UNIVERSITY OF WASHINGTON

CHILDREN'S HOSPITAL AND REGIONAL MEDICAL CENTER

ASSENT FORM

 

PRECURSORS TO DIABETES IN JAPANESE AMERICAN YOUTH

 

Principal Investigator:

 

 

Co-Investigators:

 

 

 

 

 

 

24 hour emergency phone number: University of Washington Medical Center (206) 598-6190 (Drs.                  ).  Children's Hospital & Regional Medical Center (206) 526-2000 (Drs.          ).

 

Doctor's Statement:

We are doing a research study to understand how children's bodies use food and how their bodies make fat.  There is nothing wrong with your body, and you are not sick.  Children who are in this study will have a chance to ask lots of questions about how the right kinds of food and exercise can keep them healthy.  By studying healthy children like you, we can learn more about helping children who are sick with a problem called diabetes.  Diabetes happens when the body can't use food in all the ways it is supposed to. 

 

If you want to be in this study, you will come to the clinic two times.  The first time, you will go to another building nearby and have 2 kinds of tests that look at the fat in your body.  For one of these, you will have to lie still on a table for a few minutes.  For the others, you will have to lie still for about 20 minutes.  Then, you will come to the clinic.  We will measure how tall you are, how much you weigh, measure the size of your tummy and hips with a tape measure, and do a physical exam.  We will ask you to try to remember all the different foods you ate yesterday.  We will also ask you what you did yesterday.  For example we might ask you "Did you play on the playground during recess yesterday?".  Your parents will answer questions about the whole family, and about your health.  We will also take some blood samples.  This will mean a poke in the arm.  We will take the needle out right away, but we will leave a small, soft plastic tube in your arm so that we can draw more blood without poking you again.  We will put a little bit of sugar water into the tube in your arm, and then take small amounts of blood out every few minutes.  You will need to sit or lay down while the tube is in your arm, but you can read, watch TV, or play games while you are waiting for us to finish.  We will take the tube out of your arm in one hour.  You will be asked to go without food or drinks (except for water) the night before you come in for these samples.  Two years from now, we will ask you to come back and do the whole thing again.

 

The poke for the blood sample might hurt for a little while.  Sometimes there's a bruise on the skin later on.  It also might hurt a little bit when we put the sugar water in your arm.  Very rarely, the pain may last for several days.  Some children feel embarrassed when they undress for the physical exam.  If you want, your mom or dad can be with you during the exam.  If you'd rather just have the doctor and the nurse there during your exam, that's OK too.

 

You will receive a gift certificate after each visit, as our way of thanking you for taking part in the study.

 

You don't have to be in this study if you don't want to. You can change your mind at any time and tell us you want to stop.  We'll answer all of your questions any time.

 

Doctor's Signature__________________________    Date_______________

 

Child's Statement:

The doctor has told me about this study.  I want to be in it.

 

Child's Signature_________________________Date_____________________________

 

Parent's

Signature_________________________Date_____________________________

 

Copies to: Subject/Parent

                    Investigator's file