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Children in Medical ResearchAccess versus Protection$
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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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Human Subject Protections in Pediatric Research

Human Subject Protections in Pediatric Research

Chapter:
(p.116) 7 Human Subject Protections in Pediatric Research
Source:
Children in Medical Research
Author(s):

Lainie Friedman Ross (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/0199273286.003.0008

Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that accepts federal funds. The requirement to document IRB review and the procurement of informed consent (IC) in published research reports is more recent. This chapter examines to what extent research published in three peer-reviewed pediatric journals documented IRB approval and IC, and to what extent the researchers who failed to document IRB and IC stated that they had obtained appropriate IRB review and consent from subjects. It was observed that a small but significant number of pediatric research protocols failed to obtain IRB approval or a waiver.

Keywords:   pediatric research, medical research, institutional review board, informed consent, published research

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