Hostname: page-component-745bb68f8f-f46jp Total loading time: 0 Render date: 2025-01-11T22:18:59.863Z Has data issue: false hasContentIssue false
  • English
  • Français

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.
Get access Rights & Permissions [Opens in a new window]

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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)