The New York Times
By BENEDICT CAREY
JUNE 27, 2016
Study participants with mental disorders are especially susceptible to adverse reactions, experts said. “These are people who are more vulnerable to being exploited in the research process, and more vulnerable to things going wrong during the research, so you want extra vigilance,” said Elisa Hurley, the executive director of Public Responsibility in Medicine and Research, a national nonprofit devoted to promoting high research standards. “If someone in my family were in a situation like this, I would want to be sure that the institution was crossing its t’s and dotting its i’s.”
Diane Ruffcorn, of Seattle, was a participant in the N.Y.U. study who said she had been sexually abused as a child. “I was given this drug, and all these tests, and then it was goodbye, I was on my own,” she said. “There was no follow-up.” Credit Ruth Fremson/The New York TimesNew York University’s medical school has quietly shut down eight studies at its prominent psychiatric research center and parted ways with a top researcher after discovering a series of violations in a study of an experimental, mind-altering drug.
A subsequent federal investigation found lax oversight of study participants, most of whom had serious mental issues. The Food and Drug Administration investigators also found that records had been falsified and researchers had failed to keep accurate case histories.
In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.
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