The primary testimony to a research study that involves patient volunteers and consumes public or private resources is publication in the peer-reviewed literature. Although a scientific article should be judged on it is own merits, subjectivity in study design by commercial entities, financial incentives for favorable interpretation by researchers, and other forms of bias by authors or peer reviewers may influence the final published work. The peer-reviewed literature rightfully has a powerful effect on decisions concerning both guidelines and funding of patient care, so journals strive to make their content valid and objective.
Although it is widely agreed that “industry” involvement in ophthalmic research is necessary and desirable, it has been less enthusiastically but decidedly determined that full disclosure by all involved parties presently is the acceptable vehicle that permits the transference of study results into the peer-reviewed literature. Editors and readers recognize that several nonfinancial forms of bias, such as professional, intellectual, academic competition, or subtle prejudices based on personal experience can affect a study or peer review, but these will not be discussed further here. Only financial disclosure has emerged as an attainable goal over the past few decades, but the process has not been perfected either in concept or practice. The topic of financial conflicts remains contentious in medicine, with some finding the requested reporting burdensome and others still unsatisfied that disclosure is often translucent, at best. Some major journals still do not require financial disclosure, some do not define their disclosure policy, some disagree with commonly used definitions and terms, some do not request the disclosure until after an article has passed the peer review process, and nearly every journal has a different way of conveying or not conveying information about financial relationships to the reader. There is evidence, however, that readers are mindful of disclosure information and make judgments about an article’s quality based on it, having a preference for government-funded research compared with studies supported by industry.
The New England Journal of Medicine and the Journal of the American Medical Association have led this movement in financial disclosure, catalyzed by embarrassing situations involving failure of forthright communication by their authors. As reviewed by Blum et al, there has been a concerted effort to protect the integrity and public trust in the peer-reviewed literature by the Institute of Medicine, the International Committee of Medical Journal Editors (ICMJE), the World Association of Medical Editors, the Council of Science Editors, the Committee on Publication Ethics, and others, each of which has drafted guidelines on disclosure as a means for improving transparency. A uniform ICMJE author disclosure form was suggested and then developed by the major international journals several years ago, and has now undergone a number of iterations following suggestions by users. The newest version even generates a statement about financial disclosure that could appear in the accepted publication. This disclosure form (available at www.icmje.org ) has been adopted in principle by all member journals of the ICMJE and is recommended for use by all others. It is anticipated that an author would keep this new interactive ICMJE form updated on his or her computer desktop and include the same form to each journal with every submission.
The ICMJE form requests authors to list disclosures by entity (government agency, foundation, commercial sponsor, academic institution, etc.), followed by the type of relationship (e.g., honoraria, royalties, fees for consulting, lectures, speakers bureaus, expert testimony, employment, etc.), including nonfinancial support (drugs or equipment, travel, writing assistance, administrative support, etc.). The time frame for reporting relationships associated with the submitted work comprises the date of initial conception to the time of publication. Disclosures not specifically related to the submitted work are to be reported for the 36 months before submission. Another section of the form requests information on intellectual property (patents, copyrights, royalties, licenses, etc.), and the last section is an open-ended question asking if there are other relationships or indirect or nonfinancial activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what is presented in the submitted work. The ICMJE form includes a glossary of terms on the form to assist authors, including those from non-English speaking countries. The American Journal of Ophthalmology and Ophthalmology have used this form or a modification of it for several years and are now updating to the newest version.
The ICMJE form as described above uses the terms potential conflict of interest and relevant financial activities , which we as editors have found to be ambiguous, problematic, and confusing to authors because they require a subjective decision by them about each financial relationship. Indeed, much of the information on disclosure that some journals provide is a varying definition of the terms relative and potential conflict , with examples of what to disclose differing from journal to journal. This seems to be an impediment to transparency. We would prefer the disclosure form and the corollary statement in the published manuscript to indicate all financial relationships with commercial or noncommercial companies in medicine; that is, every item reported in the ICMJE form should be included in the disclosure section of the submitted manuscript. The disclosures should be identical each time an author submits an article on any medical topic, with updates as necessary. This should promote consistency; at present, authors’ disclosures in the peer-reviewed literature, even on the same topic, often vary widely within the same year. Authors may easily make mistakes deciding about a “relative” or “potential” conflict, requiring a published correction and chastisement if discovered later.
Although an author may be able to craft his or her specific manuscript to avoid a suggestion of nonrelevant financial entanglements, later correspondence with readers may lead the author to stray. The same is true of Continuing Medical Education presentations from the podium where an author may wander during his or her presentation or during a discussion period, after having claimed no financial conflict with the content that will be presented. Continuing Medical Education programs should, and many do, require all disclosures on the first slide, and not just a subjective assertion by the presenter about which of his or her financial disclosures may or may not be relevant to the specific presentation. Ideally, the presenter should add a comment about which disclosures she or he judges to be related to the presentation, but then should expect the audience, armed with this information, to determine if the presenter is accurate. Confusion and subjectivity in reporting financial conflicts would be lessened simply by disclosing everything and having the same disclosures at each presentation and each manuscript submission, again with updates as required. A frequent refrain from physicians who have been disciplined is that they did not recognize the financial conflict of which they were accused until it was pointed out to them. The changes suggested above obviate that confusion because all disclosures are required.
The journals that we edit align with some others, such as the New England Journal of Medicine , that require all financial relationships in medicine to be provided. This is not a foreign concept; authors in the United States now must submit financial disclosures to their academic institutions, pharmaceutical companies now post such information online, and the government now requires an Internet posting with the Physician Payments Sunshine Act provisions of the Affordable Care Act. There is a related movement to produce a “harmonized and centralized conflict of interest disclosure” on a web site following an Institute of Medicine Initiative. An individual’s information should be consistent across all these reporting agencies. As regards the American Journal of Ophthalmology and Ophthalmology , we plan to include full disclosures with each published article. This disclosure policy applies to all types of manuscripts, including correspondence, and ideally should apply to everyone involved in the peer-review process and to editorial decisions. The editorial board members of our journals provide complete disclosures on our respective web sites. Peer reviewers are not required, at present, to complete the ICJME form, although reviewers always are reminded to recuse themselves from critiquing any manuscript that poses a conflict, either financial or nonfinancial. Reviewers usually are authors, so our journals have disclosure information that can be double-checked in many instances, if necessary.
As the reporting of financial disclosure becomes more prevalent, new complexities emerge. For example, evidence exists that disclosure perversely may increase bias, with the potential for harm to patients. For the moment, however, we believe that requiring greater transparency is necessary if not necessarily sufficient.