Assent Template and Assent Information

Assents and Assent Template

Assent Template

This is a library of consent language that you may use as applicable in your protocol. For any questions about the use of this language in your consent, please contact irb@od.nih.gov.

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

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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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45 CFR 46.408(e) and 21 CFR 50.55(g) are vague with regard to the details of documentation of assent. At the NIH, we encourage investigators to develop a written assent that is appropriate to the age and condition of the children being studied.  The method of obtaining assent and how it will be documented should be described in the protocol.  Investigators will be expected to follow what is in the IRB approved protocol.

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How should assent be documented?

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The regular consent document should be written as close to an 8^th grade reading level as possible.  As such, you may consider having older children (ages 14 and up) sign the regular consent as their assent document, as they are able to read and understand that document.

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AssentTemplate AssentTemplate

Assent Template