Nicolas Asfouri/Reuters
The Food and Drug Administration released a statement Monday saying the agency is investigating a Minneapolis hospital for allegedly breaking ethics rules by giving patients drugs, including the club drug ketamine, for a research study without their consent. Hennepin County Medical Center is being investigated for at least four studies that have been approved since 2014. In at least one of the studies, paramedics “agitated” patients without their consent to study ketamine’s role as a sedative, the FDA said. The agency is following up on body-camera footage from this summer from the same hospital that showed Minneapolis police officers instructing the hospital’s ER staff to inject people in custody with the drug, according to BuzzFeed.
The FDA is also investigating other studies that compared sedatives and antipsychotics along with two redacted studies. The hospital defends its studies, saying they were injected in “severely agitated patients” who posed “life threatening risk to others and to themselves.” But critics say that the studies do not meet the requirements for waived consent, and that patients in police custody could have been coerced. “When people are being pulled into studies off the street—with the involvement of police and drugs being forcibly administered—it’s right to talk about the possibility of coercion, undue influence, and vulnerable subjects,” Leigh Turner, a bioethicist at the University of Minnesota, told BuzzFeed.