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Assent from minors under Subpart D of 45 CFR 46 and 21 CFR 50

The regulations at 45 CFR 46.408 and 21 CFR 50.55 include the requirements for obtaining or waiving parental permission and assent of child participants.

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How should assent be documented?

The IRB recognizes that the abilities and needs of children vary widely, so investigators, when obtaining assent from a minor, should provide study information in a format tailored to the child that is in front of them. 

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Assent Template

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