Children in Research

• 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)

Guidance and Resources in Research A-Z

• 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

• 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

• 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Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (“Pediatric Drug Development” Draft Guidance 2022)

• 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. Any age-related exclusions must include a rationale and justification based on a scientific or ethical basis.
• Wards of the State as Research Subjects  – There are both state and federal laws that regulate what is allowed and what must be done when a ward participates in a research study.