[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.115]

[Page 298-299]
 
                        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,

[[Page 299]]

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]