[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: 21CFR56.103]
[Page 296-297]
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 A General Provisions
Sec. 56.103 Circumstances in which IRB review is required.
(a) Except as provided in Sec. Sec. 56.104 and 56.105, any clinical
investigation which must meet the requirements for prior submission (as
required in parts 312, 812, and 813) to the Food and Drug Administration
shall not be initiated unless that investigation has been reviewed and
approved by, and remains subject to continuing review by, an IRB meeting
the requirements of this part.
[[Page 297]]
(b) Except as provided in Sec. Sec. 56.104 and 56.105, the Food and
Drug Administration may decide not to consider in support of an
application for a research or marketing permit any data or information
that has been derived from a clinical investigation that has not been
approved by, and that was not subject to initial and continuing review
by, an IRB meeting the requirements of this part. The determination that
a clinical investigation may not be considered in support of an
application for a research or marketing permit does not, however,
relieve the applicant for such a permit of any obligation under any
other applicable regulations to submit the results of the investigation
to the Food and Drug Administration.
(c) Compliance with these regulations will in no way render
inapplicable pertinent Federal, State, or local laws or regulations.
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981]
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