[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR56.115]



[Page 299-300]

 

                        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



[[Page 300]]



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]