Response to Food and Drug Administration draft guidance statement on research into the treatment of life-threatening emergency conditions using exception from informed consent: testimony of the Resuscitation Outcomes Consortium.
Ornato
Joseph P
JP
Department of Emergency Medicine, Virginia Commonwealth University, Medical College of Virginia, Richmond, VA, USA. ornato@aol.com
D035843:Biomedical Research / Q000592:standards*; D004635:Emergency Medicine; D032984:Ethics, Research; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration