(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 Sec. 26.101(b)(1) through (b)(6) are applicable to this subpart.
(c) The provisions of Sec. 26.101(c) through (i) are applicable to this subpart. References to State or local laws in this subpart and in Sec. 26.101(f) are intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.
(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.