Enhanced Reporting of Potential Conflicts of Interest: Rationale and New Form

As humans, we have biases that influence our behavior, in both positive and sometimes negative ways, at least as judged by other individuals. The reporting of potential conflicts of financial interest in articles in the medical literature is a complex, subjective, and contentious topic. The word “potential” is added, recognizing that conflict of interest is a condition, not a behavior, and that the potential for conflict of interest can exist regardless of whether an individual believes that the relationship affects his or her scientific judgment. The reader is reminded that there are often ways to “resolve” potential conflicts of interest: simply ward off payments from commercial companies; this is the suggested path for editors of medical journals and is a desirable goal for the entire editorial board, but probably not practical. In view of the evident benefits of commercial associations, the medical establishment and journals instead have generally chosen the weaker remedy of “disclosure” and then “management” of the disclosure information. While some currently feel that this topic inappropriately maligns the integrity of physicians and plea for lesser dialogue, continued reports in the literature and tabloids document unabashed bias on the part of some physicians and commercial companies in an attempt to influence the peer review literature. The Institute of Medicine, as well as many governmental agencies, prominent tabloids, and journal editors, continues to encourage or legislate for enhancement of disclosure requirements and to limit physician-industry relationships. Universities, professional societies, pharmaceutical companies, medical journals, and individual physicians are responding to this current initiative.

For the benefit of those who lament the continued discussion on this topic, two recent reports confirm that potential financial conflicts are still common and hidden by many presenters or authors. In a study reported in 2009, the presenters and planning committee of a major surgical society meeting in the United States failed to report direct financial conflicts of interest with regard to the topic of presentation 21% of the time, despite a requirement to report both direct and indirect conflicts; the documentation for their true payments came from the surgical companies themselves, who now must report (by federal court order ) such payments in public repositories. In a related later study of the same surgical specialty using data from this same public repository, 282 surgeons were reported as receiving over $100 000 in payments from commercial companies in 2007. Of the 41 individuals who received $1 million or more in 2007 from these commercial device companies, 32 published a total of 151 articles relating directly to the financial entanglement in the following year and only 50% disclosed a financial relationship between the author and the device manufacturer. They were, in effect, ignoring, circumventing, or perhaps misunderstanding the direct request of the journals to report this information. This latter study is of major concern since the literature is the permanent scientific record of the profession and influences physicians, practice guidelines, purchasers of healthcare, and most importantly, patients. It has been reported that conflict of interest is widespread among the authors of published manuscripts and that these authors are more likely to present positive findings. Research has also confirmed that the declaration of financial conflict of interest can have a significant (negative) effect on readers’ perceptions of the scientific credibility of published research ; the reader has the right to know this information and authors have the obligation to inform. Clearly, some authors are not getting the message regarding disclosure reporting requirements and, with these amounts of money involved, the medical establishment and public can easily lose trust in what journals report and the professional integrity (or at least the research conduct) of some physicians is being appropriately challenged.

Each journal has a different process for requesting and then listing the authors’ potential conflict-of-interest statements, in turn creating burdensome efforts and confusion for authors and reviewers attempting to comply with disclosure requirements. Recognizing this predicament, the International Committee of Medical Journal Editors (ICMJE) recently developed an electronic uniform disclosure form and placed it in the public domain. The form has been piloted and undergone a comment period, and the form, or some modification of it, is now in use by many journals, including all the member journals of the ICMJE; the ICMJE recommends that all medical journals use this reporting form or a modification of it. The ICMJE invites you to comment about the form, since a new version may be formatted after a May 2011 comment period ends. Beginning in early 2011 the Journal will require this form (or its later versions) at the submission stage so that there will be access to this information during the entire peer review process.

In an editorial simultaneously published in all ICMJE member journals, the newly introduced form outlined the disclosure of 3 types of information requested from each author at the time of submission. First is the authors’ associations with commercial entities that provided support for the work reported in the submitted manuscript (the time frame for disclosure in this section of the form is the lifespan of the work being reported). Second is the authors’ financial relationships with any entities in the biomedical arena that could be perceived to influence, or that give the appearance of potentially influencing, what the authors wrote in the submitted work (the time frame for disclosure in this section is the 36 months before submission of the manuscript). Third is an open-ended section that requests authors to report 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. Examples of this latter might include intellectual conflicts, academic commitments, personal relationships, political or religious belief, or institutional affiliations. While some will consider this form intrusive and burdensome, others feel it has not gone far enough in reporting disclosure. True transparency would require requesting and then publishing specific amounts of the commercial payments to the authors; some journals will continue to request this information and may choose to publish it. Prior pilot versions of this form requested information about the financial involvement of the spouse and children and also requested that the author provide nonfinancial conflicts of interest, but these were removed after the pilot review of the form because the former was judged intrusive and the latter ill-defined. The ICMJE encourages the journals to display this disclosure information in association with the article for the benefit of the reader but does not set guidelines. Some journals may publish the form online only; the Journal, as many ICMJE member journals have elected, will have the authors incorporate the information on the form into text at the end of the paper or within the Acknowledgment section of the printed and online article.

The form now posted on the ICMJE website ( www.icmje.org/coi_disclosure.pdf ) and included as a Supplemental Figure (available at AJO.com ) includes instructions to help authors provide the information; a sample completed form is also available ( http://www.icmje.org/sample_disclosure ). For nonnative English speakers, there is a glossary of the terms used in the form, and guidelines for translation of the form’s instructions into multiple languages is planned, in recognition that some nuances may not be understood or well known in some cultures.

Authors can download the form from the ICMJE website or from the Author Instructions of the American Journal of Ophthalmology, add the requested information, and save the completed form on their computer. The completed form can then be uploaded to the website of the journal that has requested the information. Over time, each journal may request the identical document, which will simply need to be updated by the authors in relation to the current manuscript prior to uploading.

Authors are often in the best position to know individuals competing in their field of interest, and authors often provide the editors with the names of persons they feel should not be asked to review a manuscript because of potential conflicts of interest—usually professional, but now or in the future they may know of potential financial conflicts as well. The Journal has always permitted authors to recommend or request avoidance of certain reviewers, but it now seems fair to encourage this practice so that authors can be better assured of reviews by less conflicted colleagues. The reason for the avoidance of a specific reviewer should be stated in general terms by the submitting author.

The disclosure of financial relationships with commercial companies is an essential, albeit small, step in managing the full spectrum of the many potential conflicts of interest in research publication. Society has permitted physicians to regulate themselves, placing great trust in the medical profession. The public, governmental agencies, legislators, and the medical profession itself is growing weary of the bias and conflicts in some medical literature, and this behavior additionally risks damage to effective collaborations with commercial companies. Loss of trust by any important group will ultimately lead to onerous regulation and less effective research. Evidence that this self-regulation has already been eroded is demonstrated in the settlement agreements with the US Department of Justice, in which 5 biomedical companies are required to release information about their payments to physicians and healthcare organizations. An additional 10 companies have also agreed to list this information in public websites in order to improve their reputation. Under the recently enacted healthcare reform legislation, beginning in 2013, healthcare companies of pharmaceuticals, medical devices, biological products, and medical supplies will be required to report all payments to physicians worth more than $10 in a publicly available and searchable online format. So, in effect, we have already lost some of the self-regulation that past professional colleagues have strived to protect for generations.

Journals will be vigilant in the quest to ensure that the public continues to trust that the medical literature and their authors are not inappropriately influenced by their financial relationships with industry or other prejudices. If allegations arise, the journals must and will react.


Jan 16, 2017 | Posted by in OPHTHALMOLOGY | Comments Off on Enhanced Reporting of Potential Conflicts of Interest: Rationale and New Form

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