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Children


HHS has recently promulgated specific regulations for research involving children. These are in addition to the general IRB regulations.

(a)
"Children" are persons who have not attained the legal age for consent to treatments or procedures involved in 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 is authorized under applicable State or local law to consent on behalf of a child to general medical care. (sec. 45 CFR 46.402)



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