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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
cell research (NBAC, 1999b), all of which address issues of research oversight and IRB function. Forthcoming reports will address ethical principles for U.S. interests conducting clinical trials abroad (NBAC, forthcoming-a) and describe a 5-year review of the adequacy of the system of human subjects protection in the United States (NBAC, forthcoming-b).
Reports from DHHS Office of the Inspector General
In June 1998, the Office of the Inspector General (OIG) of DHHS issued a report, Institutional Review Boards: A Time for Reform (DHHS OIG, 1998b). The report's foremost finding was that “the effectiveness of IRBs is in jeopardy” (p. ii) and that IRBs are facing overwhelming demands. A system that was originally devised as a volunteer effort to oversee a much smaller research effort in the 1970s was characterized as contending with its growing burden with scant resources. Recommendations included better training of IRB members and investigators, recasting of federal requirements to give IRBs more flexibility yet require more accountability, reduction of potential conflicts of interest among IRBs to enhance independence, and improvement of feedback to IRBs about developments in multisite trials and prior reviews of research plans. Echoing one of the charges to the present committee, the DHHS OIG report called for greater attention to the development and reading of indicators of how well IRBs were doing their job.
A Time for Reform was the flagship in a convoy of DHHS OIG reports on the protection of human research subjects. Three other DHHS OIG reports came out at the same time: (1) promising approaches to improving protections, (2) a description of the IRB process, and (3) a description of the emergence of independent boards, that is, IRBs that mainly review drug, device, and biologics trials sponsored by private industry under FDA regulations (DHHS OIG, 1998c,d,e). In April 2000, the DHHS OIG issued an update on A Time for Reform. It noted the increased enforcement efforts of both OPRR and FDA but little overall progress on its other recommendations (DHHS OIG, 2000b). DHHS OIG staff testified at hearings in both the U.S. House and U.S. Senate as Congress turned its attention to human subject protections in the year 2000 (Grob, 2000). The April 2000 DHHS OIG update specifically lauded the efforts of PRIM&R to develop standards for accreditation of IRBs and research institutions. A pair of reports published in June 2000 focused on recruiting human subjects, with one describing pressures in industry-sponsored clinical research and the other listing sample guidelines for practice (DHHS OIG, 2000c,d).
Shutdowns of Clinical Research at Academic and VA Medical Centers
In May 1999, OPRR halted human research studies at Duke University Medical Center, sending shock waves throughout the research community. Within a year, FDA and OPRR proceeded to halt all or some clinical research