Risky Psychiatric Studies to Get Tighter Review

Most psychiatric studies that could pose hazards for human volunteers will soon face additional scrutiny before they win federal funding. Under a plan approved today, the National Institute of Mental Health (NIMH)--the nation's largest funder of clinical psychiatric research--will establish a special working group to screen grant applications for studies that would exacerbate patients' symptoms (known as "challenge" studies) or withdraw medication (known as "drug washout" studies). Such studies have drawn rising criticism in Congress and from some patient advocates.

NIMH director Steven Hyman described the proposed review procedure, which was first reported in Science, to his top advisory council today. It gave him a unanimous go-ahead. "If there is research that causes distress, it should be for a very good and clear reason," Hyman said. "I think all of us agree that research that might cause distress should never be used in an endless, exploratory fashion."

Hyman envisions a working group of eight to 10 people, including bioethicists and some "genuine outsiders" such as patients or their families. It would review applications that have been approved for funding by a peer review panel and require changes to protocols if necessary. "Delay in funding grants will be minimal," Hyman said in a written draft of his proposal. But he acknowledged that some applications may not get funded because of questions about the science or their impact on human subjects.

Hyman, who indicated only a handful of projects are likely to get this additional review each year, emphasized that the new system is "an experiment." But he told the council that "we have to be proud of and ready to defend" any research that NIMH funds. "We need to get this right," Hyman said.