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Their parents
l age for consent to treatments orin the research, under the applicable law of the jurisdiction in which the research will be conducted.
(b) "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
(c) "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
(d) "Parent" means a child's biological or adoptive parent.
(e) "Guardian" means an individual who isState or local law to consent on behalf of a child to general medical care.
§46.403 IRB duties.
In addition to other responsibilities assigned to IRBs under this part, each IRBresearch covered by this subpart and approve onlythe conditions of all applicable sections of this subpart.
§46.404 Research not involving greater than minimal risk.
DHHS 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 as
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