40 CFR § 26.402 - Definitions.

---
identifier: "/us/cfr/t40/s26.402"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "40 CFR § 26.402 - Definitions."
title_number: 40
title_name: "Protection of Environment"
section_number: "26.402"
section_name: "Definitions."
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"
---


# 26.402 Definitions.

The definitions in § 26.102 shall be applicable to this subpart as well. In addition, the following terms are defined:

(a) For purposes of this subpart, *Administrator* means the Administrator of the Environmental Protection Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been delegated by the Administrator.

(b) *Assent* means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

(c) *Permission* means the agreement of parent(s) or guardian to the participation of their child or ward in research.

(d) *Parent* means a child's biological or adoptive parent.

(e) *Guardian* means an individual who is authorized under applicable State, Tribal, or local law to consent on behalf of a child to general medical care.

(f) *Observational research* means any research with human subjects that does not meet the definition of research involving intentional exposure of a human subject in § 26.202(a).

[71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019]