[Code of Federal Regulations]
[Title 45, Volume 1, Parts 1 to 199]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.113]

[Page 113-114]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
  Subpart A--Basic HHS Policy for Protection of Human Research Subjects
 
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

[[Page 114]]

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 
9999-0020)