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Child Assent Form

This child assent form is for a study testing the efficacy of an ABC medication for children exhibiting ADHD-like symptoms, with and without behavioral modification. If the child agrees to participate, they will take ABC medication tablets twice daily and complete surveys with their parents/guardians every two weeks. For the behavioral modification group, the child must follow guidelines around diet, sleep, and exercise. The child will visit the doctor's office twice over the course of the study. They are not obligated to participate and can withdraw consent at any time without penalty.

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34 views2 pages

Child Assent Form

This child assent form is for a study testing the efficacy of an ABC medication for children exhibiting ADHD-like symptoms, with and without behavioral modification. If the child agrees to participate, they will take ABC medication tablets twice daily and complete surveys with their parents/guardians every two weeks. For the behavioral modification group, the child must follow guidelines around diet, sleep, and exercise. The child will visit the doctor's office twice over the course of the study. They are not obligated to participate and can withdraw consent at any time without penalty.

Uploaded by

Dana
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Child’s Assent Form

Study Title: A Study to Determine Efficacy of ABC Medication with and without Behavior
Modification on Children Exhibiting Behavior Disorders including ADHD like Symptoms.
Principal Investigator: «First Name» «Last Name», «Degree»
Sponsor: ABC Hospital

What is a research study?

When doctors and scientists want to learn more about something, they have to test it on people to
see if it helps people and make sure it doesn’t hurt them.

Why do you want me to be in this study?

The people who are running this study think that a dietary supplement called ABC Medication
and changes to how you eat, sleep, and exercise will help children like you who have trouble
focusing. But, they have to be able to tell doctors how to use the dietary supplement in children.
That is why we are asking you to help us test ABC Medication. You do not have to be in the
study if you do not want to be.

What do I have to do?

If you choose to be in this study:

 Your parents/guardians will pick up a ABC Study Kit at the pharmacy


 Your parents/guardians/teacher will answer a survey before you start and every 2 weeks
during the study
 You will take ABC Medication tablets two times a day.
 If you are in the behavioral change group, you will have to eat a good breakfast and avoid
caffeine, sugar, and eating close to bedtime. You will need to get plenty of sleep. You
will need to get some exercise most days.

You will take 1-6 pills a day during the study.

You will go to the doctor’s office 2 times, one time before you start the study and one time at the
end.

You can ask any question you want before you decide if you want to be in this research study or
not. The doctor or nurse will answer your questions.
What if I do not want to be in this study?

You do not have to be in this study. If you do not want to be in the study, the doctor will not
force you to be in it. If you decide to be in the study, but change your mind, you can stop being
in the study.

If you do not want to be in the study, or if you change your mind, just tell the doctor or nurse.
You might have to have some more tests to make sure you are OK, but then you will not be in
the study any more.

Will I get anything for being in the study?

You will not get anything for being in this study.

Could I be hurt if I am in the study?

The ingredients in the dietary supplement have been tried on many adults and children already,
so the doctors really think that it will not harm you.

If you feel sick or are afraid that something is wrong with you, tell an adult at once.

Now I think I know about the study and what it means- Here is what I decided:

□ No, I do not want to be in the study


□ OK, I will be in the study
_____________________________________________ ____________________
Your name (printing is OK) Date

I certify that this study and the procedures involves have been explained to (Insert Subjects
Name) in terms he/she could understand and that he/she freely assented to participate in this
study.

_____________________________________________ ____________________
Signature of Person Obtaining Consent Date/Time

__________________________________________________________________________
Name (print)

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