title: Permission form synopses to improve parents' understanding of research: a randomized trial.
abstract: We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control).
  
  
  
  This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.
  
  
  
  Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).
  
  
  
  A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
authors.affiliation: Department of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
authors.forename: C T
authors.initials: CT
authors.lastname: D'Angio
authors.affiliation: Department of Biostatistics, University of Rochester, Rochester, NY, USA.
authors.forename: H
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.|St Francis Hospital and Medical Center, University of Connecticut, Hartford, CT, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Hunn
authors.affiliation: Department of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
authors.forename: G S
authors.initials: GS
authors.lastname: Pryhuber
authors.affiliation: Department of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
authors.forename: P R
authors.initials: PR
authors.lastname: Chess
authors.affiliation: Department of Pediatrics, University at Buffalo, Buffalo, NY, USA.
authors.forename: S
authors.initials: S
authors.lastname: Lakshminrusimha
mesh_terms: D000328:Adult; D032882:Comprehension; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007231:Infant, Newborn; D016014:Linear Models; D008297:Male; D015999:Multivariate Analysis; D009518:New York; D033282:Parental Consent / Q000523:psychology*; D010865:Pilot Projects; D012106:Research; D016037:Single-Blind Method; D055815:Young Adult