Guidance

Children in Research

IRBMED

Mar 8, 2021 3:00 pm

The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow.

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 (45 CFR 46.402)

Neonates (less than 28 days of age)
Regulations: Research Involving Neonates of uncertain viability, and nonviable neonates (45 CFR 46.205)

Research on viable neonates is covered under regulations on child subjects, 45 CFR 46 Subpart D (.401 and following)
Assent (pediatric subject's agreement to participate in research)
Assent of Children in Research

Assent Template recommended for children ages 10- to 14-years-old

Assent Guidelines--tool demonstrating common IRB determinations for when assent is required, based on the age of the participant and whether the study offers the prospect of direct benefit
Office of Human Research Protections (OHRP)
Regulations: Additional Protections for Children Involved as Subjects in Research (45 CFR 46, Subpart D)

Frequently Asked Questions: Children in Research

Research with Children: What Parents Need to Know – 7-minute video

Special Protections for Children as Research Subjects (Overview of the 4 regulations under which child subjects are permitted)

Research involving greater risk than 'minor increase over minimal' without direct benefit to participants -- Guidance for 45 CFR 46.407
Food and Drug Administration (FDA)
Regulations: Additional Safeguards for Children in Clinical Investigations (21 CFR 50, Subpart D)

General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (“Pediatric Drug Development” Draft Guidance 2014)
Other
National Cancer Institute Guidance: Children’s Assent
Information directed at parents, and in ‘plain language,’ on the process and meaning of children’s assent; illustrative for all types of research.

NIH Inclusion Across the Lifespan Policy
Applications and proposals involving human subjects research must address plans for including individuals across the lifespan in the PHS Human Subjects and Clinical Trial Information Form.

Units: Institutional Review Boards (IRBMED)

Topic: Informed Consent & Assent Investigator & Study Team Responsibilities Regulations & Policies (Federal, State & Local) Subject Payments & Reimbursement

Questions?

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Edited By: [email protected]
Last Updated: March 19, 2021 2:30 PM

Children in Research

Neonates (less than 28 days of age)

Assent (pediatric subject's agreement to participate in research)

Office of Human Research Protections (OHRP)

Food and Drug Administration (FDA)

Other

Questions?

Guidance by Topic / Unit

See Also

Pages

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