Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging

Quantitative Study of Tobacco Facts Designed to Inform Youth Tobacco Prevention Messaging

RIHSC No. 18-049CTP

OMB No. 0910-0810

Exp. Date: 10/31/2021

Attachment F1: AI/AN Email Invitation and Parental Permission Form (Online Panel Recruit)

[FIRST SCREEN]
Dear Lucid participant,

Your [INSERT CHILD’S AGE] year-old SON/DAUGHTER is invited to participate in a research study conducted by Fors Marsh Group on behalf of the U.S. Food and Drug Administration. The study will ask approximately 400 youth ages 13-17 to complete and online survey about their perceptions of tobacco-related facts. Your child’s answers will help inform messaging for future youth tobacco prevention campaigns. It will take about 20 minutes for HIM/HER to complete. The [STUDY NAME] survey will be quite similar to the kinds of surveys your child may have already been involved in as a Lucid Member.

The potential risk to respondents from completing the survey is minimal. Some questions might make him or her feel uncomfortable, but they have the right to skip any questions they don't want to answer. Participation is completely voluntary and your child may withdraw HIS/HER consent or discontinue participation at any time without penalty. If your child decides to take the survey, you will receive ‘points’ with approximate value of $10 for their participation. The points can be redeemed for items or gift cards through the Lucid system.

[SECOND SCREEN]
As always, his or her identity will be unknown in all data resulting from the study. The researchers will not have access to any of your child’s identifying information (such as his or her name). Everything your child shares will be kept private to the extent allowed by law. All of the conditions and terms described in the "Lucid Privacy & Terms of Use Policy" document that you received when you got your recruitment packet are in effect for this study. If you have any questions about the study, you may contact the research team through Shane Mannis of FMG at 571-858-3757 (24 Hours) or pi@forsmarshgroup.org. If you have any questions about your child’s rights as a study participant, you may contact FDA IRB at RIHSC@fda.hhs.gov.

This research is covered by a special protection (called a Certificate of Confidentiality) from the Food and Drug Administration (FDA). This special protection requires that researchers involved in this study protect your child’s privacy.  This means researchers generally cannot provide your child’s name, or any other information that could identify your child, to anyone who is not connected with the research. Researchers cannot share this information in court or during other legal proceedings, unless you or your child agree, even if there is a court order for the information.  However, in other settings, researchers may share study information that could identify your child if:

• you or your child agree to share information (for example, to get medical treatment);

• the study information is used for other scientific research that follows federal law;

• the FDA, which is paying for the study, needs information to check how their research money is being spent; or

• a law requires sharing information (for example, when researchers must report to FDA, or if researchers hear threats of harm to others or reports of child abuse).

The Certificate of Confidentiality does not prevent you and your child from sharing any personal information or information about your child’s involvement in this study with others. For example, you can share that your child is in this research study or your child’s history of tobacco use.

I have read and understand this information, and the study purpose and process are clear to me.

Do you give your consent for your child to complete this survey?

Yes No

If “Yes”, please provide your child’s email address so we can send him/her a link to the survey: __________________________________________ (Child’s email address)

A copy of the form will also be sent to the email address that Lucid has for you on file.

Paperwork Reduction Act Statement: 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. The public reporting burden for this information collection has been estimated to average 5 minutes per response to complete the Parental Permission Form (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.