WEST LOS ANGELES: VA Halts Research at Largest Hospital
The West Los Angeles VA Healthcare Center, the largest VA hospital in the U.S., has been ordered by the Department of Veterans Affairs to suspend research activities by Friday due to its failure "to comply with regulations safeguarding patients involved in studies." The Los Angeles Times reports that the suspension, which could potentially affect 500 studies being conducted by more than 100 researchers, "climaxes six years of government inquiries" and represents the first time the federal agency has imposed such an order at one of its 173 VA hospitals. The order covers the flagship West L.A. hospital as well as "affiliated clinics and research facilities in the VA Greater Los Angeles Healthcare System." It "blocks recruitment of new subjects into existing studies, delays decisions on proposed research" and only allows ongoing experiments funded by the National Institutes of Health or other federal agencies where it "is in the best interests of individual subjects." Officials did not cite specific examples of negligence in their two-page order, yet they noted "unresponsiveness" on the part of management and a "general failure to meet federal regulations and guidelines." Dr. Kenneth Kizer, VA undersecretary for health, said in the letter, "The lack of adherence to research policy and operational requirements is a very grave matter." Included in the order were references to "numerous problems with the hospital's Institutional Review Board," including having too few members present at meetings where the validity of research proposals was discussed and a failure to include a nonscientist at meetings as a patient proxy. According to the Times, 10 violations were listed in the suspension order. Although VA officials maintain that they have "no evidence" that the alleged "lax oversight" has caused patients or animals any harm, they said they ordered the research suspension as a "preemptive" strike.
Not the First Time
The VA's actions take into account not only the agency's own findings, but also those by the federal Office for Protection From Research Risks, which has been investigating the West Los Angeles VA hospital since 1993. At that time, the organization "cited the facility for errant informed-consent procedures." Over the past six years, the risk office has sent the hospital "at least five notices detailing shortcomings in its oversight of safety and ethics procedures," and in 1995 the risks office put the hospital on probation, requiring quarterly progress reports. On Monday the office suspended the hospital's contract, which means it can no longer do studies funded by the U.S. Dept. of Health and Human Services (Monmaney, 3/24).