title: The role of the consent document in informed consent for pediatric leukemia trials.
abstract: OBJECTIVE
  To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials, as well as relationships between the use of the document and parental understanding of essential elements of informed consent.
  
  
  METHODS
  Participants included 140 parents of children diagnosed with pediatric leukemia. Informed consent conferences in which randomized clinical trials were discussed were observed, audiotaped, and coded for specific behaviors. Parents were also interviewed within 48 h of their participation in informed consent conferences.
  
  
  RESULTS
  Observations revealed that 74% of cases included explanation of consent documents during consent conferences. Parents who reported that they read the consent document were more likely to understand differences between the clinical trial and off study therapy and were more likely to understand the right to withdraw. Reading of the consent document was not associated with understanding of voluntariness. In comparison to racial/ethnic majority parents, racial/ethnic minority parents were less likely to report that they read the consent document, understand voluntariness or the right to withdraw, and were less likely to be able to distinguish between the clinical trial and off study therapy. Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy.
  
  
  CONCLUSIONS
  Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance understanding of essential elements of informed consent.
authors.affiliation: Department of Pediatrics, Rainbow Babies and Children's Hospital of University Hospitals of Cleveland, Cleveland, OH 44106-6038, USA.
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Hazen
authors.forename: Dennis
authors.initials: D
authors.lastname: Drotar
authors.forename: Eric
authors.initials: E
authors.lastname: Kodish
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D032962:Consent Forms; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D015470:Leukemia, Myeloid, Acute / Q000628:therapy*; D008297:Male; D010290:Parents / Q000193:education* / Q000523:psychology; D028701:Patient Rights; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011932:Reading