Adult Consent Form

Attachment 3B: Adult Consent Form

Flesch-Kincaid Reading level – 7.2

Adult Consent Form for Blood and Urine Testing

ATSDR Exposure Investigation (EI)

Anaconda, Montana II

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 Services (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 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

   • You will bring the first morning urine sample that you collected at home and froze to the blood testing location.

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

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

2. Answer a Short Questionnaire

   • We will ask you some questions about your home and how you might be exposed to lead and arsenic.

   • This should take about 20 minutes.

3. Blood Collection and Testing for Lead

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

• This will take 10 minutes or less.

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

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

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

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

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

When will you get the test results?

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

What are the benefits of being in this EI?

• You 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 that 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.

• If you are pregnant there is no risk to the pregnancy from the blood collection.

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 health department 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 you.

• 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. Arthur Wendel at 206-553-0454

  • Dr. Matt Karwowski at 404-718-5867

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

Voluntary Consent

• I agree to be tested.

• I agree to answer questions.

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

• I know that having the test 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 give my permission to be tested and agree to answer questions.

May we share the test results with other federal, state, and local health and environmental agencies? YES / NO (please circle one)

___________________________________ __________________ ______

Signature of Person Giving Consent Date Age

Address _____________________________ Telephone __________________

______________________________

______________________________

Lab ID Number____________________

Certification of Consent Form Administrator:

I read the consent 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 consent