[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.104]
[Page 297]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 56 INSTITUTIONAL REVIEW BOARDS--Table of Contents
Subpart A General Provisions
Sec. 56.104 Exemptions from IRB requirement.
The following categories of clinical investigations are exempt from
the requirements of this part for IRB review:
(a) Any investigation which commenced before July 27, 1981 and was
subject to requirements for IRB review under FDA regulations before that
date, provided that the investigation remains subject to review of an
IRB which meets the FDA requirements in effect before July 27, 1981.
(b) Any investigation commenced before July 27, 1981 and was not
otherwise subject to requirements for IRB review under Food and Drug
Administration regulations before that date.
(c) Emergency use of a test article, provided that such emergency
use is reported to the IRB within 5 working days. Any subsequent use of
the test article at the institution is subject to IRB review.
(d) Taste and food quality evaluations and consumer acceptance
studies, if wholesome foods without additives are consumed or if a food
is consumed that contains a food ingredient at or below the level and
for a use found to be safe, or agricultural, chemical, or environmental
contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or the
Food Safety and Inspection Service of the U.S. Department of
Agriculture.
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991]
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