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5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b).
56 FR 28012, 28022, June 18, 1991, unless otherwise noted.
71 FR 6168, Feb. 6, 2006, unless otherwise noted.
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71 FR 6168, Feb. 6, 2006, unless otherwise noted.
This subpart applies to any research subject to subpart K of this part.
[78 FR 10544, Feb. 14, 2013]
The definitions in § 26.1102 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. In addition, a child is a person who has not attained the age of 18 years.
Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support research covered by § 26.1201 that involves 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]