(a) Except as provided in paragraph (b) of this section, this subpart applies to all observational research involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the Environmental Protection Agency (EPA). This includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees.
(b) The exemptions at § 26.104(d) are applicable to this subpart.
(c) The provisions of § 26.101(c) through (m) are applicable to this subpart.
(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
[71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019]
The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition, observational research means any human research that does not meet the definition of research involving intentional exposure of a human subject in § 26.202(a).
The provisions of 45 CFR 46.203 are applicable to this section.
The provisions of 45 CFR 46.204 are applicable to this section.
The provisions of 45 CFR 46.206 are applicable to this section.
source: 56 FR 28012, 28022, June 18, 1991, unless otherwise noted.
cite as: 40 CFR 26.304