[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: 21CFR56.108]
[Page 298]
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 C IRB Functions and Operations
Sec. 56.108 IRB functions and operations.
In order to fulfill the requirements of these regulations, each IRB
shall:
(a) Follow written procedures: (1) For conducting its initial and
continuing review of research and for reporting its findings and actions
to the investigator and the institution; (2) for determining which
projects require review more often than annually and which projects need
verification from sources other than the investigator that no material
changes have occurred since previous IRB review; (3) for ensuring prompt
reporting to the IRB of changes in research activity; and (4) for
ensuring that changes in approved research, during the period for which
IRB approval has already been given, may not be initiated without IRB
review and approval except where necessary to eliminate apparent
immediate hazards to the human subjects.
(b) Follow written procedures for ensuring prompt reporting to the
IRB, appropriate institutional officials, and the Food and Drug
Administration of: (1) Any unanticipated problems involving risks to
human subjects or others; (2) any instance of serious or continuing
noncompliance with these regulations or the requirements or
determinations of the IRB; or (3) any suspension or termination of IRB
approval.
(c) Except when an expedited review procedure is used (see Sec.
56.110), review proposed research at convened meetings at which a
majority of the members of the IRB are present, including at least one
member whose primary concerns are in nonscientific areas. In order for
the research to be approved, it shall receive the approval of a majority
of those members present at the meeting.
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28028, June 18, 1991; 67
FR 9585, Mar. 4, 2002]
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