Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D

Document information
Reference	USA 45 CFR Part 46 09-Apr-2025
Validity area	USA
Scope(s)	G
Document name	45 CFR Part 46
Version / Revision	09-Apr-2025
Status	Current
Document type	Legal act
Language(s)	EN
Description	Title 45—Public Welfare Subtitle A—Department of Health and Human Services Subchapter A—General Administration Part 46 Protection of Human Subjects https://www.ecfr.gov/current/title-45
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.1.4
Scope	G
Document part	Subpart D
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Minor / Paediatric, Assent, Legal representative, Ethics committee, Definition
Comment	Additional protections for children as research subjects

Content

Subpart D—Additional Protections for Children Involved as Subjects in Research […] § 46.402 Definitions. 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.

§ 46.403 IRB duties. [...] § 46.404 Research not involving greater than minimal risk. [...] § 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. [...] § 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. [...] § 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. [...] § 46.408 Requirements for permission by parents or guardians and for assent by children. [...] § 46.409 Wards. [...]