Institutional Review Board s1

Institutional Review Board FWA 00002292

Please use this template to create an assent document for your research project. To use this template, follow the instructions in blue and complete the document as fully as possible. Unless otherwise indicated as “if appropriate”, all yellow fields are required. Once completed please delete all of the options that are not applicable and all template instructions (in blue text).

MINOR ASSENT FORM

Study name

Name of PI is doing a research study to learn more about study topic in easy to understand language.

Why are we doing this research study? The reason we are doing this research is to simple explanation of study purpose.

Why are you being asked to be in this research study? You are being asked if you want to be in this research study because list condition(s) which renders the individual eligible. You don’t have to be in the study if you don’t want to be.

What will happen during this study? This study will take place at study site and will last duration For younger children, provide a comprehensible measure of time—for example, the length of time of a TV show or movie, for a morning or afternoon.

If you decide that you want to be in this research study, this is what will happen to you:

1. List procedures in an easy to understand way.

2. Use commonly understood units of measurement (such as teaspoons) when possible.

3. Indicate length of time of the participant's active involvement.

What are the good things that might happen in this study? People may have good things happen to them because they are in research studies. These good things are called “benefits.”

Include one of the following: The benefits of this study to you might be: list benefits (do not include payments or incentives in this section)

There is little chance of benefit to you from being in the research study.

of 3 Informed Assent Template v. 1.1 06/07/2011 There are no benefits to you from being in the research study.

Consider adding: We hope to find benefits for people in the future.

What are the problems that might happen in this study? Focus on the risks specifically related to enrollment in the research study. Remember to use simple terms. If there are no known risks, state this fact.

Sometimes people have problems in research studies that make them feel bad. Some problems that might happen during this study are:

Bulleted list of study risks in easily understood terms

Not all of these problems will happen to you. Some problems might happen that the researchers don’t know about. It is important to let the researchers and your parents or guardians know right away if there is anything that you don’t like about the research study. Sometimes things that bother one person don’t bother another person at all, so you need to let us know when something is bothering you.

You can stop whenever you want and no one will be mad.

Who will be told the things we learn about you in the study? Describe who will have access to the study information (PI, other researchers, nurses, subjects’ physician, parents, etc.). Be clear about whether pregnancy, illegal activity, or psychological tendencies will be reported and to whom. Be very clear about what parents and teachers will be told.

Your name will not be in any report of the results of this study.

If applicable: A number or code will be used instead of your name in the study materials.

Will you get any money for being in this research study? Choose ONE applicable sentence. Only indicate if the minor is receiving money or gift. Address how payment will be prorated in the event that the minor withdraws from the study prior to completion.

You will not receive any money or gifts for being in this research study.

You will receive Payment Amount for being in the study.

Who should you ask if you have any questions? You can ask PI Name, any of the study researchers or your parents/guardians about anything in this study at any time.

If you or your parents have other questions, worries, or complaints, you can call the Carle Institutional Review Board at (217) 383-4366.

What if you or your parents/guardians don’t want you to be in the study? Your parents/guardians need to give us permission for you to be in this study. You do not have to be in this study if you don’t want to, even if your parent/guardian has already given us permission.

Choose ONE applicable sentence below:

of 3 Informed Assent Template v. 1.1 06/07/2011 If you or your parents/guardians don’t want you to be in this study, here are some other things you may be able to do: Bu lleted list of available alternatives If the study is clinical research, describe standard care and alternative treatments here.

If you or your parents/guardians don’t want you to be in this study, you do not have to be a part of the study Choose this option if the only alternative to study participation is to not participate.

What if you change your mind? You can stop being in the study at any time. If you want to stop, just tell one of us and we will stop right away. If you decide to stop, no one will be angry or upset with you. You can ask questions at any time.

If applicable: Your doctors will still continue to take good care of you.

Signing this paper means that you have read it or had it read to you, and that you want to be in the study. If you do not want to be in the study, do not sign the paper.

You don’t have to be in this research study if you don’t want to. Nobody will be mad at you if you say no. Even if you say yes now and change your mind after you start doing this study, you can stop and no one will be mad. You agree that you have been told about this study, why it is being done, and what to do.

___ Yes, I will be in this research study.

___ No, I don’t want to do this.

______Printed Name of Person Agreeing to be in the Study Date Signed

______Signature of Person Agreeing to be in the Study Date Signed

______Printed Name of Person Obtaining Informed Assent Date Signed

______

Signature of Person Obtaining Informed Assent Date Signed

of 3 Informed Assent Template v. 1.1 06/07/2011