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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 34Part 97Subpart D - Subpart D—Additional ED Protections for Children Who Are Subjects in Research
§ 97.401 - To what do these regulations apply?
§ 97.402 - Definitions.
§ 97.403 - IRB duties.
§ 97.404 - Research not involving greater than minimal risk.
§ 97.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
§ 97.406 - 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.
§ 97.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
§ 97.408 - Requirements for permission by parents or guardians and for assent by children.
§ 97.409 - Wards.
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