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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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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2019. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 18 November 2019

Overview of the Common Rule and Subpart D

Overview of the Common Rule and Subpart D

Chapter:
(p.63) 3 Overview of the Common Rule and Subpart D
Source:
Children in Medical Research
Author(s):

Lainie Friedman Ross (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/0199273286.003.0004

The Code of Federal Regulations (CFR) 45 part 46, Federal Policy for the Protection of Human Subjects, were developed based on reports published by the National Commission (for the Protection of Human Subjects of Biomedical and Behavioral Research). Subpart A of 45 CFR 46 is known as the Common Rule since it has been adopted by sixteen federal agencies and departments of the US government. Subpart D provides additional protections for research involving children. This chapter examines in detail 45 CFR Part 46 as it applies to children subjects. It argues that even after 20 years, the regulations to protect human subjects remain quite viable and useful, although a few modifications may be necessary.

Keywords:   children, protection, medical research, pediatric research, Code of Federal Regulations, Subpart D

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