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e-CFR Data is current as of December 5, 2007


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

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Subpart B—Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women

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

§ 26.201   To what does this subpart apply?

(a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child 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 requirements of this subpart are in addition to those imposed under the other subparts of this part.

§ 26.202   Definitions.

The definitions in §26.102 shall be applicable to this subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart.

(a) Research involving intentional exposure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject's participation in the study.

(b) A child is a person who has not attained the age of 18 years.

§ 26.203   Prohibition of research conducted or supported by EPA involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child.

Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child.

[71 FR 36175, June 23, 2006]

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