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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