The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
Recommendation 8: Directly Involve Research Participants in AccreditationPrograms and HRPPPs
The formulation of accreditation standards, the accreditation process,and HRPPP operations should directly involve research participants.10
Accreditation bodies should formally solicit input from and directly involve the groups of people who will be studied in research carried out by the organizations that they will accredit. Participant perspectives are an essential element in research design, especially as it pertains to informed consent and the minimization of risk, and participant representatives should be directly involved in IRB review and should be members of the programmatic leaderships of accreditation review groups, site visit teams, monitoring boards, and oversight and advisory groups in research institutions. Standards should also reflect stronger participant involvement beyond securing signatures on informed-consent documents.
Recommendation 9: Use Modified NCQA Standards to Initiate Pilot Programs
Pilot accreditation programs should start from the accreditationstandards and processes proposed by NCQA for VA facilities, as adaptedfor use in other organizational contexts. In expanding the draftNCQA accreditation standards for use beyond VA facilities, the standardsshould be strengthened in six specific ways as pilot testing commences.
The PRIM&R standards were prepared for a broad set of potential applicant organizations, which would include but not be restricted to academic health centers. The NCQA standards were explicitly prepared for accreditation of VA medical facilities. In this instance, the applicant pool is defined, and, in fact, pilot tests that will use those standards are being planned as this report goes to press.
As noted throughout this discussion of report recommendations, the committee regards the NCQA standards as an excellent starting point for accreditation of VA facilities. The committee recommends, however, that the NCQA standards be strengthened in six areas, discussed in more detail in Chapter 3, to specify (1) how investigators will be reviewed beyond the review of the protocols that they submit for IRB approval; (2) whether and how research sponsors will be assessed in the accreditation process; (3) how participants will be involved in setting standards and accrediting HRPPPs; (4) how oversight mecha-
By “participants,” the committee refers to those whose background and expertise are credible to a lay constituency external to the research institution and who are knowledgeable about the research process and research protections. The term is further defined in Chapter 1.