“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.

Keywords:

• Clinical trials
• IRB
• Conflict-of-interest