---
kind: "section"
citation: "40 C.F.R. § 26.1117"
title: "40"
number: "26.1117"
heading: "Documentation of informed consent."
url: "https://uscodex.org/cfr/40/26.1117"
---

# §26.1117. Documentation of informed consent.

- (a) Informed consent shall be documented by the use of a written consent form approved by the IRB and signed (including in an electronic format) by the subject. A written copy shall be given to the subject.
- (b) The informed consent form may be either of the following:
  - (1) A written informed consent form that meets the requirements of [§ 26.1116](/cfr/40/26.1116.md). The investigator shall give the subject adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject.
  - (2) A short form written informed consent form stating that the elements of informed consent required by [§ 26.1116](/cfr/40/26.1116.md) have been presented orally to the subject, and that the key information required by [§ 26.1116(a)(5)(i)](/cfr/40/26.1116.md?p=a-5-i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary must be given to the subject, in addition to a copy of the short form.

## Notes

### Source

Source: 84 FR 35318, July 23, 2019, unless otherwise noted.

### Authority

Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b).

### Source

Source: 56 FR 28012, 28022, June 18, 1991, unless otherwise noted.