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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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