Chapter

Protecting Human Subjects: Bits, Bytes, and Biopsies

in Law in the Laboratory

Published by University of Chicago Press

Published in print July 2010 | ISBN: 9780226101644
Published online March 2013 | e-ISBN: 9780226101668 | DOI: http://dx.doi.org/10.7208/chicago/9780226101668.003.0004
Protecting Human Subjects: Bits, Bytes, and Biopsies

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This chapter discusses how and why the government and universities got involved in regulating clinical research. It also explains the five types of rules that govern research involving human subjects: (i) the common law; (ii) the Common Rule; (iii) the special Food and Drug Administration (FDA) rules that apply when studying an unapproved new drug, biologic, or device in a human; (iv) federal privacy laws; and (v) special federal guidelines affecting the manipulation of genes. Case studies are included at the end of the chapter.

Keywords: clinical research; research regulation; common law; Common Rule; FDA; federal privacy laws; federal guidelines

Chapter.  31725 words. 

Subjects: Environment and Energy Law

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