To the Editor: Dr Woodward1
cites 1 study to generalize a claim that institutional review boards (IRBs)
are overtaxed with protocols and spend only a cursory amount of time reviewing
studies. My personal experience with 3 review boards, including 4 years of
recent experience as an IRB member, goes against this. Under our current IRB
rules, each study is reviewed in depth by 2 people, sometimes 3. This takes
from a few minutes to an hour. At the IRB meeting, discussions of a well-constructed
study without consent issues require 5 to 10 minutes. Studies with poor consent
design or problems relating to their underlying science have taken over 45
minutes to resolve, often with a requirement that the investigator reply to
criticisms at a later meeting. Our level of review is careful, and our IRB
chair has explicitly defined our duty to protect research subjects.
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