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e-CFR data is current as of January 26, 2021

Title 45Subtitle ASubchapter APart 46Subpart D → §46.402


Title 45: Public Welfare
PART 46—PROTECTION OF HUMAN SUBJECTS
Subpart D—Additional Protections for Children Involved as Subjects in Research


§46.402   Definitions.

The definitions in §46.102 of subpart A shall be applicable to this subpart as well. In addition, as used in this subpart:

(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.

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