COIs: Concepts, Conundrums, and Course of Action

A Closer Look at COI

Conflicts of interest are sometimes dichotomized as conscious vs unconscious, inherent vs induced, or financial vs nonfinancial. An inherent COI might exist, for example, in any type of medical research, because the researcher almost always seeks to benefit mankind while also seeking to advance his or her own career. There is nothing unethical in this tension between altruism and self-interest. In contrast, an induced COI is said to exist when a researcher knowingly creates situations of financial or other types of dependency that may compromise judgment.^[3]

Several writers have pointed out that physicians and other researchers are not always aware of their own COIs, and are truly surprised when an outside observer points it out to them; thus, not all COI is conscious or "knowing." With respect to nonfinancial COIs, this may arise, for example, if a physician is asked to review a study by a colleague whom he or she deeply dislikes, or whose paper strongly criticizes the would-be reviewer's own long-standing views.

A COI can occur in many professional contexts, ranging from a physician's ties to industry (eg, speakers' bureaus, stipends for lectures, research support) to bias in the publication of research studies (eg, failing to publish negative outcome studies) and COI stemming from the physician/patient relationship. Often, these areas overlap or interact to produce the COI. In a seminal article, Dennis Thompson defined a COI as "...a set of conditions in which professional judgment concerning a primary interest (such as a patient's welfare or the validity of research) tends to be unduly influencedby a secondary interest (such as financial gain)."^[4]

Thompson's definition emphasizes the likelihood or probability of a bias developing ("...tends to be unduly influenced") and includes a semiquantitative specifier; that is, there must be an undue degree of influence from a secondary interest. This is important, because it implies that a COI may not be present if the degree of influence remains modest or moderate (for example, within some unspecified parameters of acceptability). In Thompson's view, not every situation in which bias might occur -- or be perceived by others as existing -- would be an actual, full-blown COI (in contrast to the Columbia definition of COI).

Similarly, the International Committee of Medical Journal Editors (ICMJE), in their Uniform Requirements for Manuscripts Submitted to Biomedical Journals,^[5] state that:

Conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from negligible to great potential for influencing judgment. Not all [financial or personal] relationships represent true conflicts of interest (italics added).

In short, the ICMJE does not see a COI as an all-or-none phenomenon; there is a wide range of circumstances that create a continuum of COI.

Conflict of Interest vs Vested Interest

It is also important to distinguish a COI from a vested interest. For example, Dr. A, in the first vignette, has a legitimate, vested interest in educating her audience about the risks associated with antidepressant use during pregnancy. A psychiatrist also has a legitimate vested interest in seeing his or her practice grow and flourish. There is no COI in either case, unless and until the vested interest bumps up against a competinginterest.

To understand this, let's suppose that in the interest of growing your psychiatric practice, you create a Website that provides information about you, your education, areas of expertise, how to set up appointments, and so on. There is no COI in any of this. But now, suppose you have been treated recently for a significant and chronic mood disorder. Do you disclose this on your Website?

It could be argued, on various grounds, that such disclosure is in the best interests of your current and prospective patients. On the other hand, some potential patients may find this personal disclosure worrisome and seek help elsewhere, even though you are perfectly capable of treating them effectively. This, of course, could reduce your net income. Thus, over and above the legitimate vested interest, there is at least a potential COI.

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