---
kind: "section"
citation: "28 C.F.R. § 46.115"
title: "28"
number: "46.115"
heading: "IRB records."
url: "https://uscodex.org/cfr/28/46.115"
---

# §46.115. IRB records.

- (a) An institution, or when 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 in the same detail as described is [§ 46.103(b)(3)](/cfr/28/46.103.md?p=b-3).
  - (6) Written procedures for the IRB in the same detail as described in [§ 46.103(b)(4)](/cfr/28/46.103.md?p=b-4) and [§ 46.103(b)(5)](/cfr/28/46.103.md?p=b-5).
  - (7) Statements of significant new findings provided to subjects, as required by [§ 46.116(b)(5)](/cfr/28/46.116.md?p=b-5).
- (b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.

## Notes

### Amendments

[56 FR 28012, 28020, June 18, 1991, as amended at 70 FR 36328, June 23, 2005]

### Authority

Authority: 5 U.S.C. 301; 28 U.S.C. 509-510; 42 U.S.C. 300v-1(b).

### Source

Source: 56 FR 28012, 28020, June 18, 1991, unless otherwise noted.

### Amendments

[56 FR 28012, 28020, June 18, 1991, as amended at 70 FR 36328, June 23, 2005]