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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
Accreditation might also serve as an important educational tool. The process of preparing for accreditation would force institutions to attend to their HRPPPs, and that attention would necessarily entail education about the importance of protection of human participants in research. Accreditation could raise the median performance (average middle performance) of HRPPPs. It might offer HRPPPs located within research institutions, both public and private, a potent argument when asking their administrative supervisors for additional resources. (This is a major role played by accreditation of academic units within a university and is used as a tool to effect changes in, for example, library services, curricula, and services.) Accreditation could not serve these ends, however, until it became widely accepted as a mark of excellence. Any accreditation program seeking to establish its value on the basis of these terms would first need to achieve broad recognition as a credible program. All previous accreditation programs faced a similar dilemma when they were initiated, and some have succeeded in attaining credibility, but others have not.7
Accreditation that would supplant regulation (the deemed-starus model) could have several attractive features. Both OHRP and FDA have signaled that they might consider accreditation by a nongovernmental accreditation organization presumptive evidence of compliance with regulations. In the case of research institutions under OHRP oversight, accreditation could serve as a partial substitute for the assurance and compliance functions, reducing FDA and OHRP scrutiny of accredited organizations (allowing them to concentrate their scrutiny on nonaccredited organizations). FDA and OHRP would necessarily retain independent oversight authority (e.g., inspections “for cause”) and independent investigation and enforcement capacity if violations are alleged or documented and would periodically need to ”accredit the accreditors,“ as in other deemedstarus accreditation models. However, before the usefulness of this approach can be assessed in the case of HRPPP accreditation, an accreditation program(s) will need to be much further along in its development.
The regulatory enforcement model is also worth considering, particularly as a starting point. It might be wise to start, as NCQA apparently proposes to do under its contract with the VA, with a focus on innovative or more effective means of evaluating regulatory compliance before moving on to a program that raises standards above the regulatory minimum. This approach could, however, have the effect of inundating HRPPPs with further paperwork if additional requirements are imposed on current ones. If the goal is to shift from a focus on such paper compliance to a focus on more meaningful performance measures,
Some accreditation programs fail to take root and flourish. An AMA physician certification program was announced with great fanfare in late 1996, but AMA discontinued the program in April 2000 because it had not been widely adopted. JCAHO implemented an accreditation program for managed care in 1987 but stopped in 1990, until a new managed care accreditation program was put in place in 1995 (BNA, 1996, 2000; Dimmitt, 1995).