“Conflict-of-Interest” and Participation in IRB Deliberations: An Alternative Perspective

Abstract

A natural tension exists as an IRB attempts of fulfill its mission of providing an independent and unbiased evaluation of a study while also insuring appropriate consideration of all relevant risks, benefits, and alternative strategies. IRB members with often critically relevant knowledge of unique issues involved in a protocol under review may be the individuals with the greatest potential for a perceived “conflict,” due to current or past involvement in sponsor-associated research in the particular area. Management of real or perceived conflict must include full disclosure, but exclusion of such individuals from the deliberative process may result in undesirable consequences.