An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements.
D001927:Brain Diseases; D001930:Brain Injuries; D016638:Critical Illness; D015507:Drugs, Investigational; D004632:Emergency Medical Services; D017041:Ethics Committees; D028744:Ethics Committees, Research; D005190:Family; D035082:Federal Government; D006076:Government; D033161:Government Regulation; D017408:Guidelines as Topic; D006761:Hospitals; D006805:Human Experimentation; D006801:Humans; D016743:Mental Competency; D015337:Multicenter Studies as Topic; D019724:Presumed Consent; D011897:Random Allocation; D012106:Research; D035842:Research Subjects; D012926:Social Control, Formal; D036302:Therapeutic Human Experimentation; D020458:Third-Party Consent; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration; D014947:Wounds and Injuries
Biomedical and Behavioral Research; Legal Approach; Office for Protection from Research Risks; University of Nebraska Medical Center