§46.110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in approved
(a) The Secretary, HHS, has established, and published as a Notice 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, after consultation with other departments and agencies, through
periodic republication by the Secretary, HHS, in the FEDERAL REGISTER. A copy of
the list is available from the Office for Human Research Protections, HHS, or
any successor office.
(b) An IRB may use the expedited review procedure to review either or both of
(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 one
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
chairperson from among 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 non-expedited procedure set
forth in §46.108(b).
(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 department or agency head may restrict, suspend, terminate, or choose
not to authorize an institution's or IRB's use of the expedited review
[56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23,