Att. E_Consent Form

Attachment E1 – Consent Form

Agreement to Participate in the Child Seat Belt Fit Study

Parent Permission Form

This study requires a parent/guardian of a child under 18 years old to agree to allow their child to participate. If you are the parent/guardian of a child under 18 years old, who is being invited to be in this study, you will be asked to read and sign this form to give permission for your child to participate.

This study is sponsored by the Centers for Disease Control and Prevention (CDC). Please read this form carefully.

To help you decide if you want your child to participate, the form provides important information about what your child will be asked to do during the study, the risks and benefits of the study, and your child’s rights as a research subject.

• If you have any questions or do not understand something in this form, you should ask the researcher for more information.

• You should discuss your child’s participation with anyone you choose, such as family or friends.

• Do not agree to participate in this study unless the research team has answered all your questions and you decide that you want your child to be part of this study.

• Your child is being asked to participate in a study to update the rules for booster seat and seat belt use in children ages 6-12. If you agree to allow your child to participate, please sign your name at the end of this form. We will also ask your child if he/she would like to be in the study.

You will receive a copy of this for your records.

Purposes and Procedures. During the study, the following measurements will be collected from your child:

• Standing and sitting height,

• Upper and lower leg length,

• Shoulder height and width, and

• His or her weight.

We will also be taking measurements while your child sits in different seating positions in 3 cars to help us see how well the seat belt fits. This will require your child to sit still. The car will never be on or moving. In order to take the measurements, our researchers will have physical contact with your child. For example, to measure the seat belt fit we will need to measure the location of the hipbone and the shoulder, which will require a researcher to feel for the appropriate locations. You will be asked to be present at all times. The entire session will take up to 2 hours to complete. We will be videotaping and taking photographs to help with writing a report of our findings.

Participation. Participating in this research study is completely voluntary. You may agree or refuse to allow your child to participate. If you agree to allow your child to be in the study, you can stop at any time during the study. Your child will receive $50 for helping us and we will give it to you to sign for and accept for your child once the session is over. We will also give you safety information on child restraint use developed by the CDC and Safe Kids.

Confidentiality. Your child will never be identified in any reports that we write. Likewise, all information collected during the study is confidential to the fullest extent of the law and will not be presented in any form that identifies you or your child. Any information gathered, will be used only by Westat and CDC staff who are involved in the project. All documents containing identifying information about your or your child will be destroyed within three months of the end of this research study.

Risks. There are no expected risks in participating in this study.

Benefits. The findings of this study may be used to improve safety for child passengers. There are no direct benefits to you or your child.

Questions.

If you have any questions about this study please contact:

Dr. Doreen De Leonardis

(301) 315-5963

Westat

1600 Research Boulevard

Rockville, MD 20850

If you have any questions about your child’s rights and welfare as a research participant, please call the Westat Human Subjects Protection office at 1-888-920-7631. Please leave a message with your full name and the name of the study, “Child Seat Belt Fit Study”, and a phone number beginning with the area code. Someone will return your call as soon as possible.

Authorization. By signing this form, you certify that you have read this form and that you give permission for your child to take part in the study.

Parent, Guardian or Legally Authorized Representative’s Name and Relationship to Child Participant:

__________________________________________ _______________________________

(Parent/Guardian’s Name - printed) (Relationship to Child Participant- printed)

__________________________________________

(Child’s Name - printed)

__________________________________________ _______________________________

(Signature of Parent, Guardian or (Date)

Legally Authorized Representative)

Statement of Person Who Obtained Consent

I have discussed the above points with the participants or, where appropriate, with the child participant’s legally authorized representative. It is my opinion that the participants understand the risks, benefits, and procedures involved with participation in this research study.

__________________________________________ _______________________________

(Signature of Person who Obtained Consent) (Date)

Agreement to be in the Child Seat Belt Fit Study

1. I am asking you to take part in a research study because we are trying to learn about seat belts and how well they fit. We are doing this study for the Federal Government.

2. If you agree to be in the study, you will:

• Let us take your height and weight and other measures of your shoulders and legs.

• Test out the seat belts in a few cars and I will measure how well the seat belt fits you. You need to sit still while being measured. It is important that you know that I will have to touch you on your shoulders and hips when I measure you. Your parent/guardian will be with us at all times.

• Allow cameras in the car to record us. Only the people working on the study will be able to look at the pictures and videos.

• Help us today for about two hours.

3. There are no real risks to you being in this study. The cars will be turned off. In any reports that we write, we will not include your name or use any of the pictures or videos that we take.

4. Helping us today will give us the information we need to make sure that booster seats and seat belts are working safely.

5. Your parent has already given permission for you to be in this study. However, if you do not want to be in this study, you do not have to. Being in this study is up to you and no one will be upset if you do not want to or even if you change your mind later and want to stop.

6. You can ask any questions that you have about the study.

7. You will receive $50 for helping us. I will give the money to your parent/guardian when we are done.

8. Writing your name on this form means that you agree to be in the study.

_______________________________ _____________

(Your Name - Printed) (Age)

_______________________________ _____________

(Your Signature) (Date)

Statement of Person Who Obtained Assent

I have discussed the above points with the participant or, where appropriate, with the child participant’s legally authorized representative. It is my opinion that the participant understands the risks, benefits, and procedures involved with participation in this research study.

__________________________________________ _____________

(Signature of Person who Obtained Assent) (Date)