Cambridge Quarterly of Healthcare Ethics



SPECIAL SECTION: ETHICAL LIMITS IN HUMAN SUBJECTS RESEARCH

Inconsistent Regulatory Protection under the U.S. Common Rule


BARBARA J.  EVANS  a1
a1 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.

Article author query
evans bj   [PubMed][Google Scholar] 

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.



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