Though reporting conflicts of interests is a standard part of any medical publication, there’s a bit of confusion over what warrants disclosure and when it’s a good idea to disclosure potential conflicts. Here, we’ll provide a simple, straightforward guide on understanding conflicts of interest and recognizing the appropriate circumstances for disclosing them.
What are Conflict of Interest Disclosures?
First, let’s lay our groundwork. Conflicts of Interest (COIs), also called competing interests, disclosures, or declarations, can be defined as any real or perceived influential factor that may influence, bias, or affect the motivations of a researcher, thereby affecting their research’s integrity. Though we most often talk about study authors’ COIs, the journal’s editors and peer reviewers can also have COIs that affect the publication process.
It’s important note the use of the term ‘may’ in this definition. Regardless of whether you feel that your judgment is affected by the relationship, COI disclosures are focused on whether an involved third party could recognize the capacity or capability for a corrupted influence. In other words, disclosing a COI does not mean that you’re admitting to being influenced by an external factor—just that you recognize that the external factor could have the capacity to affect your motivations. Many potential COIs are legitimate, legal, and ethical activities that aren’t inherently problematic but may require extra scrutiny in relation to your research.
There are two main subtypes of conflicts of interest:
Financial gain
As the most common type of COI and typically what comes to mind when considering disclosures, a financial COI exists when the researcher may financially benefit from certain study results. These financial relationships are very common—though exact estimates vary, a large proportion of clinical trials are directly funded by industry sponsors (oftentimes pharmaceutical companies).
Example: Dr. John Doe leads a clinical trial for New Drug X while also receiving honoraria/speaker fees from the pharmaceutical company manufacturing said drug. If the drug is found to be effective and, consequentially, is used more often, the company will financially benefit and will likely continue paying Dr. Doe honoraria fees. Therefore, Dr. Doe may benefit from positive study results.
Non-financial interest
This is a wide category that refers to “personal, political, academic, idological, or religious” interests that may create bias.
Example: a researcher submits a paper to a journal that they serve on the editorial board for. The handling editor assigned to manage this submission recognizes the author and is influenced to accept their manuscript out of fear of being fired or discriminated against if they reject the paper.
Additional examples can be found here.
When Should COIs be Disclosed?
If you learn one thing from this article, let it be this: it’s always better to err on the side of overdisclosure than nondisclosure. If you think a relationship or situation could possibly be viewed as a conflict of interest, disclose it.
With that being said, it’s not advisable to include a page-long document that outlines every professional relationship you’ve ever held. There are some general guidelines you can follow when determining whether a disclosure is relevant for a certain paper. Here’s our suggested workflow for determining what conflicts to disclose with a manuscript submission:
- Consider all professional relationships you hold, particularly those that you’re paid for. This includes companies or groups you’re a consultant for, speaking bureaus, and advocacy group involvement. This can also include side projects/secondary streams of income, such as inventions, intellectual property, investments, and patents.
- Evaluate whether the relationships could influence your research. Are there any overlapping topics or similarities between the relationship and your research? Would the success of your research influence or affect this relationship?
To illustrate this point, let’s return to a previous example. There certainly is an overlapping interest between Dr. John Doe’s research evaluating the efficacy of New Drug X for treating breast cancer and their involvement with the company that manufactures the drug; however, say Dr. Doe also holds a patent for a specialized type of catheter. It’s reasonable to assume that the success of New Drug X and wouldn’t influence success of the catheter, so this probably doesn’t need to be disclosed.
This part of the workflow is the most vague because it’s the most subjective to individual circumstances. If you’re unsure about whether something should be disclosed, you can always contact whichever department in your institution manages responsible conduct of research; alternatively, you can email the journal’s editorial board, explain the situation, and ask whether you should include the disclosure.
- Check the Instructions for Authors. Once you’ve selected a target journal, review their policies for COI disclosures. Some journals will provide specific guidance on what relationships to disclose, and many journals have specific COI forms they request authors complete. Journals are also increasingly requiring authors to include statements outlining the role of the funding source in the research’s design, execution, interpretation, and manuscript writing.
- Draft your disclosure. Always try to be as specific as possible with your disclosure; typically, for financial conflicts, it’s not required to disclose the specific amount paid. There are some excellent templates available online.
What Happens if I Didn’t Disclose a COI?
Don’t panic—in most situations, lack of COI disclosure won’t warrant an article retraction. If you recognize that you had a COI that you should have disclosed but didn’t, email the editor you worked with during the publication process to let them know. Usually, the journal will issue a correction to the article. The research will still be considered valid and citable, but readers will be able to consider the updated disclosure when interpreting the findings.
If the journal editors identify the COI without you notifying them, they’ll typically follow the same workflow (ie, a correction). However, if a COI is considered strong enough to reasonably assume that it affected the research integrity or that you knowingly and intentionally did not disclose a COI, the editors may consider retracting the publication.
