ER patients given ketamine in clinical trials without their consent, FDA finds - STAT
Their report, obtained by Public Citizen through a public records request and shared with STAT, examined additional clinical trials beyond those initially flagged. It found that in four, the hospital IRB “did not determine that informed consent would be sought from each prospective subject” as required by law, while in another five, the IRB granted fast-track review to studies that didn’t qualify for it.
At least three of the studies cited by the FDA inspectors involved people brought to the emergency room with “severe” agitation, as assessed by emergency technicians using criteria developed by the researchers. The study leaders apparently persuaded the IRB that such patients could not provide informed consent, and so could be swept into the trial unknowingly.
In fact, such patients are considered “vulnerable,” said bioethicist Leigh Turner of the University of Minnesota, who signed the Public Citizen letter. According to federal law, they are supposed to receive special safeguards, such as having a family member or other representative give or decline consent. That did not happen.