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?
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