Abstract

In lieu of an abstract, here is a brief excerpt of the content:IRBs Under the MicroscopeJonathan D. Moreno (bio)The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services’s Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.Underlying these proximate causes for the IRB blitz is a growing realization that the already considerable clinical trial enterprise will expand significantly over the next few years. Congress is talking about giving the politically popular NIH half again the budget it currently receives, which in turn will stimulate more commercially supported research. The director of the National Cancer Institute is considering a five-fold increase in the number of subjects enrolled in oncology studies over the next several years. Phase I cancer studies are among the most ethically sensitive, so IRBs will have more work cut out for them if this goal is reached. Adding to the rush of interest in IRBs are the government’s recent apology to the survivors of the syphilis study in Tuskegee, continuing congressional dissatisfaction with the way the Pentagon handled its vaccine distribution during the Gulf War, and the controversy about AZT trials in developing countries.On the HillCongressman Christopher Shays, the moderate Connecticut Republican who has developed an interest in human research issues, convened hearings on human [End Page 329] subjects research and the IRB system on 11 June 1998. Shays chairs the House Government Reform/Human Resources Subcommittee. The committee’s ranking minority member is Edolphus Towns of Brooklyn, NY, who shares Shays’s interest in this area.The immediate rationale for the hearings was the release that day of the DHHS-IG report, Institutional Review Boards: A Time for Reform. The subtitle was changed from A System in Jeopardy apparently after some people in DHHS expressed reservations about its seemingly alarmist tone, but the IG staffers who testified before Shays’s subcommittee insisted that they stood behind the message that the IRB system is in trouble if considerable reforms are not undertaken. Among the factors in the research environment cited as support for the bleak forecast: managed care, commercialization, multi-site trials, high IRB workloads, minimal IRB oversight of approved studies, conflicts of interest, insufficient training of IRB members and investigators, and lack of IRB self-studies (DHHS-IG 1998).As is normally the case for congressional oversight hearings, the first panel of witnesses consisted of executive branch officials, including Eric Meslin, Executive Director of the National Bioethics Advisory Commission, and Gary Ellis, Director of the Office for Protection from Research Risks (OPRR). Shays pressed Ellis on the extent to which OPRR conducts on-site investigations of complaints about abuse of human subjects. Admitting that on-site investigations are rare, Ellis suggested that the agency is inadequately staffed to follow up on complaints as quickly as it might wish. The members of Congress who were present at the hearings generally expressed concern about the DHHS-IG’s findings.The second panel that day, which Shays was unable to attend, set a different tone. Four of the panelists—Paul Appelbaum of the University of Massachusetts at Worcester, Robert Levine of Yale University, Angela Bowen of the Western IRB (a private clinical trials review firm), and I—were invited as authorities on the current condition of the IRB system. Bert Spilker...