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FDA warns Chicago-area health system over study

CHICAGO – A warning letter from the U.S. Food and Drug Administration accuses a Chicago-area health care system of failing to get the consent of emergency room patients before enrolling them in a clinical study.

The agency criticized Advocate Health Care over a study involving patients who needed intubation, an emergency procedure in which a tube is inserted down the throat to open an airway or give medication. The study was designed to test the effectiveness of a sedative called etomidate.

The Chicago Tribune reported Saturday that the subjects were patients at Advocate Christ Medical Center in Oak Lawn.

Advocate said in a statement it has "taken immediate steps to ensure this does not occur again" and is confident the matter will soon be resolved with the FDA.

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Information from: Chicago Tribune, http://www.chicagotribune.com

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