Assent Form/Guidance

The following form is appropriate for 8 - 11 year old participants.  For 12 - 17 year old participants, the Assent Form can be closer to the adult Consent Form, but the language and wording should be simplified.  Imagine talking to a 12-year-old when writing the form.

  1. Why is this study being done?

    We are trying to find out more about….

  2. Do I have to be in the study?

    No, you can just say no, and that will be OK.

  3. What will happen to me if I’m in the study?

    (Simple explanation of what the child will be asked to do)

  4. Will anything bad happen to me:

    (Answer honestly, if there will be any pain or discomfort, and explain what will be done to make it easier)

  5. Can this study help me?

    (Answer honestly, either that it will help the child or that it will not help the child personally, but may be helpful in some other way)

  6. Will I get anything if I decide to be in the study?

    (Answer honestly, whether they will receive payment of any kind or not.)

  7. Will people know that I am in the study?

    If you don’t want anyone to know, we won’t tell them. The researchers and your parents, will, of course, know. (If anyone else will know about their participation, you must say so.)

  8. Is there anything else that I should know about the study?

    You don’t have to be in the study if you don’t want to be. If we learn of any reasons why you might change your mind about being in the study, we will tell you. We will try to answer all of your questions.

Suggested language regarding assessing behavioral assent:

Assent will be assessed behaviorally based on whether or not the participant expresses reluctance or objection, including attention to body language (e.g., stiffness, withdrawal, head shaking) and facial expression (e.g., eye narrowing or mouth tightening). When describing a blood draw, we point to the arm where blood will be drawn. Expression of dissent include persistent concerns about missing program activities, for example, even after reassurance or expressing reluctance about any of the study procedures. An independent staff member or family member who knows the potential participant well are present throughout the assent process and provide an independent assessment of willingness to participant. They and the potential participant sign the assent form. Even after assent for study procedures has been obtained, participants may refuse any component of the study at any time during participation and may withdraw from the study at any time. Assent is obtained at every visit.

Blood draws

For blood draws in studies involving children consider specifying in the PSF and CF that EMLA cream (a topical anesthetic) will be used.