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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.

Is our IRB overtaxed? This . . . [Full Text of this Article]

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Challenges to Human Subject Protections in US Medical Research
Beverly Woodward
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