Title 45

PART 46 SUBPART D

Subpart D - Additional Protections for Children Involved as Subjects in Research Source:48 FR 9818, Mar. 8, 1983, unless otherwise noted.

• 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
• Source:

45:1.0.1.1.26.4.1.1	SECTION 46.401	46.401 To what do these regulations apply
45:1.0.1.1.26.4.1.2	SECTION 46.402	46.402 Definitions.
45:1.0.1.1.26.4.1.3	SECTION 46.403	46.403 IRB duties.
45:1.0.1.1.26.4.1.4	SECTION 46.404	46.404 Research not involving greater than minimal risk.
45:1.0.1.1.26.4.1.5	SECTION 46.405	46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
45:1.0.1.1.26.4.1.6	SECTION 46.406	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.
45:1.0.1.1.26.4.1.7	SECTION 46.407	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.
45:1.0.1.1.26.4.1.8	SECTION 46.408	46.408 Requirements for permission by parents or guardians and for assent by children.
45:1.0.1.1.26.4.1.9	SECTION 46.409	46.409 Wards.

---