December 07, 2009

It Is Time to Professionalize Institutional Review Boards

Author Affiliations

Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2009

Arch Pediatr Adolesc Med. 2009;163(12):1163-1164. doi:10.1001/archpediatrics.2009.225

The study by Finch et al1 about inconsistent and lengthy institutional review board (IRB) reviews of a minimal risk protocol should surprise nobody. Previous studies have shown that IRBs are inefficient,2 inconsistent,3 idiosyncratic,4 and often ineffective.5 They spend much of their time monitoring low-risk protocols6 or inadequately wordsmithing informed consent forms7 and sometimes approving protocols that should not be approved.8 While IRB oversight of low-risk protocols is scrupulous, oversight of high-risk innovations may not take place at all. Such innovations may not be conceptualized as research and so are able to be introduced into clinical medicine without IRB approval.9 Why do we put up with such a dysfunctional system of regulation?

First Page Preview View Large
First page PDF preview
First page PDF preview