STAT+: FDA warns a hospital and two physicians for putting patients at ‘significantly increased’ risk in trials
In harsh tones, U.S. regulators warned a Minnesota hospital and two of its physicians for violating regulations on human research in studies that tested antipsychotics and the potent anesthetic ketamine on patients in emergency rooms or prior to their arrival.
The warnings were issued by the Food and Drug Administration after its inspectors found Hennepin County Medical Center and the physicians failed to obtain consent from subjects for trials that involved testing the safety and effectiveness of the medications for managing agitation. The inspections took place in April 2019 and the FDA letters were sent last May, but only became publicly available this week.
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