Assent Form - Children Younger than 18 Years of Age

Attachment 3D: Assent Form for Children younger than 18 Years of Age

Flesch-Kincaid Reading level – 6.6

Assent Form for Blood and Urine Testing

Children between 7 and 17 years of age

ATSDR Exposure Investigation (EI)

Anaconda, Montana

Who are we?

• We are from a federal public health agency, the Agency for Toxic Substances and Disease Registry (ATSDR)

Who are we working with?

• Region 8 Environmental Protection Agency (EPA)

• Anaconda Deer Lodge County (ADLC) Health Department

• Montana Department of Public Health and Human Service (MDPHHS)

Why we are doing this Exposure Investigation (EI)?

• We are doing this EI to respond to community concerns about lead and arsenic in the environment and to help people find out if they are exposed

• We are testing lead in blood samples and arsenic in urine samples

What are we asking you to do?

• You are invited to have your blood tested for lead and urine tested for arsenic.

• There is NO COST to you or your parents for the testing.

• Collect a urine sample at home and bring it to the blood collection location.

• Complete a brief questionnaire with that will ask questions regarding how you may be exposed to lead and arsenic.

• Allow a licensed phlebotomist to take a sample of your blood.

What is included in my participation?

There are three parts to your participation.

1. Urine Collection and Testing for Arsenic

   1. The first morning urine sample that you collected at home and froze was brought to the blood testing location.

   2. We will send your urine to a lab to test it for arsenic.

   3. The blood will not be tested for drugs, alcohol or HIV.

2. Answer a Short Questionnaire

1. We will ask you some questions about how you might be exposed to lead and arsenic. Your parents can help you answer the questions on the form.

2. This should take about 20 minutes

3. Blood Collection and Testing for Lead

1. We will collect less than 1 teaspoon (3 milliliters) from a vein in your arm.

2. This will take 10 minutes or less.

3. We will send your blood to a lab to test it for lead.

4. The urine will not be tested for drugs, alcohol or HIV.

What will happen to any leftover blood after testing is finished?

• The blood and urine will not be used or tested for anything else.

• The lab will throw out any leftover blood and urine.

When will you get the test results?

• Your parents will get your test results by mail about 12 weeks after testing.

What are the benefits of being in this EI?

• You and your parents will know the levels of lead in your blood and arsenic in your urine.

• If you are found to have high levels of lead or arsenic, ATSDR and ADLC will recommend you follow-up with your physician and will provide you with information that will help you reduce contact with lead and arsenic.

What are the risks of this EI?

• The needle stick might hurt a little.

• Some bruising may happen where the blood is taken.

• You may feel a little lightheaded for a short time.

How will we protect your privacy?

• We will protect your privacy as much as the law allows.

  • Montana law requires that we report blood lead levels to the ADLC if the result is greater than 5 µg/dL.

  • Montana law requires that information given to the state may be made public if someone asks them for the information but your name and address will not be released.

  • We will share the results with other agencies only with your permission. We will require our government partners to treat your information as private.

• We will give you an identification (ID) number.

  • Your ID number, not your name, will go on the tube of blood and urine sample.

  • We will keep a record, under lock-and-key, of your name, address, and ID number. The information will be used by ATSDR to link the results to each person and send your blood and urine test results to your parents.

• We will not use your name in any report we write. Only group information that does not include individual names will be reported.

When can you ask questions about the testing?

• If you have any questions about this testing, you can ask us now.

• If you have questions later, you can call:

  • Dr. Luly Rosales-Guevara at 770-488-0744

  • Dr. Matt Karwowski at 404-718-5867

  • The Anaconda Exposure Investigation toll free number (888) 892-1320

Child Assent

• Your parent/guardian said it is all right for you to have the blood and urine tests.

• Your parent/guardian said it is all right for you to answer some questions.

• You don’t have to have these tests to answer questions if you don’t want to.

Voluntary Assent

• I agree to be tested.

• I agree to answer questions.

• I was given the chance to ask questions and feel my questions were answered.

• I know that having these tests done is my choice.

• I know that even though I have agreed to this testing, I may leave at any time without penalty.

Signature

I agree to be tested and to answer questions.

_________________________________________ ___________ ______________

Printed name of child Age of child Sex of child

______________________________________________ __________________

Signature or written name of child in child’s handwriting Date

__________________________

Printed name of parent/guardian

Address of child ______________________________ Telephone __________________

______________________________

______________________________

Lab ID Number____________________

Certification of Assent Form Administrator:

I read the assent form to the person named above. He/she had the opportunity to ask questions about the Exposure Investigation and had the questions answered.

_______________________________________

Signature of person administering the assent