Complaint filed over ketamine research without prior consent

Published 8:22 am Thursday, July 26, 2018

MINNEAPOLIS — A consumer rights group has filed a complaint alleging a Minneapolis health care provider ignored ethical practices and federal safeguards when it researched the effect of the powerful sedative ketamine on more than 100 participants without their prior consent.

The Public Citizen complaint asks the Food and Drug Administration and the Office for Human Research Protection to investigate whether Hennepin Healthcare complied with federal regulations during clinical trials of ketamine. In the trials, paramedics sedated people before taking them to the hospital.

The federal complaint alleges researchers put patients at unnecessary risk and enrolled them in the study without their prior consent, The Star Tribune reported. The complaint also accuses the hospital’s Institutional Review Board of failing to fulfill its duty by allowing researchers to enroll members of the public in the study without consent.

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