Institutional Review Boards for Clinical Trials

       In the United States, clinical trials are reviewed and approved by institutional review boards (“IRBs”).  IRBs are most often composed of physicians, scientists, and lay people.  They review study protocols and consent documents in order to make sure that the participants’ rights are protected, and that the particular study does not pose a burdensome or unnecessary risk to the participants. 

      It is very important for those conducting and participating in clinical trials to know that not all IRBs are equal.  Many IRBs have trouble keeping up with their workload, which could mean that protocols developed by well-regarded doctors and professors at some major institutions are basically automatically approved by the IRBs.  Other IRBs may prove ineffective due to the mix of characters on the board, with lay people intimidated by the stronger personalities in the medical field. 

     Clinical trial providers and their sponsors should screen IRBs as a regular risk management practice.  Sponsor companies may want to prequalify IRBs.  Sponsor companies may also attempt to determine whether all of the members of an IRB are qualified to be on the board.  Companies should try to select IRBs that are working toward accreditation.  Seeking out IRBs that meet these standards is certainly in the best interests of the sponsor.  Sponsors clearly want IRBs to approve their study, but if the IRB does not perform its job properly and something goes wrong during the clinical trial, the sponsor company could be held liable.  As such, screening IRBs is a positive preventive measure that all clinical trials providers and sponsors should consider implementing as a necessary part of their clinical trial procedure.[1]


[1] Jill Wadlund, Heading Off a Clinical Trial Liability Lawsuit, APPLIED CLINICAL TRIALS, vol. 12, no. 4, pp. 50-53.



© 2008 Parsonage Vandenack Williams LLC


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