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Assent Policy

If minors (those under 18 years of age) will be enrolled in your study, you need:

• A parental permission document (similar in format to a consent document)
• An adolescent assent document, for participants ages 14-17
• A child assent document, for participants ages 9-13

In some instances (i.e. minimal risk studies), one assent document may be used for all minor participants (ages 9-17), but it must be written in language that will be easily understood by the youngest participants.

Click here for an assent template to be followed when writing assent documents.

Definitions

• Child Assent Document – an age-appropriate form (2nd to 3rd-grade reading level) with a simple explanation of why the study is being done, why they are being invited to be in the study, what they will be asked to do if they are in the study, common risks and benefits, and a clear statement that participation is voluntary. This document will be used to help obtain assent from children between ages 9-13.
• Adolescent Assent Document – an age-appropriate form, written at most on an 8th-grade reading level, with an explanation of the study purpose, procedures, risks and benefits, and a clear statement that participation is voluntary. This document will be used to help obtain assent from children between ages 14-17 years.
• Permission Document – a form written on an 8th-grade reading level (similar to a consent document, but using “your child” throughout) that contains all essential elements of consent. This form will be used to help obtain permission from a minor’s parent(s) or legally authorized representative for a minor’s study participation.