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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
NCQA standards appear to be closer to adaptation for such use than the PRIM&R standards do (see Recommendation 9).
Recommendation 2: Establish a Nongovernmental Accreditation Organization(s)
Organizations formulating accreditation standards and carrying outthe accreditation process should be independent, nongovernmentalorganizations. These organizations should include within their programmaticleaderships the perspectives of the relevant stakeholders in theapplicant HRPPP community (i.e., institutions, investigators, sponsors,and participants).
An accreditation process is only as credible as the organizations that carry it out. The foremost criterion is independence (Hamm, 1997). Organizations formulating standards and conducting the accreditation process should
be national in scope;
be familiar with the operations of institutions that apply for accreditation; and
incorporate the perspectives of research participants within their programmatic leadership.
An accreditation process should directly involve the kinds of institutions being accredited, but an accreditation organization should not be beholden to any particular stakeholder or interest group. Accreditation bodies for HRPPPs will require input from academic health centers, organizations representing research sponsors, nongovernmental research organizations, private firms developing products and services tested in studies with humans, participants, IRB members and staff from both academic and nonacademic institutions, research administrators in both academic and nonacademic institutions, and individuals from a range of research fields appropriate to the intended range of applicant institutions.
Research participant representatives will be particularly important in formulating the overall goals of the HRPPP systems, and their perspectives should be systematically solicited in both the formulation of standards and the execution of the accreditation process. This involvement will also include representation on groups that set standards and teams that conduct external evaluations and site visits. National accreditation bodies should seek to involve organizations that have both a genuine national constituency that corresponds to the interests of the research participants4 and a demonstrated familiarity with the research process and research protection rules and regulations (see Recommendation 8).
In the case of the VA, for example, this would include national veterans organizations; for medical research, this would include health advocacy organizations; and for community-based or population-based research, this would include organizations representing the communities or the full range of subpopulations sampled.