[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: 21CFR56.113]



[Page 299]

 

                        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.  56.113  Suspension or termination of IRB approval of research.



    An IRB shall have authority to suspend or terminate approval of 

research that is not being conducted in accordance with the IRB's 

requirements or that has been associated with unexpected serious harm to 

subjects. Any suspension or termination of approval shall include a 

statement of the reasons for the IRB's action and shall be reported 

promptly to the investigator, appropriate institutional officials, and 

the Food and Drug Administration.