[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: 21CFR56.110]
[Page 299-300]
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
[[Page 300]]
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]
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