Form 1 Attachment E Individual Interview Parent Permission Form

OMB Control Number: 0925-XXXX Expiration Date: XX/XX/XXXX

Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do not return the completed form to this address.

innovation Research & Training, Inc.

Address: 1415 W. NC Highway 54, Suite 121, Durham NC 27707

Voice: 919 493-7700 Fax: 919 493-7720

Dear Parent or Guardian,

We are asking permission for your child to be a part of a project to develop a web-based resource to educate youth about participating in pediatric clinical trials or research studies. Your child will be asked to provide feedback on the content and activities that will be included in a new web resource.

Please read this letter to be sure you know what will take place and what we will be asking your child to do, so you can decide if you want your child to be a part of the project. Please contact us if you have questions after reading the letter. Your child will also be asked if he or she wants to participate before taking part in this study, so even if you agree, it is still your child’s decision.

What is the purpose of this project?

This project is funded by the National Heart, Blood, and Lung Institute a part of the National Institutes of Health (NIH). The purpose of the project is to develop a new web-based resource to educate youth who have a chronic illness or disease about pediatric clinical trials. The resource will include interactive learning modules, video testimonials, and an electronic comic book.

In order to create a web-based resource that is easy-to-use and engaging for children, we would like to gain feedback from children about some of the content and activities that will be included in the web-based resource. We are asking for your child to review content in the web-based resource and provide us with feedback on his/her experiences.

What will my child’s participation involve?

Your child will be asked to review a portion of our web-based resource which aims to educate youth about pediatric clinical trials. Your child will be asked some questions about the usability and functionality of the web-based resource (e.g., “I found the feature stories easy to understand”) as well as some questions about the overall quality of the web-based resource. This interview will be led by a member of our research team and will last up to 2 hours. The interview will be audiotaped so we can be sure to capture all the comments that your child makes. Your child may take a break during the interview, if needed.

Will my child’s answers be kept private?

The information your child provides will be kept anonymous and private. This means that only project staff members will have access to the information. All of the responses will be kept in a locked file cabinet at IRT. Secret identification (ID) numbers will be used in place of names on the interview documents so that none of the information can be linked to your child after the interview. The interview will be audiotaped and to maintain your child’s privacy, no names will be used during the interview. Audio recordings will be destroyed at the end of the study.

What happens if my child does not participate in the project?

Participation by your child is voluntary. There will be no penalty if he/she decides not to participate in this study. In addition, your child has the right to decline to participate in any activity during the interview, to choose to not answer the questions, and to choose to withdraw from the study at any point without penalty or consequence.

Are there any risks involved in being in the project?

No risks are foreseen to your child from participating in this study. Your child will be told, and reminded from time to time, that he/she can refrain from answering questions if needed. Your child may also leave the study at any time without consequence.

Will anything good happen as result of my child being in the project?

The feedback received from your child will contribute to the development of a web-based resource to educate youth about clinical trials that has the potential to greatly benefit many children.

Will my child be compensated for participation in the project?

Your child will receive $25 for participation in this study.

Who should I contact if I have any questions about the project?

The project is being done by Dr. Alison Parker and Dr. Tracy Scull of innovation, Research, & Training. If at any point during your participation in this project, you have any additional questions or concerns, please contact Dr. Parker, at (919) 493-7700, email: [email protected].

If you have any questions or concerns about your child’s rights as a research participant or how your child was treated, you should contact Barbara Goldman, Ph.D., Chair of the iRT Institutional Review Board (IRB), which reviewed and approved this study at [email protected] or 919-966-7169.

Thank you in advance for your cooperation and support. We hope that you will agree to let your child participate in this project.

Sincerely,

Alison Parker, Ph.D. Tracy Scull, Ph.D.

Co-Principal Investigator Co-Principal Investigator

innovation Research &Training innovation Research & Training

Interview Study

PARENT PERMISSION

The goal of this project is to gain feedback from children on content developed for a web-based resource.

In this study, children will be asked to:

• Review the web-based resource

• Provide feedback on the content in the resource

Participation is voluntary and participants can stop at any time. All responses will be kept anonymous. You have been given a copy of this entire 4-page letter to keep for your records.

In order for your child to participate, please check the box below and fill out the additional information so we can contact you.

• I give permission for my child to participate in the Interview Study.

Your name (signature): _______________________________________ Date: __________

Your name (please print): _______________________________________

Mailing address: ____________________________________

____________________________________

____________________________________

Phone number: _________________________ Email address: __________________________

Child’s name (please print): ________________________________

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