Parental permission

Appendix B3: Parental Permission Form

Form Approved

OMB No. 0923-xxxx

Exp. Date xx/xx/20xx

PFAS Exposure Assessment, Biological Sampling

Parental Permission Form (<18 years of age)

Flesch-Kincaid Reading Level: 9.2

ATSDR estimates the average public reporting burden for this collection of information as 10 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0923-xxxx).

We are doing a study on chemicals called PFAS. PFAS stands for Per- and Polyfluoroalkyl Substances. We want to give you some information about it so you can decide whether you want your child/ward to participate.

PFAS have been found in the drinking water supply in (insert name of city/town/place here). PFAS are chemicals that were used in a wide range of ways in the United States. PFAS are found in the environment (in the air, soil, and water). And they can stay in the human body for years.

Scientists and doctors don’t yet know how PFAS may affect people’s health. The first step in figuring that out is measuring the amount of PFAS in the bodies of people who may have come into contact with this contaminated water.

The main goal for this assessment is to find out how much PFAS are in the blood and urine of people in (Insert name of city/town/place here) who may have been exposed to contaminated drinking water. We will conduct this study from (insert dates here).

We hope you will agree to let your child be part of this exposure assessment. If you have any questions about this form at any time while filling it out, please don’t hesitate to ask. Thank you for considering allowing your child/ward to be in this assessment.

Follow these instructions: This form contains information about the assessment and what will happen if you and your child decide to participate. If you and your child agree for the child to take part in this assessment, please sign at the end of the form.

Procedures for the Exposure Assessment

First, we will ask you to answer a few questions.

We will also ask your child to give us a blood and urine sample. A phlebotomist will draw a small amount of his or her blood for testing. We will ask for the urine sample your child collected this morning. Your child’s samples will be labeled with a code only. Only the project coordinator will be able to identify who gave the blood and urine samples. The questionnaire should take about 15 minutes to complete.

We will send your child’s blood to the National Center for Environmental Health (NCEH) laboratory in Atlanta, GA, for analysis. Your child’s urine sample will be sent to [insert name and location of bio-specimen repository].

Only recently have scientists been able to measure PFAS in urine. Because the method for measuring PFAS in urine is developing, not all urine samples collected will be analyzed for PFAS. Instead, ATSDR will randomly chose a percentage of urine samples for PFAS analysis. All of the blood and urine samples will be stored and may be analyzed in the future. If your child’s urine or blood samples are analyzed in the future, we will give you the results.

Your child’s blood and urine will not be tested for HIV, or for the presence of alcohol or drugs and your DNA will not be used for any purpose. There will be no charge for the sample collection or the laboratory analysis.

At the completion of the exposure assessment, we will mail your child’s test results to you at the address you provide today. If you would like to talk with a doctor about your results, you can talk to one working on the exposure assessment free of charge.

ATSDR will also use your child’s PFAS level results (not including any information that would identify him or her personally) to better understand PFAS exposure in your community.

Research to better understand the health effects associated with PFAS exposure is ongoing, but scientists are not currently certain of how PFAS levels in the blood can affect a person’s health. More research is needed to clarify the risks posed by PFAS exposure. It is possible that new tests will be developed in the future that will increase our understanding of how PFAS impact human health. We would like to keep your child’s blood and urine samples so that scientists can test for more things if new tests are developed. To do this, we need your permission. If your child’s samples are tested again in the future, you will be contacted again to give permission for the tests.

The Benefits of Taking Part in Our Exposure Assessment

Your child’s participation in this assessment will help us understand the range of PFAS exposure and possible exposure sources in your community. Work to better understand the health effects associated with PFAS exposure is ongoing, but scientists are not currently certain of how PFAS levels in the body can affect a person’s health. More work is needed to clarify the risks posed by PFAS exposure. Your child’s participation in this assessment will help advance this knowledge.

We will not be able to tell you if the PFAS levels in your child’s blood or urine will make your child sick now or later in life. You will be able to call project staff during and after the exposure assessment if you have any questions about your child’s results. If your child’s doctor has questions about PFAS, he or she may also call project staff or the physician working on the exposure assessment. The names and phone numbers of people to call are listed below.

The Risks of Taking Part in Our Exposure Assessment

This exposure assessment requires approximately 6 milliliters of blood (which is about 1 teaspoon). Your child may feel a sharp sting from the needle used to draw your blood. Sometimes a bruise or small blood clot appears at the site. These bruises or clots usually go away on their own. Putting heat on the site can also help the bruise or clot to go away. Although it is not common, the needle could irritate a nerve. This irritation may cause temporary numbness in part of the arm.

Risk of injury from the blood draw is higher for people with bleeding disorders, such as aplastic anemia, and for anyone on blood thinning medications (such as Coumadin) and other therapies. If your child has such a bleeding disorder or are taking blood thinning medication, we recommend that you talk to your doctor before joining this exposure assessment. Infection could also develop as a result of the puncture through the skin. You or your health insurance company would be responsible for any follow-up care if your child is injured as a result of the blood draw.

Additional Information:

• Results: We will send you a letter with your child’s PFAS test results along with how they compare to levels in other children in the United States. All participants will receive blood testing results and a percentage of participants will receive urine testing results. We do not yet know enough to say whether there are levels in the blood or urine that are safe or unsafe. This assessment will only tell you how much PFAS are currently in your child’s body. It will not tell you when or for how long your child was exposed.

• Privacy: All personally identifiable information (PII) (such as name, address, date of birth) gathered during the exposure assessment is private and will not be publically released. This information is protected to the extent possible by (insert name of state here) and federal laws and regulations related to privacy protection. Only trained and authorized project staff will have access to information that can identify your child, and we will keep all of the information in a secure, locked database or file at all times. Aside from the exposure assessment team, you are the only one who will receive your child’s individual results. In accordance with CDC/ATSDR’s policy regarding data access, sampling results that do not include PII may be used by public health researchers for approved research purposes.

• Voluntary Participation: Participation in this exposure assessment is completely voluntary. Your choice will not affect your current or future relationships with groups that are part of the exposure assessment. Even if you decide to let your child participate, you are free to quit the exposure assessment at any time. If project staff decide it is in your child’s best interest, or if your child fails to meet the exposure assessment qualifications, he or she may be removed from the exposure assessment without your consent. If at any time in the future, you would like to have your child’s blood or urine sample destroyed or removed from the assessment, please call (insert name and phone number of Study coordinator).

Consent Form

By marking the check boxes below and signing this form, you are confirming that you understand the goals of the exposure assessment, and that you agree, of your own free will, to let your child participate. You are also confirming you will allow the project staff to collect, store, and share the information gathered for the exposure assessment as described above. You will receive a copy of this form for your records.

I agree to allow my child/ward to participate in this Exposure Assessment and that a blood and urine sample will be collected.

 Yes  No

I understand that I will receive my child/ward’s PFAS test results by mail. I will be able to compare some of my child/ward’s test results with national averages.

 Yes  No

I understand that project staff will not be able to determine if the PFAS levels in my child/ward’s body will impact my health.

 Yes  No

I agree that my child/ward’s PFAS test results may be shared with other federal, state, and local environmental and health agencies. Your identifying information will be protected to the extent possible by law should you choose to share your results with other federal, state or local agencies.

 Yes  No

I understand that my child/ward’s PFAS test results and questionnaire data may be used for additional analysis in the future.

 Yes  No

I agree to allow my child/ward’s blood and urine samples to be saved and used for other PFAS-related tests. If your child/ward’s blood and urine are analyzed in the future, we will send you the results.

 Yes  No

I agree to let ATSDR/NCEH keep my child/ward’s contact information and contact me in the future for possible follow-up studies (may be research or non-research studies).

 Yes  No

Parent/Guardian’s Name:__________________________________________________________

(Printed)

Parent/Guardian’s Signature:________________________________________________________

Child/Ward Name and Age:

____________________________________________

Respondent ID No:

Date Signed:__________________________________________________________________________

Street Address: ______________________________________________________________________

City: _____________________________________________ State: ________ Zip: ___________

Phone number (area code): __________________________________

Project Representative’s Name:____________________________________________________________

(Printed)

Project Representative’s Signature:_________________________________________________________