. "6 Improving Human Research Participant Protection Program Performance and Clarifying Roles." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
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Responsible Research: A Systems Approach to Protecting Research Participants
group began pilot site visits at the end of 2001 and finalized its standards11 and procedures based on public comment and the results of pilot site visits in the spring of 2002, at which point it also began accepting applications for accreditation (AAHRPP, 2002a; Softcheck, 2002; Speers, 2002a). Accreditation evaluations of applicant institutions are expected to begin in the fall of 2002.12
Under AAHRPP’s program, an institution will receive Full Provisional Status or Qualified Accreditation, or Accreditation Withheld, based on a self-evaluation process and a subsequent site visit. The program will operate on a fee-for-service basis, with fees depending on several variables, including the number of research protocols and Research ERBs at an institution (AAHRPP, 2002d). The accreditation will be valid for three years.
Future Opportunities in Accreditation
The committee is encouraged by the efforts of these two organizations and notes that the fact that difficulties were encountered during the initial roll-out of accreditation programs is not unexpected. As the committee stated in Preserving Public Trust, “accreditation will not be successful until it is widely accepted as a mark of excellence” (IOM, 2001a, p.86), and this will require consistent and iterative feedback between the various parties involved. AAHRPP indicates that its accreditation standards are intended to apply to universities, hospitals, and pharmaceutical companies among others. NCQA, while currently applying its accreditation standards and procedures to VA medical centers under its contract, indicates that it is developing a business plan for accreditation of other sites and research sponsors as well (Briefer French, 2002). These two programs are to be commended for their progress, but the committee stresses that accreditation remains a nascent process that will require substantial time and development before a meaningful assessment of its added value can be made (see Recommendation 6.4).
Recommendation 6.3: Human Research Participant Protection Program accreditation programs should include a standard directed at establishing and identifying accountability for specific protection functions.