Parent Consent for Youth Cognitive Testing

OMB Control Number 0910-0932 

Expiration Date 05/31/2027

Submitted to:

CDC OSH

Submitted by:

ICF

Deloitte proprietary and confidential. Do not copy, distribute, or disclose.

Attachment 2

2026 NYTS Cognitive Testing Parent/ Guardian Consent

Qualitative Inquiry to Support Tobacco-Related Surveillance

Parent/Guardian Email and Informed Consent for Cognitive Interviews

Note: The email will be sent to the parent/guardian email provided by Panel to recruit their child to participate in the study. The consent section is at 9.4 readability on the Flesch-Kincaid Grade Level scale.

Dear PARENT NAME,

Thank you for completing the short survey for Food and Drug Administration (FDA) and Deloitte about your child. We are interested in contacting your child about participating in two interviews to help FDA test questions on health and tobacco product use.

If selected to participate in the interviews, your child would receive a $50 Amazon gift card after the completion of each one-hour interview (total of two $50 gift cards).

Please click the link below to view the consent form and let us know if you consent to your child participating. Please know that not all youth who want to participate will be selected.

Thank you!

LINK

Sincerely,

Deloitte

Public reporting burden for this collection of information is estimated to average 30 minutes per survey, including 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: Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov, ATTN: PRA (0910-0932).

**** CONSENT FORM BELOW IS LINKED FROM EMAIL ABOVE ****

Your child is invited to participate in virtual interviews. U.S. Food and Drug Administration (FDA) has hired Deloitte to interview 24-30 youth to participate in two interviews, with each interview scheduled approximately 2-4 weeks apart. Deloitte is a company hired by the FDA with conduct the interviews. These interviews will help FDA design questions for young people so we can learn about their health and tobacco product use. The purpose of the interviews is to help FDA test questions on health and tobacco product use. Additionally, prior to the first interview your child will be asked to complete a short survey so that we can learn a little more about them. Your child will further be asked to provide their consent before they participate in an interview.

We will conduct 24-30 interviews with youth in grades 6-12 during [INSERT DATES]. Each interview will last up to 1 hour. If your child participates, they will receive a $50 Amazon gift card after each interview in appreciation of their time. The interview will be virtual. It will take place through a secure web browser using Zoom. If you agree to let your child participate, we will arrange for the interviews to occur on a date and time convenient for your child. The interviews will be audio recorded.

Your child’s participation is voluntary. All responses shared during the interviews are private (unless comments indicate a threat or danger to self or others). The information provided during the interviews will be combined with the responses of other students in a summary report that does not identify your child. There is no penalty for not doing the interview. Participants have the right to refuse to answer any question. They may stop participating in the interview at any time.

Participating in the interviews involves little to no risks. Some youth may find certain questions to be sensitive. We will gather some personal information about your child, such as age, sex, and whether they use tobacco products. Participants may benefit from knowing that they may help the FDA improve the National Youth Tobacco Survey (NYTS).

If you have any questions about the survey or this study, email Deloitte’s Project Manager, Lauren Degiorgi, at ldegiorgi@DELOITTE.com.

Child's name: ____________________________ Grade: ________________________

I have read this form and agree to the activities described above.

Please check one box:

YES, my child may take part in this interview.

NO, my child may not take part in this interview.

[Electronic Signature]

By typing your name below, you are signing this parental permission form electronically.

Parent or guardian’s signature:

Date: _________________________

Use or disclosure of data contained on this sheet is subject to the restrictions on the title page of this report. 3