[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: 21CFR56.120]



[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 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.