1. LawStack
  2. Title 45 - Public Welfare
  3. Chapter I - DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter A - GENERAL ADMINISTRATION
  5. Part 46 - PROTECTION OF HUMAN SUBJECTS
  6. Subpart D - Additional Protections for Children Involved as Subjects in Research
  7. 45 CFR § 46.404
45 CFR § 46.404
Research not involving greater than minimal risk
April 14, 2021
CFR

HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in §46.408.

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§ 46.403 IRB duties
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§ 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects

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