institutions put too little effort into supporting and compensating IRB members, which makes it difficult to retain the people best suited for the job. "Where more and more responsibility is being put on IRBs, you have to remember these are non-paid slots, voluntary, and a lot of time is required," said Pearl O'Rourke from NIH's Office of the Director, who recently moved from the University of Washington, where she served on an IRB. While there, O'Rourke found that many clinicians were hesitant to serve on the IRB because it represented 8 hours a month of their time that weren't billable hours. "I also found that as a physician I could sway any vote because community members and others [on the IRB] did not have a clue about genetic information. I also felt that in terms of the local interests as soon as you have NIH or any federal moneys on a grant there is the bias that you have to okay this project because it is good for the institution." If IRBs are to be effective, she said, institutions must find some way to reward or ''validate" service on them. ''It cannot just be this volunteer, non-paid, 'Oh, yeah, I can do it' thing."

Besides attracting and keeping good members, IRBs must find some way to keep up-to-date on the areas of research that they are considering, and they do not seem to be doing a good job of that now. "Professor Mildred Chou at the University of Pennsylvania and I have published a study of IRBs in the Journal of Investigative Medicine focusing on a genetic issue," said Paul Billings. We concluded that most IRBs were seemingly poorly informed about much that was going on at the national level or in states about the social, ethical and legal issues surrounding genetics." One potential solution, Billings suggested: "It might benefit IRBs substantially to have some sort of network of communication, and sharing of information, that apparently is not present currently. IRBs should be informed of research findings, board reprints, commissions and other sources relevant to their deliberations."

Finally, David Korn argued that although the local character of IRBs may have advantages, it also carries a cost. "There may be two or three thousand IRBs extant in the country right now, and every one of them is on its own in trying to interpret a particular research proposal and determine what standards it needs with regard to authorization or this or that or the other." This lack of standardization means that similar research projects performed at different institutions may be evaluated quite differently and placed under quite different constraints. The result is that researchers never quite know what to expect.

"We hear all kinds of scare stories from institutions around the country where research proposals involving issues of genetic information and data privacy have been sitting in the local IRB for up to 2 years while these people sit and have talmudic discussions about whether it can or it can't or what should be done and what shouldn't be done," Korn said. "Mr. Whelan's IRB may be an excellent, well-functioning IRB. But many of them are troubled by these issues and don't really know where to go. So, I think that a federal standard that provided some clarity would be useful."



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