FDA: Hennepin Healthcare flouted patient safety rules in sedation studies

A board that approves research at Minnesota's largest safety-net hospital failed to follow federal rules designed to protect patients when it fast-tracked studies on powerful sedatives, including ketamine, according to inspection reports from the Food and Drug Administration (FDA).

The Institutional Review Board (IRB) at Hennepin Healthcare expedited approval for at least four studies between 2014 and 2018 that did not require patients to consent beforehand, even though they included a likelihood of using "vulnerable subjects."

http://www.startribune.com/fda-hennepin-healthcare-flouted-patient-safety-rules-in-sedation-studies/498891251/