[Code of Federal Regulations]

[Title 28, Volume 2]

[Revised as of July 1, 2005]

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

[CITE: 28CFR46.110]



[Page 21]

 

                    TITLE 28--JUDICIAL ADMINISTRATION

 

              CHAPTER I--DEPARTMENT OF JUSTICE (CONTINUED)

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

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 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 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.



[56 FR 28012, 28020, June 18, 1991, as amended at 70 FR 36328, June 23, 

2005]