This article is being published jointly in Gastrointestinal Endoscopy and Endoscopy.
Copyright © 2020 by the American Society for Gastrointestinal Endoscopy and Georg
Thieme Verlag KG
Abbreviations
COI:
conflict of interest
COPE:
Committee on Publications Ethics
ICMJE:
International Committee of Medical Journal Editors
The goal of scientific publications is to advance and share knowledge through the
scientific process. All scientific observations are, however, prone to bias. One form
of bias that is particularly important is a financial conflict of interest (COI).
The potential for financial gain can significantly influence how authors present,
as well as how readers interpret, scientific data. Although it is not possible to
eliminate these biases, it is critically important that such COIs be disclosed so
that readers can take them into account when interpreting scientific results. In this
article, we review the principles of COI disclosure with regard to scientific publications,
and we highlight how our journals manage such COIs.
Several recent high-profile examples of nondisclosure of COIs have raised the awareness
of how this can inappropriately influence the scientific process [1]
[2]. Failure to disclose a relevant COI is a major ethical violation. Most scientific
journals, including ours, follow the principles outlined by the International Committee
of Medical Journal Editors (ICMJE) as well as the Committee on Publications Ethics
(COPE). The ICMJE defines COIs as “relationships with entities in the bio-medical
arena that could be perceived to influence, or that give the appearance of potentially
influencing, what you wrote in the submitted work” [3]. The scope of this relationship is quite broad. It includes relationships that are
both directly influential, such as consulting income from a company that makes the
specific product being studied, as well as more broadly influential, such as companies
or other entities that make similar or competing products. For example, if a scientific
article is about a particular endoscopic stent, any relationship with the manufacturer
of that stent or the manufacturer of competing stents or related devices should be
disclosed.
Other relevant conflicts of interest include patents or copyrights or other intellectual
property related to the product or technique described in the publication, ownership
of a company, or significant stock in a company. This may also extend to the spouse
of the author. Of note, ownership of general stock funds, such as mutual funds or
index funds, is generally not considered a COI because the purchase or sale of individual
companies within those funds is outside of the control of the author.
The timeframe for inclusion varies somewhat from journal to journal. The ICMJE recommends
a timeframe that includes any relationships or anticipated payments within the prior
36 months.
The author may not be the direct recipient of funds but should disclose consulting
fees, research grants, or funds paid to the individual’s institution on their behalf.
Other nonfinancial support should also be reported, including the provision of drugs
or devices, travel expenses, administrative support, or writing assistance.
In the United States, a central reporting system has been developed for this purpose.
All medical companies that provide support to physicians are required to report on
this Federal website [4]. Although there are known limitations and inaccuracies of these data, the site does
provide a central and transparent source of information to crosscheck potential COIs.
Our journals routinely crosscheck this website when articles are submitted from U.S.-based
authors. This is particularly true for manuscripts that report on a specific company’s
product. In Europe, there is no equivalent centralized reporting system in place.
Only in certain countries, such as France, Portugal, and Latvia, are medical device
companies required by law to report support to physicians.
As editors we follow the guidelines set forth by COPE when managing suspected nondisclosure
of a COI. Typically, we ask authors to clarify any discrepancies between what is reported
by the authors on the COI form and what is reported on the Federal or national websites.
In most cases, nondisclosure is inadvertent and can be corrected by simple completion
of the COI forms. In more serious or repeated cases of nondisclosure, manuscripts
may be rejected and the author sanctioned.
Ultimately it is the author’s responsibility to disclose all potential COIs. Several
recent systems have made this process less burdensome. One such system is the Convey
software, developed by the Association of American Medical Colleges [5], which allows authors to maintain an ongoing list of potential COIs as well as relevant
topics and dates. The Convey system works similarly to reference management software,
which allows the author to maintain a database of potential COIs and upload the information
in a variety of formats, whether to journals, medical education programs, or their
institutions.
In summary, complete disclosure of potential COIs is the authors’ responsibility and
should broadly include any entity that can influence or be perceived to influence
the scientific work. Journal editors are responsible for ensuring that all COIs are
published alongside the article. The trust that the general public as well as scientific
colleagues have in the scientific process critically depends on such disclosure.
