[Code of Federal Regulations]
[Title 40, Volume 1, Part 1 to 49]
[Revised as of July 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR26.110]

[Page 272]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
               CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
 
PART 26--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
Sec. 26.110  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 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. 26.108(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.