Title 34

PART 97 SUBPART D

Subpart D - Additional ED Protections for Children Who Are Subjects in Research Source:62 FR 63221, Nov. 26, 1997, unless otherwise noted.

• 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; 42 U.S.C. 300v-1(b).
• Source: 56 FR 28012, 28021, June 18, 1991, unless otherwise noted.

34:1.1.1.1.31.3.121.1	SECTION 97.401	97.401 To what do these regulations apply
34:1.1.1.1.31.3.121.2	SECTION 97.402	97.402 Definitions.
34:1.1.1.1.31.3.121.3	SECTION 97.403	97.403 IRB duties.
34:1.1.1.1.31.3.121.4	SECTION 97.404	97.404 Research not involving greater than minimal risk.
34:1.1.1.1.31.3.121.5	SECTION 97.405	97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
34:1.1.1.1.31.3.121.6	SECTION 97.406	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.
34:1.1.1.1.31.3.121.7	SECTION 97.407	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.
34:1.1.1.1.31.3.121.8	SECTION 97.408	97.408 Requirements for permission by parents or guardians and for assent by children.
34:1.1.1.1.31.3.121.9	SECTION 97.409	97.409 Wards.

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