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Electronic Code of Federal Regulations

e-CFR Data is current as of December 15, 2014

Title 40Chapter ISubchapter APart 26 → Subpart C


Title 40: Protection of Environment
PART 26—PROTECTION OF HUMAN SUBJECTS


Subpart C—Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA


Contents
§26.301   To what does this subpart apply?
§26.302   Definitions.
§26.303   Duties of IRBs in connection with observational research involving pregnant women and fetuses.
§26.304   Additional protections for pregnant women and fetuses involved in observational research.
§26.305   Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.

Source: 71 FR 6168, Feb. 6, 2006, unless otherwise noted.

§26.301   To what does this subpart apply?

(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 §26.101(b)(1) through (b)(6) are applicable to this subpart.

(c) The provisions of §26.101(c) through (i) are applicable to this subpart. References to State or local laws in this subpart and in §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.

§26.302   Definitions.

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).

§26.303   Duties of IRBs in connection with observational research involving pregnant women and fetuses.

The provisions of 45 CFR 46.203 are applicable to this section.

§26.304   Additional protections for pregnant women and fetuses involved in observational research.

The provisions of 45 CFR 46.204 are applicable to this section.

§26.305   Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.

The provisions of 45 CFR 46.206 are applicable to this section.



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