title: Assent observed: children's involvement in leukemia treatment and research discussions.
abstract: OBJECTIVE
  Assent is a critical issue in pediatric ethics that has not been well-studied. We examined the role of older children in discussing a recent diagnosis of acute leukemia and treatment options, including participation in a randomized, clinical trial (RCT).
  
  
  METHODS
  Our sample was drawn from data collected as part of a larger, National Cancer Institute-funded study in which we observed, tape-recorded, and transcribed the informed consent conference (ICC) for children with leukemia at 6 institutions. We analyzed the data for the child's presence and role, examined 5 discussion categories relevant to assent in the context of pediatric cancer treatment/research, conducted parent interviews, and administered clinician questionnaires to examine these issues. We report a qualitative analysis of 14 cases in which the child was present for the ICC.
  
  
  RESULTS
  Clinicians varied with regard to whom they directed specific discussions when patients were present. Questions asked by the children predominantly related to details of the disease and treatment, with few questions about the RCT. Clinicians and parents attribute responsibility for decision-making about participation in RCTs in a variety of ways. In conferences that included the child-patient, parents asked significantly fewer questions than in other ICCs.
  
  
  CONCLUSIONS
  There is significant variation among ICCs that include the older child. Additional empirical study of assent is warranted, and our data suggest several hypotheses that should be tested in future research.
authors: Rainbow Center for Pediatric Ethics, Department of Pediatrics, Rainbow Babies and Children's Hospital of University Hospitals of Cleveland, Cleveland, Ohio 44106, USA.
authors: Joseph Quinn
authors: JQ
authors: Olechnowicz
authors: Michelle
authors: M
authors: Eder
authors: Christian
authors: C
authors: Simon
authors: Stephen
authors: S
authors: Zyzanski
authors: Eric
authors: E
authors: Kodish
mesh_terms: D002648:Child; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D007938:Leukemia / Q000188:drug therapy*; D010358:Patient Participation; D010372:Pediatrics / Q000592:standards; D016032:Randomized Controlled Trials as Topic; D012106:Research / Q000592:standards*