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Studies Involving Children

  • Gwen O’Sullivan

Abstract

The two principal factors which set apart the review of research involving children from studies that use competent adults are the difficulties of obtaining a truly informed consent and the method for assessment of risk/benefit ratio. Since standard procedures for IRB review of research have already been covered in a prior chapter, this chapter will deal solely with those added dimensions regarding the use of minors. Children are defined as persons who have not yet attained the legal age of consent, which is likely to be 18 in most states but can vary widely.

Keywords

Herpes Zoster Minimal Risk Direct Benefit Competent Adult Intellectual Capability 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Reference Notes

  1. 1.
    HHS Protection of human subjects, Proposed regulations on research involving children, Federal Register, Volume 43, No. 141, p. 31786-31794 July 21 1978.Google Scholar
  2. 2.
    FDA Protection of human subjects, Proposed establishment of regulations, Federal Register, Volume 44, No. 80, pp 24106-24111 April 24 1979.Google Scholar
  3. 3.
    HHS proposed regulations, 46.403 (j) and FDA proposed regulations, 50.3 (t).Google Scholar
  4. 4.
    Office for the Protection from Research Risks, verbal communication.Google Scholar
  5. 5.
    HHS proposed regulations 46.407.Google Scholar
  6. 6.
    HHS proposed regulations 46.408.Google Scholar
  7. 7.
    HHS proposed regulations 46.403.Google Scholar
  8. 8.
    HHS proposed regulations 46.409 (a).Google Scholar
  9. 9.
    HHS proposed regulations 46.409 (c).Google Scholar
  10. 10.
    Br. Med. J., Guidelines to aid ethical committees considering research involving children, No. 6209, p. 229, 26 January 1980.Google Scholar
  11. 11.
    Br. Med. J., Guidelines to aid ethical committees considering research involving children, No. 6209, p. 230, 26 January 1980.Google Scholar

Copyright information

© Plenum Press, New York 1982

Authors and Affiliations

  • Gwen O’Sullivan
    • 1
  1. 1.The Children’s Hospital Medical CenterBostonUSA

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