<b> <i>Overview of the Common Rule and Subpart D</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:

Series: Issues in Biomedical Ethics

  Overview of the Common Rule and Subpart D

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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

Chapter.  5353 words. 

Subjects: Moral Philosophy

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