Avoiding pitfalls in conflict of interest disclosure

By: Karen Innocent, DNP, CRNP, ANP-BC, Executive Director, Continuing Education Health Learning, Research & Practice, Wolters Kluwer

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 conflicts of interest in medical and healthcare-related publishing. According to the Institutes of Medicine, these risks include damage to authors’ and their institutions’ reputations 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), “A conflict of interest 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).”⁴ Contrary to the opinion that these biases do not exist, the Institute of Medicine conducted an examination of meta-analyses that showed a correlation between pharmaceutical industry funding and research conclusions in favor of the funders’ products despite lack of data to show product superiority.² To 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 for readers to make informed decisions about the merits of each article.^2,4,5

Another group responsible for these guidelines is the Committee on Publishing Ethics (COPE). COPE is an international organization based in the United Kingdom that develops and maintains the code of conduct in publishing across a wide range of disciplines.⁵ COPE’s codes of conduct include standards for publishers and editors to obtain and to publish disclosure of COI, which are located at https://publicationethics.org/files/Code_of_conduct_for_journal_editors_Mar11.pdf. To support that requirement among biomedical journals, ICMJE developed a disclosure document that publishers may adopt to help maintain the standards of COI disclosure. The ICMJE disclosure form can be found at http://icmje.org/conflicts-of-interest.

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.^6,7,8 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.⁹ To maintain transparency, editors print these letters¹⁰ and have a responsibility to keep the public informed of how the concern is being investigated and resolved.⁵ A third method of addressing suspicion of undisclosed COI is for institutions or individuals to report nondisclosure to COPE.⁵ Following the investigation(s) by the publisher or COPE, the findings may be serious enough for a decision to retract the article.⁵

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 guidelines for authors for the journal to which you plan to submit your paper.

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 of author COI, authors will be prepared to accurately disclose their COI in their manuscripts. To delve further into COI for other roles (editors, peer reviewers, and editorial board members) involved in publishing journal articles, go to the International Committee for Medical Journal Editor’s website at icmje.org or visit the Committee for Publication Ethics website at publicationethics.org.

References

1. Welch S. Conflict of interest and financial disclosure: judge the science, not the author. Chest. 1997;112(4):865-867.
2. Institute of Medicine. Conflict of Interest in Medical Research, Practice, and Education. 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. Author responsibilities: conflict of interest. 2015. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html (accessed May 1, 2015).
5. Committee on Publication Ethics. About COPE. n.d. https://publicationethics.org/about/our-organisation (accessed May 1, 2015).
6. Author conflict of interest error in: Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2013;144(5):1743. doi:10.1378/chest.13-2144.
7. Missing conflict of interest disclosure. JAMA Intern Med. 2014;174(11):1875.. doi:10.1001/jamainternmed.2014.5554.
8. Missing conflict of interest disclosures statement. JAMA Otolaryngol Head Neck Surg. 2015;141(3):210. doi:10.1001/jamaoto.2015.0408.
9. Kempen P. Corporate interests necessitate conflict of interest declarations by all authors. Anesthesiology. 2014;121(2):431-432. doi:10.1097/ALN.0000000000000326.
10. Isaacs D, Kent A. Conflict of interest: editor’s commentary. J Paediatr Child Health. 2013;49(10):874-875. doi:10.1111/jpc.12420.