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May 10, 2000

Protection for Human Subjects in Medical Research

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor

JAMA. 2000;283(18):2387-2390. doi:10.1001/jama.283.18.2387

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.