Parental Consent

Attachment K:

ODPHP Physical Activity Guidelines, 2^nd Edition

Informed Consent and Participant Information Form Parental Consent – Focus Groups with Minors

OMB Control Number: 0990-0281

December 21, 2017

Submitted to:

Sherrette Funn

Office of the Chief Information Officer

U.S. Department of Health and Human Services

Submitted by:

Frances Bevington

Strategic Communication and Public Affairs Advisor

Office of Disease Prevention and Health Promotion

U.S. Department of Health and Human Services

Informed Consent and Participant Information Form

Parental Consent – Focus Groups with Minors

CommunicateHealth

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Sponsor / Study Title:	CommunicateHealth / “ODPHP-PAG Audience Research to Understand Needs and Preferences of Parents, Children, and Adolescents”
Principal Investigator:	Corinne Berry
Telephone:	413-582-0425 (24 Hours)
Address:	CommunicateHealth 26 Market St Northampton, MA 01060

Please review the following information about this project. Feel free to ask us any questions

you may have.

Who is working on this project?

This research project is being coordinated by CommunicateHealth, a health communication consulting firm, on behalf of the Office of Disease Prevention and Health Promotion (ODPHP), which is part of the U.S. Department of Health and Human Services (HHS).

What is the goal of this project?

We are working to identify the best way to communicate about physical activity. Our goal is to develop information and tools that help families be more physically active.

How can I help?

There will be 12 focus groups with about 88 participants. This focus group will last approximately 60 minutes for your child. The focus groups will include a moderator and a note taker and will include discussion on beliefs, attitudes, and perceptions around physical activity, especially for children and teens.

Corinne Berry

Chesapeake IRB Approved Version 11 Dec 2017

CommunicateHealth

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We are interested in learning from your child’s experiences and preferences. Your child’s feedback in this focus group will help us make sure we create physical activity-related information and tools that meet the needs of families like yours.

Does my child have to participate in this project?

No. Research is voluntary. It is your and your child’s choice whether to participate or not. Your child can stop at any time and doesn’t have to answer any questions they don’t want to answer. If you don’t want your child to participate or decide they should stop, that’s okay.

Will my child be compensated for participation?

Yes, your child will be offered a $40 cash incentive for participation. Parents or guardians of minor participants will receive $35.— you will be required to stay onsite during the focus groups. You and your child will be paid at the end of their participation. There is no cost to you for taking part in this study.

Are there risks?

There is a possible risk of breach of confidentiality. This risk is minimized by protections described in the “How will you protect our privacy?” section below.

Are there benefits?

Neither you nor your child will benefit directly from this study, but it is hoped that your child’s participation will help others in the future.

How will you protect our privacy?

We will keep your identities and all of your personal information confidential — that means we will not share them with ODPHP or anyone outside of our project staff. We will not collect or store any of your personal information. Also, your child’s responses will not be linked with their name.

For more information:

You can ask questions about this consent form or the project (before you decide to let your child start the focus group or at any time). Questions may include:

• Any payment for being in the study

• Your rights and your responsibilities as a study subject

• Other questions

Talk to the focus group staff with any questions or concerns. If you have questions about the project, contact Project Manager Dena Fisher at [email protected] or (413) 582-0425. 

Corinne Berry

Chesapeake IRB Approved Version 11 Dec 2017

CommunicateHealth

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If you have any questions or complaints about your rights as a research subject, contact:

• By mail:

Study Subject Adviser

Chesapeake IRB

6940 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

• or call toll free: 877-992-4724

• or by email: [email protected]

Please reference the following number when contacting the Study Subject Adviser: Pro00023762.

Parental Consent

I, , agree to let my child,

, take part in this focus group study.

I understand that [child’s initials] does not have to be in this focus group and can leave at any time without penalty. I understand that [child’s initials] can agree to be in the study and then change their mind later.

I allow the Office of Disease Prevention and Health Promotion (ODPHP) — which is part of the U.S. Department of Health and Human Services (HHS) — to use the information from this discussion. I understand that the information is for research only, and that ‘s [child’s initials] name will not be shared with anyone else.

I understand that if researchers learn about current or ongoing child abuse or neglect, they will report this to the appropriate authorities.

I agree to ask questions about the discussion if I don’t understand something that [child’s initials] is being asked to do as part of this project. If I have questions after the project is over, I can contact Dena Fisher at [email protected] or at 413-582-0425.

Audio Recording Release

I understand that the discussion will be audio-recorded during this project. I allow ODPHP to use the recordings of [child’s initials] for research purposes only. I understand that

‘s [child’s initials] name will not be used for any other purpose. I give up any rights to the recording and understand the recording may be copied and used by ODPHP without my permission.

Corinne Berry	Chesapeake IRB Approved Version 11 Dec 2017
CommunicateHealth			Page 4 of 4

Summary

I have read and understood this consent form. I understand that I will get a copy of this form.

Parent Name (Print):

Parent Signature:

Date:

Corinne Berry

Chesapeake IRB Approved Version 11 Dec 2017