VA mandates review of research programs
The Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to "shape up" or else. The department ordered a 90-day review in its 115 medical centers following a series of accidents, including the death of one patient at an undisclosed location.
The review, outlined in a March 6 memo to VA research personnel, requires individuals who run and oversee medical research to update their training on patient protection.
The VA is responsible for more than 15,000 research studies involving around 150,000 patients each year, according to the agency. As a result of the review process, each hospital involved in research must confirm to VA headquarters that it ensures its ethics procedures and system for catching errors meet widely accepted human research standards. Incidents cited, while not specific because of the ongoing investigation, include:
- falsified individual patient data that contributed to the death of one patient;
- a patient overdose in drug study project at another center;
- an experimental procedure that was conducted without the approval of the IRB;
- a drug study conducted with a researcher without clinical privileges permitted to prescribe the study medication;
- failure of a review board to meet even minimally required standards.
Medical directors and chiefs of staff for research will have to attest that the IRB and research and development committees are appropriately constituted and meet on a regular basis to provide timely review and oversight of new and continuing protocols and a review of adverse events and serious adverse events, according to the memo. The review will last until June 6.
The Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to shape up or else.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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