[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: 21CFR56.120]
[Page 301-302]
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
[[Page 302]]
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.
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