Ambulatory Pediatrics
Volume 5, Issue 1 , Pages 47-49 , January 2005

Responsible Research Involving Children

  • Marilyn J. Field, PhD

      Affiliations

    • From the Institute of Medicine, National Academy of Sciences, Washington, DC (Dr Field), and the Education Steering Committee, Federation of Pediatric Organizations (Dr Behrman)
    • Corresponding Author InformationMarilyn J. Field, PhD, Senior Program Officer, Institute of Medicine, National Academy of Sciences, 500 Fifth St NW, Washington, DC 20001
    • ,
  • Richard E. Behrman, MD

      Affiliations

    • From the Institute of Medicine, National Academy of Sciences, Washington, DC (Dr Field), and the Education Steering Committee, Federation of Pediatric Organizations (Dr Behrman)

Received 8 September 2004 ,Accepted 21 October 2004.

REFERENCES 

  1. US Food and Drug Administration. . Possible barriers to the availability of medical devices intended to treat or diagnose diseases and conditions that affect children; Request for comments . Fed Reg . 2004;69:34374–34375
  2. Institute of Medicine Committee on Clinical Research Involving Children . In: Field MJ , Behrman RE editor. Ethical Conduct of Clinical Research Involving Children . Washington, DC: National Academy Press; 2004;
  3. Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants . In: Federman DD , Hanna KE , Rodriguez LL editor. Responsible Research: A Systems Approach to Protecting Research Participants . Washington, DC: National Academy Press; 2003;
  4. National Bioethics Advisory Commission . Ethical and Policy Issues in Research Involving Human Participants . Bethesda, Md: National Bioethics Advisory Commission; 2001;
  5. Janofsky J , Starfield B . Assessment of risk in research on children . J Pediatr . 1981;98:842–846
  6. Rogers AS , Schwartz DF , Weissman G , English A . Adolescent Medicine HIV/AIDS Research Network. A case study in adolescent participation in clinical research: eleven clinical sites, one common protocol, and eleven IRBs . Instit Rev Board . 1999;21:6–10
  7. Wendler D . The ethics of pediatric research . Washington, DC: Presented to the Committee on Clinical Research Involving Children, Institute of Medicine; January 9, 2003;
  8. Shah S , Whittle A , Wilfond B , et al.   How do institutional review boards apply the federal risk and benefit standards for pediatric research? . JAMA . 2004;291:476–482
  9. Faden R , Beauchamp T . A History and Theory of Informed Consent . New York, NY: Oxford University Press; 1986;
  10. 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 Research . Washington, DC: US Government Printing Office; 1978;

PII: S1530-1567(05)60005-6

doi: 10.1367/1539-4409(2005)5<47:RRIC>2.0.CO;2

Ambulatory Pediatrics
Volume 5, Issue 1 , Pages 47-49 , January 2005

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