---
kind: "section"
citation: "40 C.F.R. § 26.1125"
title: "40"
number: "26.1125"
heading: "Prior submission of proposed human research for EPA review."
url: "https://uscodex.org/cfr/40/26.1125"
---

# §26.1125. Prior submission of proposed human research for EPA review.


Any person or institution who intends to conduct or sponsor human research covered by [§ 26.1101(a)](/cfr/40/26.1101.md?p=a) shall, after receiving approval from all appropriate IRBs, submit to EPA prior to initiating such research all information relevant to the proposed research specified by [§ 26.1115(a)](/cfr/40/26.1115.md?p=a), and the following additional information, to the extent not already included:

- (a) **A discussion of—**
  - (1) The potential risks to human subjects;
  - (2) The measures proposed to minimize risks to the human subjects;
  - (3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue;
  - (4) Alternative means of obtaining information comparable to what would be collected through the proposed research; and
  - (5) **The balance of risks and benefits of the proposed research.**
- (b) All information for subjects and written informed consent agreements as originally provided to the IRB, and as approved by the IRB.
- (c) Information about how subjects will be recruited, including any advertisements proposed to be used.
- (d) A description of the circumstances and methods proposed for presenting information to potential human subjects for the purpose of obtaining their informed consent.
- (e) **All correspondence between the IRB and the investigators or sponsors.**
- (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that research involving human subjects has been reviewed and approved by an IRB.

## 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.