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ResourcesHuman Research Ethics(US) ER patients given ketamine, other powerful drugs in clinical trials without their consent, FDA finds – STAT (Sharon Begley | October 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) ER patients given ketamine, other powerful drugs in clinical trials without their consent, FDA finds – STAT (Sharon Begley | October 2018)

 


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Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined.

Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a letter to the Food and Drug Administration and the Department of Health and Human Services office that protects human research subjects, Public Citizen also called for regulators to immediately launch an investigation into the conduct and oversight of the studies and “impose severe sanctions for the serious ethical and regulatory lapses that have occurred in the ketamine clinical trials and other studies” at Minneapolis’s Hennepin County Medical Center.

The hospital committee that green-lighted the studies, called an institutional review board (IRB), “appears incapable of doing its job,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, who organized the letter. It acted unethically and placed patients in danger, he said, “including by waiving the requirement for informed consent in situations where that is not allowed.”

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