san diego

An interim research management team was sent last week from Washington to direct future research efforts at the troubled veteran's hospital system in Los Angeles, where all research has been suspended by federal officials who are concerned about failures to correct long-running deficiencies in compliance with federal ethics rules.

The identified deficiencies were restricted to the sprawling West Los Angeles Veterans' Affairs (VA) Healthcare Center. But they caused federal officials to shut down human and animal research at all VA facilities throughout the Los Angeles region.

Up to 1,200 research projects could be affected, according to VA officials. No patients can be enrolled in a research project and no new protocol can start until scientists and administrators can document that all federal requirements will be met. Only studies in which the lives of patients or animals are at risk can continue, said officials.

Troubling questions about scientific practices at the West Los Angeles VA Healthcare Center — the largest of the VA hospitals — have been raised by the breadth of problems with the studies, the apparent lack of knowledge of senior federal officials about some unethical practices, and inadequate responses from management to years of administrative deficiencies.

Kenneth W. Kizer, the VA under-secretary for health in Washington DC, suspended all VA research in Los Angeles from 26 March, four days after the National Institutes of Health's Office for Protection from Research Risks suspended the assurance agreement under which VA scientists in Los Angeles conducted federally funded human studies.

In his letter suspending human and animal studies, Kizer wrote: “The lack of adherence to research policy and operational requirements is a very grave matter. Regrettably, facility management's unresponsiveness now adversely affects individual investigators.”

VA officials in Los Angeles responded by replacing the acting director of research, appointing new chairmen to the human institutional review boards and animal review committees, and reassessing all committee membership.