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Editorial
December 11, 2018

Conflicts of Interests, Authors, and JournalsNew Challenges for a Persistent Problem

Author Affiliations
  • 1JAMA and the JAMA Network, Chicago, Illinois
JAMA. 2018;320(22):2315-2318. doi:10.1001/jama.2018.17593

Conflict of interest affects virtually every aspect of medicine, including research, teaching, and clinical care. In May 2017, JAMA published a theme issue that included 23 articles on conflicts of interest (COIs) that represented “the multifaceted aspects and complexity of COI from numerous perspectives,”1 such as academia,2,3 medical education,4,5 medical practice,6 and research7; industry payments to physicians8,9 and industry funding of and collaboration with researchers,10,11 guideline panels,12 professional associations,13 and academic medical centers14; why COIs matter and how they are defined and managed15-18; disclosures to patients19,20; and the roles of journals21,22 and authors.23

However, despite the increased awareness of COIs by physicians, emphasis by academic medical centers for faculty physicians to report COIs,24 regulation in the United States with national disclosure of payments from industry to physicians and teaching hospitals (eg, Open Payments),25 and tracking of payments to physicians by consumer groups (eg, Dollars for Docs),26 problems with COI reporting by authors of articles published in biomedical journals persist. These problems include failure to disclose financial and other important potential COIs, as well as incomplete disclosures, inconsistent disclosures, and misinterpretation of what represents a relevant disclosure.

The recent investigation of a prominent cancer researcher for failure to disclose substantial financial and administrative relationships with drug and health care companies in leading medical journals and his subsequent resignation as chief medical officer of a leading cancer center has once again placed the issue of COI center stage.27 Although failure to disclose COIs is not limited to the field of oncology, a recent study found that 32% of 344 oncologist authors did not fully disclose payments from the sponsors of clinical trials of oncology drugs published in major medical journals.28

Other recent studies have documented incomplete COI disclosures among medical specialties, with inaccurate disclosures of industry relationships involving 22 (55%) of 40 authors of dermatology clinical practice guidelines,29 and discrepancies between disclosure statements and publicly available data on payments from industry involving 3 (6%) of 49 authors of otolaryngology clinical practice guidelines.30 Another study of the 100 physicians who received the highest compensation from large device manufacturers in 2015 revealed that of the 225 articles published in 2016 by these physicians and for which these payments were relevant, only 84 articles (37.3%) included self-declared COI information from the authors.31 These recent reports follow the publication of numerous previous articles indicating that disclosure of COIs in medical journals is inadequate.32-34

Responsibilities of Authors

Authors and journals have important responsibilities regarding potential COIs. Authors must be transparent, forthcoming, and consistent in reporting COI information. However, with respect to specific relationships, authors may not agree that a particular relationship represents an actual or relevant COI. In general, because a potential COI can depend on individual perceptions and beliefs about what may represent a conflict or pose a bias, the approach at JAMA and the JAMA Network journals is to encourage authors to provide complete and broad disclosure, thereby allowing readers to be aware of authors’ potential COIs and enabling readers to decide whether a COI disclosure is important in their interpretation of the article.

As indicated in the JAMA and JAMA Network journals’ Instructions for Authors, “Authors are expected to provide detailed information about all relevant financial interests, activities, relationships, and affiliations (other than those affiliations listed in the title page of the manuscript) including, but not limited to, employment, affiliation, funding and grants received or pending, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.”35 These journals follow the International Committee of Medical Journals (ICMJE) guidelines for definitions and terms of COI disclosures (Box).36

Box Section Ref ID
Box.

International Committee of Medical Journal Editors (ICMJE) Definition and Terms for Conflict of Interest Disclosures

  • Any potential conflicts of interest “involving the work under consideration for publication” (during the time involving the work, from initial conception and planning to present),

  • Any “relevant financial activities outside the submitted work” (over the 3 years prior to submission), and

  • Any “other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing” what is written in the submitted work (based on all relationships that were present during the 3 years prior to submission).

Earlier this year, JAMA and the JAMA Network journals began to implement a new process for reporting of author COI disclosure statements. For many years, JAMA and some of the JAMA Network journals have required authors to submit 2 separate forms: the universal COI disclosure form developed by the ICMJE36 and a separate Authorship Form.37 Beginning this year, all JAMA Network journals require authors to submit a single electronic Authorship Form, which includes the questions from the ICMJE Form for Disclosure of Potential Conflicts of Interest. Recognizing concern about inadequate reporting of COI and to help authors avoid incomplete or inaccurate disclosures, each time an author answers “no” to 1 of 4 specific questions about potential COIs, a pop-up message appears asking if the author is certain that “no” is the correct answer. In addition, the pop-up message asks if the author’s answer is consistent with disclosures in recently published articles. One of the recurring issues is inconsistency in an author’s reporting of specific COIs. Often, when allegations of inadequate COI disclosures are made, it is because authors have reported inconsistent disclosures in related recent publications (eg, in different articles or in different journals). Sometimes these differences are appropriate (such as when different journals have different disclosure policies), but sometimes they are not, and some readers (often with their own conflicts) and investigative journalists have asked about such inconsistent reporting of disclosures.

However, these new approaches, prompts, and reminders for reporting COI disclosures will not be effective if authors fail to completely report or misrepresent their COI information. Just as authors are expected to operate under the principles of honesty and integrity in reporting the results of research studies, authors also are expected to operate under these same principles with reporting of financial and other COI disclosures. Complete and detailed reporting of potential COIs is essential to maintain confidence and trust in biomedical research, and to ensure transparency with respect to understanding possible relationships between authors’ potential COIs and the information reported in their articles. In addition to reporting complete and detailed financial COI information, authors are encouraged to report other information that may be relevant to the subject matter of their article. For instance, an author who serves or recently has served as an officer of a medical society or advocacy organization who writes about topics that have relevance for that organization also is expected to include that additional information in his or her COI disclosures.

Some have suggested that there should be a central database of all author COI disclosures and financial interests to which journals can link or that editors and readers could search to check for COIs of authors of submitted manuscripts and published articles. Such systems may be feasible and some are operating,25,26,38 but they are based in the United States and may not work for authors outside of the United States, may contain incomplete or inaccurate information, and may be expensive and burdensome to manage and function effectively within the editorial evaluation and publication processes. In addition, such centralized systems might not address that relevant COIs may vary from article to article. Moreover, disassociating authors’ disclosures with specific submitted manuscripts and published articles (even with linking to disclosures in an external database) could make real-time assessment more challenging for editors and peer reviewers, and ultimately for readers. In addition, it is not clear how these systems, or how reporting financial disclosure information on institutional sites, such as is required by some academic medical centers, can address intellectual COIs or other relevant disclosures that can influence an individual’s interpretation of data.7

Allegations of Lack of Disclosure

Allegations received by the editors of JAMA and the JAMA Network journals of undeclared, incomplete, or inconsistent reporting of COI information in a published article are carefully evaluated. Authors of the article are contacted about the concerns, with a request for a complete and detailed explanation. In most cases, the authors’ responses and the additional information provided are sufficient to resolve the concerns. For cases involving verified problems with incomplete or inaccurate COI disclosures in published articles, JAMA and the JAMA Network journals publish Letters of explanation from the authors and corrections to the article with the incorrect disclosure information. For example, JAMA and the JAMA Network journals recently published Letters of explanation with Corrections regarding articles in 5 journals to correct and clarify the originally published incomplete or inaccurate COI disclosure statements of authors.39,40

In addition, academic medical centers and other organizations have increased efforts to encourage24 and promote transparent reporting of financial interests and other COI disclosures, such as by posting faculty COI information on institutional websites. Botkin41 has suggested that institutional COI policies should be strengthened, such as by considering the intentional or negligent failure to disclose significant financial relationships relevant to the conduct of research to be a form of research reporting misconduct. Accordingly, the editors are considering a plan to notify the institution or organization responsible for oversight of the author who has a substantial undeclared or inaccurate COI disclosure in a published article by sending the institution the subsequently published Letter reporting the problematic disclosures. The editors are also considering, on a case-by-case basis, notifying the funding source or sponsor for the work reported in the article that involved undisclosed COI information. Institutions and funders could then decide whether further action is required. Additional steps may be necessary to help reduce the occurrence of undeclared, incomplete, or inconsistent reporting of COI information in published articles. If problems with reporting COI disclosures persist, especially if more high-profile cases occur, public trust in biomedical research and medical journals will be adversely affected, and government agencies and others may consider further regulatory action.

Responsibilities of Editors

While authors must be forthcoming about reporting their potential COIs, journal editors also have an important responsibility in ensuring that all articles, including research reports, reviews, and opinion pieces, accurately reflect scientific evidence, regardless of the COI disclosures of authors. For example, editors must review invited opinion manuscripts linked to specific research articles (eg, Editorials and Commentaries) and ensure that the authors adequately assess the accompanying research report, provide a balanced discussion of the key issues, do not misinterpret the data, do not exaggerate the findings, or introduce new data that has not been previously published. The same is true for opinion pieces that are not linked to articles (eg, Viewpoints); editors have a responsibility to ensure appropriate recognition of factual information, prevent inclusion of self-serving information, minimize the risk of bias, and ensure complete disclosure of COI information.

Editors also have a responsibility to manage their own potential COIs. JAMA and the JAMA Network journals have formal policies for disclosure and management of potential COIs of editors.1,21 JAMA Network journal editors complete a COI disclosure statement annually, in which any potential conflicts and relationships are disclosed and reported to the editor in chief. If an editor has a potential COI with a specific manuscript or author, that editor is recused from the editorial and peer review processes. JAMA and the JAMA Network’s journal policy indicates that “final decisions regarding manuscript publication are made by the editor in chief or a designated editor who does not have any relevant COIs.”35 This includes financial and nonfinancial potential COIs. A similar recusal policy is in place for peer reviewers of these journals.

Conclusions

COIs are likely to become more challenging in the years to come. As more investigators and their institutions have and enter into financial relationships from which they benefit, it is critical that authors report COI information accurately, completely, and transparently so readers can evaluate whether the information in the article could be biased because of authors’ potential COIs. Equally as important, if not more important, are the responsibilities of editors to ensure that published information is accurate and objective and to maintain the integrity of the scientific record. Ultimately, physicians, other health care professionals, and other readers must assess the information available to them, determine the value and importance of an article, and make decisions about its applicability to clinical care and contribution to health.

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Article Information

Corresponding Author: Howard Bauchner, MD, Editor in Chief, JAMA, 330 N Wabash Ave, Chicago, IL 60611 (howard.bauchner@jamanetwork.org).

Published Online: October 26, 2018. doi:10.1001/jama.2018.17593

Conflict of Interest Disclosures: Dr Bauchner serves as the JAMA representative to the International Committee of Medical Journal Editors. Dr Fontanarosa is an adjunct faculty member of the Northwestern University Feinberg School of Medicine. Ms Flanagin is an unpaid member of the board of STM: International Association of Scientific, Technical, and Medical Publishers.

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