Activity 2 Consent, Assent, Permission Forms

Attachment 5c. Activity 2 Consent, Assent, Permission Forms

5c1. Adult Consent – Adult Activity Questionnaire

5c2. Adult Consent – Exposure Measurement

5c3. Adult Consent – Activity Video

5c4. Parental Permission (Adolescent) – Human Activity Questionnaire

5c5. Adolescent Assent - Human Activity Questionnaire

5c6. Parental Permission (Youth) - Human Activity Questionnaire

5c7. Youth Assent - Human Activity Questionnaire

5c8. Parental Permission (Adolescent/Youth) - Exposure Measurement

5c9. Adolescent/Youth Assent - Exposure Measurement

5c10. Parental Permission (Adolescent/Youth) - Activity Video

5c11. Adolescent/Youth Assent - Activity Video

5c12. Parental Consent and Permission – Child Activity Questionnaire and Exposure Measurement

5c13. Child Assent – Child Activity Questionnaire and Exposure Measurement

5c14. Parental Permission Consent – Activity Video

5c15. Child Assent – Activity Video

Attachment 5c1. Adult Consent – Adult Activity Questionnaire

Flesch-Kincaid Reading Level 8.9

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you, as an adult aged 18 or older (or the legal age in your state), to be in a research study. Your participation is voluntary. We invite you to read or hear about the study. Before you decide to take part, please ask questions if there is anything that you do not understand.

What is the purpose of this study?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We want to ask some questions about your activities on synthetic turf fields. This information will help us see if people might be exposed to chemicals from playing on synthetic turf fields. We will use the results of this study to guide public health actions.

Why are you being asked to be in this study?

You were chosen to take part in this study because you work out on synthetic turf fields. We want to talk to people like you take part in recreation, training, or organized sports on these fields.

ATSDR and EPA hope to enroll 60 people to answer some questions.

• We also want you to know about other parts of the research for some of the people who are interviewed.

  • We will ask a smaller group of people who complete the interview if they are willing to provide blood, urine, and skin wipe samples so we can look what you are exposed to while playing on the field.

  • We will videotape 24 of these people during their on-field activities.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking you to do?

We will ask you a few questions about yourself in an interview. We will ask questions about your activities on synthetic turf fields. We want to know about the types of your activities, how often you play on the fields, and how long you have been playing on the fields.

We also want you to tell us if you are interested in hearing more about the smaller, more detailed exposure study and the activity videotape.

How long will this take?

It will take about 30 minutes to complete the interview. We want you to know if you are selected to take part in the smaller, more detailed exposure study, it will take about three more hours. If you are selected to take part in the activity videotaping, it will take about an hour.

Are there any risks or discomforts to you if you decide to be in this study?

We don’t think these questions are sensitive. But the interview may be stressful if you have to recall events that are upsetting. You are free to skip any question for any reason.

Are there any benefits to you from being in this study?

There will be no direct benefits to you from being in this study.

Who will see the information you give the researchers?

All information about you (including name and address, this form, and interview answers) will be secure. We will track your information using a code number rather than name. We will keep paper records in locked files. Electronic records will be stored on password protected computers at USEPA and at ATSDR. Only trained study staff will be allowed to look at your records. Federal policy requires making the data we collect available to the public, but we will never include your name or other identifying information in a public release.

What is the cost to you and what compensation will you get?

The only cost for being in our study is your time and effort to take part. We will give you a $25 gift card as a “thank you” when you complete the interview. You can use the gift card at most stores or for online shopping.

People who go also provide blood, urine, and skin wipe samples or complete the video component of the study will get additional gift cards.

What are your choices about participating?

Your taking part in the interview is voluntary. You are free to be a part of it or not. You can refuse to answer any questions. You can choose to leave the research study at any time, even after you have signed the consent form.

Who should you contact if you have questions later on?

If you have any questions about the study or wish to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel you have been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you do not understand what we are asking you to do, please ask questions. After all your questions have been answered to your satisfaction and if you want to be in this study, please sign the consent form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions and I had all my questions answered.

By signing below, I agree to take part in the research and the interview.

_______________________________________________

Participant’s name (Print)

_______________________________________________

Participant's signature / Date

By signing below, I agree to be contacted about the smaller, more detailed exposure study.

_______________________________________________

Participant’s name (Print)

_______________________________________________

Participant's signature / Date

Attachment 5c2. Adult Consent – Exposure Measurement

Flesch-Kincaid Reading Level 8.8

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you, as an adult aged 18 or older (or legal age in your state), to be in a research study about personal exposure measures from synthetic turf fields. Your participation is voluntary. We invite you to read or hear about the smaller, more detailed exposure study. Before you decide to take part, please ask questions if there is anything that you do not understand.

What is the purpose of collecting more detailed measurements?

The purpose is to see how people might come into contact with chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We will collect some samples from you. This information will help us see if people might be exposed to chemicals from playing on synthetic turf fields. We will use the results of this study to better understand the most relevant chemicals, potential exposures to those chemicals, and toxicity information available for those chemicals found in crumb rubber infill used in synthetic turf fields

Why are you being asked to be in this smaller, more detailed exposure study?

You were chosen to take part in this smaller, more detailed exposure study because you work out on synthetic turf fields, and you agreed to be in the main part of the study. We want to talk to people who take part in recreation, training, or organized sports on these fields.

ATSDR and EPA hope to enroll 45 people to take part in this smaller, more detailed exposure study.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking you to do?

• We will take some measures during one of your normal activities on synthetic turf fields. These measures will include monitoring of the air that you are breathing with a small sampling tube attached to your clothes during the activity. Your air sample will analyzed by laboratories at the EPA.

• Following the activity we will collect wipe samples of your hands and areas of your arms and legs. The wipe sampling will be done with pads wetted with water, and pads wetted with a water and alcohol mixture. Your skin wipe samples will be analyzed by laboratories at the EPA.

• We will collect urine and blood samples two times: before your activity and directly after your activity. We will ask you a few questions to be sure that you can safely give blood. Each time:

  • A person trained to draw blood will collect about 15 ml (about 1 tablespoon) of blood from a vein in your arm.

  • You will be asked to provide 50-100 ml (about ½ cup) of urine in a cup. You will do this in private in a restroom.

• In the future, your blood and urine samples will be analyzed to look for some chemicals that are in the crumb rubber infill. Afterwards, the samples will be stored for the indefinite future. This is in case we get more information in the future about what chemicals to look for or new methods are developed to test for chemicals. 

We will not analyze these samples for DNA, drugs, tobacco, or health conditions.

• You will not receive a copy of your test results.

• In the future, your urine and blood results may be linked to the rest of your study data for research purposes.

How long will this take?

It will take about three hours to finish the measurements. This includes setting up and collecting the air sampler, collecting the skin wipe, urine, and blood samples.

Are there any risks or discomforts to you if you decide to be in this smaller, more detailed exposure study?

You may feel a slight sting or "pinch" in your arm when the blood is drawn. You may also get a small bruise. Some people may faint, but this is rare. There are no medical risks from providing urine.

The skin wipe sampling will involve personal contact by a research staff member with your hands, arms, and legs.

Are there any benefits to you from being in this smaller, more detailed exposure study?

There will be no direct benefits to you from being in this study.

Who will see the information you give the researchers?

All information about you (including name and address, this form, and interview answers) will be secure. We keep track of your information using a code number rather than a name. We will keep paper records in locked files and electronic records are stored on password protected computers at USEPA and ATSDR. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at the paper and electronic records. Federal policy requires making the data we collect available to the public, but we will never include your name or other identifying information in public release.

Who will have access to my air, skin wipe, blood, and urine samples?

Your air sample and skin wipe samples will be shipped to and analyzed by the laboratory at the EPA. Your blood and urine samples will be shipped to and stored at the Centers for Disease Control and Prevention (CDC) laboratory in Atlanta, GA. These samples will be analyzed at a later time. The chemical tests have not been chosen yet. Your samples will be labeled with a code number only.

What is the cost to you and what compensation will you get?

The only cost for being in our study is your time and effort to take part. We will give you a gift card each time you give us blood and urine samples ($15 pre-activity and $25 post-activity). You can use the gift cards at most stores or for online shopping.

What are your choices about participating?

Your participation in this study is voluntary. You are free to be a part of it or not. You can refuse to have your blood drawn, give a urine sample, and take part in air and skin wipe sampling. You can choose to leave at any time, or withdraw your blood and urine samples from storage, even after you have signed the consent form.

Who should you contact if you have questions later on?

If you have any questions about the study or wish to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel you have been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you do not understand what we are asking you to do, please ask questions. After all your questions have been answered to your satisfaction and if you want to be in this study, please sign the consent form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions, and I had all my questions answered.

By signing below, I agree to provide an air sample and skin wipe samples. The air and skin wipe samples will not be immediately tested for chemicals. I give ATSDR and USEPA permission to store my air and skin wipe samples to do the tests later. I understand that USEPA and ATSDR will not send my test results to me.

_______________________________________________

Participant’s name (Print)

_______________________________________________

Participant's signature / Date

By signing below, I agree to provide blood and urine samples. The blood and urine samples will not be immediately tested for chemicals. I give ATSDR and USEPA permission to store my blood and urine to do the tests later. I understand that USEPA and ATSDR will not send my test results to me.

_______________________________________________

Participant’s name (Print)

_______________________________________________

Participant's signature / Date

Attachment 5c3. Adult Consent – Activity Video

Flesch-Kincaid Reading Level 9.4

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you, as an adult aged 18 or older (or legal age in your state), to be in a research study to videotape people’s activities at synthetic turf fields. Your participation is voluntary. Before you decide to take part, please ask questions if there is anything that you do not understand.

What is the purpose of this video activity?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We will ask to videotape people’s on-field activities. Videos will help us see how much people come in contact with crumb rubber while playing on synthetic turf fields. We will use the results of this study to guide public health actions.

Why are you being asked to be in this video activity?

You were chosen to take part in this activity because you take part in recreation, training, or organized sports on these fields and you agreed to be in the main part of the study.

ATSDR and EPA hope to enroll 24 people to take part in this activity.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking you to do?

• We will videotape you during a physical activity on a synthetic turf field.

How long will this take?

It will take about one hour.

Are there any risks or discomforts to you if you decide to be in this video activity?

You may feel uncomfortable being videotaped. You are free to stop recording at any time.

Are there any benefits to you from being in this video activity?

There will be no direct benefits to you from being in this activity.

Who will see the information you give the researchers?

All information about you (including name and address, this form, and interview answers) will be secure. We keep track of your information using a code number rather than a name. We will keep paper records in locked files and electronic records are stored on password protected computers at USEPA. Only staff working on the study will be allowed to look at the paper and electronic records. Federal policy requires making the data we collect available to the public, but we will never include your name or other identifying information in public release.

The videos will be shipped to US EPA labeled only with a code number. The files will be secured to allow access only by trained study staff. No video or still images will be made public.

What is the cost to you and what compensation will you get?

The only cost for being in our study is your time and effort to take part. We will give you a $10 gift card for being videotaped. You can use the gift cards at most stores or for online shopping. Video recordings will be destroyed no later than 5 years from now.

What are your choices about participating?

Your taking part in this study is voluntary. You are free to be a part of it or not. You can choose to leave at any time, or withdraw your videotape from storage, even after you have signed the consent form.

Who should you contact if you have questions later on?

If you have any questions about the study or wish to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel you have been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you do not understand what we are asking you to do, please ask questions. After all your questions have been answered to your satisfaction and if you want to be in this study, please sign the consent form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

CONSENT TO PARTICIPATE IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions, and I had all my questions answered.

By signing below, I agree to being videotaped while I am playing or training on synthetic turf fields.

_______________________________________________

Participant’s name (Print)

_______________________________________________

Participant's signature / Date

Attachment 5c4. Parental Permission (Adolescent) – Human Activity Questionnaire

Flesch-Kincaid Reading Level 9.6

PARENTAL/GUARDIAN PERMISSION FOR ADOLESCENT PARTICIPATION IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you to give permission for your adolescent, aged 13 to 17 years (or up to the legal age in your state), to be in a research study. Your adolescent’s participation is voluntary. We invite you both to read or hear about the study. Before you decide to permit him/her to take part, please ask questions if there is anything that you both do not understand.

What is the purpose of this study?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We want to ask some questions about your adolescent’s activities on synthetic turf fields. This information will help us see if people might be exposed to chemicals from playing on synthetic turf fields. We will use the results of this study to guide public health actions.

Why is your adolescent being asked to be in this study?

Your adolescent was chosen to take part in this study because he/she works out on synthetic turf fields. People like him/her take part in recreation, training, or organized sports on these fields.

• ATSDR and EPA hope to enroll 60 people to answer some questions.

• We also want you both to know about other parts of the research for some of the people who are interviewed.

  • We will ask a smaller group of people who complete the interview if they are willing to provide blood, urine, and skin wipe samples so we can look what you are exposed to while playing on the field.

  • We will videotape 24 of these people during their on-field activities.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking you to do?

We will ask him/her a few questions in an interview. We will ask questions about his/her activities on synthetic turf fields. We want to know about the types of his/her activities, how often he/she plays on the fields, and how long he/she has been playing on the fields.

We also want you both to tell us if you are interested in hearing more about the smaller, more detailed exposure study and the activity videotape. Indicating interest in the smaller, more detailed exposure study does not mean that you will be asked to participate.

How long will this take?

It will take about 30 minutes to complete the interview. We want you and your adolescent to know if he/she is selected to take part in the smaller, more detailed exposure study, it will take about three more hours. If he/she is selected to take part in the activity videotaping, it will take about an hour.

Are there any risks or discomforts to your youth if he/she decides to be in this study?

We don’t think these questions are sensitive. But the interview may be stressful if he/she has to recall events that are upsetting. Your adolescent is free to skip any question for any reason.

Are there any benefits to your adolescent from being in this study?

There will be no direct benefits from being in this study.

Who will see the information your adolescent gives the researchers?

All information about your adolescent (including name and address, this form, and interview answers) will be secure. We will track his/her information using a code number rather than name. We will keep paper records in locked files. Electronic records will be stored on password protected computers at USEPA and at ATSDR. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at your adolescent’s records. Federal policy requires making the data we collect available to the public, but we will never include your adolescent’s name or other identifying information in a public release.

What is the cost to your youth and what compensation will he/she get?

The only cost for being in our study is your adolescent’s time and effort to take part. We will give you (or him/her) a $25 gift card as a “thank you” when the interview is completed. The gift cards can be used at most stores or for online shopping.

People who also provide blood, urine, and skin wipe samples or complete the video activity will get additional gift cards.

What are your adolescent’s choices about participating?

Your adolescent’s taking part in the interview is voluntary. He/she is free to be a part of it or not. He/she can refuse to answer any questions. Your adolescent can choose to leave the research study at any time, even after you both have signed the permission form and the assent form.

Who should you contact if you have questions later on?

If you or your adolescent have any questions about the study or he/she wishes to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your adolescent’s rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel your adolescent has been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you or your adolescent do not understand what we are asking him/her to do, please ask questions. After all your questions have been answered to your satisfaction and if you permit your adolescent to be in this study, please sign the permission form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

PARENTAL/GUARDIAN PERMISSION FOR ADOLESCENT PARTICIPATION IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions and I had all my questions answered.

By signing below, I permit my adolescent to take part in the research and the interview.

__________________________________________________

Adolescent name (Print) / Relationship to Parent/Legal Guardian

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

By signing below, I agree to be contacted about the smaller, more detailed exposure study for my adolescent.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

Attachment 5c5. Adolescent Assent – Human Activity Questionnaire

Flesch-Kincaid Reading Level 5.7

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

ADOLESCENT ASSENT TO BE IN A RESEARCH STUDY

We are doing a study to learn about how people use playing fields with crumb rubber and to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black stuff that makes the fields soft to play on. It is usually made from recycled tires. We also want to learn if people are exposed to chemicals from the crumb rubber. We are asking you to help because we do not know very much about how young people play or practice on these fields.

If you agree to be in our study, we are going to ask you some questions about how you play or practice on the fields. For example, we want to know how often you fall or slide on the ground.

You can ask questions about this study at any time. It should take about 30 minutes to finish the interview. If you decide at any time not to finish, you can ask us to stop.

The questions we will ask are about how you play or practice on the fields. There are not right or wrong answers because this is not a test.

Your mom/dad has said it is ok for you to be in the study. But it is up to you if you want to take part. If you sign this paper, it means that you have read this, or had this read to you, and that you want to be in the study. If you don’t want to be in this study, don’t sign this paper. Being in the study is up to you, and no one will be upset if you don’t sign this paper or if you change your mind later.

If You Have Questions

If you have any questions now, please ask us. If you have questions later, your parents/guardians have information about who to call.

_______________________________________________

Adolescent’s name (Print)

_______________________________________________

Adolescent’s signature / Date

_______________________________________________

Person obtaining assent’s name (Print)

_______________________________________________

Person obtaining assent’s signature / Date

Attachment 5c6. Parental Consent and Permission –Youth Activity Questionnaire

Flesch-Kincaid Reading Level 8.9

PARENTAL/GUARDIAN CONSENT AND PERMISSION FOR YOUTH PARTICIPATION IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you and your youth, aged 10-12 years, to be in a research study. Your and your youth’s participation is voluntary. We invite you both to read or hear about the study. Before you both decide to take part, please ask questions if there is anything that you do not understand.

What is the purpose of this study?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We want to ask you some questions about your youth’s activities on synthetic turf fields. This information will help us see if people might be exposed to chemicals from playing on synthetic turf fields. We will use the results of this study to guide public health actions.

Why are you and your youth being asked to be in this study?

We are asking you to answer some questions about your youth’s activities on synthetic turf fields. Your youth was chosen to take part in this study because he/she works out on synthetic turf fields. People like him/her take part in recreation, training, or organized sports on these fields.

• ATSDR and EPA hope to enroll 60 people to answer some questions.

• We also want you both to know about other parts of the research for some of the people who are interviewed.

  • We will ask a smaller group of people who complete the interview if they are willing to provide blood, urine, and skin wipe samples so we can look what you are exposed to while playing on the field..

  • We will videotape 24 of these people during their on-field activities.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking you and your youth to do?

We will ask you a few questions about your child in an interview. We will ask questions about his/her activities on synthetic turf fields. We want to know about the types of his/her activities, how often he/she plays on the fields, and how long he/she has been playing on the fields.

We also want you both to tell us if you are interested in hearing more about the smaller, more detailed exposure study and the activity videotape.

How long will this take?

It will take about 30 minutes to complete the interview. We want you and your youth to know if he/she is selected to take part in the smaller, more detailed exposure study, it will take about three more hours. If he/she is selected to take part in the activity videotaping, it will take about an hour.

Are there any risks or discomforts to you and your youth if you both decide to be in this study?

We don’t think these questions are sensitive. But the interview may be stressful if you have to recall events that are upsetting about your youth. You are free to skip any question for any reason.

Are there any benefits to you and your youth from being in this study?

There will be no direct benefits from being in this study.

Who will see the information you or your youth gives the researchers?

All information about you and your youth (including name and address, this form, and interview answers) will be secure. We will track you information using a code number rather than name. We will keep paper records in locked files. Electronic records will be stored on password protected computers at USEPA and at ATSDR. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at both your records. Federal policy requires making the data we collect available to the public, but we will never include your or your youth’s name or other identifying information in a public release.

What is the cost to you and your youth and what compensation will you get?

The only cost for being in our study is your time and effort to take part. We will give you a $25 gift card as a “thank you” when the interview is completed. You can use the gift card at most stores or for online shopping.

People who also provide blood, urine, and skin wipe samples or the complete the video activity will get additional gift cards.

What are your and your youth’s choices about participating?

Your taking part in the interview is voluntary. You are free to be a part of it or not. You can refuse to answer any questions. You and your youth can choose to leave the research study at any time, even after you both have signed the permission form and the assent form.

Who should you contact if you have questions later on?

If you or your youth have any questions about the study or he/she wishes to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your youth’s rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel your youth has been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you or your youth do not understand what we are asking him/her to do, please ask questions. After all your questions have been answered to your satisfaction and if you permit your youth to be in this study, please sign the permission form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

PARENTAL/GUARDIAN CONSENT AND PERMISSION FOR

YOUTH PARTICIPATION IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions and I had all my questions answered.

By signing below, I permit my youth to take part in the research, and I agree to take part in the interview about my youth.

__________________________________________________

Youth name (Print) / Relationship to Parent/Legal Guardian

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

By signing below, I agree to be contacted about the smaller, more detailed exposure study for my youth.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

By signing below, I agree to be contacted about the activity videotaping for my youth.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

Attachment 5c7. Youth Assent – Youth Activity Questionnaire

Flesch-Kincaid Reading Level 5.6

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

YOUTH ASSENT TO BE IN A RESEARCH STUDY

We are doing a study to learn about how people use playing fields with crumb rubber and to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black stuff that makes the fields soft to play on. It is usually made from recycled tires. We also want to learn if people are exposed to chemicals from the crumb rubber. We are asking you to help because we do not know very much about how kids your age play or practice on these fields.

If you agree to be in our study, we are going to ask your Mom/Dad/guardian some questions about how you play or practice on the fields. You can help with the answers. For example, we want to know how often you fall or slide on the ground.

You and your Mom/Dad/guardian can ask questions about this study at any time. It should take about 30 minutes to finish the interview. If you both decide at any time not to finish, you can ask us to stop.

We will ask are about how you play or practice on the fields. There are not right or wrong answers because this is not a test.

Your mom/dad has said it is ok for you to be in the study but it is up to you if you want to take part. If you sign this paper, it means that you have read this, or had this read to you, and that you want to be in the study. If you don’t want to be in this study, don’t sign this paper. Being in the study is up to you. No one will be upset if you don’t sign this paper or if you change your mind later.

If You Have Questions

If you have any questions now, please ask us. If you have questions later, your parents/guardians have information about who to call.

_______________________________________________

Youth’s name (Print)

_______________________________________________

Youth’s signature / Date

_______________________________________________

Person obtaining assent’s name (Print)

_______________________________________________

Person obtaining assent’s signature / Date

Attachment 5c8. Parental Permission (Adolescent/Youth) – Exposure Measurement

Flesch-Kincaid Reading Level 9.6

PARENTAL/GUARDIAN PERMISSION FOR ADOLESCENT/YOUTH PARTICIPATION IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you to give permission for your adolescent/youth, aged 10 to 17 years (or up to the legal age in your state), to be in a research study about personal exposure measures from synthetic turf fields. Your youth/adolescent’s participation is voluntary. We invite you both to read or hear about this smaller, more detailed exposure study. Before you decide to permit him/her to take part, please ask questions if there is anything that you both do not understand.

What is the purpose of collecting more detailed measurements?

The purpose is to see how people might come into contact with chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We will collect some samples from your adolescent/youth. This information will help us see if people might be exposed to chemicals from playing on synthetic turf fields. We will use the results of this study to better understand the most relevant chemicals, potential exposures to those chemicals, and toxicity information available for those chemicals found in crumb rubber infill used in synthetic turf fields.

Why are you being asked to be in this smaller, more detailed exposure study?

Your adolescent/youth was chosen to take part in this smaller, more detailed exposure study because he/she works out on synthetic turf fields, and you agreed to allow him/her to participate in the main part of the study. We want to talk to people who take part in recreation, training, or organized sports on these fields.

• ATSDR and EPA hope to enroll 45 people to take part in this study.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking your adolescent/youth to do?

• We will take some measures during one of your adolescent/youth’s normal activities on synthetic turf fields. These measures will include monitoring of the air that he/she is breathing with a small sampling tube attached to his/her clothes during the activity. The air samples will be analyzed by the laboratory at EPA.

• Following the activity we will collect wipe samples of your adolescent/youth’s hands and areas of his/her arms and legs. The skin wipe sampling will be done with pads wetted with water, and pads wetted with a water and alcohol mixture. The skin wipe samples will be analyzed by the laboratory at EPA.

• We will collect urine and blood samples two times: before the activity and directly after activity. We will ask him/her a few questions to be sure that he/she can safely give blood. Each time:

  • A person trained to draw blood will collect about 15 ml (about 1 tablespoon) of blood from a vein in his/her arm.

  • Your adolescent/youth will be asked to provide 50-100 ml (about ½ cup) of urine in a cup. Your adolescent/youth will do this in private in a restroom.

• In the future, your adolescent/youth’s blood and urine samples will be analyzed to look for some chemicals that are in the crumb rubber infill. Afterwards, the samples will be stored for the indefinite future. This is in case we get more information in the future about what chemicals to look for or new methods are developed to test for chemicals.  You and your adolescent/youth will not receive a copy of his/her test results.

• We will not analyze these samples for DNA, drugs, tobacco, or health conditions.

• In the future, your adolescent/youth’s urine and blood results may be linked to the rest of his/her study data for research purposes.

How long will this take?

It will take about three hours to finish the measurements. This includes setting up and collecting the air sampler, collecting the skin wipe, urine, and blood samples.

Are there any risks or discomforts to your adolescent/youth if he/she decides to be in this smaller, more detailed exposure study?

Your adolescent/youth may feel a slight sting or "pinch" in his/her arm when the blood is drawn. He/she may also get a small bruise. Some people may faint, but this is rare. There are no risks from giving urine.

The skin wipe sampling will involve personal contact by a research staff member with your adolescent/youth’s hands, arms, and legs.

Are there any benefits to your adolescent/youth from being in this smaller, more detailed exposure study?

There will be no direct benefits from being in this study.

Who will see the information your youth gives the researchers?

All information about your adolescent/youth (including name and address, this form, and interview answers) will be secure. We will track his/her information using a code number rather than name. We will keep paper records in locked files. Electronic records will be stored on password protected computers at USEPA and at ATSDR. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at your adolescent/youth’s records. Federal policy requires making the data we collect available to the public, but we will never include your adolescent/youth’s name or other identifying information in a public release.

Who will have access to my youth’s air, skin, blood, and urine samples?

Your adolescent/youth’s air sample and skin wipe samples will be shipped to and analyzed by the laboratory at EPA. His/her blood and urine samples will be shipped to and stored by the Centers for Disease Control and Prevention (CDC) laboratory in Atlanta, GA. His/her samples will be labeled with a code number only.

What is the cost to your adolescent/youth and what compensation will he/she get?

The only cost for being in our study is your adolescent/youth’s time and effort to take part. We will give you (or him/her) a gift card each time he/she gives us blood and urine samples ($15 pre-activity and $25 post-activity). The gift cards can be used at most stores or for online shopping.

.

What are your adolescent/youth’s choices about participating?

Your adolescent/youth’s participation in this study is voluntary. He/she is free to be a part of it or not. He/she can refuse to have his/her blood drawn, give a urine sample, and take part in air and skin wipe sampling. Your adolescent/youth can choose to leave at any time, or withdraw his/her blood and urine samples from storage, even after you both have signed the permission and the assent form.

Who should you contact if you have questions later on?

If you or your adolescent/youth have any questions about the study or he/she wishes to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your adolescent/youth’s rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel your adolescent/youth has been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you or your youth do not understand what we are asking him/her to do, please ask questions. After all your questions have been answered to your satisfaction and if you permit your adolescent/youth to be in this study, please sign the permission form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

PARENTAL/GUARDIAN PERMISSION FOR ADOLESCENT/YOUTH PARTICIPATION IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions, and I had all my questions answered.

By signing below, I permit my adolescent/youth to provide air monitoring and skin wipe samples. The air and skin wipe samples will not be immediately tested for chemicals. I give ATSDR and USEPA permission to store my youth’s air and skin wipe samples to do the tests later. I understand that USEPA and ATSDR will not send my adolescent/youth’s test results to me.

__________________________________________________

Youth name (Print) / Relationship to Parent/Legal Guardian

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

By signing below, I permit my adolescent/youth to provide blood and urine samples. The blood and urine samples will not be immediately tested for chemicals. I give ATSDR and USEPA permission to store my adolescent/youth’s blood and urine to do the tests later. I understand that USEPA and ATSDR will not send my adolescent/youth’s test results to me.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

Attachment 5c9. Adolescent/Youth Assent – Exposure Measurement

Flesch-Kincaid Reading Level 5.7

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

ADOLESCENT AND YOUTH ASSENT TO BE IN A RESEARCH STUDY

We are doing a study to learn about how people use playing fields with crumb rubber. Crumb rubber is the black stuff that makes the fields soft to play on. It is usually made from recycled tires. We also want to learn if people are exposed to chemicals from the crumb rubber. We are asking adolescents and youths, 10 to 17 years of age, to participate in this study. You were selected to take part in this study because you play on synthetic turf with crumb rubber and because you said you would be in the main part of the study.

If you decide to take part, we will take some measurements while you are playing on the field. We will ask you to wear a small tube that collects some of the chemicals in the air you are breathing; the small tube will be pinned to your clothing. This will take about 15 minutes to set up. After the activity, we will wipe your hands and parts of your arms and legs with a wet cloth to see what you came into contact with on the field. This will take about 45 minutes.

We will also ask you to collect two urine and blood samples, one before you begin your activity on the field and one after you finish your activity on the field. We will ask you to collect your urine in a cup we will give you. It should take you less than 5 minutes to do this. We will also collect some of your blood (about 3 teaspoons) at each of these points. This should take about 15 minutes.

The total time to collect all samples is about three hours.

Other Information

You may feel a slight sting or "pinch" in your arm when the blood is drawn. You may also get a small bruise. Some people may faint, but this is rare. There are no risks from giving urine.

You might be uncomfortable at having a person wiping your hands, arms, and legs.

Your mom/dad has said it is ok for you to be in the study but it is up to you if you want to take part. You can decide whether or not to take part in this study. You can ask questions about this study at any time. If you decide at any time not to finish, you can ask us to stop.

If You Have Questions

If you have any questions now, please ask us. If you have questions later, your parents/guardians have information about who to call.

_______________________________________________

Adolescent/Youth’s name (Print)

_______________________________________________

Adolescent/Youth’s signature / Date

_______________________________________________

Person obtaining assent’s name (Print)

_______________________________________________

Person obtaining assent’s signature / Date

Attachment 5c10. Parental Permission – Activity Video

Flesch-Kincaid Reading Level 9.6

PARENTAL/GUARDIAN PERMISSION FOR YOUTH/ADOLESCENT PARTICIPATION IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you to give permission for your adolescent or youth, 10 to 17 years of age (or up to the legal age in your state), to be in a component of the research study to videotape people’s activities at synthetic turf fields. Your adolescent/ youth’s participation is voluntary. We invite you both to read or hear about the activity. Before you decide to permit him/her to take part, please ask questions if there is anything that you both do not understand.

What is the purpose of this video component?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We will ask to videotape your adolescent/youth’s on-field activities. Videos will help us see how much people come in contact with crumb rubber while playing on synthetic turf fields. We will use the results of this study to guide public health actions.

Why is your adolescent/youth being asked to be in this video activity?

• Your adolescent/youth was chosen to take part in this activity because he/she takes part in recreation, training, or organized sports on these fields, and you agreed for him/her to be in the main part of the study. ATSDR and EPA hope to enroll 24 people to take part in this activity.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking your youth to do?

• We will videotape your adolescent/youth during a physical activity on a synthetic turf field.

How long will this take?

It will take about one hour.

Are there any risks or discomforts to your adolescent/youth if he/she decides to be in this video activity?

Your adolescent/youth may feel uncomfortable being videotaped. He/she is free to stop recording at any time.

Are there any benefits to your adolescent/youth from being in this video activity?

There will be no direct benefits from being in this activity.

Who will see the information your adolescent/youth gives the researchers?

All information about your adolescent/youth (including name and address, this form, and interview answers) will be secure. We keep track of his/her information using a code number rather than a name. We will keep paper records in locked files and electronic records are stored on password protected computers at USEPA. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at the paper and electronic records. Federal policy requires making the data we collect available to the public, but we will never include your adolescent/ youth’s name or other identifying information in public release.

The videos will be shipped to USEPA labeled only with a code number. The files will be secured to allow access only by trained study staff. No video or still images will be made public. Video recordings will be destroyed no later than 5 years from now.

What is the cost to your adolescent/youth and what compensation will he/she get?

The only cost for being in our study is your adolescent/youth’s time and effort to take part. We will give you (or him/her) a $10 gift card for being videotaped. You (or he/she) can use the gift cards at most stores or for online shopping.

What are your adolescent/youth’s choices about participating?

Your adolescent/youth taking part in this study is voluntary. He/she is free to be a part of it or not. He/she can choose to leave at any time, or withdraw his/her videotape from storage, even after you both have signed the permission form and assent form.

Who should you contact if you have questions later on?

If you or your adolescent/youth have any questions about the study or he/she wishes to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your adolescent/youth’s rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel your adolescent/youth has been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you or your adolescent/youth do not understand what we are asking him/her to do, please ask questions. After all your questions have been answered to your satisfaction and if you permit your adolescent/youth to be in this study, please sign the permission form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

PARENTAL/GUARDIAN PERMISSION FOR YOUTH PARTICIPATION IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions, and I had all my questions answered.

By signing below, I permit my adolescent/youth to be videotaped while he/she is playing or training on synthetic turf fields.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

Attachment 5c11. Adolescent/Youth Assent – Activity Video

Flesch-Kincaid Reading Level 6.4

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

ADOLESCENT/YOUTH ASSENT TO BE IN A RESEARCH STUDY

We are doing a study to learn about how people use playing fields with crumb rubber. Crumb rubber is the black stuff that makes the fields soft to play on. It is usually made from recycled tires. We also want to learn if people are exposed to chemicals from the crumb rubber. We will videotape their activity while playing on the field. This will help us find out how much contact people have with field materials.

We are asking adolescents and youth, 10 to 17 years of age, to participate in this activity. You were selected to take part in this study because you play on synthetic turf with crumb rubber and because you said you would be in the main part of the study.

If you decide to take part, we will videotape you while you are playing on the field. This will take about one hour.

Other Information

You might be uncomfortable about people recording your play on the field.

Your mom/dad has said it is ok for you to be in the study, but it is up to you if you want to take part. You can decide whether or not to take part in this study. You can ask questions about this study at any time. If you decide at any time not to finish, you can ask us to stop.

If You Have Questions

If you have any questions now, please ask us. If you have questions later, your parents/guardians have information about who to call.

_______________________________________________

Adolescent/Youth’s name (Print)

_______________________________________________

Adolescent/Youth’s signature / Date

_______________________________________________

Person obtaining assent’s name (Print)

_______________________________________________

Person obtaining assent’s signature / Date

Attachment 5c12. Parental Permission – Activity Questionnaire and Exposure Measurement Sub-Study

Flesch-Kincaid Reading Level 8.3

PARENTAL/GUARDIAN CONSENT AND PERMISSION FOR

CHILD PARTICIPATION IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you and your child, aged 7-9 years, to be in a research study. Your and your child’s participation is voluntary. We invite you both to read or hear about the study. Before you both decide to take part, please ask questions if there is anything that you do not understand.

What is the purpose of this study?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We want to ask you some questions about your child’s activities on synthetic turf fields. This information will help us see if people might be exposed to chemicals from playing on synthetic turf fields. We will use the results of this study to better understand the most relevant chemicals, potential exposures to those chemicals, and toxicity information available for those chemicals found in crumb rubber infill used in synthetic turf fields.

Why are you and your child being asked to be in this study?

We are asking you to answer some questions about your child’s activities on synthetic turf fields. Your child was chosen to take part in this study because he/she works out on synthetic turf fields. People like him/her take part in recreation, training, or organized sports on these fields.

• ATSDR and EPA hope to enroll 60 people to answer some questions.

• We will also be taking more detailed measurements, skin wipe, urine, and blood samples, in 45 of these people and we will videotape about half of the 45 people (a total of 24 will be videotaped).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking you and your child to do?

We will ask you a few questions about your child in an interview. We will ask questions about his/her activities on synthetic turf fields. We want to know about the types of his/her activities, how often he/she plays on the fields, and how long he/she has been playing on the fields. We will also be asking for the following items/activities from your child:

• We will take some measures during one of your child’s normal activities on synthetic turf fields. These measures will include monitoring of the air they breathe with a small sampling tube attached to his/her clothes during the activity. The air samples will be analyzed by the laboratory at EPA.

• Following the activity, we will collect wipe samples of your child’s hands and areas of his/her arms and legs. The skin wipe sampling will be done with pads wetted with water, and pads wetted with a water and alcohol mixture. The skin wipe samples will be analyzed by the laboratory at EPA.

• We will collect blood and urine samples two times: before activity and directly after activity. We will ask him/her a few questions to be sure that he/she can safely give blood. Each time:

  • A person trained to draw blood will collect about 15 ml (about 1 tablespoons) of blood from a vein in his/her arm.

  • Your child will be asked to provide 50-100 ml (about ½ cup) of urine in a cup. Your child will do this in private in a restroom.

• In the future, your child’s blood and urine samples will be analyzed to look for some chemicals that are in the crumb rubber infill. Afterwards, the samples will be stored for the indefinite future. This is in case we get more information in the future about what chemicals to look for or new methods are developed to test for chemicals.  You and your child will not receive a copy of his/her test results.

• We will not analyze these samples for DNA, drugs, tobacco, or health conditions.

• In the future, your child’s blood and urine results may be linked to the rest of his/her study data for research purposes.

How long will this take?

It will take about 30 minutes to complete the interview. It will take about three more hours to finish the different activities. This includes setting up and collecting the personal air sampler, collecting the skin wipe, urine, and blood samples.

Are there any risks or discomforts to you and your child if you both decide to be in this study?

We don’t think these questions are sensitive. But the interview may be stressful if you have to recall events that are upsetting about your child. You are free to skip any question for any reason.

Your child may feel a slight sting or "pinch" in his/her arm when the blood is drawn. He/she may also get a small bruise. Some people may faint, but this is rare. There are no risks from giving urine.

The skin wipe sampling will involve personal contact by a research staff member with your child’s hands, arms, and legs.

Are there any benefits to you and your child from being in this study?

There will be no direct benefits from being in this study.

Who will see the information you or your child gives the researchers?

All information about you and your child (including name and address, this form, and interview answers) will be secure. We will track your information using a code number rather than name. We will keep paper records in locked files. Electronic records will be stored on password protected computers at USEPA and at ATSDR. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at both your records. Federal policy requires making the data we collect available to the public, but we will never include your or your child’s name or other identifying information in a public release.

Who will have access to my child’s air, skin, blood, and urine samples?

Your child’s air sample and skin wipe samples will be shipped to and analyzed by the laboratory at US EPA. His/her blood and urine samples will be shipped to and stored by the Centers for Disease Control and Prevention (CDC) laboratory in Atlanta, GA. His/her samples will be labeled with a code number only.

What is the cost to you and your child and what compensation will you get?

The only cost for being in our study is your and your child’s time and effort to take part. We will give you a $25 gift card as a “thank you” when the interview is completed. We will give you (or your child) a gift card each time he/she gives us blood and urine samples ($15 pre-activity and $25 post-activity). We will give you (or your child) a $10 gift card when he/she completes the activity videotaping. The gift cards can be used at most stores or for online shopping.

What are your and your child’s choices about participating?

Your taking part in the interview is voluntary. You are free to be a part of it or not. You can refuse to answer any questions. Your child’s participation in this study is voluntary. He/she is free to be a part of it or not. He/she can refuse to have his/her blood drawn, give a urine sample, and take part in air and skin wipe sampling. Your child can choose to leave at any time, or withdraw his/her blood and urine samples from storage, even after you both have signed the permission and the assent form.

You and your child can choose to leave the research study at any time, even after you both have signed the permission form and the assent form.

Who should you contact if you have questions later on?

If you or your child have any questions about the study or he/she wishes to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your child’s rights as a research subject, please contact:

Centers for Disease Control and Prevention CDC/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel your child has been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you or your child do not understand what we are asking him/her to do, please ask questions. After all your questions have been answered to your satisfaction and if you permit your child to be in this study, please sign the permission form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

PARENTAL/GUARDIAN CONSENT AND PERMISSION FOR

CHILD PARTICIPATION IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions and I had all my questions answered.

By signing below, I permit my child to take part in the research, and I agree to take part in the interview about my child.

__________________________________________________

Child name (Print) / Relationship to Parent/Legal Guardian

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

By signing below, I permit my child to provide air monitoring and skin wipe samples. The air and skin wipe samples will not be immediately tested for chemicals. I give ATSDR and USEPA permission to store my child’s personal air and skin wipe samples to do the tests later. I understand that USEPA and ATSDR will not send my child’s test results to me.

__________________________________________________

Child name (Print) / Relationship to Parent/Legal Guardian

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

By signing below, I permit my child to provide blood and urine samples. The blood and urine samples will not be immediately tested for chemicals. I give ATSDR and USEPA permission to store my child’s blood and urine to do the tests later. I understand that USEPA and ATSDR will not send my child’s test results to me.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

Attachment 5c113. Child Assent – Exposure Measurements

Flesch-Kincaid Reading Level 5.0

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Child Assent Form

We are doing a study to learn about how people use playing fields with crumb rubber. Crumb rubber is the black stuff that makes the fields soft to play on. It is usually made from recycled tires. We also want to learn if people are exposed to chemicals from the crumb rubber. We are asking kids ages 7-9 to participate in this study. You were picked because you play on fields with crumb rubber.

If you decide to be in the study, we are going to ask your Mom or Dad some questions about how you play on the fields. You can help with the answers. For example, we want to know how often you fall or slide on the ground.

We will ask you to pee in a cup two times, once before you play and once after you play. It should take you less than 5 minutes to do this. We will also take some of your blood (about three teaspoons) before and after you play on the field. This should take about 15 minutes.

We will pin a small tube on your clothes to wear while you are playing on the field. The tube helps us measure chemicals in the air. After you finish playing, we will wipe your hands and parts of your arms and legs with a wet cloth. This will let us measure chemicals on your skin. This will take about 45 minutes.

Other Information

You might feel a small sting or "pinch" in your arm when we take your blood. You might also get a small bruise. Some people may faint, but this doesn’t happen very often. Peeing in a cup might be a bit weird but it can’t hurt you. You will do this in private in the restroom. You might be uncomfortable at having a person wiping your hands, arms, and legs.

Your mom/dad has said it is ok for you to be in the study, but it is up to you if you want to take part. You can ask us to stop at any time if you don’t want to finish.

If You Have Questions

If you have any questions now, please ask us. If you have questions later, your Mom or Dad will know who to call.

Your signature: Date: 2016

Your printed name: Date: 2016

Signature of person obtaining consent: Date: 2016

Printed name of person obtaining consent: Date: 2016

Attachment 5c14. Parental Permission – Activity Video

Flesch-Kincaid Reading Level 9.4

PARENTAL/GUARDIAN PERMISSION FOR CHILD PARTICIPATION IN A RESEARCH STUDY

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

Overview

The Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) invite you to give permission for your child, 7 to 9 years of age, to be in a research study to videotape people’s activities at synthetic turf fields. Your child’s participation is voluntary. We invite you both to read or hear about the video activity. Before you decide to permit him/her to take part, please ask questions if there is anything that you both do not understand.

What is the purpose of this video activity?

The purpose is to see how people might be exposed to chemicals in crumb rubber infill in synthetic turf. Crumb rubber is the black material used as cushioning in synthetic turf fields. The crumb rubber is most often made from recycled tires. We will ask to videotape your child’s on-field activities. Videos will help us see how much people come in contact with crumb rubber while playing on synthetic turf fields. We will use the results of this study to guide public health actions.

Why is your child being asked to be in this video activity?

Your child was chosen to take part in this activity because he/she works out on synthetic turf fields, and you agreed for him/her to participate in the main part of the study. We want to talk to people who take part in recreation, training, or organized sports on these fields.

• ATSDR and EPA hope to enroll 24 people to take part in this activity.

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

Public reporting burden of this collection of information is estimated to average 5 minutes per response for total participation, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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 Reports Clearance Officer; 1600 Clifton Road, MS D-74, Atlanta, GA 30333, ATTN: PRA (0923-XXXX).

What are we asking your child to do?

• We will videotape your child during a physical activity on a synthetic turf field.

How long will this take?

It will take about one hour.

Are there any risks or discomforts to your child if he/she decides to be in this video activity?

Your child may feel uncomfortable being videotaped. He/she is free to stop recording at any time.

Are there any benefits to your child from being in this video activity?

There will be no direct benefits from being in this activity.

Who will see the information your child gives the researchers?

All information about your child (including name and address, this form, and interview answers) will be secure. We keep track of his/her information using a code number rather than a name. We will keep paper records in locked files and electronic records are stored on password protected computers at USEPA. Only EPA and ATSDR staff and their contractors authorized to work on the study will be allowed to look at the paper and electronic records. Federal policy requires making the data we collect available to the public, but we will never include your child’s name or other identifying information in public release.

The videos will be shipped to USEPA labeled only with a code number. The files will be secured to allow access only by trained study staff. No video or still images will be made public. Video recordings will be destroyed no later than 5 years from now.

What is the cost to your child and what compensation will he/she get?

The only cost for being in our study is your child’s time and effort to take part. We will give you (or him/her) a $10 gift card for being videotaped. The gift cards can be used at most stores or for online shopping.

.

What are your child’s choices about participating?

Your child taking part in this study is voluntary. He/she is free to be a part of it or not. He/she can choose to leave at any time, or withdraw his/her videotape from storage, even after you both have signed the permission form and assent form.

Who should you contact if you have questions later on?

If you or your child have any questions about the study or he/she wishes to drop out, please contact:

Dr. Elizabeth Irvin-Barnwell

[email protected]

770-488-3684

For questions about your child’s rights as a research subject, please contact:

Centers for Disease Control and Prevention (CDC)/ATSDR Human Research Protection Helpline

800-584-8814

Please leave a message and say you are calling about protocol 6881.

If you feel your child has been harmed by this study please contact:

Dr. Angela Ragin

[email protected]

770-488-3807

What should you do after reading this information?

If you or your child do not understand what we are asking him/her to do, please ask questions. After all your questions have been answered to your satisfaction and if you permit your child to be in this study, please sign the permission form on the next page. You will be given a copy of this form for your records.

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

PARENTAL/GUARDIAN PERMISSION FOR CHILD PARTICIPATION IN A RESEARCH STUDY

I have read the above information, or it has been read to me, about the study titled Collections Related to Synthetic Turf Fields with Crumb Rubber Infill. I have been allowed to ask questions, and I had all my questions answered.

By signing below, I permit my child to be videotaped while he/she is playing or training on synthetic turf fields.

_______________________________________________

Parent/Legal Guardian’s name (Print)

_______________________________________________

Parent/Legal Guardian’s signature / Date

Attachment 5c15. Child Assent – Activity Video

Flesch-Kincaid Reading Level 5.1

United States Environmental Protection Agency and Agency for Toxic Substances and Disease Registry

Collections Related to Synthetic Turf Fields with Crumb Rubber Infill

CHILD ASSENT TO BE IN A RESEARCH STUDY

We are doing a study to learn about how people use playing fields with crumb rubber. Crumb rubber is the black stuff that makes the fields soft to play on. It is usually made from recycled tires. We also want to learn if people are exposed to chemicals from the crumb rubber. We will videotape their activity while playing on the field. This will help us find out how much contact people have with field materials.

We are asking kids, 7 to 9 years of age, to take part in this activity. You were picked to take part because you play on synthetic turf with crumb rubber and because you said you would be in the main part of the study.

If you decide to take part, we will videotape you while you are playing on the field. This will take about one hour.

Other Information

You might be uncomfortable about people recording your play on the field.

Your mom/dad has said it is ok for you to be in the study but it is up to you if you want to take part. You can decide whether or not to take part in this study. You can ask questions about this study at any time. If you decide at any time not to finish, you can ask us to stop.

It should take an hour to finish.

If You Have Questions

If you have any questions now, please ask us. If you have questions later, your Mom or Dad will know who to call.

_______________________________________________

Child’s name (Print)

_______________________________________________

Child’s signature / Date

_______________________________________________

Person obtaining assent’s name (Print)

_______________________________________________

Person obtaining assent’s signature / Date