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Inconsistent Regulatory Protection under the U.S. Common Rule

Published online by Cambridge University Press:  03 December 2004

BARBARA J. EVANS
BARBARA J. EVANS
Affiliation:
Barbara J. Evans, J.D., Ph.D., LL.M., is a practicing attorney specializing in regulatory matters and is Visiting Scholar at the Center for Bioethics at Indiana University/Purdue University at Indianapolis.
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Extract

U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration (FDA). This paper examines a deeper problem: Even when the regulations do apply, they still do not afford consistent standards of protection. The U.S. Common Rule and related FDA regulations lack a workable regulatory control mechanism.

Type
SPECIAL SECTION: ETHICAL LIMITS IN HUMAN SUBJECTS RESEARCH
Information
Cambridge Quarterly of Healthcare Ethics , Volume 13 , Issue 4 , October 2004 , pp. 366 - 379
Copyright
© 2004 Cambridge University Press

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