40 CFR 26.1704 - Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults.

Regulations last checked for updates: May 18, 2024

Title 40 - Protection of Environment last revised: May 16, 2024

View all text of Subpart Q [§ 26.1701 - § 26.1706]

§ 26.1704 - Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults.

(a) This section applies to research subject to this subpart that is not subject to § 26.1705.

(b) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section if there is clear and convincing evidence that:

(1) The conduct of the research was fundamentally unethical (e.g., the research was intended to seriously harm participants or failed to obtain informed consent); or

(2) The conduct of the research was deficient relative to the ethical standards prevailing at the time the research was conducted in a way that placed participants at increased risk of harm (based on knowledge available at the time the study was conducted) or impaired their informed consent.

[78 FR 10545, Feb. 14, 2013]

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

cite as: 40 CFR 26.1704