A.2 LOI2-QUEX-5 Exemplar Consent Form

Attach 2: Exemplar Consent Form

Bayley-3 Short Form

Parental Permission for the Bayley Child Development Study

Parents of Children 5- to 44-Months Old

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You are being asked to allow your child to be in a study, the “Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-3 for short). The Bayley is the gold standard for measuring children’s development and their thinking, learning, communicating, and motor development. The purpose of this study is to develop a short form of The Bayley-3 (Bayley-3 Short Form) that can be used in The National Children’s Study and other large-scale studies of children’s development. Westat staff trained on The Bayley and who have backgrounds in child development, developmental psychology, and school psychology will do the Bayley-3 Short Form with your child.

Your child will sit on your lap so that you can watch what your child does. The Bayley is described below so that you can decide freely whether you want your child to be in the study. You and your child’s participation in this study is voluntary. Refusal to join will result in no penalty or loss of benefit to you or your child. You will be given a copy of this consent form. If you have any questions at any time, please ask the Bayley staff member or the person named below.

What is the purpose of this activity?

The purpose of this study is to develop a short form of The Bayley-3. The following skills are explored:

• How children think, learn, and solve problems

• How children understand gestures and words and how they use language

• Fine motor skills, such as grabbing, and gross motor skills such as crawling, walking, etc.

We would also like to include basic information about your family (e.g., parent education, number of older/younger children) to help us understand our results better.

How many children will be in this study?

There will be about 1000 children in this study.

What is involved in this study and how long will our involvement be?

This activity can be completed in a single session. The Bayley Child Development Study will take about 45 to 65 minutes, during which the researcher will do different activities with your child to see what he or she can do.

Are there any reasons your child should not be in the study?

The risks to your child from these activities are minimal and no pain is involved. Your child may become fussy or may cry, but this is normal for children this age. If your child becomes fussy and does not want to continue, we will stop the session.

What are the possible benefits?

Although there are no direct benefits for being in this study for you or your child, there are indirect benefits. You and your child will help us create a new tool that shows what and how children learn that can be used to study the well-being of the nation’s children in future national studies. Parents also report that they enjoy watching their children learn and use new skills.

If you choose not to allow your child to be in the study, what other options do you have?

Your child does not have to be in this study. There are no alternatives to The Bayley Child Development Study: your child’s involvement is entirely your choice.

Can I withdraw my child’s involvement in this study?

Yes, you may withdraw your child’s involvement at any time without penalty. You still will receive compensation if your child does not complete The Bayley Child Development Study.

How will your family’s confidentiality be protected?

Your participation in this study and all data collected will not be shared with anyone but the staff members on the project. Your child’s name will not be on any of the Bayley-3 Short Forms. All forms from the study and all identifying information about you and your child will be kept in locked cabinets in locked offices or on secure, password protected computer networks. Only approved Westat staff members will have access to identifying information. Researchers from the National Children’s Study will have access only to data without identifiers. Your child’s information will be combined with the information of all study participants. Your child’s information will not be individually identified.

Will you or your child be paid for participating or will it cost you to participate?

There is no cost to you for your child to be in this study. You will receive $25 as a gesture of appreciation for your time and effort for being in this study and your child will receive a toy.

What if you have questions about this study?

If you have questions about this study, please ask the staff member working with your child. If you have questions about the purpose and content of this study, please contact the study’s Principal Investigator, Carol Andreassen, PhD, at (301) 610-4838. If you have any questions about your rights as a research participant or have concerns about your involvement, please contact the Westat IRB administrator, Sharon Zack, at (301) 251-1500.

Parent’s Permission:

I have read the information provided above. I have been given the chance to ask questions and these questions have been answered. I voluntarily agree to allow my child to participate in this study.

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Printed Name of Child

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Signature of Parent/Legally Authorized Representative Date

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Printed Name of Parent/Legally Authorized Representative

Person Obtaining Consent/Parental Permission:

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Signature of Person Obtaining Consent/ Parental Permission Date

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Printed Name of Person Obtaining Consent/Parental Permission

Consent Form Version Date: 4/22/2013

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