. "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
Amendments to improve and strengthen accreditation standards are also sometimes derived from these site visits. For example, descriptions of standards in accreditation guidance, responses to inquiries, Web site documents, and manuals produced and disseminated by federal and other research sponsors have the potential to raise the bar for future human protection program expectations and accomplishments.
Subsequent to the committee’s initial report, both the NCQA and AAHRPP accreditation programs have continued to work toward implementation. Each has developed its own set of standards and has conducted pilot site visits to begin refining them.
National Committee on Quality Assurance
NCQA is in the second year of a five-year contract with VA to develop and implement an accreditation program, which will apply to more than 120 VA medical centers that conduct research involving human participants. On November 15, 2001, NCQA released its final VA Human Research Protection Accreditation Program Accreditation Standards,7 to remain in effect until July 1, 2004 (NCQA, 2001). However, in response to problems identified during the initial series of site visits, revised standards currently are under development8 (Otto, 2002a). NCQA indicates that it will review and revise the standards annually in the future (Briefer French, 2002). As drafted in November 2001, however, the standards continue to fall short of sufficiently ensuring meaningful participant protection at various levels of program decision making and policy making.
During 2001, NCQA conducted pilot tests and subsequently more extensive field tests at VA hospitals to prepare to conduct active accreditation visits. Accreditation site visits began in September 2001, with visits to additional VA medical centers planned to take place at approximately weekly intervals. One anecdotal impression concerning the initial evaluations offered to the committee was a curious lack of awareness of CQI on the part of research institutions (Briefer French, 2002). Formal QI efforts— which are at the heart of health care delivery and hospital accreditation— seem more or less unknown and little practiced in research programs within the same settings. If this is so, it is a gap that accreditation preparation should close through the provision of training programs, the dissemination of research reports, and the provision of greater specificity in standards, guidelines, and site visit measurement tools.