Healthy Skepticism Library item: 16325

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Publication type: Journal Article

Weinfurt KP, Hall MA, King NMK, Friedman JY, Schulman KA, Sugarman J
Disclosure of Financial Relationships to Participants in Clinical Research
NEJM 2009 Aug 27; 361:(9):916
http://content.nejm.org/cgi/content/full/361/9/916

Abstract:

In keeping with previous statements by a number of prominent groups,1,2,3,4 the Institute of Medicine has recently stressed the need for vigilance in managing conflicts of interest to ensure the integrity of clinical research.5 The Institute of Medicine adopts a position similar to that of the Association of American Medical Colleges1 – that is, it assumes that there is a rebuttable presumption of a conflict of interest if the investigator has a financial interest in the outcome of research that involves human subjects. Although the institute’s report emphasizes the need for disclosure of financial interests to institutions and peer reviewers, it differs from many of the earlier guidelines in that it stresses the need to limit researchers’ financial interests more than the need to disclose such interests to research participants.

Nevertheless, at times such disclosures may be called for. In some cases, the relevant institutional body will conclude that a potential conflict of interest is tolerable. In others, it might view a financial relationship as not posing any conflict of interest (e.g., the study sponsor’s paying an investigator for the costs of conducting a study). Finally, bans on financial relationships with trial sponsors are only recommended, not required, so some institutions might still allow them. In all three of these circumstances, it may be reasonable to expect that – at a minimum – disclosure to the research subjects would be required.

Sound management of conflicts of interest should be based on clear policy goals and, whenever possible, rely on valid empirical data.6 To help researchers better understand the proper role of disclosure to trial participants as one of several techniques for managing conflicts of interest, we draw on 5 years of empirical data from the Conflict of Interest Notification Study, which was supported by the National Institutes of Health, as well as from other research findings, to formulate six suggested goals of disclosure.