title: Assent in research: the voices of adolescents.
abstract: OBJECTIVE
  Adolescents join clinical research after investigators obtain their positive agreement or "assent." Although intended to respect adolescents, little is known about the views of adolescents or their parents regarding assent or research enrollment decisions. This study aimed to better understand perspectives of adolescent research participants and their parents about assent and parental permission.
  
  
  METHODS
  Structured interviews were conducted with 13- through 17-year-old teens, enrolled in clinical research at the National Institutes of Health or Seattle Children's Hospital, and separately with one parent.
  
  
  RESULTS
  One hundred and seventy-seven adolescent-parent pairs were interviewed. Teens were well distributed by age and gender, represented a wide variety of research and illnesses ranging in severity from mild to life threatening; 20% were healthy volunteers. Teens and parents were generally satisfied with the assent/permission process. Normally, they made the enrollment decision together and teens wanted parents' input and support. About 25% of teens reported pressure to enroll, not only from parents or relatives but also from doctors/nurses/research teams. Only 2% of teens preferred not to sign a consent form.
  
  
  CONCLUSIONS
  Despite some differing views about how decisions should be made, the current assent/permission process is perceived as satisfactorily respectful by most teens in research. Many teens want to sign consent forms, and teens' signatures should generally be sought. Flexible guidance allows research teams and Institutional Review Boards to customize the assent process for teens in particular studies in order to facilitate an appropriate balance between giving teens a voice reflective of their emerging independence and enabling supportive collaboration with parents.
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, Maryland. Electronic address: cgrady@nih.gov.
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
authors.affiliation: Pediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
authors.forename: Lori
authors.initials: L
authors.lastname: Wiener
authors.affiliation: University of California San Francisco, San Francisco, California.
authors.forename: Emily
authors.initials: E
authors.lastname: Abdoler
authors.affiliation: University of Virginia Medical School, Charlottesville, Virginia.
authors.forename: Emily
authors.initials: E
authors.lastname: Trauernicht
authors.affiliation: Pediatric Oncology Branch, National Cancer Institute, Bethesda, Maryland.
authors.forename: Sima
authors.initials: S
authors.lastname: Zadeh
authors.affiliation: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Diekema
authors.affiliation: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.
authors.forename: Benjamin S
authors.initials: BS
authors.lastname: Wilfond
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, Maryland.
authors.forename: David
authors.initials: D
authors.lastname: Wendler
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000523:psychology*; D000328:Adult; D000367:Age Factors; D035843:Biomedical Research / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010287:Parent-Child Relations; D033282:Parental Consent / Q000523:psychology*; D012107:Research Design; D035842:Research Subjects / Q000523:psychology*; D014861:Washington / Q000453:epidemiology
keywords: Adolescents; Assent; Clinical research