Assent Form for Minors

Appendix B4: Assent Form for Minors

Form Approved

OMB No. 0923-xxxx

Exp. Date xx/xx/20xx

Respondent ID No:

PFAS Exposure Assessment, Biological Sampling

Assent Form (12-17 years of age)

Reading Level: 7.0

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

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

PFAS have been found in the drinking water supply in (insert name of city/town/place here). Scientists and doctors don’t yet know how PFAS may affect people’s health. The first step in figuring that out is measuring the amount of PFAS in the bodies of people who may have come into contact with this contaminated water.

PFAS are chemicals that were used in a wide range of ways in the United States. PFAS are found in the environment (in the air, soil, and water). And they can stay in the human body for years.

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

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

The questionnaire should take about 15 minutes to complete.

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

What will happen?

If you choose to be in this assessment, we will draw a small amount of blood from a vein in your arm. First we will clean the skin on your arm by gently rubbing it with alcohol. The needle stick may hurt a little for a few seconds. The person taking the blood will be very careful. You will also be asked to give us the urine sample you collected this morning. Your blood and urine samples will not have your name or other personal information on them. Your blood and urine will not be tested for HIV, or for the presence of alcohol or drugs and your DNA will not be used for any purpose.

You have the right to refuse or withdraw.

It is your choice whether to be in this assessment. You can expect the same medical care from your doctor whether you are in the assessment or not in the assessment. There is no penalty if you choose not to be in this assessment. You may stop being in this assessment at any time. If at any time in the future, you would like to have your blood or urine sample destroyed or removed from the assessment, please call (insert name and phone number of Study coordinator).

Do you want more information?

We will give you a copy of this form to keep. If you have any questions, concerns, or complaints about this assessment, please contact the following people:

• If you have questions about this assessment or questions related to injury from the assessment, call (insert name and phone number of Study coordinator).

• If you have questions about your rights as a participant in this assessment, please call (insert name and phone number of Study coordinator).

Project Name: _______________________________________________________________________

Project Coordinator’s Name:____________________________________________________________

(Printed)

Project Coordinator’s Signature:_________________________________________________________

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

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

I agree to have a sample of my blood drawn from my arm with a needle.

	I agree to give a urine sample.
	I agree to allow my blood and urine samples to be saved and used for other PFAS-related tests in the future.

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

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

Participant’s Name:____________________________________________________________________

(Printed)

Participant’s Signature:_________________________________________________________________

Date Signed: ___________________________________________________ `

Street Address: ___________________________________________________

City: ______________________________ State: ______ Zip: __________

Phone number (area code): ___________________________________