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Children in Medical ResearchAccess versus Protection$
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Children in Medical Research: Access versus Protection

Lainie Friedman Ross

Print publication date: 2006

Print ISBN-13: 9780199273287

Published to Oxford Scholarship Online: May 2006

DOI: 10.1093/0199273286.001.0001

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Informed Consent in Pediatric Research

Informed Consent in Pediatric Research

Chapter:
(p.87) 5 Informed Consent in Pediatric Research
Source:
Children in Medical Research
Author(s):

Lainie Friedman Ross (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/0199273286.003.0006

This chapter presents an overview of the informed consent requirements and waivers in pediatric research under current federal regulations. These consent policies were adopted by the Food and Drug Administration in April 2001 with the exception of parental waivers under Code of Federal Regulations section 46.408. The moral bases for these requirements are examined: whether the current policies are consistent with these moral foundations, and if not, how the policies should be modified.

Keywords:   informed consent, waivers, pediatric research, Code of Federal Regulations, medical research

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