title: The Benefits and Challenges of Preconsent in a Multisite, Pediatric Sickle Cell Intervention Trial.
abstract: Enrollment of patients in sickle cell intervention trials has been challenging due to difficulty in obtaining consent from a legal guardian and lack of collaboration between emergency medicine and hematology. We utilized education and preconsent in a pediatric multisite sickle cell intervention trial to overcome these challenges. Overall, 48 patients were enrolled after being preconsented. Variable Institutional Review Board policies related to preconsent validity and its allowable duration decreased the advantages of preconsent at some sites. The utility of preconsent for future intervention trials largely depends on local Institutional Review Board policies. Preeducation may also benefit the consent process, regardless of site differences.
authors.affiliation: Pediatric Emergency Medicine, Medical College of Wisconsin, and the Children's Research Institute, Milwaukee, Wisconsin.
authors.forename: Mark
authors.initials: M
authors.lastname: Nimmer
authors.affiliation: Pediatric Emergency Medicine, Wayne State University/Children's Hospital of Michigan, Detroit, Michigan.
authors.forename: Jason
authors.initials: J
authors.lastname: Czachor
authors.affiliation: Division of Emergency Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Laura
authors.initials: L
authors.lastname: Turner
authors.affiliation: Pediatric Emergency Medicine, Children's National Medical Center, Washington, District of Colombia.
authors.forename: Bobbe
authors.initials: B
authors.lastname: Thomas
authors.affiliation: Pediatric Emergency Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors.forename: Ashley L
authors.initials: AL
authors.lastname: Woodford
authors.affiliation: Pediatric Emergency Medicine, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Karli
authors.initials: K
authors.lastname: Carpenter
authors.affiliation: Pediatric Emergency Medicine, Baylor College of Medicine/Texas Children's Hospital, Houston, Texas.
authors.forename: Victor
authors.initials: V
authors.lastname: Gonzalez
authors.affiliation: Hematology, Oncology & Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.
authors.forename: Robert I
authors.initials: RI
authors.lastname: Liem
authors.affiliation: Pediatric Emergency Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
authors.forename: Angela
authors.initials: A
authors.lastname: Ellison
authors.affiliation: Pediatric Emergency Care Applied Research Network Data Coordinating Center, University of Utah, Salt Lake City, Utah.
authors.forename: T Charles
authors.initials: TC
authors.lastname: Casper
authors.affiliation: Pediatric Emergency Medicine, Medical College of Wisconsin, and the Children's Research Institute, Milwaukee, Wisconsin.
authors.forename: David C
authors.initials: DC
authors.lastname: Brousseau
mesh_terms: D000755:Anemia, Sickle Cell / Q000628:therapy*; D004636:Emergency Service, Hospital; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D016032:Randomized Controlled Trials as Topic
keywords: consent; preconsent, pediatric hematology/oncology; sickle cell disease