The Journal of Pediatrics
Volume 149, Issue 1, Supplement , Pages S31-S33 , July 2006

Children are not small adults: Documentation of assent for research involving children

  • David Ungar, MD

      Affiliations

    • Corresponding Author InformationReprint requests: Dr David Ungar, Division of Pediatric Hematology/Oncology, Penn State Children’s Hospital, MC085, Hershey, PA 17033.
    • ,
  • Steven Joffe, MD
    • ,
  • Eric Kodish, MD

References 

  1. “Permissible Medical Experiments,” Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946-April 1949, vol 2 (Washington D.C.: U.S. Government Printing Office, n.d.): 181-2.
  2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . The Belmont Report (Ethical principles and guidelines for the protection of human subjects of biomedical and behavioral research) . Washington, DC: U.S. Government Printing Office; 1979;
  3. World Medical Association Declaration of Helsinki (ethical principles for medical research involving human subjects) . JAMA . 2000;284:3043–3045
  4. US Department of Health and Human Services . Subpart D--Additional protections for children involved as subjects in research (45 CFR 46) . Federal Register . 1983;48:9818; March 8
  5. Committee on Bioethics of the American Academy of Pediatrics . Informed consent, parental permission, and assent in pediatric practice . Pediatrics . 1995;95:314–317
  6. Tarnowski KJ , Allen DM , Mayhall C , Kelly PA . Readability of pediatric biomedical research informed consent forms . Pediatrics . 1990;85:58–62
  7. Grossman SA , Piantadosi S , Covahey C . Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? . J Clin Oncol . 1994;12:2211–2215
  8. Mason SA , Allmark PJ . Obtaining informed consent to neonatal randomised controlled trials (interviews with parents and clinicians in the Euricon study) . Lancet . 2000;356:2045–2051
  9. Kodish E , Eder M , Noll RB , et al.   Communication of randomization in childhood leukemia trials . JAMA . 2004;291:470–475
  10. Tait AR , Voepel-Lewis T , Malviya S . Do they understand? I (parental consent for children participating in clinical anesthesia and surgery research) . Anesthesiology . 2003;98:603–608
  11. Whittle A , Shah S , Wilfond B , Gensler G , Wendler D . Institutional review board practices regarding assent in pediatric research . Pediatrics . 2004;113:1747–1752
  12. Tait AR , Voepel-Lewis T , Malviya S . Do they understand? II: assent of children participating in clinical anesthesia and surgery research . Anesthesiology . 2003;98:609–614
  13. Toner K , Schwartz R . Why a teenager over age 14 should be able to consent, rather than merely assent, to participation as a human subject of research . Am J Bioeth . 2003;3:38–40
  14. Olechnowicz JQ , Eder M , Simon C , Zyzanski S , Kodish E . Assent observed (children’s involvement in leukemia treatment and research discussions) . Pediatrics . 2002;109:806–814

PII: S0022-3476(06)00374-X

doi: 10.1016/j.jpeds.2006.04.048

The Journal of Pediatrics
Volume 149, Issue 1, Supplement , Pages S31-S33 , July 2006

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