Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest
Public trust in the scientific process and the credibility of published articles depend in part on how transparently an author’s relationships and activities, directly or topically related to a work, are handled during the planning, implementation, writing, peer review, editing, and publication of scientific work.
The potential for conflict of interest and bias exists when professional judgment concerning a primary interest (such as patients' welfare or the validity of research) may be influenced by a secondary interest (such as financial gain). Perceptions of conflict of interest are as important as actual conflicts of interest.
Individuals may disagree on whether an author’s relationships or activities represent conflicts. Although the presence of a relationship or activity does not always indicate a problematic influence on a paper’s content, perceptions of conflict may erode trust in science as much as actual conflicts of interest. Ultimately, readers must be able to make their own judgments regarding whether an author’s relationships and activities are pertinent to a paper’s content. These judgments require transparent disclosures. An author’s complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the scientific process.
Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents, and paid expert testimony) are the most easily identifiable, the ones most often judged to represent potential conflicts of interest and thus the most likely to undermine the credibility of the journal, the authors, and of science itself. Other interests may also represent or be perceived as conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs.
Authors should avoid entering into agreements with study sponsors, both for-profit and non-profit, that interfere with authors’ access to all of the study’s data or that interfere with their ability to analyze and interpret the data and to prepare and publish manuscripts independently when and where they choose. Policies that dictate where authors may publish their work violate this principle of academic freedom. Authors may be required to provide the journal with the agreements in confidence.
Purposeful failure to report those relationships or activities specified on the journal’s disclosure form is a form of misconduct, as is discussed in section III.B.
All participants in the peer-review and publication process—not only authors but also peer reviewers, editors, and editorial board members of journals—must consider and disclose their relationships and activities when fulfilling their roles in the process of article review and publication.
When authors submit a manuscript of any type or format they are responsible for disclosing all relationships and activities that might bias or be seen to bias their work. The ICMJE has developed a Disclosure Form to facilitate and standardize authors’ disclosures. ICMJE member journals require that authors use this form, and ICMJE encourages other journals to adopt it.
b. Peer Reviewers
Reviewers should be asked at the time they are asked to critique a manuscript if they have relationships or activities that could complicate their review. Reviewers must disclose to editors any relationships or activities that could bias their opinions of the manuscript, and should recuse themselves from reviewing specific manuscripts if the potential for bias exists. Reviewers must not use knowledge of the work they’re reviewing before its publication to further their own interests.
c. Editors and Journal Staff
Editors who make final decisions about manuscripts should recuse themselves from editorial decisions if they have relationships or activities that pose potential conflicts related to articles under consideration. Other editorial staff members who participate in editorial decisions must provide editors with a current description of their relationships or activities (as they might relate to editorial judgments) and recuse themselves from any decisions in which an interest that poses a potential conflict exists. Editorial staff must not use information gained through working with manuscripts for private gain. Editors should regularly publish their own disclosure statements and those of their journal staff. Guest editors should follow these same procedures.
Journals should take extra precautions and have a stated policy for evaluation of manuscripts submitted by individuals involved in editorial decisions. Further guidance is available from COPE and WAME.
2. Reporting Relationships and Activities
Articles should be published with statements or supporting documents, such as the ICMJE Disclosure Form, declaring:
- Authors’ relationships and activities; and
- Sources of support for the work, including sponsor names along with explanations of the role of those sources if any in study design; collection, analysis, and interpretation of data; writing of the report; any restrictions regarding the submission of the report for publication; or a statement declaring that the supporting source had no such involvement or restrictions regarding publication; and
- Whether the authors had access to the study data, with an explanation of the nature and extent of access, including whether access is on-going.
To support the above statements, editors may request that authors of a study sponsored by a funder with a proprietary or financial interest in the outcome sign a statement, such as “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis.”