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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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Article Information

vol. 134 no. 5 1006-1012
DOI 
https://doi.org/10.1542/peds.2014-0207
PubMed 
25287456

Published By 
American Academy of Pediatrics
Print ISSN 
0031-4005
Online ISSN 
1098-4275
History 
  • Accepted April 2, 2014
  • Published online October 31, 2014.

Copyright & Usage 
Copyright © 2014 by the American Academy of Pediatrics

Author Information

  1. Mark S. Schreiner, MDa,b,
  2. Dalia Feltman, MDc,d,
  3. Thomas Wiswell, MDe,
  4. Susan Wootton, MDf,
  5. Cody Arnold, MD, MSf,
  6. Jon Tyson, MD, MPHf, and
  7. John D. Lantos, MDg,h
  1. aThe Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania;
  2. bPerelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;
  3. cNorthshore Evanston Hospital, Evanston, Illinois;
  4. dUniversity of Chicago Pritzker School of Medicine, Chicago, Illinois;
  5. eFlorida Hospital Orlando, Orlando, Florida;
  6. fUniversity of Texas at Houston, Houston, Texas;
  7. gUniversity of Missouri–Kansas City, Kansas City, Missouri; and
  8. hChildren’s Mercy Hospital, Kansas City, Missouri
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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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    • 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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