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* 1. Please read this paragraph for Assent, then provide open-ended feedback to let us know if the paragraph was understandable and easy to be read.  If not, please state why.  

WHAT SHOULD I KNOW ABOUT BEING IN A STUDY? 

• We will tell you about this study. We will give you a copy of this form to take home. 

• If you don’t understand something, please ask us as many questions as you need. 

• Your parent[s] (or whoever is taking care of you) needs to say yes to letting you be in the study. 

• You do not have to be in this study if you don’t want to, even if your parent[s] has already said yes. 

• If you say yes to be in this study now, you can change your mind after you start doing the study. 

• If you choose not to be in this study or choose to stop being in this study, your doctors will continue to take care of you and they will not be mad at you. 

• If you become pregnant during this study, please let us and your doctor know.

Question Title

* 2. Please read this paragraph for Assent, then provide open-ended feedback to let us know if the paragraph was understandable and easy to be read. If not, please state why.

WHY AM I BEING ASKED TO BE IN THIS STUDY?

You are being asked if you want to be in this study because you are being given a medicine by your doctor which we are studying. 

WHY IS THE STUDY BEING DONE? 

We want to learn more about how certain medicines work in the bodies of children and young people.

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* 3. Please read this paragraph for Assent, then provide open-ended feedback to let us know if the paragraph was understandable and easy to be read. If not, please state why.

WHAT IS GOING TO HAPPEN WHEN I AM IN THE STUDY?

You will be in this study for up to 90 days at a time. 

We will do everything we need to do for the study while you are seeing your doctor for a regular visit. You do not have to come to see your doctor for extra visits if you are in this study. If you decide you want to be in this study, this is what will happen to you. 

• We will look at your doctor’s records to find out more information about you. We will write this information down. 

• We will measure your height and weight. 

• We will try to collect a little more of your blood when you are already having it taken as part of your regular care. This may not always be possible, so we may need to collect your blood up to 10 extra times, about half a teaspoon each time. You may need to have extra needle sticks for this. 

• We will use the blood we collect to measure the amount of medicine we are studying in your blood. 

• Your leftover blood may be used for future testing. We don’t know what this testing will be. Your blood may be stored forever in the United States. 

• You will be asked some questions about how you are feeling. 

• We will use some of the blood to study how the medicine(s) we are studying works in the body if a child has certain genes. Genes control things like eye color, height, and how the body works. Your genes may affect how the medicine(s) we are studying is broken down in the body. We will not give you an extra needle stick to collect this blood. 

• We may use some of the blood to test for certain biomarkers. Biomarker tests can help us better understand the body’s response to certain medicines(s). 

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* 4. Please read this paragraph for Assent, then provide open-ended feedback to let us know if the paragraph was understandable and easy to read.  If not, please state why.  

WILL BEING IN THE STUDY HELP ME? 

We do not know if being in this study will help you. We hope that what we learn from this study will help other children/young people in the future. 

CAN BAD THINGS HAPPEN TO ME DURING THE STUDY?

Sometimes things happen to people in studies that may make them feel bad. 

When you have your blood taken: 

• it may hurt 

• you may get a bruise at the place where the blood is taken 

• you might feel dizzy 

• there is a small chance you might get infections where the blood is taken 

These things may or may not happen to you. You may have other feelings or problems that have not happened before. Tell your parents or tell your doctor or the study doctor if you feel sick during the study.

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* 5. Please read this paragraph for ASSENT, then provide open-ended feedback to let us know if the paragraph was understandable and easy to read.  If not, please state why. 

CHILD’S ASSENT
My questions have been answered about the study. I have read this form, or had it read to me and I understand: 

• Why this study is being done. 

• What is going to happen to me when I’m in the study 

• Who I can ask if I have questions 

• I don’t have to be in this study if I don’t want to, even if my parent says yes. 

• I can stop at any time and my doctor will still take care of me. 

Child’s Name (printed): 

By signing or marking below, I am agreeing to be in this study 

Date: Child’s Signature/Mark: 

STUDY STATEMENT OF PERSON OBTAINING ASSENT 

• I have explained the study in the language understood by the participant. 

• I have answered all the questions of the participant relating to this study. 

• The participant agrees to be in the study. 

• I believe the participant’s decision to be in this study is voluntary. The information below can only be completed by the person obtaining permission/assent. 

Person Obtaining Assent Name (printed): 

Person Obtaining Assent Signature: Date: 



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