[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: 21CFR56.108]



[Page 296-297]

 

                        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.  56.108  IRB functions and operations.





    In order to fulfill the requirements of these regulations, each IRB 

shall:

    (a) Follow written procedures: (1) For conducting its initial and 

continuing review of research and for reporting its findings and actions 

to the investigator and the institution; (2) for determining which 

projects require review more often than annually and which projects need 

verification from sources other than the investigator that no material 

changes have occurred since previous IRB review; (3) for ensuring prompt 

reporting to the IRB of changes in research activity; and (4) for 

ensuring that changes in approved research, during the period for which 

IRB approval



[[Page 297]]



has already been given, may not be initiated without IRB review and 

approval except where necessary to eliminate apparent immediate hazards 

to the human subjects.

    (b) Follow written procedures for ensuring prompt reporting to the 

IRB, appropriate institutional officials, and the Food and Drug 

Administration of: (1) Any unanticipated problems involving risks to 

human subjects or others; (2) any instance of serious or continuing 

noncompliance with these regulations or the requirements or 

determinations of the IRB; or (3) any suspension or termination of IRB 

approval.

    (c) Except when an expedited review procedure is used (see Sec.  

56.110), review proposed research at convened meetings at which a 

majority of the members of the IRB are present, including at least one 

member whose primary concerns are in nonscientific areas. In order for 

the research to be approved, it shall receive the approval of a majority 

of those members present at the meeting.



[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991; 67 

FR 9585, Mar. 4, 2002]