[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.110]

[Page 300]
 
                        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 C_IRB Functions and Operations
 
Sec.  56.110  Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

    (a) The Food and Drug Administration has established, and published 
in the Federal Register, a list of categories of research that may be 
reviewed by the IRB through an expedited review procedure. The list will 
be amended, as appropriate, through periodic republication in the 
Federal Register.
    (b) An IRB may use the expedited review procedure to review either 
or both of the following: (1) Some or all of the research appearing on 
the list and found by the reviewer(s) to involve no more than minimal 
risk, (2) minor changes in previously approved research during the 
period (of 1 year or less) for which approval is authorized. Under an 
expedited review procedure, the review may be carried out by the IRB 
chairperson or by one or more experienced reviewers designated by the 
IRB chairperson from among the members of the IRB. In reviewing the 
research, the reviewers may exercise all of the authorities of the IRB 
except that the reviewers may not disapprove the research. A research 
activity may be disapproved only after review in accordance with the 
nonexpedited review procedure set forth in Sec.  56.108(c).
    (c) Each IRB which uses an expedited review procedure shall adopt a 
method for keeping all members advised of research proposals which have 
been approved under the procedure.
    (d) The Food and Drug Administration may restrict, suspend, or 
terminate an institution's or IRB's use of the expedited review 
procedure when necessary to protect the rights or welfare of subjects.

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991]