Second Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation

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Public Citizen, joined by two bioethicists from the University of Minnesota, wrote to the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) to highlight key observations made by FDA inspectors during an inspection of the Hennepin County Medical Center’s (HCMC’s) institutional review board from August 7 to August 23, 2018. The inspection confirmed that HCMC violated federal regulations when it conducted high-risk clinical trials that involved testing the safety and effectiveness of the ketamine compared with other potent sedative drugs for management of pre-hospital agitation without the informed consent of the subjects.

November 16, 2018, FDA acknowledgment letter.

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