Attachment 6. Young Adult Consent MIA Study Wave1

RTI International

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YOUNG ADULT INFORMED CONSENT FORM

For Adults 18 to 20 (19 to 20 in AL and NE)

Sponsor / Study Title:	RTI International / “Monthly Implementation Assessment Study”
Study Provider:	Ipsos KnowledgePanel
Telephone:	1-800-782-6899
Address:	Ipsos KnowledgePanel Panel Relations 1 Upper Pond Rd #D-2 Parsippany, NJ 07054
Email Address:	[email protected]

Key Information

We are talking to young people all over the United States about a study sponsored by the United States Food and Drug Administration (FDA). We are asking you to take part in the Media and Advertisements Study. We are interested in hearing your thoughts about advertisements that you may have seen on digital channels such as Hulu, YouTube, and Instagram. If you take part in this study, which involves completing an online survey, you will be one of about [FILL WITH FINAL SAMPLE SIZE] people to do so each month. The FDA selected RTI International (RTI), a nonprofit research organization, to conduct this study.

This study will provide the FDA, policy makers, and researchers with important information about how aware teens are of advertisements, whether the advertisements are effective, as well as attention and understanding of the advertisements. The mission of the FDA is to promote public health.

It is your choice to take part in this study, and you are not under any obligation to take part in this study. There is no penalty for not taking part. You will not lose any benefits or rights as a result of not participating. If you give your permission, you may change your mind at any time.

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 will not personally benefit from taking part in this study, but your answers will contribute to important research.

You can take the survey on your computer or another device like a smartphone or tablet. It should take approximately 25 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 10 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 study staff 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 personal identifiable 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.

You may be asked to take another survey at a later time. It is up to you to decide whether you would like to participate in future surveys.

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.

Whom to Contact About This Study

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

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

• Your responsibilities as a research participant;

• Eligibility to participate in the study;

Please contact Ipsos KnowledgePanel at the telephone number or email address 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:          [email protected]

Please reference the following number when contacting the Study Subject Adviser: Pro00073709.

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.

I understand the study purpose and process.

Do you agree to participate in this study?

Yes, I agree to participate in this study.

No, I DO NOT want to participate in this study.

If you would like to participate, please click “next” to take the survey.

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Ipsos KnowledgePanel

Advarra IRB Approved Version 10 Oct 2023