Letter to the FDA and OHRP Calling for Investigations of Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation

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Public Citizen and 64 doctors, bioethicists, and academics called on the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to immediately investigate two prospective clinical trials that involved testing the dangerous general anesthetic ketamine and powerful sedatives on agitated patients without their consent. Disturbingly, these experiments were incorrectly determined by the researchers and the Hennepin County Medical Center’s institutional review board (IRB) to involve no more than minimal risk to the subjects and, based on that determination, the IRB waived the informed consent requirements.

July 25, 2018, OHRP acknowledgment email.

August 3, 2018, FDA acknowledgment letter.

See Public Citizen’s other work on ethics and clinical trials.