A Minneapolis health system could face an FDA warning on charges it mishandled an ethics review of a clinical trial testing sedatives on agitated patients by paramedics.

Consumer watchdog group Public Citizen posted Oct. 29 an inspection form from the Food and Drug Administration that found a Hennepin Healthcare ethics board didn’t comply with the agency’s regulations to protect research participants from undue harm. Public Citizen obtained the Form 483 by submitting a Freedom of Information Act request.

The observations...