Consent Form for Venous Blood Lead Testing and Questionnaire - Pregnant Women and Women of Childbearing Age

Att3C Consent Form_BLL Iola 0923-0048.docx

ATSDR Exposure Investigations (EIs)

Consent Form for Venous Blood Lead Testing and Questionnaire - Pregnant Women and Women of Childbearing Age

OMB: 0923-0048

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Attachment 3C: Consent Form for Pregnant Women & Women of Child Bearing Age

Flesch-Kincaid Reading level – 5.2


Consent Form for Venous Blood Lead Testing and Questionnaire

Pregnant Women & Women of Child Bearing Age

ATSDR Exposure Investigation (EI)

Iola, Kansas

Who are we?

  • We are from a federal public health agency, the Agency for Toxic Substances and Disease Registry (ATSDR)


Who are we working with?

    • Region 7 Environmental Protection Agency (EPA)

    • Kansas Department of Health and the Environmental (KDHE) South Eastern Kansas Multi County Health Department (SEKMCHD) and

    • Region 7 Pediatric Environmental Health Specialty Unit (PEHSU)


Why we are doing this Exposure Investigation (EI)?

  • We are doing this EI to find out if pregnant women and women of childbearing age living in Iola, Kansas have high levels of lead in their blood.

  • EPA has been conducting soil testing for lead. We would like to share your blood lead testing data with EPA to help them identify families and homes that need soil cleanup the most.


What are we asking you to do?

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

  • There is NO COST to you for the testing.

  • The blood collection will take place at _________________________


What is included in my participation?
There are two 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 10 minutes or less.

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


2. Answer a Short Questionnaire

    • We will ask you some questions about how you might be exposed to lead.

    • This should take about 20 minutes.


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

  • The blood will not be used for anything else.

  • The lab will throw out any leftover blood.


When will you get the test results?

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


What are the benefits of being in this EI?

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

  • If you have a high blood lead level, ATSDR and Region 7 PEHSU can provide you with information that will help you reduce your contact with lead.

  • If your blood lead level is 10 µg/dL or higher, EPA will cleanup your yard faster if there are high lead levels in your soil.


What are the risks of this EI?

  • The needle stick might hurt a little.

  • Some bruising may happen where the blood is taken.

  • 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.


How will we protect your privacy?

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

    • Kansas law requires that we report blood lead levels to KDHE if the result is greater than 25 µg/dL.

    • Kansas law requires that information given to the state may be made public if someone asks them for the information but your name and address will not be released.

    • We will share the results with other agencies only with your permission. We will require our government partners to treat your information as private.

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

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

    • We will keep a record, under lock-and-key, of your name, address, and ID number. The information will be used by ATSDR to link the results to each person and send your blood 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. Luly Rosales-Guevara at (770) 488-0744 or 

    • The Iola Exposure Investigation toll free number (888) 892-1320


Voluntary Consent

  • I agree to be tested.

  • I agree to answer questions.

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

  • I know that having the test 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 and agree to answer questions.


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



___________________________________ __________________ ______

Signature of Person Giving Consent Date Age

Address _____________________________ Telephone __________________

______________________________

______________________________


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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