40 C.F.R. § 26.1704

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

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(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]

Notes of Decisions

Cited in 2 cases, 2011–2011 · leading case: Nat. Resources Def. Council v. United States Env't Prot. Agency, 658 F.3d 200 (2d Cir. 2011).

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Nat. Resources Def. Council v. United States Env't Prot. Agency, 658 F.3d 200 (2d Cir. 2011). · cites it 2× “40 C.F.R. § 26.1704 . NRDC asserted that the Gledhill study was both “fundamentally unethical and significantly deficient relative to prevailing ethical standards at the time.”

Nat. Res. Def. Council v. Epa (2d Cir. 2011). · cites it 2× “40 C.F.R. § 26.1704 . NRDC asserted that the Gledhill study was both “fundamentally unethical and -10- significantly deficient relative to prevailing ethical standards at the time.”

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