[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR56.104]



[Page 295-296]

 

                        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



[[Page 296]]



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]