title: When is waiver of consent appropriate in a neonatal clinical trial?
abstract: It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.
authors.affiliation: The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;
authors.forename: Mark S
authors.initials: MS
authors.lastname: Schreiner
authors.affiliation: Northshore Evanston Hospital, Evanston, Illinois; University of Chicago Pritzker School of Medicine, Chicago, Illinois;
authors.forename: Dalia
authors.initials: D
authors.lastname: Feltman
authors.affiliation: Florida Hospital Orlando, Orlando, Florida;
authors.forename: Thomas
authors.initials: T
authors.lastname: Wiswell
authors.affiliation: University of Texas at Houston, Houston, Texas;
authors.forename: Susan
authors.initials: S
authors.lastname: Wootton
authors.affiliation: University of Texas at Houston, Houston, Texas;
authors.forename: Cody
authors.initials: C
authors.lastname: Arnold
authors.affiliation: University of Texas at Houston, Houston, Texas;
authors.forename: Jon
authors.initials: J
authors.lastname: Tyson
authors.affiliation: University of Missouri-Kansas City, Kansas City, Missouri; and Children's Mercy Hospital, Kansas City, Missouri jlantos@cmh.edu.
authors.forename: John D
authors.initials: JD
authors.lastname: Lantos
mesh_terms: D004632:Emergency Medical Services / Q000941:ethics* / Q000379:methods; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000941:ethics; D033282:Parental Consent / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods
keywords: child; consent; equipoise; ethics; meconium aspiration; research