Att5_Example AssentConsentParental Permission

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ATSDR Exposure Investigations (EIs)

Att5_Example AssentConsentParental Permission

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Attachment 5

Example Assent/Consent Forms





ASARCO Smelter EI Parental Permission/Assent/Consent/ Forms

ASARCO Smelter EI



Attachment 5A

Parental Permission Form for Blood Sampling for Lead

Children 9 months to less than 72 months of age

ATSDR Exposure Investigation (EI)

ASARCO Smelter - Hayden/Winkelman, AZ

Who are we?

  • We are from a federal public health agency, the Agency for Toxic Substances and Disease Registry (ATSDR), and the Arizona Department of Health Services (ADHS).


Why we are doing this Exposure Investigation?

  • We are doing this Exposure Investigation to find out if children living in Hayden or Winkelman, AZ, have high levels of lead in their blood.


What do we want you to do?

  • Your child is invited to have his/her blood tested for lead.

  • There is NO COST to you for the testing of your child.

  • The blood collection will take place at XXX.

What is included in my child’s participation?

There are two parts to your child’s participation.

  1. Blood Collection and Testing for Lead

    • We will collect less than 1 teaspoon (3 milliliters) of blood from a vein of your child’s arm.

    • This will take 5 minutes or less.

    • We will send your child’s blood to a lab to test it for lead.

  1. Answer Some Questions:

    • We will ask you some questions about your child.

    • This should take about 20 minutes.


What will happen to any leftover blood after testing is finished?

  • The lab will throw out any leftover blood. It will not be used or tested for anything else.


When will you get the test results?

  • You will get your child’s test results by mail about 12 weeks after testing.


What are the benefits from being in this Exposure Investigation?

  • You will know if your child has a high level of lead in blood.

  • If your child has a high blood lead level, ATSDR and ADHS will provide you with information that will help you reduce your child’s contact with lead.


What are the Risks of this EI?

  • Your child might cry because the needle hurts

  • Your child’s arm may become bruised where the blood is taken from.

  • Your child may feel dizzy or lightheaded


How will we protect your privacy?

  • We will protect your and your child’s privacy as much as the law allows.

    • Arizona law requires that we report blood lead levels to ADHS.

    • Arizona law requires that information given to the state may be made public if someone asks them for the information.

  • We will give your child an identification (ID) number.

    • Your child’s ID number, not his/her name, will go on the tube of blood.

    • We will keep a record, under lock-and-key, of your child’s name, address and ID number. We will use this information to link your child’s results with his/her name so we can send you your child’s test results.

  • We will not use your or your child’s name in any report we write. Only group information that does not include individual names will be reported.


When can you ask questions about the testing?

  • If you have any questions about this testing, you can ask us now.

  • If you have questions later, you can call:

    • Dr. Bruce Tierney at 770-488-0771 

    • The ATSDR toll free number 1-888-320-5291


Parental/Guardian Voluntary Permission

  • I agree to have my child tested.

  • I was given the chance to ask questions on behalf of my child. I feel my questions have been answered.

  • I know that having these tests done is my choice.

  • I know that even though we agreed to this testing, I and my child may leave at any time without penalty.


Signature

I give permission for my child to be tested.


______________________________________ ______ ___________

Printed name of child Age Sex of child


___________________________________ __________________

Signature of parent/guardian Date


___________________________________

Printed name of parent/guardian



Address of Child _____________________________ Telephone __________________

______________________________

______________________________


May we share the test result with other federal, state, and local health and environmental agencies? YES / NO (please circle one)


Lab ID Number____________________


Certification of Permission Form Administrator:

I read the permission form to the person named above. He/she had the opportunity to ask questions about the Exposure Investigation and had the questions answered.


_______________________________________

Signature of person administering permission



Attachment 5B


Parental Permission Form for Blood Lead and Urine Arsenic Testing


Children and Youth 6 years to less than 18 years of age

ATSDR Exposure Investigation (EI)


ASARCO Smelter - Hayden/Winkelman, AZ



Who are we?

  • We are from a federal public health agency, the Agency for Toxic Substances and Disease Registry (ATSDR), and the Arizona Department of Health Services (ADHS).


Why we are doing this Exposure Investigation?

  • We are doing this Exposure Investigation to find out if children living in Hayden or Winkelman, AZ, have high levels of lead in their blood and arsenic in urine.


What do we want you to do?

  • Your child is invited to have his/her blood tested for lead and urine tested for arsenic.

  • There is NO COST to you for the testing of your child.


Place for Blood and Urine Collection

  • The blood collection will take place at XXX. The urine collection will take place in your home or at XXX.


What is included in my child’s participation?
There are three parts to your child’s participation.

  1. Blood Collection and Testing for Lead

    • We will collect less than 1 teaspoon (3 milliliters) from a vein of your child’s arm.

    • This will take 5 minutes or less.

    • We will send your child’s blood to a lab to test it for lead.

  1. Urine Collection and Testing for Arsenic:

    • The urine should be collected the day of the blood collection. You can collect the urine at your home or at the blood collection facility.

    • Help your child collect his/her urine in a plastic cup we give you. Put the lid on.

    • Write your child’s name on the label on the side of the cup.

    • Put the cup in a zip lock bag in the refrigerator until you bring it to XXX.

    • It should take 5 minutes or less to help collect your child’s urine.

    • We will send your child’s urine to a lab to test it for arsenic.

  1. Answer Some Questions:

    • During the appointment we will ask your child some questions for 20 min.

    • You may help your child answer the questions.


What will happen to any leftover blood and urine after testing is finished?

  • The lab will throw out any leftover blood and urine. It will not be used for anything else.


When will you get the test results?

  • You will get your child’s test results by mail about 12 weeks after testing.


What are the benefits from being in this Exposure Investigation?

  • You will know if your child has a high level of lead in blood and arsenic in urine.

  • If your child has a high blood lead level, ATSDR and ADHS will provide you with information that can help you reduce your child’s contact with lead.


What are the Risks of this EI?

  • Some bruising may happen on your child’s arm where the blood is taken.

  • There may be some pain from the needle stick and they may feel dizzy or lightheaded.

  • There is no risk from collecting urine.


How will we protect your privacy?

  • We will protect your and your child’s privacy as much as the law allows.

    • Arizona law requires that we report blood lead levels to ADHS.

    • Arizona law requires that information given to the state may be made public if someone asks them for the information.

  • We will give your child an identification (ID) number.

    • Your child’s ID number, not his/her name, will go on the tube of blood and the urine cup.

    • We will keep a record, under lock-and-key, of your child’s name, address and ID number. We will use this information to link your child’s results with his/her name so we can send you your child’s test results.

  • We will not use your or your child’s name in any report we write. Only group information that does not include individual names will be reported.


When can you ask questions about the testing?

  • If you have any questions about this testing, you can ask us now.

  • If you have questions later, you can call:

    • Dr. Bruce Tierney at 770-488-0771 

    • The ATSDR toll free number 1-888-320-5291


Child Assent

  • Your child said it is alright to have these blood and urine tests.

  • Your child doesn’t have to have these tests if you don’t want him/her to.


Parental/Guardian Voluntary Permission

  • I agree to have my child tested.

  • I and my child were given the chance to ask questions. We feel our questions have been answered.

  • I know that having these tests done is our choice.

  • I know that even though we agreed to this testing, I and my child may leave at any time without penalty.


Signature

I give permission for my child to be tested.


______________________________________ ___________ ___________

Printed name of child Age of child Sex of child


___________________________________ __________________

Signature of parent/guardian Date

___________________________________

Printed name of parent/guardian


______________________________________________ __________

Signature or written name of child in child’s handwriting Date


Address of Child _____________________________ Telephone __________________

______________________________

______________________________

May we share the test results with other federal, state, and local health and environmental agencies? YES / NO (please circle one)


Lab ID Number____________________


Certification of Permission Form Administrator:

I read the permission form to the person named above. He/she had the opportunity to ask questions about the Exposure Investigation and had the questions answered.


_______________________________________

Signature of person administering permission



Attachment 5C


Assent Form for Blood Lead and Urine Arsenic Testing


Children and Youth 6 years to less than 18 years of age


ATSDR Exposure Investigation (EI)


ASARCO Smelter - Hayden/Winkelman, AZ


Who are we?

  • We are from a federal public health agency, the Agency for Toxic Substances and Disease Registry (ATSDR), and the Arizona Department of Health Services (ADHS).


Why we are doing this Exposure Investigation?

  • We are doing this Exposure Investigation to find out if children and youth living in Hayden or Winkelman, AZ have high levels of lead in their blood and arsenic in urine.


What are we asking you to do?

  • You are invited to have your blood tested for lead and your urine tested for arsenic.

  • There is NO COST to you or your parents for the testing.

Place for Blood and Urine Collection

  • The blood collection will take place at XXX. The urine collection will take place in your home or at the XXX.


What is part of my participation?

There are three parts to your participation.

  1. Blood Collection and Testing for Lead

    • We will take less than 1 teaspoon (3 milliliters) of blood from your arm.

    • This will take 5 minutes or less.

    • We will send your blood to a lab to test it for lead.

  1. Urine Collection and Testing for Arsenic

    • The urine should be collected the day of the blood collection. You can collect the urine at your home or at the blood collection facility.

    • You will collect your urine in a plastic cup we give you. Your parents can help you do this, if you need help.

    • It takes 5 minutes to collect your urine.

    • We will send your urine to a lab to test it for arsenic.

  1. Answer Some Questions

    • During the appointment we will ask you some questions

    • This will take about 20 minutes.

    • Your parents can help you with the questions, if you want.


What will happen to any leftover blood and urine?

  • The lab will throw out any leftover blood and urine. It will not be tested or used for anything else.


When will you get the test results?

  • You will get your test results by mail about 12 weeks after testing.


What are the benefits from being in this Exposure Investigation?

  • Your parents and you will know if you have a high level of lead in your blood and arsenic in your urine.

  • If you have a high blood lead level, ATSDR and ADHS will provide you and your parents with information that can help you reduce your contact with lead.


What are the Risks of this EI?

  • The needle stick might hurt a little and you may feel a little dizzy for a short time.

  • Your arm may get a black and blue mark where the blood is taken.

  • If you are pregnant there is no risk to the pregnancy from the blood collection

  • There is no risk from collecting urine.


How will we protect your privacy?

  • We will protect your privacy as much as the law allows.

    • Arizona law requires that we report blood lead levels to ADHS.

    • Arizona law requires that information given to the state may be made public if someone asks them for the information.

  • We will give you an identification (ID) number.

    • We will use your ID number on the tube of blood and the urine cup.

    • We will keep a record, under lock-and-key, of your name, address and ID number so we can send the test results to your parents.

  • We will not use your name in any report we write. Only group information that does not include your name will be reported.


When can you ask questions about the testing?

  • If you have any questions about this testing, you can ask us now.

  • If you have questions later, you can call:

    • Dr. Bruce Tierney at 770-488-0771

    • The ATSDR toll free number 1-888-320-5291


Child Assent

  • Your parent/guardian said it is all right for you to have these blood and urine tests.

  • You don’t have to have these tests if you don’t want to.


Voluntary Assent

  • I agree to be tested.

  • I was given the chance to ask questions and feel my questions were answered.

  • I know that having these tests done is my choice.

  • I know that even though I have agreed to this testing, I may leave at any time without penalty.


Signature

I agree to be tested.


_________________________________________ ___________ ______________

Printed name of child Age of child Sex of child


______________________________________________ __________________

Signature or written name of child in child’s handwriting Date


__________________________

Printed name of parent/guardian



Address of child ______________________________ Telephone __________________

______________________________

______________________________

May we share the test results with other federal, state, and local health and environmental agencies? YES / NO (please circle one)


Lab ID Number____________________


Certification of Assent Form Administrator:

I read the assent form to the person named above. He/she had the opportunity to ask questions about the Exposure Investigation and had the questions answered.


_______________________________________

Signature of person administering the assent



Attachment 5D


Consent Form for Blood Lead and Urine Arsenic Testing


Pregnant Women and Women of Child Bearing Age 18 years of age and over


ATSDR Exposure Investigation (EI)


ASARCO Smelter - Hayden/Winkelman, AZ


Who are we?

  • We are from a federal public health agency, the Agency for Toxic Substances and Disease Registry (ATSDR), and the Arizona Department of Health Services (ADHS).


Why we are doing this Exposure Investigation?

  • We are doing this Exposure Investigation to find out if adults living in Hayden or Winkelman, AZ, have high levels of lead in their blood or arsenic in their urine.


What are we asking you to do?

  • You are invited to have your blood tested for lead and your urine tested for arsenic.

  • There is NO COST to you for the testing.


Place for Blood and Urine Collection

  • The blood collection will take place at XXX. The urine collection will take place in your home or at XXX.


What is included in my participation?
There are three parts to your participation.

  1. Blood Collection and Testing for Lead

    • We will collect less than 1 teaspoon (3 milliliters) from a vein in your arm.

    • This will take 5 minutes or less.

    • We will send your blood to a lab to test it for lead.

  1. Urine Collection and Testing for Arsenic

    • The urine should be collected on the same day as the blood collection. The urine can be collected in your home or at the blood collection facility.

    • Collect your urine in a plastic cup we give you. Put the lid on.

    • Write your name on the label on the side of the cup.

    • Put the cup in a zip lock bag in the refrigerator until you bring it to XXX.

    • It should take 5 minutes or less for you to collect your urine.

    • We will send your urine to a lab to test it for arsenic.

  1. Answer a Short Questionnaire

    • We will ask you some questions. It will take about 20 minutes.


What will happen to any leftover blood and urine after testing is finished?

  • The lab will throw out any leftover blood and urine. It will not be used for anything else.


When will you get the test results?

  • You will get your test results by mail about 12 weeks after testing.


What are the benefits from being in this Exposure Investigation?

  • You will know if you have high level of lead in your blood and arsenic in your urine.

  • If you have a high blood lead level, ATSDR and ADHS will provide you with information that will help you reduce your contact with lead.


What are the risks of this EI?

  • Some bruising may happen where the blood is taken from.

  • The needle stick might hurt a little and you may feel a little lightheaded for a short time.

  • If you are pregnant there is no risk to the pregnancy from the blood collection

  • There is no risk from collecting urine.


How will we protect your privacy?

  • We will protect your privacy as much as the law allows.

    • Arizona law requires that we report blood lead levels to ADHS.

    • Arizona law requires that information given to the state may be made public if someone asks them for the information.

  • We will give you an identification (ID) number.

    • Your ID number, not your name, will go on the tube of blood and the urine cup.

    • We will keep a record, under lock-and-key, of your name, address, and ID number. The information will be used by ATSDR scientists to link the results to each person and send your blood and urine test results to you.

  • We will not use your name in any report we write. Only group information that does not include individual names will be reported.


When can you ask questions about the testing?

  • If you have any questions about this testing, you can ask us now.

  • If you have questions later, you can call:

    • Dr. Bruce Tierney at 770-488-0771 

    • The ATSDR toll free number 1-888-320-5291


Voluntary Consent

  • I agree to be tested.

  • I was given the chance to ask questions and I feel my questions were answered.

  • I know that having these tests done is my choice.

  • I know that even though I have agreed to this testing, I may leave at any time without penalty.


Signature

I give my permission to be tested.

___________________________________ __________________ ______

Signature of Person Giving Consent Date Age

Address _____________________________ Telephone __________________

______________________________

______________________________

May we share the test results with other federal, state, and local health and environmental agencies? YES / NO (please circle one)


Lab ID Number____________________


Certification of Consent Form Administrator:

I read the consent form to the person named above. He/she had the opportunity to ask questions about the Exposure Investigation and had the questions answered.


_______________________________________

Signature of person administering the consent







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