Assent Template and Assent Information

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Assent

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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.The regulations define when assent of children will be required and when it can be waived. The IRB can waive the requirement for assent if either:

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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.

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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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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