Assent_Consent_Parental Permission - Sample

Appendix B1 Privacy Act Statement

Thank you for participating in the environmental sampling EI.

Please read the Privacy Act Statement to better understand how ATSDR will protect your privacy during the Exposure Investigation.

PRIVACY ACT STATEMENT

FOR

SUPPLEMENTAL EXPOSURE INVESTIGATION AT SELECT PFAS EA SITES

This statement provides the notice required by the Privacy Act of 1974 (5 USC § 552a(e)(3)).

• Authority: The Agency for Toxic Substances and Disease Registry (ATSDR) has the authority to collect this information under the ‘‘Comprehensive Environmental Response, Compensation, and Liability Act of 1980’’ (CERCLA) as amended by ‘‘Superfund Amendments and Reauthorization Act of 1986’’ (SARA) (42 U.S.C. 9601, 9604).

• Purpose: ATSDR is conducting this environmental sampling exposure investigation to study your exposure to per- and polyfluoroalkyl substances (PFAS) from non-drinking water sources. ATSDR is collecting this information on you or your child for:

  • Adult consent, parental permission, and child assent to participate in questionnaires and environmental sample collection.

  • Sending your household sampling results back to you.

• Routine Uses:

  • ATSDR will share these records with the U.S. Environmental Protection Agency (EPA). EPA may provide investigation or support staff, laboratory and statistical analysis, etc.

  • ATSDR may disclose these records to its contractors to locate individuals exposed or potentially exposed to PFAS, and to conduct interviews and other assessment activities. The contractor must comply with the requirements of the Privacy Act to protect your or your child’s records.

  • Other routine uses as described in System of Records Notice (SORN) No. 09-19-0001 - ‘‘Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances.” See https://www.gpo.gov/fdsys/pkg/FR-2011-01-25/pdf/2010-33004.pdf.

• Disclosure: Providing this information is voluntary. ATSDR needs this information for you or your child to take part in the investigation. ATSDR may not include incomplete records in the data analysis. ATSDR needs up-to-date contact information to send your environmental sampling results.

Appendix B2: Adult Consent Form 1

PFAS Environmental Sampling at Select Exposure Assessment Sites

Adult Consent Form

Flesch-Kincaid Reading Level: 9.9

Thank you for participating in the environmental sampling EI.

This Adult Consent Form 1 should be completed by one adult in the household that provided a blood sample during the Exposure Assessment. The person will also agree to complete:

• The Household Questionnaire

• The Adult Personal Exposure Questionnaire

Only one adult in the household needs to complete this form allowing ATSDR to collect environmental samples in your home. Other adults in the household will complete Adult Consent Form 2 and the Adult Personal Exposure Questionnaire.

ATSDR will pick up this form from you when we come to your home for the environmental sampling.

You are invited to take part in an environmental sampling Exposure Investigation that will measure per- and polyfluoroalkyl substances (PFAS) at your home in environmental samples. We are trying to find out the levels of PFAS in the homes of people who participated in the PFAS Exposure Assessment (EA) in (Insert name of city/town/place here).

We want to give you some information about it so you can decide whether you want to participate.

The main goal for this environmental sampling is to look at non-drinking water sources of PFAS by sampling things like inside air, dust, and soil at your home. We will ask you to fill out this consent form and two questionnaires to look at potential PFAS exposure both inside and outside your home.

This form contains information about the sampling and what will happen if you decide to participate. If you agree to take part in this PFAS sampling, please sign at the end of the form.

PFAS Environmental Sampling and Questionnaire Completion

CDC/ATSDR will ask you to agree to the following to be included in the Exposure Investigation:

1. We will ask you to allow us to collect environmental samples at your home for PFAS analysis, as follows:

   1. An indoor dust sample will be collected at all homes using a pump and a small dust collection filter.

   2. At some homes (locations already identified), we will also take samples of the following:

• Indoor air: An air sampling unit will be put in a central location within your home. The unit will be left running nonstop for one week. We will pick up the sampling unit one week from the day it was put in

• Bulk Dust Sample: A sample of dust will be taken from the vacuum cleaner in your home

• Surface wipe samples: Two wipe samples will be taken on hard surfaces in your home

• Soil: Soil samples will be taken in your yard

• Wristband: The person who signs this form will be asked to wear up to 3 silicone wristbands continuously (except when showering, bathing, or swimming) for one week. We will pick up the wristbands one week from the day they are provided.

1. We will label your samples with a code only. Only the project coordinator will be able to identify whose house the samples are from. The samples will be sent to a laboratory for PFAS analysis.

2. Methods to measure PFAS in environmental samples are still being improved. It is possible that new methods will be found in the future that will increase our ability to measure PFAS in these types of samples. We would like to keep your collected samples and store them at EPA so that scientists can test for more PFAS in the future, if new tests are found. To do this, we need your permission.

1. We will ask you to fill out two questionnaires:

   1. A household questionnaire that asks questions about your home

   2. A personal exposure questionnaire that asks questions about your personal exposure, such as questions about your diet.

2. We will ask you to allow CDC/ATSDR to use the results of the PFAS blood sampling and the questionnaire from the EA to evaluate the environmental sample results. If CDC/ATSDR sampled tap water and dust samples in your home as part of the EA, we would also like to use those PFAS results. At the end of the investigation, we will send you a letter with your results (email or through the mail). If you would like to talk with an CDC/ATSDR staff person about your results, you can, free of charge.

Time required to participate in the environmental sampling and questionnaire

For those homes where an indoor dust sample is taken and the questionnaires are administered, a one-hour appointment will be required. Your household will receive a $20 gift card as a token of our appreciation for your participation.

For those homes where the more robust sampling is conducted and the questionnaires are administered, two, 2-hour appointments, one week apart will be required. Your household will receive a $20 gift card as a token of our appreciation for your participation for each appointment for a total of $40.

There will be no cost to you for the sample collection or the laboratory analysis. No blood or urine sampling will be completed as part of this EI.

The Benefits of Taking Part in Our Exposure Investigation

Your participation in this investigation will help us better understand exposure to PFAS that is not in drinking water. You will find out the levels of PFAS in your home.

We will be providing a $20 gift card per household as a token of appreciation for completing the indoor dust sampling. An additional $20 gift card (for a total of $40) will be provided to those households that complete additional environmental sampling.

The Risks of Taking Part in Our Exposure Sampling

You might be inconvenienced. CDC/ATSDR will need to have access to your home for up to two appointments, one week apart, to collect the samples and to fill out the questionnaire. Overall, it will take between 1 and 4 hours over one or two appointments to complete the sampling, depending on the types of samples we collect in your home. In addition, an air sampling unit may be placed inside your home and will run nonstop for a week. The unit may cause some minor noise inside your home.

Additional Information:

• Results: We will send you a letter (by mail or electronically) with the PFAS results for the samples taken at your home.

• Privacy: All personally identifiable information (PII) (such as name, address, date of birth) gathered for the PFAS sampling is private and will not be made public. This information is protected according to federal and state laws regarding privacy protection. Only trained and authorized project staff will be allowed to look at information that can identify you. We will keep all of the information in a secure, locked database or file at all times. Except for the environmental sampling EI team, you are the only one who will receive your 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 investigation is completely voluntary. Even if you decide to take part, you are free to quit the investigation at any time. If at any time in the future, you would like to have your samples destroyed or removed from the EI, please call Karen Scruton at 770-488-1325.

Consent Form

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

I agree to allow samples to be collected from my home and analyzed for PFAS.

 Yes  No

I agree to complete the household and personal exposure questionnaire for the environmental sampling Exposure Investigation.

 Yes  No

I agree to allow the blood and environmental samples (tap water and dust, if applicable), collected during the EA, to be used to evaluate the environmental sampling EI sampling results.

 Yes  No

I understand that I will receive my sampling results in a letter (electronically or by mail).

 Yes  No

I agree that the PFAS environmental sampling results may be shared with other federal, state, and local environmental and health agencies. Identifying information will be protected to the extent possible by law should you choose to share the results with other federal, state or local agencies.

 Yes  No

I agree that my samples may be saved for future PFAS-related analysis and that any leftover samples will be sent to EPA for storage and potential analysis in the future. If the samples are analyzed in the future, you will receive the results.

 Yes  No

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

 Yes  No

Participant’s Name:____________________________________________________________________

(Printed)

Participant’s Signature:_________________________________________________________________

Date Signed:________________________________________________________________________

Address for your results:

Street Address: _______________________________________________________

City: ________________________________ State: ________ Zip: ________

Phone number (area code): __________________________________

Project Representative’s Name:____________________________________________________________

(Printed)

Appendix B3: Adult Consent Form 2

PFAS Environmental Sampling at Select Exposure Assessment Sites

Adult Consent Form for Questionnaire

Flesch-Kincaid Reading Level: 10.6

Thank you for participating in the environmental sampling EI.

This Adult Consent Form 2 should be completed by adults in the household that provided a blood sample during the Exposure Assessment that did not complete Consent Form 1. The person will also agree to complete:

• The Adult Personal Exposure Questionnaire

ATSDR will pick up this form from you when we come to your home for the environmental sampling.

You are invited to take part in an environmental sampling Exposure Investigation (EI) that will measure per- and polyfluoroalkyl substances (PFAS) at your home. We are trying to find out the levels of PFAS in the homes of people who participated in the PFAS Exposure Assessment (EA) in (Insert name of city/town/place here).

We want to give you some information about it so you can decide whether you want to participate.

The main goal for this investigation is to look at non-drinking water sources of PFAS by sampling things like inside air, dust, and soil at your home. We will ask you to fill out this consent form and a personal exposure questionnaire to look at potential PFAS exposure both inside and outside your home.

This form contains information about what will happen if you decide to participate. If you agree to take part in this PFAS sampling, please sign at the end of the form.

PFAS Questionnaire Completion

1. CDC/ATSDR will ask you to agree to complete a personal exposure questionnaire that will evaluate potential personal PFAS exposure, such as questions about your diet.

2. We will ask you to allow CDC/ATSDR to use the results of the PFAS blood sampling and the questionnaire from the EA to evaluate the results of the environmental sampling done at your home. If CDC/ATSDR sampled tap water and dust samples as part of the EA, we would also like to use those PFAS results. At the end of the investigation, the results of the sampling done in your household will be sent to your home in a letter (email or through the mail). If you would like to talk with an CDC/ATSDR staff person about your results, you can, free of charge.

It will take about 15 minutes to complete the personal exposure questionnaire.

There will be no cost to you for the sample collection or the laboratory analysis. No blood or urine sampling will be completed as part of this EI.

The Benefits of Taking Part in Our Exposure Investigation

Your participation in this investigation will help us better understand exposure to PFAS that is not in drinking water. You will find out the levels of PFAS in your home.

We will be providing a $20 gift card per household as a token of appreciation for completing the indoor dust sampling. An additional $20 gift card (for a total of $40) will be provided to those households that complete additional environmental sampling.

The Risks of Taking Part in Our Exposure Sampling

You might be inconvenienced by completing the personal questionnaire. It will take about 15 minutes to complete.

Additional Information:

• Results: We will send your household a letter (by mail or electronically) with the PFAS results for the samples taken at your home.

• Privacy: All personally identifiable information (PII) (such as name, address, date of birth) gathered for the PFAS sampling is private and will not be made public. This information is protected according to federal and state laws regarding privacy protection. Only trained and authorized project staff will be allowed to look at information that can identify you. We will keep all of the information in a secure, locked database or file at all times. 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 investigation is completely voluntary. Even if you decide to take part, you are free to quit the investigation at any time. If at any time in the future, you would like to have your samples destroyed or removed from the EI, please call Karen Scruton at 770-488-1325.

Consent Form

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

I agree to complete the personal exposure questionnaire for the environmental sampling Exposure Investigation.

 Yes  No

I agree to allow the blood and environmental samples (tap water and dust, if applicable), collected during the EA, to be used to evaluate the environmental sampling EI sampling results.

 Yes  No

I understand that my household will receive the results of the environmental sampling in a letter (electronically or by mail).

 Yes  No

I agree that my household’s PFAS environmental sampling results may be shared with other federal, state, and local environmental and health agencies. Identifying information will be protected to the extent possible by law should you choose to share the results with other federal, state or local agencies.

 Yes  No

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

 Yes  No

Participant’s Name:____________________________________________________________________

(Printed)

Participant’s Signature:_________________________________________________________________

Date Signed:________________________________________________________________________

Address for your results:

Street Address: _______________________________________________________

City: ________________________________ State: ________ Zip: ________

Phone number (area code): __________________________________

Project Representative’s Name:____________________________________________________________

(Printed)

Project Representative’s Signature:______________________

Appendix B4: Parental Permission Form

PFAS Environmental Sampling at Select Exposure Assessment Sites

Parental Permission Form (<18 years of age)

Flesch-Kincaid Reading Level: 9.9

Thank you for participating in the environmental sampling EI.

This Parental Permission Form should be completed by one adult in the household for all children in the household younger than 18 years that provided a blood sample during the Exposure Assessment. The child (with assistance from parent as needed) will agree to complete:

• The Child Personal Exposure Questionnaire

ATSDR will pick up this form from you when we come to your home for the environmental sampling.

Your child/ward is invited to take part in an environmental sampling Exposure Investigation (EI) that will measure per- and polyfluoroalkyl substances (PFAS) at your home. We are trying to find out the levels of PFAS in the homes of people who participated in the PFAS Exposure Assessment (EA) in (Insert name of city/town/place here).

We want to give you some information about it so you can decide whether you want your child/ward to participate.

The main goal for this investigation is to look at non-drinking water sources of PFAS by sampling things like inside air, dust, and soil at your home. We will ask you to fill out a parental permission form for your child/ward so your child can complete a personal exposure questionnaire. If you child/ward is younger than 12 years old, you can complete the questionnaire for them. Older children will need to be present and complete an Assent form where they agree to participate.

We hope you will agree to let your child/ward 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.

This form contains information about the sampling and what will happen if you decide to allow your child/ward to participate. If you agree to allow your child/ward take part in this PFAS sampling, please sign at the end of the form.

PFAS Environmental Sampling and Questionnaire Completion

CDC/ATSDR will ask you to agree to the following to be included in the Exposure Investigation:

1. Sign this parental permission form allowing CDC/ATSDR to use the results of the PFAS blood sampling and the questionnaire from the EA for your child/ward. If CDC/ATSDR sampled tap water and dust samples in your home as part of the EA, we would also like to use those PFAS results.

2. Allow your child/ward to complete the personal exposure questionnaire. You may assist your child/ward or complete it for them if they are younger than 12 years old. If they are between 12 and 17 years old, they will need to complete an Assent form and must be present to complete the questionnaire.

It will take about 15 minutes to complete the personal exposure questionnaire.

There will be no cost to you for the sample collection or the laboratory analysis. No blood or urine sampling will be completed as part of this EI.

The Benefits of Taking Part in Our Exposure Assessment

Your child/ward’s participation in this investigation will help us better understand exposure to PFAS that is not in drinking water. You will find out the levels of PFAS in your home.

The Risks of Taking Part in Our Exposure Assessment

Your or your child/ward may be inconvenienced by completing the personal exposure questionnaire. It will take about 15 minutes to complete.

Additional Information:

• Results: We will send your household a letter (by mail or electronically) with the PFAS results in samples from your home.

• Privacy: All personally identifiable information (PII) (such as name, address, date of birth) gathered for the PFAS sampling is private and will not be made publicly. This information is protected according to federal and state laws regarding privacy protection. Only trained and authorized project staff will be allowed to look at information that can identify you. We will keep all of the information in a secure, locked database or file at all times. 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 investigation is completely voluntary. Even if you decide to allow your child/ward to take part, you are free to quit the investigation at any time. If at any time in the future, you would like to have your samples destroyed or removed from the assessment, please call Karen Scruton at 770-488-1325.

Parental Permission 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/ward participate. You are also confirming you will allow the project staff to collect, store, and share the information gathered for the EI as described above. You will receive a copy of this form for your records.

I agree to allow my child/ward to complete the personal questionnaire or I will complete it for them to the best of my ability, if they are younger than 12 years old.

 Yes  No

I agree to allow the blood and environmental samples (tap water and dust, if applicable) for my child/ward, collected during the EA, to be used to evaluate the EI sampling results.

 Yes  No

I understand that my household will receive the results of the environmental sampling in a letter (electronically or by mail).

 Yes  No

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

 Yes  No

I agree to let CDC/ATSDR 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:_________________________________________________________

Appendix B5: Assent Form

PFAS Environmental Sampling at Select Exposure Assessment Sites

Assent Form (12-17 years of age)

Reading Level: 7.0

We are doing a study on chemicals called PFAS. PFAS stands for Per- and Polyfluoroalkyl Substances. Your parents have said that you could take part in the study. We want to give you some information about it so you can decide whether you want to participate.

Two years ago you were part of a study where we took samples of your blood and urine and tested them for PFAS. You also completed a questionnaire about your potential exposure to PFAS. PFAS was found in the drinking water in your community and we wanted to find out if exposure to PFAS in the water may result in higher levels of PFAS in the body.

Although drinking water is one way to be exposed to PFAS, there are also other ways. Many consumer products contain PFAS and you could be exposed if you use them or come into contact with them. We are asking you to complete another questionnaire that asks questions about your use of products and food that may contain PFAS to see if you may have been exposed.

You will not be asked to give us a sample of blood or urine.

We hope you will agree to be part of this investigation. 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 being in this investigation.

If you agree to participate, please sign at the end of the form. The personal exposure questionnaire should take about 15 minutes to complete.

It is your choice whether to be in this investigation. There is no penalty if you choose not to be in this assessment. You may stop being in this assessment at any time. If at any time in the future, you would like to have your answers to the questions removed from the investigation, please call Karen Scruton at 770-488-1325.

Project Name: _______________________________________________________________________

Project Coordinator’s Name:____________________________________________________________

(Printed)

Project Coordinator’s Signature:_________________________________________________________

As described above, you are being asked to participate in an environmental sampling investigation. You may participate by indicating your assent to the items below. You may assent to all, some, or none of the items.

To be in this assessment, please sign your initials in the box next to each item you agree to.

I agree to fill out the personal exposure questionnaire.

	I agree to let the blood sample collected during the EA be used to evaluate the environmental sampling results.

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

I have read the assent form (or someone has read it to me), and I agree to be in this environmental sampling investigation and complete the questionnaire. My initials above show which parts of the assessment I agree to participate in.

Participant’s Name:____________________________________________________________________

(Printed)

Participant’s Signature:_________________________________________________________________

Date Signed: ___________________________________________________ `

Street Address: ___________________________________________________

City: ______________________________ State: ______ Zip: __________

Phone number (area code): ___________________________________