VA Orders Outside Review on 150 Research Clinics

The Department of Veterans Affairs, largely in response to extensive violations in research management at the VA Medical Center in West Los Angeles made public last year, will now require outside experts to evaluate its 150 facilities that do clinical studies, the agency said Tuesday.

The VA thus becomes the first federal research sponsor to mandate scrutiny and approval from a non-government authority. The National Committee for Quality Assurance, which accredits health maintenance organizations, will evaluate and accredit VA research facilities every three years under the terms of a $5.8-million VA grant awarded Monday.

VA officials in Washington vowed to start the accrediting program last year during a congressional hearing in which West Los Angeles research officials were chastised for failing to comply with informed consent regulations and other rules that protect human subjects.

The problems led Washington officials to suspend research at the VA Greater Los Angeles Healthcare System, which has gradually reinstated research programs.

The quality assurance group will inspect the hospital review boards that oversee the safety and validity of clinical studies, among other things. Research will be suspended at facilities with studies that fall short of VA guidelines and U.S. regulations, veterans officials said Tuesday.

“We need to reassure patients and research subjects that we are adhering to the rules,” said Dr. Thomas Garthwaite, deputy undersecretary for health. The first accreditation visit to a VA facility would occur in the fall, he said.

Also in response to last year’s research crisis, the VA established an internal Office of Research Compliance and Assurance, which trains researchers and hospital officials and fields complaints.