After federal audit, Seattle VA hospital suspends research

SEATTLE – The Veterans Affairs hospital in Seattle has halted new enrollments in human research studies after a federal audit found shortcomings in its paperwork.

Auditors determined in November that the VA Puget Sound Health Care System should have done a better job of documenting that people who enroll in the studies are not vulnerable, such as prisoners, pregnant women or those suffering from mental health disorders.

The work of some researchers could be delayed by a week or more as the hospital updates its documentation methods. The decision applies to about 600 studies being conducted at the hospital and at the University of Washington, which has close ties to the VA hospital.

No patients were endangered, and no laws were broken, said Dr. Steven Kahn, director of research and development at VA Puget Sound. He characterized the issue as an “administrative headache.”

“If a patient had been harmed, we would have been shut down,” he said. “We haven’t been shut down.”

Among the research projects affected are 15 bone marrow transplant and oncology studies at the Fred Hutchinson Cancer Research Center that recruited patients at the VA hospital.

Researchers can continue collecting blood and other samples, as well as other data, from patients already enrolled in their studies, Kahn said. But they may not add new subjects or publish results until their protocols have been re-reviewed and cleared.

Auditors have found similar issues at other VA health systems, including in Boise, and in San Diego and Palo Alto, Calif., Kahn said.