Operation Just Cause... ...for as long as it takes
Sent in by Veterans News and Information Services
WASHINGTON, D.C. — The Department of Veterans Affairs (VA) is taking the lead in increasing protection for research participants by establishing the government’s first external accreditation process for human research.
VA has awarded a $5.8 million, five-year contract to the Washington-based National Committee for Quality Assurance (NCQA). Under the agreement, NCQA will implement an accreditation program for biomedical research at 150 VA medical centers nationwide.
Under the terms of the contract, which began May 1, each VA medical center conducting human research will undergo an accreditation visit by independent experts at least once every three years. These teams will certify that the medical centers are effectively managing research risk, and will identify improvements needed.
NCQA is a private, not-for-profit organization dedicated to improving the quality of health care. Since 1979, it has been a leader in developing performance measurement and accreditation standards for health-care activities, including clinical trials and other research. Its agreement with VA includes a subcontract with Medical Care Management Corporation of Bethesda, Md., a leader in conducting external reviews for state health agencies, health plans and other organizations.
Last year, research programs at several universities and affiliated VA medical centers were suspended when federal oversight agencies found shortcomings in review procedures for protecting human subjects. VA responded promptly with a proposal to establish an external accreditation program designed to fortify monitoring and compliance with its own and other federal regulations.
"Clinical trials of new treatments that help our veterans and all of us are a vital part of the VA research program," said Dr. Thomas L. Garthwaite, VA’s Deputy Under Secretary for Health. "As a leader in such studies, VA holds itself to the highest standard in protecting veterans from unacceptable risks. This new accreditation program will make our already stringent observation of federally mandated human research standards even stronger."
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