---
kind: "section"
citation: "21 C.F.R. § 56.115"
title: "21"
number: "56.115"
heading: "IRB records."
url: "https://uscodex.org/cfr/21/56.115"
---

# §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)](/cfr/21/56.108.md?p=a) and [(b)](/cfr/21/56.108.md?p=b).
  - (7) Statements of significant new findings provided to subjects, as required by [§ 50.25](/cfr/21/50.25.md).
- (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.

## Notes

### Amendments

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 67 FR 9585, Mar. 4, 2002]

### Authority

Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262.

### Source

Source: 46 FR 8975, Jan. 27, 1981, unless otherwise noted.

### Amendments

[46 FR 8975, Jan. 27, 1981, as amended at 56 FR 28029, June 18, 1991; 67 FR 9585, Mar. 4, 2002]