The ins and outs of independent IRBs.

Independent institutional review boards (IRBs) are playing an increasingly important role in the review of human subjects research. Many research institutions have been hesitant to use independent IRBs because regulatory recognition of their use has been inconsistent and clear guidance has been lacking. The authors review the evolution of the independent IRB and address how acceptance has differed between the two primary regulatory agencies, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The article briefly describes the history of independent IRBs, how they currently fit into the regulatory schemes of HHS and FDA, factors relating to the decision to use an independent IRB (including advantages and disadvantages of their use), factors to consider when selecting an independent IRB, practical guidelines for use of an independent IRB by a research institution, and contractual issues involved in implementing a relationship with an independent IRB.