[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.120]

[Page 329]
 
                        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 E_Administrative Actions for Noncompliance
 
Sec. 56.120  Lesser administrative actions.


    (a) If apparent noncompliance with these regulations in the 
operation of an IRB is observed by an FDA investigator during an 
inspection, the inspector will present an oral or written summary of 
observations to an appropriate representative of the IRB. The Food and 
Drug Administration may subsequently send a letter describing the 
noncompliance to the IRB and to the parent institution. The agency will 
require that the IRB or the parent institution respond to this letter 
within a time period specified by FDA and describe the corrective 
actions that will be taken by the IRB, the institution, or both to 
achieve compliance with these regulations.
    (b) On the basis of the IRB's or the institution's response, FDA may 
schedule a reinspection to confirm the adequacy of corrective actions. 
In addition, until the IRB or the parent institution takes appropriate 
corrective action, the agency may:
    (1) Withhold approval of new studies subject to the requirements of 
this part that are conducted at the institution or reviewed by the IRB;
    (2) Direct that no new subjects be added to ongoing studies subject 
to this part;
    (3) Terminate ongoing studies subject to this part when doing so 
would not endanger the subjects; or
    (4) When the apparent noncompliance creates a significant threat to 
the rights and welfare of human subjects, notify relevant State and 
Federal regulatory agencies and other parties with a direct interest in 
the agency's action of the deficiencies in the operation of the IRB.
    (c) The parent institution is presumed to be responsible for the 
operation of an IRB, and the Food and Drug Administration will 
ordinarily direct any administrative action under this subpart against 
the institution. However, depending on the evidence of responsibility 
for deficiencies, determined during the investigation, the Food and Drug 
Administration may restrict its administrative actions to the IRB or to 
a component of the parent institution determined to be responsible for 
formal designation of the IRB.