title: Informed consent.
authors.forename: M B
authors.initials: MB
authors.lastname: Bracken
authors.forename: M J
authors.initials: MJ
authors.lastname: Shepard
mesh_terms: D002986:Clinical Trials as Topic; D006259:Craniocerebral Trauma / Q000523:psychology; D006801:Humans; D007258:Informed Consent; D016743:Mental Competency; D014481:United States; D014486:United States Food and Drug Administration