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MODELS OF ACCREDITATION 50 compliance with relevant regulatory and ethical standardsâ (PRIM&R, 2001b). As this report went to press, AAHRPP was supported by a consortium of interested groups, including PRIM&R, the Association of American Medical Colleges (AAMC), the Association of American Universities, the Federation of American Societies for Experimental Biology, the National Health Council, the National Association of State Universities and Land Grant Colleges, and the Consortium of Social Science Organizations (Accrediting Body for Human Subjects Research Nears Reality, 2001). The VA and NCQA Accreditation Process In March 1999, clinical research at the West Los Angeles VA Medical Facility was suspended because of noncompliance with the Common Rule (see Chapter 1). In the ensuing months four additional VA medical centers were affected by Food and Drug Administration (FDA) or Office for Protection from Research Risks (OPRR) sanctions. This shone a spotlight on Veterans Affairs, just as OPRR and FDA shutdowns had done at other academic health centers. In April 1999, the VA announced the formation of a national office, the Office of Research Compliance and Assurance. In June 1999, the General Accounting Office commenced a study of human subject protections at VA medical centers and made eight site visits (GAO, 2000). That report identified three specific weaknesses: â(1) VA headquarters has not provided medical center research staff with adequate guidance about human subject protections; (2) insufficient monitoring and oversight of local human subject protections; and (3) insufficient funds allocated for IRB operations and human subject protection oversightâ (p. 5). To address these deficiencies, the VA awarded a $5.8 million, 5-year contract to establish a national accreditation system for VA medical centers engaged in research (VA, 2000). The contract was awarded to NCQA, which then began to devise and carry out an accreditation and oversight process (NCQA, 2001b). NCQA has joined with Medical Care Management Corporation (MCMC) to design the program and to recruit, credential, and schedule surveyors. NCQA and MCMC together will provide a routine external evaluation of compliance with policies. In addition, NCQA plans to convene two advisory groups and one decision- making group to help develop and implement standards and survey methods for the program. NCQA presented the rationale behind its approach at IOM's January 2001 public forum and later provided the committee with a set of its draft standards (see Chapter 3 and Appendix C). Private consulting and management firms such as Deloitte & Touche and PricewaterhouseCoopers have been hiring staff with HRPPP expertise and may assist with preparations for accreditation efforts. Other organizations may yet step forward to offer accreditation for HRPPPs.
