Title 40

SECTION 26.1704

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

§ 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.

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

[78 FR 10545, Feb. 14, 2013]

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