Screener and Survey Invitation - English

OMB No: [FILL NUMBER]

Expiration Date: [FILL DATE]

Attachment 3. Screener Invitation

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The time required to complete this information collection is estimated to average 1 minute(s) per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRASTAFF@fda.hhs.gov.

Screener Invitation Email to Parent – Quantitative Study

Email Subject: A New KnowledgePanel Survey for You! Survey on Media and Advertisements

Email Body:

Dear <<Name>>

Thanks for being an integral part of KnowledgePanel! We have a new survey for you. The study is sponsored by the United States Food and Drug Administration (FDA). Your participation in the study is voluntary.

Please click the link below to get started.

[link to screener and survey]

Our Panel Member Support Center is available if you have questions or comments. You can contact us toll free at 1-800-782-6899, or simply reply to this email invitation. To better serve you, please be sure to reference [PROJECT ASSIGNMENT NUMBER] in the subject of your message. We are always happy to hear from you! If you have any questions about your rights as a study participant, you can contact Advarra IRB by email at adviser@advarra.com, or by phone at 1-877-992-4724 (a toll-free number). Please reference the following number when contacting the Study Subject Adviser: [insert protocol number].

Thanks,

The KnowledgePanel Team

Screener Invitation Email to Participant – Quantitative Study

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The time required to complete this information collection is estimated to average 1 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. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRASTAFF@fda.hhs.gov.

Email Subject: A New KnowledgePanel Survey for You! Survey on Media and Advertisements

Email Body:

Thanks for being an integral part of KnowledgePanel! We have a new survey for you. The study is sponsored by the United States Food and Drug Administration (FDA). Your participation in the study is voluntary.

Please click the link below to get started.

[insert link to survey]

Our Panel Member Support Center is available if you have questions or comments. You can contact us toll free at 1-800-782-6899, or simply reply to this email invitation. To better serve you, please be sure to reference [PROJECT ASSIGNMENT NUMBER] in the subject of your message. We are always happy to hear from you! If you have any questions about your rights as a study participant, you can contact Advarra IRB by email at adviser@advarra.com, or by phone at 1-877-992-4724 (a toll-free number). Please reference the following number when contacting the Study Subject Adviser: [insert protocol number].

Thanks,

The KnowledgePanel Team

Screener Invitation – Mixed Methods Study

INTRODUCTION [FOR POTENTIAL YOUTH PARTICIPANTS]:

READ TO PARENT/GUARDIAN

Hello, my name is ___________, and I am calling on behalf of [MARKETING RESEARCH COMPANY], a professional marketing research company. We are currently inviting youth to participate in a discussion group to talk about their opinions/thoughts on videos or ad concepts related to health. We’re hoping that your child may qualify. I want to assure you that we are not trying to sell your child anything. We just want to find out what people care about and their thoughts about health. This study is sponsored by the U.S. Food and Drug Administration. The focus group will be held virtually and your child’s total participation in the study will last approximately 95 minutes. Those who participate will receive a monetary incentive as a thank you for their time. May I please ask you a few questions to see if someone in your household qualifies for this study?

1. Do you have any children currently living in the household?

1. Yes

2. No [Terminate]

2. Please tell me the sex, age, and grade level of the children living in the home.

CHILD 1: (SEX) _____ (AGE)_____ (GRADE) ____

CHILD 2: (SEX) _____ (AGE)_____ (GRADE) ____

CHILD 3: (SEX) _____ (AGE)_____ (GRADE) ____

CHILD 4: (SEX) _____ (AGE)_____ (GRADE) ____

3. Are you the parent or legal guardian of the children living in the household?

1. Yes [Skip question 4]

2. No

4. Can I speak to the parent or legal guardian of the children?

1. Yes

2. No [If not home, find out when they will be home and call back]

READ TO PARENT/GUARDIAN: Thanks for the information. Your child may be eligible to participate in our discussion groups. As I mentioned before, the discussion group will be held virtually. The discussion group will last 90 minutes. There will also be a 5-minute technology check prior to the group to ensure audiovisual connection for the group discussion.

READ TO YOUTH/YOUNG ADULT:

[Speaking to potential focus group participant] Hi, my name is _______. We are doing a survey to see if you qualify for a discussion group with young people to talk about your opinions/thoughts on creative concepts. I want to assure you that we are not trying to sell you anything. We just want to find out what people care about and their thoughts about health.

We are holding these groups online so you can participate at home. Participation is completely voluntary, and your responses will be kept confidential. The discussion groups will last 90 minutes. There will also be a 5-minute technology check prior to the group to ensure audiovisual connection for the group discussion. If you are eligible and you attend the discussion group, you’ll receive a monetary incentive for sharing your thoughts and opinions. In order to see if you are eligible, we need to ask you some questions about yourself. However, keep in mind that we will not share the answers with anyone, including parents/guardians. Some of the questions may be sensitive or make you uncomfortable. You do not have to answer any questions that make you uncomfortable. Before I ask you a few questions, can you please move to a private area where you will not be overheard by others?

[FIELD SCREENER QUESTIONS FROM ATTACHMENT 2a/2b to confirm eligibility]

This form is to be kept separate from the screener, in a secure location. Upon delivery of incentives to participants, this information should be securely destroyed.

1. Can you please confirm the following contact information? None of this information will be connected to questions you just answered. This is just so we can re-contact you if you are invited to participate in a discussion group.

2. What is your availability during the week we are holding focus groups? [Customize response options to available slots]

Participant Contact Information

ID: _________

Full name: Best phone number:

___________________________________ ___________________________________

Email address: Recruited for session number:

___________________________________ ___________________________________

Availability notes:

_____________________________________________________________________________

____________________________________________________________________________

Parent/Guardian Contact Information - For Participants 13-17 Years Old Only

[We’ll need your parent’s permission for you to participate in a discussion group. Can you please provide contact information for your parent or guardian? Don’t worry, none of the answers you provided will be shared with them. We just need a way to verify that they have given permission for you to take part.]

Full name:

___________________________________

Phone number:

___________________________________

Email address:

___________________________________