[Code of Federal Regulations]

[Title 40, Volume 1]

[Revised as of July 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR26.110]



[Page 290-291]

 

                   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



[[Page 291]]



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 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]