21 CFR 56.115: IRB records
Requires institutions or IRBs to maintain documentation of IRB activities, including proposals, minutes, correspondence, member rosters and procedures, retain it at least 3 years after research completion, and allow FDA inspection or risk rejection of studies.
Part 56, Institutional Review Boards · Subpart D, Records and Reports
Recent 483s citing 56.115
- Baystate Medical Center IRB · Springfield, MassachusettsMinutes of IRB meetings have not been prepared in sufficient detail to show actions… Feb 2, 2026
- Curia Global, Inc. · Albany, New YorkMinutes of IRB meetings have not been prepared in sufficient detail to show… May 9, 2025
- Burzynski Research Institute/ IRB · Houston, TexasCopies haye not been maintained ofaU research proposals reviewed… Jul 17, 2015
- BRI-IRB · Houston, TexasA list of IRB members has not been prepared and maintained, identifying members by… Feb 7, 2013
- Burzynski Research Institute/ IRB · Houston, TexasCopies have not been maintained of all approved sample consent documents and… Oct 28, 2010
The regulation text
§ 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 § 56.108 (a) and (b).
(7)Statements of significant new findings provided to subjects, as required by § 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]
Questions
What does 21 CFR 56.115 require?
Requires institutions or IRBs to maintain documentation of IRB activities, including proposals, minutes, correspondence, member rosters and procedures, retain it at least 3 years after research completion, and allow FDA inspection or risk rejection of studies.
Which sections are cited alongside 56.115?
In the same 483s, investigators most often also cite 56.108 (IRB functions and operations), 56.109 (IRB review of research), 56.111 (Criteria for IRB approval of research), 211.100 (Written procedures; deviations).