[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.66]

[Page 86]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
        Subpart D--Responsibilities of Sponsors and Investigators
 
Sec. 312.66  Assurance of IRB review.

    An investigator shall assure that an IRB that complies with the 
requirements set forth in part 56 will be responsible for the initial 
and continuing review and approval of the proposed clinical study. The 
investigator shall also assure that he or she will promptly report to 
the IRB all changes in the research activity and all unanticipated 
problems involving risk to human subjects or others, and that he or she 
will not make any changes in the research without IRB approval, except 
where necessary to eliminate apparent immediate hazards to human 
subjects.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0014)

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987]

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