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Regulations last checked for updates: May 23, 2025

Title 45 - Public Welfare last revised: May 05, 2025
All TitlesTitle 45Chapter APart 46Subpart D - Subpart D—Additional Protections for Children Involved as Subjects in Research
  • § 46.401 - To what does this subpart apply?
  • § 46.402 - Definitions.
  • § 46.403 - IRB duties.
  • § 46.404 - Research not involving greater than minimal risk.
  • § 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
  • § 46.406 - Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
  • § 46.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
  • § 46.408 - Requirements for permission by parents or guardians and for assent by children.
  • § 46.409 - Wards.
authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b)
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