edgeable commissions has been that the current HRPPP system emphasizes administrative compliance when it would do better to focus on the rights and interests of research participants, the risks that they face, and whether their choices are fully autonomous. Yet, the federal regulations governing the protection of human research subjects have been largely the same for 25 years, and it took a decade to get agreement on the federal Common Rule among 18 agencies. The arduousness of that task has itself become an argument for leaving the regulations intact, but that is a recipe for stagnation in a research enterprise that is rapidly growing and changing. Even an experiment to have a “central IRB” at the National Cancer Institute took 2 years to launch. The federal regulatory system is indeed rigid and focused on documentation rather than performance (see discussion under Applying the Models to Human Research Oversight).

An accreditation process should “emphasize outcomes or performance rather than structure, process, and procedures,” and “successful accreditation bodies are flexible, future-oriented, and constantly looking at changes taking place in their fields to make sure the standards and review process are relevant to the needs of the accredited entities” (Hamm, 1997, pp. 72–73). For the first time in decades, the HRPPP system is in flux with the elevation of OHRP out of NIH and a recent shift to an IRB registration process linked to a streamlined assurance process by OHRP (OHRP, 2000b) along the lines of a recommendation by C. K. Gunsalus in a report to NBAC (Gunsalus, forthcoming). These changes were possible without a revamping of federal regulations, but flexibility beyond this will be more difficult to achieve. If a nongovernmental accreditation system could fulfill the promise of flexibility, provide an orientation toward performance, and provide adaptability, it could measurably improve the HRPPP system over time.

In the immediate future, the emphasis on HRPPP accreditation, based on the draft standards and procedures proposed, appears to be bringing existing HRPPPs into compliance with existing federal regulations. The aspiration, however, is higher, and that may be possible, but the problem is difficult. In congressional testimony in 1994, Robyn Nishimi of the Office of Technology Assessment observed:

The current system, while changing incrementally, has fallen short of implementing, or did not implement at all, recommendations made between 1973 and 1982 by an ad hoc committee of DHEW, a congressional report and two congressionally mandated commissions (Nishimi, 1994, p. 149).

Since Nishimi made that statement, the nation has had reports from ACHRE (ACHRE, 1995), the General Accounting Office (GAO, 1996), and DHHS OIG (DHHS OIG, 1998a,b,c,d,e, 2000a,b,c). NBAC's report on those with mental disabilities and two forthcoming NBAC reports also contain many recommendations that warrant action (NBAC, 1998, forthcoming-a,b). An independent voluntary accreditation system appears to be one element that could improve the system as part of a long-term strategy and, thus, should be pilot tested and evaluated over the next several years.



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