18 years of age)

Attachment 3A: Adult Consent Form for Blood and Urine PFC Testing and Questionnaire (≥ 18 years of age)

(ATSDR OMB Control No. 0923-0048 / Expiration Date: 5/31/2016)

U.S. Department of Health and Human Services

Agency for Toxic Substances and Disease Registry

PFC Exposure Investigation, blood and urine sampling

Adult Consent Form (≥ 18 years of age)

Flesch-Kincaid Reading Level (without agency or chemical names): 8.0

Who are we and why are we doing this blood and urine testing?

We are from the Agency for Toxic Substances and Disease Registry (ATSDR), a federal public health agency based in Atlanta. We are inviting you to have a blood and urine test for a family of chemicals called Perfluoroalkyl Compounds (PFC). We are offering this test to find out how much of these chemicals is getting into your body and how quickly they are being removed from your body, and to do research on biological modeling of these chemicals. The data from your samples will be used to help us understand how you might be exposed to these chemicals.

The Environmental Protection Agency has found these chemicals in your community in soil fields treated with sludge from the local wastewater treatment plant. People that work or live near these fields may come into contact with these chemicals. Some private drinking water wells have been contaminated with this chemical. Recent tests in one public water system have found these PFC chemicals at levels below current guidelines. PFCs can be found in consumer products like non-stick cookware, paper coatings, stain-resistant carpets, nail polishes and fire-fighting foam. More research is needed to understand PFCs effect on human health.

What is involved in this testing?

In the blood test, a 5 milliliter (mL) sample of blood (about 1 teaspoon) will be collected from a vein in your arm. The blood sample will be tested for 12 different types of PFC chemicals. If you are anemic (low blood cells) or have a bleeding disorder then we will not be able to sample your blood.

In urine test, you will be provided a container in which to collect all of your urine the first time you urinate the day of your sample collection.

You will also be asked to report the time of the last time you urinate prior to collecting your urine sample. The urine sample will be tested for 5 different types of PFC chemicals.

You will also be asked to have your height, weight, and body fat percentage measured using a measuring stick, scale, and digital body fat analyzer and recorded. These characteristics impact how PFCs behave in your body and will allow ATSDR to better understand your exposures.

Your blood and urine will be sent to a lab for testing. We will mail you the test results along with what they mean approximately 6 months after testing, but some delays might occur. You may share these results with your doctor - it is your choice.

PFCs are beginning to generate increased interest across the United States. As a result, data from your samples (without any personal identifying information) will be kept for potential additional analysis in the future. Your blood sample may also be saved for future tests if you give consent. You will need to sign an additional consent form if you agree to allow your blood sample to be stored for future tests.

What are the benefits from being involved in this testing effort?

By being part of this testing effort, you will find out the amount of the PFC chemicals in your blood and how these levels have changed since 2010. We may also be able to tell you how quickly your kidneys remove some PFC chemicals from your body. If the tests show levels of PFC in your blood that are higher than most people or a rate of PFC removal slower than most people, you will get tips on how to avoid current and future exposure to PFC chemicals. We will give you written information about PFC chemicals.

Research to better understand the health effects associated with PFC exposure is ongoing, but scientists are not currently certain of how PFC levels in the blood can affect a person’s health. More research is needed to clarify the risks posed by PFC exposure. Your participation in this study will help advance this research. We will not be able to tell you if the PFC levels in your blood will make you sick now or later in life.

We will not be able to tell you specifically from where or how the PFC chemicals entered your body. No medical diagnosis, treatment, or additional testing will be offered from this testing effort.

This testing is free for you.

What are the risks of being tested?

There may be some discomfort and minor bruising in area where the blood sample is collected. The entire collection (distributing consent forms, completion of questionnaire, blood and urine collection) will require approximately 35 minutes of your time.

What about my privacy?

We will protect your privacy as much as the law allows. We will give you an identification (ID) number. This number, not your name, will go on the blood and urine samples. We will not use your name in any report we write. We will keep a record of your name, address, and ID number so that we can send you the test results and an interpretation of what they mean. We keep all records with your name on them in a locked file cabinet or in a password-protected computer file. Your identifying information will also be protected should you choose to share your results with other federal or state agencies. Personal identifying information will not be shared with other agencies. Personal identifying information will be deleted from all records when it is no longer needed and will not be kept longer than five years. All collection logs and questionnaire forms with personal information will be shredded as soon as they are no longer needed and will not be kept longer than five years.

Who do I contact if I have questions?

If you have any questions about this testing, you can ask us now. If you have questions later, you can call Rachel Worley or Bruce Tierney, MD of ATSDR toll-free at 1-855-288-0242, or email them at [email protected] or [email protected]. If you have questions about your study rights you may contact the Centers for Disease Control and Prevention’s Institutional Review Board at 1-800-584-8814.

Voluntary Consent

I agree to be tested. I have been given a chance to ask questions and feel that all questions have been answered. I know that being in this testing is my choice. I know that after choosing to be in this testing, I may stop at any time.

SIGNATURE

Place ID # label here

For office use only

I have read this form or it has been read to me. I have had a chance to ask questions about this testing and my questions have been answered. I agree to be a part of this testing.

________________________________________________

Participant - Printed Name

________________________________________________ ______________

Participant - Signature Date

May we share these test results with other Federal and State health and environmental agencies? Your identifying information will be protected should you choose to share your results with other federal or state agencies.

YES or NO (Circle One)

Address: ____________________________________________

____________________________________________

Phone - Home #: __________________

Phone - Cell #: ___________________