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Working with Children

Children are one of the populations for which there are special protections as defined by Federal Regulations 45CFR46 and 21CFR50. There are certain issues to consider when working with children. Researchers will want to address the rationale for including children as part of the subject population.


Researchers should refer to the Assent Guidelines. Assent and parental permission examples are provided on the forms page.


OHRP Special Protections for Children as Research Subjects

OHRP FAQs about Research with Children

Inclusion of Children Policy Implementation NIH

Children’s Assent to Clinical Trial Participation

Checklist for Research Involving Minors