40 CFR 26.1704 : Protection Of Environment (§ 1.1 To Parts 1851-1899) — (§ 1.1 To Appendix To Subpart M Of Part 49) — Environmental Protection Agency (§ 1.1 To Appendix To Subpart M Of Part 49) — General (§ 1.1 To § 29.13) — Protection Of Human Subjects (§ 26.101 To § 26.1706) — Standards For Assessing Whether To Rely On The Results Of Human Research In Epa Actions (§ 26.1701 To § 26.1706) — 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.

(c) The prohibition in this section is in addition to the prohibitions in § 26.1703.