40 CFR § 26.1117 - Documentation of informed consent.

---
identifier: "/us/cfr/t40/s26.1117"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "40 CFR § 26.1117 - Documentation of informed consent."
title_number: 40
title_name: "Protection of Environment"
section_number: "26.1117"
section_name: "Documentation of informed consent."
chapter_name: "ENVIRONMENTAL PROTECTION AGENCY"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "26"
part_name: "PROTECTION OF HUMAN SUBJECTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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)."
regulatory_source: "56 FR 28012, 28022, June 18, 1991, unless otherwise noted."
cfr_part: "26"
---


# 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. 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 have been presented orally to the subject, and that the key information required by § 26.1116(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.