[Code of Federal Regulations]
[Title 40, Volume 1]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR26.110]

[Page 306-307]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
               CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
 
PART 26_PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
Subpart A_Basic EPA Policy for Protection of Subjects in Human Research 
                      Conducted or Supported by EPA
 
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 
Human Research Protections, HHS, or any successor office.
    (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

[[Page 307]]

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.

[56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23, 
2005]