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The importance of disclosure for publication

Tuesday, August 1, 2017

As clinical trial researchers seek to improve human health through their biomedical discoveries, medical journals seek to provide information and data about these discoveries in an objective and credible way. Conflict of interest (COI) issues can undermine the trust of this information, JAMA authors say in the May 2, 2017, issue primarily dedicated to the issue of COI. “[I]t is more important than ever that editors and publishers of medical journals work intelligently, and together, to redefine their policies about conflict of interest issues and to reaffirm their values focused on public trust for the integrity and independence of the editorial process,” says Thomas J. Easley, senior vice president and publisher of the JAMA Network.

Medical journal publishers succeed only when their journals ensure the content they publish is credible and editorial independence is authentic, and accordingly publishers must care as much about conflict of interest as editors do, he writes in his article “Medical journals, publishers, and conflict of interest.”1 A journal can succeed in the long term only if its audience perceives that the journal has not compromised its principles to generate revenue and, just as important, that the journal clearly upholds an authentic commitment to conflict of interest standards, he says.

Requirement for publication

When manuscripts are accepted in the JAMA Network, disclosures of COIs and relevant financial interests, activities, relationships, and affiliations, and declarations for each of the authors are published in the Acknowledgment section of the article, and thereby disclosed to readers, say Phil Fontanarosa, executive editor, and Howard Bauchner, editor-in-chief.2 In addition, all financial and material support for the research and the work is reported in the published article along with the specific role of the funding organization or sponsor in each of the following: “design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.”

“The purpose of requiring detailed reporting of COIs and financial support and making this information available to readers (either in the published article or as some journals do, by posting the submitted financial disclosure forms online along with the published article) is to enable readers to evaluate the authors’ COI disclosures and the financial aspects of the published article and to interpret the information in the article accordingly in light of those disclosures,” they say.

Research reports usually do not have the same concern about potential COI as manuscripts, but some issues require more attention, Fontanarosa and Bauchner say. For example, it is preferable in studies with industry support for these sponsors to have a limited role that is “prospectively defined and detailed.”

The authors also disdain statements in protocols and agreements that state a “funder” has the right to review a manuscript prior to submission and even delay its publication. “Delaying publication of any manuscript at the request of any funder (beyond a reasonable time for its review) is unacceptable, and no investigator or institution should engage in a contractual arrangement in which the funder can delay publication or has rights to veto publication.” They also wonder about the amount of oversight some government agencies are using over their research manuscripts. “It is not clear how often manuscripts have been delayed or changed because of these reviews. However, all authors should be afforded the protection and academic freedom to publish the results of studies regardless of the interest of the funder, whether a governmental agency, foundation, or for-profit company,” they say.

Consequences for nondisclosure

Investigators have legal duties and responsibilities spanning from study design beyond the time of publication, says the legal counsel for the JAMA Network. “‘Scientific misconduct’ includes a host of offenses, ranging from plagiarism to fabrication, false claims of authorship, and omission,” says Joseph P. Thornton, in his article “Conflict of interest and legal issues for investigators and authors.”3 Among the affirmative duties of authors is making a candid disclosure of the financial interests and affiliations that could affect their judgment and objectivity. Investigators who are employees, officers, or owners of for-profit companies, or who have patent or copyright interests, have additional responsibilities and are especially vulnerable to legal and ethical risks, he says.

One legal hurdle that investigators often overlook is the publishing contract itself. Unlike confidential agreements, this contract—with a description of author contributions or a COI disclosure statement—may be published with the article, Thornton says. According to the agreement, coauthors must say that the work is original and valid, that the study was approved by an institutional review board (unless not necessary), and that they will cooperate in any investigation of the accuracy and integrity of the article. The authors then usually fill out and sign a form such as the one from the International Committee of Medical Journal Editors (ICMJE) that spells out affiliations, financial interests, and funding/support relevant to the article, and the subject matter of the manuscript.3

“Complete disclosure” of past research and consulting work ordinarily is sufficient to journal editors, Thornton says, but authors should not only focus on COIs in the past but report any potential conflicts coming soon and “overdisclose” any involvement that could be a potential COI, too. “Journals expect and rely on each coauthor to detail any relationship or engagement regarding the study and broader topic that could be called into question upon publication in order to identify authors and evaluate manuscripts of authors who have a secondary interest, such as financial gain or celebrity status, at play. Admittedly, sometimes there is a disagreement between readers and authors of whether a specific relationship is a COI, but it is better for authors to fully disclose, and let the reader decide.”

If a potential COI is omitted, then the question becomes was the omission a misrepresentation, fraud, or just a mistake? Some investigators have faced criminal charges after not disclosing that they own stock relevant to the treatment drug. Even if investigators don’t face criminal charges for COI omission, they definitely are not immune to embarrassment if readers scour payment information on online sources and realize the investigators weren’t fully forthcoming in their COI disclosures. “[A]uthors must remember that the threshold for a reader complaint is low, the threat is high, and the reaction is potentially painful,” Thornton says. “Full, frank, and thoughtful disclosures at the time of submission of a manuscript, throughout revision, and again upon acceptance, help to protect the authors, editors, and journals from the epidemic surge of surprise and outrage known as ‘gotcha.’”

Is there such a thing as a potential COI anyway, argue Matthew S. McCoy, fellow in advanced biomedical ethics, and Ezekiel J. Emanuel, professor, both from the Department of Medical Ethics and Health Policy, Perelman School of Medicine at the University of Pennsylvania in Philadelphia. They wrote about potential COIs in their article, “Why there are no ‘potential’ conflicts of interest.”4 The notion of a potential COI reflects the “mistaken view” that a COI exists only when bias or harm actually occurs, they say. “This way of reasoning confuses a real situation marked by the potential for bias with a potential situation.”

COI disclosures are critical to the trust and confidence scientists and clinicians want to place in journals and peer-reviewed research, Thornton says. “Readers rely on journals to report whether the authors had affiliations that might have influenced their hypothesis, approach, or conclusions. When authors are lax about reporting their relationships or other COIs to editors, and journals publish that authors have nothing to disclose, readers may feel betrayed, critics may be offended, and bloggers and other ‘COI watchers’ who scour the literature for failures to disclose become energized to expose the breach of trust.”

If journal editors find authors did not disclose a COI, then the process could include a correction, Failure to Disclose Note, and written apology linked to the original publication. “The point is not to shame authors or reward those focused on appropriate reporting of COI, but to protect and correct the scientific literature,” Thornton says. “The ICMJE and other COI disclosure forms are in some ways similar to a surgeon’s pre-op checklist; glossing over them might save seconds but could spawn complications that may have lasting ramifications.”

References

  1. Easley TJ. Medical journals, publishers, and conflict of interest. JAMA 2017;317:1759-1760.
  2. Fontanarosa P, Bauchner H. Conflict of interest and medical journals. JAMA 2017;317:1768-1771.
  3. Thornton JP. Conflict of interest and legal issues for investigators and authors. JAMA 2017;317:1761-1762.
  4. McCoy MS, Emanuel EJ. Why there are no ‘potential’ conflicts of interests. JAMA 2017;317:1721-1722.

 

By Sue Coons, MA

This article was reprinted from Research Practitioner, Volume 18, Number 3, July-August 2017. Subscribe >>

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