[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]