iv. Teenage Subjects and How to Handle Wording on the Consent Document

If investigators plan to recruit teenage subjects (in this instance, teenage means a child older than 12 but less than 18 years of age), and the Informed Consent Document is written at an appropriate reading level, both the teenager and the parent/guardian should sign the Informed Consent.  The teenager’s signature on the Informed Consent Document indicates knowledgeable agreement to participate (assent), and the parent/guardian’s signature indicates legal consent.

In this situation, rather than using “you/your child,” use the word “you” throughout, and insert the following statements at the very beginning of the Consent:

• If you are the parent/guardian of a child who is being invited to be in this study, the word “you” in this document refers to your child.  You will be asked to read and sign this document to give permission for your child to participate.
• If you are a teenager reading this document because you are being invited to be in this study, the word “you” in this document refers to you.  You will be asked to read and sign this document to indicate your willingness to participate.