title: Balancing ethical goals in challenging individual participant scenarios occurring in a trial conducted with exception from informed consent.
abstract: In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decision-maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.
authors.affiliation: The Department of Emergency Medicine Hennepin County Medical Center and University of Minnesota, Minneapolis, MN.
authors.forename: Michelle H
authors.initials: MH
authors.lastname: Biros
authors.forename: Neal W
authors.initials: NW
authors.lastname: Dickert
authors.forename: David W
authors.initials: DW
authors.lastname: Wright
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Scicluna
authors.forename: Deneil
authors.initials: D
authors.lastname: Harney
authors.forename: Robert
authors.initials: R
authors.lastname: Silbergleit
authors.forename: Kurt
authors.initials: K
authors.lastname: Denninghoff
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Pentz
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D004636:Emergency Service, Hospital / Q000941:ethics* / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards; D011446:Prospective Studies; D020458:Third-Party Consent / Q000941:ethics*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards