Attachment 6. Young Adult Consent ExPECTT 3_Baseline

RTI International

Page 0 of 5 OMB Control Number: 0910-XXXX Expiration Date: XX/XX/XXXX

YOUNG ADULT INFORMED CONSENT FORM (Main Data Collection)

For Children Who Become Adults During the Study

Sponsor / Study Title:	RTI International / “The Real Cost Campaign Outcomes Evaluation Study: Cohort 3”
Principal Investigator: (Study Investigator)	Anna MacMonegle
Telephone:	866-800-9177 (24 Hour)
Address:	RTI International 3040 Cornwallis Rd Research Triangle Park, NC 27709
Email Address:	HealthAndMediaStudy@rti.org

Key Information

We are talking to young people about a study sponsored by the United States Food and Drug Administration (FDA). You have been asked to take part in a national study, which involves completing an online survey, called the “Health and Media Study”. This study is being conducted by RTI International (RTI is a research organization). We are doing this research to learn about media, tobacco, and marijuana use among young people. We will ask about 7,500 people in the United States to take this survey.

You are currently participating in this research study. Now that you have become an adult, we are asking for your consent to continue your participation. It is your choice to take part in this study or not. You do not have to take this survey if you don’t want to. If you complete this survey, we may ask you to complete another survey in the future. There is no cost to you for participating in this study. There are no benefits to you from taking this survey, but your answers will contribute to important research. This information will help keep the FDA up to date on tobacco use among people your age. The mission of the FDA is to promote public health. The FDA does not support or encourage tobacco use.

Some of the questions might make you feel bad or upset. You can choose “prefer not to answer” for any question. You may not move on to the next question in the survey if an item is left blank, but you may move on to the next question if you select “prefer not to answer”.

If you are doing the survey and decide you don’t want to anymore, you can stop. If you don't want to answer a certain question, that is okay too. You can drop out of the survey at any time, for any reason. Nothing bad will happen and no one will be upset if you do not take this survey or if you change your mind after you start.

You can take the survey on your computer or another device like a smartphone or tablet. It should take you about 30 minutes. To protect your privacy, you may not go back to questions you already answered, and you will be logged out if you do not enter any responses for 20 minutes (to reduce the chance that someone else might see survey answers on the screen). You can take a break at any time and start again when you are ready. Please take the survey in a private place so no one sees your answers.

The research team understands that the security of online transmissions is not guaranteed due to the risk of interception by third parties, or the possibility of monitoring software installed on research participants’ electronic devices. Your answers will be combined with everyone else’s and shared with the FDA but will otherwise be kept private. We will not share your name or other personal information with the FDA. We will not share your individual survey responses with anyone outside of the FDA and RTI staff. However, your answers could be used for future research studies or distributed to another investigator for future research studies without additional informed consent. If that happens, all identifiable private information will be removed before your answers are shared. Your identity will not be known in the results of the study. Data will not be analyzed or reported in such a way that it will be possible to identify any individual participant. There is no guarantee that the information you send online will not be seen by others, but we will do everything we can to keep your information private.

The investigator can stop your participation at any time without your consent for the following reasons:

• If you fail to follow directions for participating in the study;

• If it is discovered that you do not meet the study requirements;

• If the study is canceled; or

• For administrative reasons.

This study is for research purposes only. The only alternative is to not participate in this study. Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.

As a thank you for completing this survey, we will mail you $30 if you complete the survey before [ADD DATE], or $25 after [ADD DATE]. You can choose between cash or a Visa gift card. If you do not complete the survey, you will not receive a Visa gift card or cash. If asked to take another survey at a later time, you will receive a Visa gift card or cash for each additional survey you complete.

Whom to Contact About This Study

During the study if you have questions, concerns, or complaints about the study such as:

• Payment or incentive for being in the study, if any;

• Your responsibilities as a research participant;

• Eligibility to participate in the study;

• The Investigator’s or study site’s decision to withdraw you from participation;

Please contact the Investigator at the telephone number listed on the first page of this consent document.

An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:

• By mail:

Study Subject Adviser

Advarra IRB

6100 Merriweather Dr., Suite 600

Columbia, MD 21044

• or call toll free:    877-992-4724

• or by email:          adviser@advarra.com

Please reference the following number when contacting the Study Subject Adviser: Pro00065019.

Certificate of Confidentiality

This study is covered by a special protection called a Certificate of Confidentiality (CoC). The CoC requires staff involved in this study to protect your privacy. We cannot provide information that could identify you to anyone who is not connected with the study. We cannot share your information in legal proceedings (for example, in a court case), even if there is a court order, unless you agree. We may share your information if:

• You 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 money is being spent.

• A law requires sharing information (for example, when we must report to the FDA, or if we hear about threats of harm or reports of child abuse).

The CoC does not prevent you from sharing personal information or talking about this study with others. For example, you can share that you are in this study or your history of tobacco use.

I understand the study purpose and process.

Would you like to participate in this survey?

Yes, I want to take the survey.

No, I do NOT want to take the survey.

CONTACT INFO

Thank you for taking part in this important study. You will be offered a $25 Visa gift card or $25 cash if you complete the survey before [END DATE] [IF DATE IS BEFORE EARLY BIRD DATE ADD: and a bonus $5 if you complete it on or before [EARLY BIRD DATE].

The gift card or cash will be mailed to you within 2 weeks of when you complete the survey, but first we need to collect your name and mailing address. This information will be kept completely confidential in secure and protected data files and will be separated from the responses provided in the survey.

Please provide your name, address, and telephone number.

First Name: ___________________________________________________

Last Name: ___________________________________________________

Mailing Address:

Street _______________________________

City_________________________________

State____________________________________

ZIP code___________________________________

Telephone Number: __________________________________________________

E-mail Address: __________________________________________

SMS_PERMISS

Do we have your permission to send you text messages about the study? We will not share your telephone number with anyone else and will only use it to communicate with you about the study.

1. Yes

2. No

OMB No: [FILL NUMBER] Expiration Date: [FILL DATE]

Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 2 minutes 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.

Anna MacMonegle

Advarra IRB Approved Version 18 Aug 2022