A.4 LOI3-BIO-0 Child Assent

CHILD’S/ADOLESCENT’S ASSENT FORM TEMPLATE

CHILDREN'S MEMORIAL HOSPITAL

INSTITUTIONAL REIVEW BOARD

Adolescent’s Agreement to Participate in a Research Study

Ages 12- 17

We are asking you to be in a research study called:

Analysis of Environmental Chemicals in Dried Blood Spots

(Title of study)

The study is being done by Thomas McDade at Northwestern University’s Department of Anthropology.

WHY IS THIS STUDY BEING DONE?

We want to tell you about a research study at Children’s Memorial Hospital. Research studies help us find better ways to take care and treat children who are sick with a disease, to learn how medicines work, and how our bodies work. Research studies are voluntary, which means that you only have to participate in the study if you want to.

We are asking you to be in this research study because we want to learn more about what bad things can get in children’s blood to make them sick, and what is the best way to take blood. Our researchers want to take blood from children in Chicago, to see what kinds of bad things are there. Different things can get into the blood from water, air, soil, and even gasoline, wood, and smoke – things children are around every day. If researchers can find what gets in in children’s blood and can find easy ways to take blood, they may be able to find ways to make children healthier.

WHAT HAPPENS IN THE STUDY AND HOW LONG WILL I BE IN THE STUDY?

If you want to be in the study, here is what will happen: first, the nurse or doctor will prick your finger and drop three to five spots of blood onto a piece of paper. Then, they will draw a small tube of blood, about the size of your thumb, from your arm at the same time that you are already having your blood taken. This will only take a few minutes. The nurse or doctor will ask you for your age and whether you are a boy or a girl. These are the only things you will be asked to do if you decide to be in this study. In the future, the blood we draw from you today could be used in another study trying to answer the same kinds of questions.

WHAT ARE THE GOOD THINGS ABOUT THE STUDY?

Although you may not be helped by this study, we hope to learn something that could help other children in the future who have health problems that are caused by what is around them in their everyday lives.

WHAT ARE THE NOT-SO-GOOD, BAD, OR HARMFUL THINGS THAT COULD HAPPEN TO ME IF I AGREE TO BE IN THIS STUDY?

When we take blood from your arm or finger, the needle might hurt and you might get a bruise, but we will do everything we can to make sure it won’t hurt as much.

WHAT OTHER OPTIONS ARE THERE?

You do not have to be in this study if you don’t want to. Your doctors will not be upset with you. If you join the study and then change your mind, it is okay for you to leave this study.

What about my confidentiality?

We will do everything possible to make sure that your participation in this study is kept private. Participation in this study may be included in your medical records.

Unless required by law, only representatives of the following groups or organizations can review your study records.

• The Principal Investigator

• The Children’s Memorial Hospital Institutional Review Board (IRB): This is the hospital’s board that is in charge of protecting the rights of all adults and children who participate in research studies.

They are required to keep your personal information private.

WILL I RECEIVE ANY PAYMENT OR GIFTS IF I AM IN THIS STUDY?

To thank you for helping us with this study, we will give you a $15 gift card.

WHAT IF I HAVE QUESTIONS?

You can ask questions whenever you have them. You can ask your doctor, nurse or other people working with them on the study. You can also ask your parents.

Your parents know about the study and said that it is okay if you want to be in the study. If you don’t want to be in the study, that is okay.

If you are not happy with this study and want to talk with someone else, not the doctor or the people working with the doctor, you may contact Philip V. Spina, Senior Vice-President and Chief Operating Officer at Children’s Memorial Research Center, at 773-755-6301 or pspina@childrensmemorial.org. His address is 2300 Children’s Plaza, no. 205, Chicago, Illinois 60614-3394.

You will be given a signed and dated copy of this form.

SIGNATURES

I have read this assent form, and I agree to take part in this study as it is explained in this assent form.

Date Signature of Child or Adolescent (only 12-17 years old)

____________________________________________

Printed Name of Child/Adolescent

Please indicate how assent was obtained by initialing the applicable line.

____ I certify that I have explained the above to this research subject and believe that the signature was affixed freely. I also agree to answer any questions that may arise.

____ Written assent was not obtainable because __________________. However, I certify that I have explained the above to this research subject and believe that verbal assent was freely given. I also agree to answer any questions that may arise.

____ Verbal assent could not be obtained because ___________________________. (Contact IRB Chair or his/her designee for approval of a waiver of assent prior to proceeding with research).

Date Signature of Person Obtaining Consent

Printed Name of Person Obtaining Consent

Date Signature of Principal Investigator (if not

listed above)

Printed Name of Interpreter: _____________________________

Printed Name of Witness: _______________________________

Signature of Witness: __________________________________

Assent Version 05/31/11