The debate within the medical profession over “conflicts of interest” (COIs) has often been shrill, and sometimes seems to be based on misunderstandings or myths about what COIs entail. In this psychiatrist’s view, it is helpful to step back from confident proclamations, acknowledge that the issues involved are complex, and aspire to some semblance of humility. Nobody has cornered the market on “the right way” to deal with COI in the realms of medical research, publication, and education.1 At the same time, as Alan Stone, MD, has noted (personal communication, August 27, 2009), ethical considerations lie at the heart of any debate on COI—in particular, the ancient dictum, “Do no harm.” Indeed, ethicist James M. DuBois has pointed out a direct connection between some types of COI and harm to the general public: “Mental health consumers are at risk when studies that involve questionable scientific and publication practices are translated into therapeutic practice.”1(p205)
What follows are simply the views of this educator, editor, and sometime-researcher—views strongly held but not intended as “proclamations.” With that prologue, here is my “User’s Guide” to COI, written in the form of questions and answers.
In the health care field, what is the professionally accepted definition of COI?
There is no single, universally accepted definition of COI, although there is substantial convergence around a few general definitions of the term. Therefore, when someone is alleged to have a COI, the first order of business is to ask the person making the allegation to define COI.
But aren’t professional journals and organizations providing reasonably clear definitions of COI?
Yes, but the definitions differ in important ways and are sometimes difficult to interpret. Most definitions of COI—both outside and within the medical profession—follow 1 of 3 underlying paradigms—which we might call the “3 Ps”: perception, potential, and probability. These are founded, respectively, on judgments regarding how observers perceive the situation in question; on whether the situation has any potential for conflict of interest; and on whether the situation is more likely than not to lead to such conflict. For example, one definition of COI from the business world emphasizes perception: “We can define a COI as a situation in which a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties as, say, a public official, an employee, or a professional [italics added].”2
He who proclaims will proclaim flat. —Lionel Ziprin
Note that this definition does not require any actual influence on the person’s objective exercise of duties. Neither does it require either the potential or the probability of an actual COI arising—rather, it falls under the rubric of “having the appearance of impropriety.” Of course, one might suspect that if there is such an appearance, there must also be a reasonable likelihood of COI (“Where there’s smoke, there’s fire!”). However, this line of reasoning fallaciously assumes that all perceptions of COI are necessarily accurate or objective, and are not themselves influenced by all manner of malign motives and biases.
Another widely cited definition of COI from Columbia University emphasizes the potential of some situation to compromise one’s objectivity: “The simplest working definition [of COI] states: A COI is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.”3
The Columbia definition of COI, like that of MacDonald and colleagues,2 does not require that any decision actually be biased, or even that such bias be likely; on the contrary, the Columbia doctrine is clear that “a COI exists whether or not decisions are affected by a personal interest; a COI implies only the potential for bias, not a likelihood [italics added].”3