Protection for Human Subjects in Medical Research

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 depends on what the public expects of research professionals. We choose to remain on the IRB out of a sense of responsibility, as the local "cop on the beat" to protect both subjects and researchers. Reviewing studies is done away from the office, and it is certainly an imposition on the family lives of reviewers. Institutional review board meetings increasingly compete with patient care demands, and moving IRB meetings to the end of the day does not eliminate the problem of achieving a quorum of members when the hospital is very busy. Fortunately, our IRB is chaired by an experienced researcher who keeps the members away from the most onerous paperwork. If the hospital or IRB sponsor does not adequately support the research director, the IRB will not work and research subjects will not be protected.

In his Editorial, Dr Ellis² misses a major point in calling for studies to determine unmet needs of IRB members. Why not pay the members? Every academic center IRB with which I have experience has expected the scientist and physician members to donate their time and expertise. Is our time away from clinical services not worth something? I believe that even a small payment for the time it takes to review studies would not overtax the research infrastructure of this nation, and it would go far in alleviating some of the burden for IRB members. It is no longer acceptable to assume that if we are on a teaching faculty that our services to committees, such as the IRB, are included in our salary structure, especially when much of the critical work is done at home in the evening hours.