[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.110]

[Page 122-123]
 
                        TITLE 45--PUBLIC WELFARE
 
                    SUBTITLE A--DEPARTMENT OF HEALTH
                         AND HUMAN SERVICES
 
PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
  Subpart A_Basic HHS Policy for Protection of Human Research Subjects
 
Sec. 46.110  Expedited review procedures for certain kinds of research 

involving no more than minimal risk, and for minor changes in approved 
research.

    (a) The Secretary, HHS, has established, and published as a Notice 
in the

[[Page 123]]

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 
Protection from Research Risks, National Institutes of Health, HHS, 
Bethesda, Maryland 20892.
    (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 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 Sec. 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 procedure.