[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR56.110]



[Page 298]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 56_INSTITUTIONAL REVIEW BOARDS--Table of Contents

 

                 Subpart C_IRB Functions and Operations

 

Sec.  56.110  Expedited review procedures for certain kinds of research 

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

research.



    (a) The Food and Drug Administration has established, and published 

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, through periodic republication in the 

Federal Register.

    (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 1 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 

IRB chairperson from among the 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 

nonexpedited review procedure set forth in Sec.  56.108(c).

    (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 Food and Drug Administration may restrict, suspend, or 

terminate an institution's or IRB's use of the expedited review 

procedure when necessary to protect the rights or welfare of subjects.



[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991]