Chapter

<b> <i>Human Subject Protections in Pediatric Research</i> </b>

Lainie Friedman Ross

in Children in Medical Research

Published in print February 2006 | ISBN: 9780199273287
Published online May 2006 | e-ISBN: 9780191603655 | DOI: http://dx.doi.org/10.1093/0199273286.003.0008

Series: Issues in Biomedical Ethics

  Human Subject Protections in Pediatric Research

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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

Chapter.  5500 words.  Illustrated.

Subjects: Moral Philosophy

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