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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
The committee believes that the ideal accreditation body is a national independent organization that is credible among the stakeholders to be accredited but that is independent of any particular interest group among them. Independence, credibility, and intimate familiarity with stakeholders' needs are desirable attributes of any accrediting body (Hamm, 1997), and particularly so for human participant protections. As described below, both NCQA and the emergent AAHRPP appear to meet these criteria.
PRIM&R and the Formation of AAHRPP
Public Responsibility in Medicine and Research (PRIM&R) is a Boston-based private nonprofit organization best known for its activities in educating institutional review board (IRB) members and staff.2 It was founded in 1974, the same year in which the first bioethics commission, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the National Commission), began its work. The framework for IRBs was not fully in place, but IRBs were already operating at NIH and in many academic health centers.
In 1999, PRIM&R formed a working group to develop accreditation standards. This grew out of discussions about the development of an accreditation process for HRPPPs (see Chapter 1), the organizational units responsible for carrying out the twin functions described by the National Bioethics Advisory Commission (NBAC) of ensuring informed consent and independently assessing risks and benefits. Under a subcontract executed for the purposes of the present committee's work, a preliminary draft of the PRIM&R standards was given to the Institute of Medicine (IOM) in December 2000 and became the focus of a January 2001 IOM public forum on the topic of accreditation standards. PRIM&R revised its draft standards after the public forum, and they appear in Appendix B. PRIM&R's proposed standards were a major input into the committee's deliberations and are discussed in greater detail in Chapter 3.
The concept of AAHRPP was originally conceived by PRIM&R and was intended to provide the organizational locus for carrying out an accreditation process by using the PRIM&R standards. AAHRPP is designed to bring together diverse stakeholder organizations with the intent of implementing a voluntary accreditation process. AAHRPP was originally incorporated in Massachusetts in March 2000, but it is expected to be incorporated in Maryland in spring 2001 as a private nonprofit corporation to “provide a process of voluntary peer review and education among organizations concerned with research involving human subjects, in order to promote preservation of rights and welfare of subjects in research and