- (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]