A "culture of noncompliance" with federal medical research regulations led to the suspension of research activities at the Department of Veterans Affairs' West Los Angeles hospital, federal investigators said last week.
In March, the VA suspended research at all its Los Angeles-area hospitals. That action came after the National Institutes of Health office that oversees federally sponsored medical research on human subjects withdrew its authorization for a schizophrenia project at the West Los Angeles facility.
The NIH human subjects protection division found lax oversight by a panel that is required to supervise the project's treatment of human subjects. The panel, called an "institutional review board," is part of the NIH's regulatory scheme for protecting patients who take part in medical research.
J. Thomas Puglisi, director of the human subjects protection division, told members of the House Veterans Affairs Committee that the investigation into the schizophrenia project dates back to 1993, when the NIH found that researchers were not providing complete information to veterans when seeking their consent to be the subject of research.
At that time, the NIH branch required changes in consent procedures and a separate board to monitor the project. The hospital, however, has never documented the creation of that board, Puglisi said.
The institutional review board also has not been getting enough information to oversee the project properly, Puglisi said. According to a review of the minutes of nine meetings, the institutional review board could not even assemble a quorum for seven of the meetings, he said.
While acknowledging the violations of research regulations, Kenneth Kizer, M.D., the VA's health undersecretary, said no veteran was harmed by the violations. He said new officials have been appointed to oversee the research in the VA's Los Angeles healthcare network.
Puglisi said the NIH is investigating research projects at VA hospitals in Cincinnati, Philadelphia and Tampa, Fla.