INFORMED CONSENT FORM Child Assent To Participate In A Research Study

INSTRUCTIONS:  DELETE the instructions and all information highlighted in blue.  Statements in red are required and, if applicable, must be included in your Informed Consent document. Optional or suggested statements are in blue and may be included at the researcher’s discretion. Change font color of required statements and optional statements to black.  The Child Assent should be written in 2nd person (e.g., you are invited to participate, you will be asked…)  The Child Assent should be written at a level the child will be able to understand.  The page numbering inserted must be maintained.  Your IRB number and expiration date will be provided by the IRB Administrator in your letter of approval. This information must be included on Informed Consent documents. A copy of the Informed Consent Document, including the IRB number and expiration date must be sent to the IRB office within 10 days of receiving IRB approval.  Generally, a child 7-18 years of age should sign an assent form.

You are being asked to be part of a project. The project is called [insert study title on IRB application]. Your parents have already been told about the project. Please read this form and ask the researcher [or teacher, if applicable] any questions you have. It is your choice to be part of the project or not.

This project is being conducted by researchers at the University of West Georgia. [Researcher should disclose role/relationship to participants or school/location where study is being conducted.]

1. What will happen to me in this project? (Description of the study) Describe, using simple terms, the research study. Explain what the child will be expected to do. Explain how long you expect it to take the child to complete assigned tasks. If media recording is to be part of the study, let the child know that you won’t record them without their permission.

2. Can anything bad happen to me? (Risks or Discomforts of Participating) Explain any potential risks (legal, physical, psychological, or social) to the child, using simple terms. Discuss any discomforts or stresses that may occur. Explain that the child should inform his/her parents if they are sick or in pain as a result of being in the study.

IRB # Page 1 of 3 IRB expiration date: Child Assent January 2012 (v-2) 3. Can anything good happen to me? (Benefits of Participating) Describe any potential benefit to the child. Include any possible future benefits to others. If there are no known benefits, state that here.

4. Do I have other choices? (Appropriate Alternatives) Describe any alternative procedures that might be available to the child other than this study. If none, this section can be omitted.

5. Will anyone know I am in the project? (Confidentiality) Explain in simple terms that the child’s participation in the study will be kept secret, but information about him/her will be given to the study sponsor. Explain that the child’s answers, actions, or statements will not be told to parents or teachers. Note: This information may not be applicable in assent forms for very young children.

6. What happens if I get hurt? (Compensation for Participation/Medical Treatment) Describe that the child’s parents/legal guardians have been given information on what to do if the child is injured during the study.

7. Who can I talk to about the project? (Contact Information) If you have any questions about the study or any problems to do with the study you can contact the Principal Investigator [name of PI]. You can call him/her at [PI’s phone number]. You can also call [name], the faculty advisor, at [phone number].

Keep the following sentence in exactly as written: If you have questions about the study but want to talk to someone else who is not a part of the study, you can call the UWG Research Compliance Officer, Charla Campbell, at 678/839-4749 or [email protected].

8. What if I do not want to do this? (Voluntary Participation) Let the child know that they can stop being in the study at any time without getting in trouble and that their doctor will continue to treat them if treatment is necessary and available.

SIGNATURE

If you agree to be in this study, please sign here:

______Signature of Child Date ______Signature of Person Obtaining Assent Date

IRB # Page 3 of 3 IRB expiration date: Child Assent January 2012 (v-2)