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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
Eligibility Criteria and an Application Process
The accreditation body must specify who can be accredited, set fees to cover its costs, and establish an application process. The NCQA accreditation of VA facilities will be done, at least initially, by self-selection. Because the VA hospital system is relatively closed, the applicant pool is clear. The eligibility criteria for HRPPPs beyond VA, including the nascent AAHRPP, have not been specified in detail. It is clear that academic or independent research centers that have an operating IRB would be eligible. The stated intention is to also invite applications from private independent IRBs. It is not clear whether larger consortia of institutions that are organized as a collaborative unit would be eligible, such as cooperative clinical trials groups,3 the Multi-Center Academic Clinical Research Organization,4 independent contract research organizations, or site management organizations.
Applying for accreditation requires considerable preparation. This typically involves the organization that is seeking accreditation to gather information relevant to the standards that will be used and to analyze how well prepared it is to address questions and concerns that may arise. This preparation can consume enormous efforts of a few staff members and draws on the resources of many parts of the organization. The mere process of self-study can reveal previously unknown weaknesses or sometimes strengths and can suggest administrative remedies. It can also draw the attention of senior administrators to the need for more resources, new programs, or management changes and can reveal the strengths and weaknesses of key personnel. Many organizations involved in accreditation processes regard the self-study as the most valuable element of the accreditation process precisely because it focuses the attention of senior administrators.
The process of self-evaluation of HRPPPs appears to be especially promising as a way to improve the system. Self-assessment combined with systematic, continual use of quality improvement programs could, for example, identify features common to many “excellent” HRPPPs, and those features could, over
Multi-Center Academic Clinical Research Organization, or MACRO, brings together five major academic health centers—Baylor College of Medicine, Harvard Clinical Research Institute, the University of Pennsylvania School of Medicine, Vanderbilt University, and Washington University School of Medicine—under a collaborative agreement that includes an agreed upon system for protocol review by IRBs among the institutions (for more information, see http://www.mc.vanderbilt.edu/ctc/macro.html).