45 CFR 46.402
§ 46.402 Definitions.
United States · 45 CFR — Public Welfare · Status: effective
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- Citation
- 45 CFR 46.402, § 46.402 Definitions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/216363
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Full text
The definitions in § 46.102 of the pre-2018 Requirements and the 2018 Requirements, as applicable, 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.