Assent Document Template

Assent template version date: 08/29/2016

ASSENT For Child Participants 7-11 Years Old

TITLE:

SPONSOR:

PROTOCOL NO.:

INVESTIGATOR:

24 HR. TELEPHONE:

WHY ARE YOU HERE?

We are asking you to be in a research study because you have [list disease/condition under study].

About [X] children will be in the study.

WHY IS THE STUDY BEING DONE?

The study is being done to find out if study medicine works and if it is safe to give to children who have [list disease/condition under study].

If applicable: [The study medicine is used in adults but it is experimental for children. This means that the study medicine has not been approved by United States government officials to be used to treat [list disease/condition under study] in children.]

of 4 WHAT WILL HAPPEN TO YOU?

If you go into the study, you will come to the study office [X] times.

The following bulleted text is used to illustrate how study procedures must be explained to children 7-11 years old. Customize the “What will happen to you?” section of the Assent with protocol-specific procedures.

The following procedures will be done:

 We will ask you how you are feeling (every time you come to the study office).  We will ask you about your medicines (every time you come to the study office).  We will measure your blood pressure ([X] times).  We will measure how tall you are and how much you weigh ([X] times).  The doctor will examine your body and listen to your heart and lungs with a stethoscope ([X] times).  We will ask you to give us a urine sample in a cup ([X] times).  We will take a blood sample from a vein in your arm, using a small needle. o At [X] visits, blood will be taken [X] times. We may put a small plastic tube in your arm so you do not have to be stuck with a needle each time.  We will put sticky pads on your chest, legs and arms so that we can do a heart beat test ([X] times).  You will keep a diary about the study medicine and how you are feeling (every day).

If applicable: [You will take study medicine pills for [X] weeks.] [You must be able to swallow a pill whole. If you have trouble doing this, you cannot be in the study.]

If applicable: [You will use the study medicine inhaler for [X] weeks.] Assent template version date: 08/29/2016

WHAT BAD EFFECTS CAN HAPPEN TO YOU BY BEING IN THE STUDY?

You may feel sick when you take the study medicine.

You may have one or more of the following from the study medicine: [list reasonably foreseen AE’s in terms appropriate for the child’s age and level of understanding].

The following bulleted text is used to illustrate how procedure risk must be explained to children 7-11 years old. Customize this section of the Assent with protocol-specific procedure risk text.

You may have bad effects from the study procedures:

 You may feel a little bit uncomfortable when we measure your blood pressure with a tight armband.  When a needle is put in your arm to collect blood, it may hurt.  The diary may be hard to complete and you may not enjoy trying to answer diary questions.

You may feel other bad effects not listed.

You must tell your parents or legal guardian and the study doctor if you feel sick or have bad effects.

WILL YOU GET BETTER IF YOU ARE IN THE STUDY?

Being in the study may or may not help you.

WHO WILL KNOW ABOUT THIS STUDY?

The study is private. What the study doctor learns about you will be shared with your parents or legal guardian. The people who make the study medicine, scientists working on the study and the part of the government that makes rules about medicine will need to see what is learned, but they are not allowed to tell anyone about you.

If any bad effects happen during the study, those effects will be reported to the company that makes the study medicine and reported to the United States government.

of 4 DO YOU HAVE TO BE IN THE STUDY?

You do not have to be in the study if you do not want to. You can stop at any time and no one will be mad at you. Your regular doctor will still take care of you. You can ask any questions about the study at any time.

I would like to be in this study.

______Printed Name of Child Participant

______Child Assent Signature Date (For Child Subjects 7 to 11 Years Old)

______Printed Name of Person Obtaining Assent

______Signature of Person Obtaining Assent Date