title: Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology.
abstract: OBJECTIVE
  To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent.
  
  
  METHODS
  A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using chi(2) statistics and t tests.
  
  
  RESULTS
  Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments.
  
  
  CONCLUSIONS
  Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.
authors.affiliation: Department of Bioethics and Rainbow Center for Pediatric Ethics, Rainbow Babies and Children's Hospital, University Hospitals of Cleveland, Case Western Reserve University School of Medicine, OH 44106, USA. cxs66@po.cwru.edu
authors.forename: Christian M
authors.initials: CM
authors.lastname: Simon
authors.forename: Laura A
authors.initials: LA
authors.lastname: Siminoff
authors.forename: Eric D
authors.initials: ED
authors.lastname: Kodish
authors.forename: Christopher
authors.initials: C
authors.lastname: Burant
mesh_terms: D000328:Adult; D000367:Age Factors; D002648:Child; D017326:Clinical Trials, Phase III as Topic / Q000941:ethics*; D003657:Decision Making; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010344:Patient Advocacy; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012189:Retrospective Studies