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.
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.