title: In case of emergency: no need for consent.
abstract: The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.
authors.forename: B A
authors.initials: BA
authors.lastname: Brody
authors.forename: J
authors.initials: J
authors.lastname: Katz
authors.forename: A
authors.initials: A
authors.lastname: Dula
mesh_terms: D035061:Control Groups; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence*; D017041:Ethics Committees; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence*; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008913:Minority Groups; D033281:Nontherapeutic Human Experimentation; D010344:Patient Advocacy; D009272:Persons; D012106:Research / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration; D035862:Vulnerable Populations