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April 09, 2008

On Perceptions & Conflicts of Interest

A new study has been published on conflicts of interest in the Journal of General Internal Medicine.  Here is the Abstract:

Clinical trial volunteers are indifferent, not blind, to conflicts

Unless a researcher has stock ownership in a company whose drug is being tested, telling potential research volunteers about an investigator's financial interests is unlikely to affect their willingness to volunteer, according to a new study published online by the Journal of General Internal Medicine. However, study results also show that many research volunteers put less trust in clinical trial leaders with financial conflicts. The study's findings suggest that researchers and policymakers involved in clinical trials should pay close attention to the impact of financial disclosures on potential study subjects. The research was conducted by investigators from the Johns Hopkins Berman Institute of Bioethics, Johns Hopkins School of Medicine, Duke University School of Medicine, and Wake Forest Schools of Medicine and Law. The study was funded by the National Institutes. The study was funded by the NIH.

Some comments: while it is always worthwhile to investigate the views of participants in clinical research, I wonder what the appropriate ethical conclusions ought to be.

First, we know that many of those actually subject to COIs labor under fundamental misunderstandings of the way that COIs actually affect human behavior (i.e., that managing COIs and disclosing them resolves all problems, that individual virtue is proof positive against the behavior-altering effects of COIs, etc.).  A fortiori there is no reason to expect that those with no experience of the pathways of those COIs would have widely different understandings.

Second, and perhaps more important, what difference does it really make if trial participants are indifferent to conflicts? It would be a rank instance of the naturalistic fallacy to conclude therefrom that we therefore ought not care much about the existence of those COIs, esp. where we have very good evidence that these COIs in fact do exert significant influences on human behavior.  So many participants don't seem to care much -- well, frankly, neither do many investigators.  But both are mistaken.  Both should care, and we ought not permit the status quo to simply sail along without at least trying to educate both professionals and participants on the nature of the problem.

Thoughts?

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