Keeping VA Research in Line

Since 1974, when federal officials first required scientists to set up review boards to protect human research subjects, most institutions have complied admirably, establishing meticulous review boards like UCLA’s Human Subjects Protection Committee.

But as a congressional hearing Wednesday made clear, there have been troubling exceptions. The hearing was held to determine how to correct research abuses at the Veterans Affairs hospital in West Los Angeles, which federal VA officials cited last month for ethics violations including failing to obtain informed consent from research subjects.

At the hearing, Undersecretary for Health Kenneth W. Kizer announced the creation of a new VA department to monitor researchers’ adherence to federal Institutional Review Board standards.

That’s a useful step, though the department’s success will only be assured if it avoids the kind of bureaucratic bungling that characterized the federal VA’s crackdown at the West L.A. facility. Appropriately, federal officials halted research involving human subjects. But without sufficient cause, they also halted studies involving cell and animal research, rightly infuriating scores of scientists working in the field. To ensure more thought in the process, the VA’s new department should be at least partly staffed from outside the federal bureaucracy.

Wednesday’s hearing also suggested the need for greater scrutiny of legal but scientifically dubious research practices. For example, at the hearing a University of Maryland scientist, Adil E. Shamoo, detailed how VA researchers in New York conducted studies in which schizophrenics were, among other things, taken off antipsychotic medications abruptly and without adequate follow-up care.

John R. Feussner, the official who oversees federal VA research, says his institution’s paramount principle of human research has always been “do no harm.” Congress and federal advisory groups like the National Bioethics Advisory Commission should help the VA do a better job of putting its high-minded principles into practice.