI disclosure is a way to discourage researchers from seeking pharmaceutical or medical product industry funding of research. However, experts encourage collaboration and industry funding because partnerships across clinical settings, academia, and industry are essential for scientific advancement and overall improvement of health care worldwide.2,3 Still, it is important to consider the risks associated with actual COIs in medical- and healthcare-related publishing. According to the National Institutes of Health (NIH) Institute of Medicine (US) Committee on COI in Medical Research, Education, and Practice, these risks include damage to the reputations of authors and their institutions and potential harm to the public if data reporting or research conclusions are manipulated to benefit parties with a stake in the results.2 To avoid any doubt about the integrity of published works, authors must understand their role in disclosing any relationships that could be perceived as a COI. 

What is conflict of interest? 

According to the International Committee of Medical Journal Editors (ICMJE), “The potential for 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.”4To protect the integrity of research and scientific publications, the international publishing community has established recommendations, guidelines, and policies to reveal these potential biases in order to help readers to make informed decisions about the merits of each article.4,5 

Another group responsible for these guidelines is the Committee on Publishing Ethics (COPE). COPE is an international organization that develops and maintains the code of conduct in publishing across a wide range of disciplines.5 COPE provides guidance on a variety of topics relating to scholarly publishing, including standards for publishers and editors to obtain and publish disclosure of COI.6 To support that requirement among medical journals, ICMJE developed a disclosure document that publishers may adopt to help maintain the standards of COI disclosure.7

Managing non-disclosure of conflict of interest 

Failures to disclose COI are managed in a few ways. If an author refuses to provide a disclosure, the editor has the responsibility to uphold ethical standards by denying acceptance of the manuscript for publication.4,5 In cases when the author COI disclosure is missing or incorrect, some journals will post an erratum in another issue. There are situations when a member of the scientific or medical community reports a suspected COI in the form of a letter to the editor.8 To maintain transparency, editors print these letters and have a responsibility to keep the public informed of how the concern is being investigated and resolved.9 A third method of addressing suspicion of undisclosed COI is for institutions or individuals to report nondisclosure to COPE. Following the investigation(s) by the publisher or COPE, the findings may be serious enough for a decision to retract the article.10

Four steps for author conflict of interest disclosure 

The following steps will guide you in correctly disclosing actual or potential COI in your future submissions. 

Step 1: Review the procedure for disclosure that is included in the intended journal’s guidelines for authors. 

Step 2: Using the disclosure guidelines as a template, the corresponding author and each of the co-authors should make a list of all their relationships with research foundations, grants, in-kind donations, use of office/research facilities, assistance with data collection or analysis, consulting relationships, speaker’s bureaus, organizational affiliations, employment, and contractor roles. Evaluate which relationships are directly involved with the article or indirectly associated with the subject or specialty. 

Step 3: Carefully complete all sections of the disclosure form for each of the authors. If required, add the disclosure statement for each author to the manuscript title page. 

Step 4: After the manuscript has been accepted for publication, take time to review the pre-publication version of the article to verify that all of the disclosures have been included, as it is your responsibility to ensure accuracy the disclosure statement. 

More information 

With this foundation of understanding author COI, you will be prepared to accurately disclose your COI in your manuscripts. To delve further into COI for other roles (editors, peer reviewers, and editorial board members) involved in publishing journal articles, go to the ICMJE’s website at icmje.org or visit the COPE website at publicationethics.org.

References

  1. Welch SJ. Conflict of interest and financial disclosure: judge the science, not the author. Chest. 1997;112(4):865-867. doi: 10.1378/chest.112.4.865-a
  2. Lo B, Field MJ. Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.
  3. Probst P, Hüttner FJ, Klaiber U, Diener MK, Büchler MW, Knebel P. Thirty years of disclosure of conflict of interest in surgery journals. Surgery. 2015;157(4):627-633. doi:10.1016/j.surg.2014.11.012 
  4. International Committee of Medical Journal Editors. Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest. Accessed August 29, 2023.http://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html
  5. Committee on Publication Ethics. About COPE. Accessed August 29, 2023. https://publicationethics.org/about/our-organisation 
  6. COPE. Conflicts of interest/Competing interests. Accessed August 29, 2023. https://publicationethics.org/competinginterests
  7. International Committee of Medical Journal Editors. Disclosure of Interest (Updated February 2021). Accessed August 29, 2023. https://www.icmje.org/disclosure-of-interest/
  8. Kempen P. Corporate interests necessitate conflict of interest declarations by all authors. Anesthesiology. 2014;121(2):431-432. doi:10.1097/ALN.0000000000000326 
  9. Isaacs D, Kent A. Conflict of interest: Editor’s commentary. J Paediatr Child Health. 2013;49(10):874-875. doi:10.1111/jpc.12420
  10. COPE Retraction Guidelines. Accessed August 29, 2023. https://publicationethics.org/retraction-guidelines


Updated from https://www.wolterskluwer.com/en/expert-insights/authors-avoiding-pitfalls-coi-disclosure by Karen Innocent

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Go to the profile of Dawn Angel
about 1 year ago

It's better to disclose too much than not enough. You want to make sure you're covered!

Go to the profile of Maya Workowski
about 1 year ago

Personally I think COI disclosures are a good idea to reduce the chances of underhand monetary benefit. Especially when it comes to drug development. This is also true for peer reviewers - making sure peer reviewers do not have any COIs with the author of the manuscript is critical to keeping the research landscape as fair as possible.