. "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
NCQA announced the results of its first 12 accreditation assessments in early April 2002. Within this group, nine VA medical centers received conditional accreditation and three failed to pass the evaluation9 (Otto, 2002b). The most common deficiencies identified included the lack of local policies and procedures regarding IRB structure and operations, inadequate procedures relating to the informed consent process and consent forms, and problems in the documentation of the initial protocol review evaluations IRBs are required to make (Roswell, 2002).
In response to feedback from VA centers that participated in the first round of the accreditation process, NCQA suspended its accreditation visits to institutions in April 2002. This pause was requested in order to assess and respond to those areas already identified through the accreditation process as requiring refinement or further development (Otto, 2002a). The committee notes that it is this ability to identify problems and take responsive action that makes the nongovernmental accreditation model advantageous.
Association for the Accreditation of Human Research Protection Programs
AAHRPP is a nonprofit organization established in 2001 that seeks to accredit organizations engaged in human research. AAHRPP’s declared intent is to provide accreditation of organizations involved in biomedical as well as social sciences, humanities, and other nonmedical types of research, such as business and engineering. AAHRPP states that its accreditation process “is voluntary, peer-driven and educationally focused, and aims to foster ‘a culture of conscience and responsibility’ within institutions seeking its services” (2002b). The accreditation process involves rigorous self-assessment, followed by a site visit from AAHRPP accreditors who are experts in practicing, teaching, and promoting human research protections.
AAHRPP released interim standards for public comment on October 15, 2001. The group was responsive to concerns expressed in this committee’s initial report10 about the need for broader utility within the standards, inclusion of more specific standards regarding participants and sponsors, and attention to CQI. One of nine “principles” enunciated by AAHRPP (Box 6.4) is that “Standards should promote the development and implementation of outcome measures that can provide a basis for demonstrating quality improvement over time” (AAHRPP, 2002c). The
As this report went to press, each of the three centers denied accreditation had appealed the NCQA ruling, as had one of the nine to receive conditional accreditation status.
In Preserving Public Trust, the committee reviewed standards provided by Public Responsibility in Medicine and Research; those standards served as the basis for AAHRPP’s standards.