[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: 21CFR56.115]
[Page 301]
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 D Records and Reports
Sec. 56.115 IRB records.
(a) An institution, or where appropriate an IRB, shall prepare and
maintain adequate documentation of IRB activities, including the
following:
(1) Copies of all research proposals reviewed, scientific
evaluations, if any, that accompany the proposals, approved sample
consent documents, progress reports submitted by investigators, and
reports of injuries to subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to
show attendance at the meetings; actions taken by the IRB; the vote on
these actions including the number of members voting for, against, and
abstaining; the basis for requiring changes in or disapproving research;
and a written summary of the discussion of controverted issues and their
resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the
investigators.
(5) A list of IRB members identified by name; earned degrees;
representative capacity; indications of experience such as board
certifications, licenses, etc., sufficient to describe each member's
chief anticipated contributions to IRB deliberations; and any employment
or other relationship between each member and the institution; for
example: full-time employee, part-time employee, a member of governing
panel or board, stockholder, paid or unpaid consultant.
(6) Written procedures for the IRB as required by Sec. 56.108 (a)
and (b).
(7) Statements of significant new findings provided to subjects, as
required by Sec. 50.25.
(b) The records required by this regulation shall be retained for at
least 3 years after completion of the research, and the records shall be
accessible for inspection and copying by authorized representatives of
the Food and Drug Administration at reasonable times and in a reasonable
manner.
(c) The Food and Drug Administration may refuse to consider a
clinical investigation in support of an application for a research or
marketing permit if the institution or the IRB that reviewed the
investigation refuses to allow an inspection under this section.
[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 67
FR 9585, Mar. 4, 2002]
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