[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: 28CFR46.113]



[Page 22]

 

                    TITLE 28--JUDICIAL ADMINISTRATION

 

              CHAPTER I--DEPARTMENT OF JUSTICE (CONTINUED)

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Sec. 46.113  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 department or agency head.



(Approved by the Office of Management and Budget under Control Number 

0990-0260)



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

2005]