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American Academy of Pediatrics
Ethics RoundsEthics Rounds

When Is Waiver of Consent Appropriate in a Neonatal Clinical Trial?

Mark S. Schreiner, Dalia Feltman, Thomas Wiswell, Susan Wootton, Cody Arnold, Jon Tyson and John D. Lantos
Pediatrics November 2014, 134 (5) 1006-1012; DOI: https://doi.org/10.1542/peds.2014-0207
Mark S. Schreiner
aThe Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania;
bPerelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;
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Dalia Feltman
cNorthshore Evanston Hospital, Evanston, Illinois;
dUniversity of Chicago Pritzker School of Medicine, Chicago, Illinois;
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Thomas Wiswell
eFlorida Hospital Orlando, Orlando, Florida;
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Susan Wootton
fUniversity of Texas at Houston, Houston, Texas;
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Cody Arnold
fUniversity of Texas at Houston, Houston, Texas;
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Jon Tyson
fUniversity of Texas at Houston, Houston, Texas;
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John D. Lantos
gUniversity of Missouri–Kansas City, Kansas City, Missouri; and
hChildren’s Mercy Hospital, Kansas City, Missouri
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Abstract

It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.

  • child
  • ethics
  • meconium aspiration
  • equipoise
  • research
  • consent
  • Accepted April 2, 2014.
  • Copyright © 2014 by the American Academy of Pediatrics

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Pediatrics
Vol. 134, Issue 5
1 Nov 2014
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When Is Waiver of Consent Appropriate in a Neonatal Clinical Trial?
Mark S. Schreiner, Dalia Feltman, Thomas Wiswell, Susan Wootton, Cody Arnold, Jon Tyson, John D. Lantos
Pediatrics Nov 2014, 134 (5) 1006-1012; DOI: 10.1542/peds.2014-0207

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When Is Waiver of Consent Appropriate in a Neonatal Clinical Trial?
Mark S. Schreiner, Dalia Feltman, Thomas Wiswell, Susan Wootton, Cody Arnold, Jon Tyson, John D. Lantos
Pediatrics Nov 2014, 134 (5) 1006-1012; DOI: 10.1542/peds.2014-0207
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    • Abstract
    • The Case
    • Does the Research Minimize Risks by Using Sound Scientific Design?
    • Are the Risks of the Research Reasonable in Relation to the Anticipated Benefits?
    • Does the Research Meet Federal Requirements (Subpart D) for Protecting Children as Research Subjects?
    • Will Informed Consent Be Obtained and Documented From Each Prospective Subject?
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