Expanding Disclosure of Conflicts of Interest: The Views of Stakeholders

Abstract

n the early 199os, the National Institutes of Health (NIH) adopted a policy for the management of conflicts of interest on the part of clinical investigators (45 CFR 50.6045). This policy emphasized disclosure of potential or actual conflicts to institutional officials who would then develop strategies for managing them. The policy was adopted as an alternative to an earlier proposal that had emphasized mandated standards and mandated external disclosures.' Recent studies of the actual operation of conflict of interest policies cast doubt on the adequacy of the approach adopted by the NIH.',3 They indicate that as a result of the discretion allowed to institutional officials, there currently exist few uniform standards and very little accountability. These studies have suggested that to increase accountability, the scope of disclosure should be widened.