VA goes under the microscope
System to be national laboratory for accreditation
The chief of the cooperative studies program of the U.S. Department of Veterans Affairs (VA) research and development department describes it as an "exceptional laboratory for conducting large scale clinical trials." The VA’s claim will now be put to the test to measure its own ability to evaluate compliance with federal regulations when it begins an accreditation process this month. Last fall, the VA awarded a five-year contract to the National Committee for Quality Assurance (NCQA) in Washington, DC, to develop accreditation standards for its 150 medical centers throughout the United States.
The VA’s cooperative studies program, which coordinates human subject research, consists of four coordinating centers, three epidemiological research and information centers, and a clinical research pharmacy. The cooperative studies program assigns research studies to one of the four coordinating centers, which in turn provide statistical and methodological assistance to VA investigators conducting clinical trials. The program oversees an average of 60 studies at any time and individual studies usually last a period of five years. NCQA’s accreditation program involves the following phases:
- development of standards for protecting human research participants, including for example, the proper operation of IRBs;
- assessment of the extent to which VA medical centers meet these standards through site surveys conducted by clinical researchers and research administrators;
- maintaining a list of the accreditation status of reviewed medical centers.
The standards are organized into the following six categories:
- institutional responsibilities;
- IRB structure and operation;
- consideration of risks and benefits;
- subject recruitment and selection;
- privacy and confidentiality;
- informed consent.
The standards were pilot tested in four facilities during April and May and the revised standards are scheduled to be published this summer, says Sandra Sanford, RN, MSN, CCRC, CIP, director of VA human research protection program accreditation at NCQA. Routine surveys will begin this month. Accreditation will apply to all human research protection activities conducted for VA research, either by its own IRB or a university affiliated IRB.
"The pilot tests were used to test our own assumptions about what we should be looking at within the VA system. We’re now in the process of analyzing that information," says Sanford. In addition to the pilot tests, the NCQA received public comments on the accreditation standards. "We received some good comments from VA, non-VA, and organizational representatives and we’re in the process of editing them based on the IOM’s recommendations, the public, and the information gained from the pilot tests," she adds.
Certified surveyors will conduct an on-site visit and verify compliance with each standard and record their assessments in a report that is then sent to the program accreditation committee. The accreditation committee reviews the report and any comments from the VA medical center, and issues a decision.
Accreditations, good for a three-year period, will be given in four categories: full accreditation, conditional accreditation, probational accreditation, or no accreditation. Remedial action, if deemed necessary by the accreditation committee, will consist of action plans and progress reports, and undergoing a follow-up survey.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content