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Scientists Seek Exemptions to LA Research Shutdown

Hundreds of scientists are anxiously appealing a government-ordered shutdown on research affiliated with the Veterans Administration (VA) in Los Angeles, California. With more than 1000 projects on hold indefinitely, investigators say they are confused, frustrated, and worried about losing the confidence of their patients and funders like the National Institutes of Health (NIH).

The VA Medical Center-West Los Angeles (VAMC-WLA) had long been scrutinized by the NIH's Office for Protection from Research Risks (OPRR), which oversees experiments on human subjects. But last week, NIH clamped down. Citing lax procedures for approving and overseeing the human studies, NIH announced that the VA Greater Los Angeles Healthcare System could no longer conduct human research supported by NIH's parent, the Department of Health and Human Services. The VA itself then shut down animal and test tube studies as well. The crackdown was first reported in the 24 March Los Angeles Times.

A 22 March memo from OPRR faults the VAMC-WLA primarily for repeatedly approving clinical studies without consulting community representatives or adequately briefing members about trial protocols. The VA's undersecretary of health, Kenneth Kizer, stressed in a memo that "there currently is no evidence to suggest any actual harm to either human or animal research subjects." In the same memo, which broadened the suspension, Kizer offered no clear explanation for the blanket shutdown but said that administrators in Los Angeles had failed "to correct deficiencies in fiscal and personnel management" and had been "unresponsive" to probes by the VA's own investigators.

Kizer said researchers could ask for exemptions to the suspension if interrupting a project posed a threat to animal or human health. Administrators were immediately flooded with requests to spare their studies. "We all have put in exemptions," says Alan Lichtenstein, a hematologist-oncologist who has worked at the VAMC-WLA 20 years. But Lichtenstein said none of his colleagues has a clue about the timeline. "We're working with bureaucracies," he says. "Who knows?"

Approval for any of the 400 or so human trials to resume would have to come from OPRR, and director Gary Ellis says he does not anticipate granting many exemptions. "Patients need treatment. But people don't ordinarily need to be research subjects," he says. According to Ellis, OPRR will evaluate research requests on a project-by-project basis as soon as the VA repairs the IRBs. "The timing of getting research up and running again at the VA is largely in their hands," he says.