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
theFederal 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 theFederal 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 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]