title: Suggestions from adolescents, young adults, and parents for improving informed consent in phase 1 pediatric oncology trials.
abstract: BACKGROUND
  Informed consent for a pediatric oncology phase 1 trial is a delicate process, and is made more complex by the difficulty of the information and the requirement for parental consent, and patient assent when applicable. This analysis identifies suggestions for improving the informed consent process received from parents and adolescent and young adult patients (aged 14 years-21 years) who had the option of participating in a phase 1 pediatric oncology trial.
  
  
  METHODS
  A total of 57 parents and 20 patients completed interviews as part of a multisite, prospective, descriptive study. These transcribed interviews were studied using established content analysis methods.
  
  
  RESULTS
  Parent and patient responses contained 220 suggestions and 54 suggestions, respectively. A total of 21 unique suggestions for improvement emerged in 3 main themes: 1) provision of more information; 2) structure and presentation of the informed consent process, and 3) suggestions for physicians conducting the process. Common suggestions included providing more specific information about the trial, allowing more time for decision-making, and using different methods to deliver information.
  
  
  CONCLUSIONS
  Participants involved in the informed consent process for a phase 1 trial provided specific recommendations to research teams to enhance the process. Physician/investigators should be informed of these recommendations and develop and test interventions incorporating them.
authors.affiliation: Division of Quality of Life and Palliative Care, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Justin N
authors.initials: JN
authors.lastname: Baker
authors.forename: Angela C
authors.initials: AC
authors.lastname: Leek
authors.forename: Halle Showalter
authors.initials: HS
authors.lastname: Salas
authors.forename: Dennis
authors.initials: D
authors.lastname: Drotar
authors.forename: Robert
authors.initials: R
authors.lastname: Noll
authors.forename: Susan R
authors.initials: SR
authors.lastname: Rheingold
authors.forename: Eric D
authors.initials: ED
authors.lastname: Kodish
mesh_terms: D000293:Adolescent; D017321:Clinical Trials, Phase I as Topic; D003657:Decision Making; D005260:Female; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent / Q000592:standards*; D007407:Interviews as Topic; D008297:Male; D009369:Neoplasms; D010290:Parents; D010819:Physician's Role; D011446:Prospective Studies; D013997:Time Factors; D055815:Young Adult
keywords: adolescent; ethics; oncology; parent; pediatrics; phase 1; research; suggestion; young adult