Parental Permission Form for Blood and Urine PFC Testing and Questionnaire for Children (12 - < 18 years of age) Participating i

Decatur EI OMB Package Attachment 3E 07152015.docx

ATSDR Exposure Investigations (EIs)

Parental Permission Form for Blood and Urine PFC Testing and Questionnaire for Children (12 - < 18 years of age) Participating i

OMB: 0923-0048

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Attachment 3E: Parental Permission Form for Blood and Urine PFC Testing and Questionnaire for Children (12 - < 18 Years) Participating in Investigation

(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

Parental Permission Form for Children (12 - < 18 Years) Participating in Investigation

Flesch-Kincaid Reading Level (without agency or chemical names): 8.2


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 your child 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 child’s body and how quickly they are being removed from your child’s body, and to do research on biological modeling of these chemicals. The data from your child’s samples will be used to help us understand how he or she 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. The effect on human health from PFC chemicals in not well understood; more research is needed.


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 child’s arm. The blood sample will be tested for 12 different types of PFC chemicals. If your child is anemic (low blood cells) or has a bleeding disorder then we will not be able to sample his or her blood.


In urine test, your child will be provided a container in which to collect all of the urine from the first time he or she urinates the day of his or her sample collection.


Your child will also be asked to report the time of the last time he or she urinates prior to collecting his or her urine sample. The urine sample will be tested for 5 different types of PFC chemicals.


Your child will also be asked to have his or her 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 child’s body and will allow ATSDR to better understand his or her exposures.


Your child’s 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 child’s doctor - it is your choice.


PFCs are beginning to generate increased interest across the United States. As a result, data from your child’s samples (without any personal identifying information) will be kept for potential additional analysis in the future. Your child’s blood sample may also be saved for future tests if you give permission. You will need to sign an additional permission form and your child will have to sign an additional assent form if you agree to allow your child’s 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, your child will find out the amount of the PFC chemicals in his or her blood and how these levels have changed since 2010. We may also be able to tell how quickly your child’s kidneys remove some PFC chemicals from his or her body. If the tests show levels of PFC in his or her blood that are higher than most people or a rate of PFC removal slower than most people, you and your child will get tips on how to avoid current and future exposure to PFC chemicals. We will give you and your child 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 child’s results will help advance this research.


We will not be able to tell you if the PFC levels in your child’s blood will make him or her sick now or later in life. We will not be able to tell you specifically from where or how the PFC chemicals entered your child’s body. No medical diagnosis, treatment, or additional testing will be offered from this testing effort.


This testing is free for your child.


What are the risks of being tested?

There may be some discomfort and minor bruising in area where the blood sample is collected.


What about my privacy?

We will protect your child’s privacy as much as the law allows. We will give your child an identification (ID) number. This number, not his or her name, will go on the blood and urine samples. We will not use your child’s name in any report we write. We will keep a record of your child’s name, address, and ID number so that we can send you and your child the test results and an interpretation of what they mean. We keep all records with your child’s name on them in a locked file cabinet or in a password-protected computer file. Your child’s identifying information will also be protected should you choose to share your child’s 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 child’s 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 for my child to be tested. I have been given a chance to ask questions and feel that all questions have been answered. I know that my child’s participation in this testing is my choice and my child’s choice. I know that after choosing to be in this testing, my child may stop at any time.


Shape1


Place ID # label here


For office use only



SIGNATURE

I have read this form or they have been read to me. I have had a chance to ask questions about this testing and my questions have been answered. I give permission for my child to be a part of this testing.


____________________________________________________

Full Name of Child


____________________________________________________

Signature of Parent/Guardian


________________________________________________

Printed Name or Parent/Guardian


May we share your child’s test results with other Federal and State health and environmental agencies? YES or NO (Circle One)


Address: ____________________________________________

____________________________________________


____________________________________________


Phone - Home #: _________________ Phone - Cell #: __________________


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorWorley, Rachel R. (ATSDR/DCHI/SSB)
File Modified0000-00-00
File Created2021-01-28

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