[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.113]
[Page 300]
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.
Back to Top
© 2007 Betterchem Corp.
|
