Attachment 4. Parent Guardian Permission MIA Study Wave1

RTI International

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

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 3 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 [email protected].

PARENT/LEGAL GUARDIAN PERMISSION FORM

For Parents of Minor Participants Ages 12 to 17 (12 to 18 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 your child to take part in the Media and Advertisements Study. We are interested in hearing your child’s thoughts about advertisements that they may have seen on digital channels such as Hulu, YouTube, and Instagram. If your child takes part in this study, which involves completing an online survey, they 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 teen attention and understanding of the advertisements. The mission of the FDA is to promote public health.

It is your child’s choice to take part in this study, and you are not under any obligation to allow your child to take part in this study. There is no penalty for not taking part. You and your child 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.

Your child can take the survey on a personal computer, smartphone, or tablet. It should take them approximately 25 minutes. To protect your child’s privacy, they may not go back to questions they already answered, and they will be logged out if they do not enter any responses for 10 minutes (to reduce the chance that someone else might see survey responses on the screen). They can take a break at any time and start again when they are ready. Please allow them to take the survey in a private place so that no one can see their answers.

Your child will not personally benefit from taking part in this study, but their answers will contribute to important research. Your child can skip any question they don’t want to answer and may drop out of the survey at any time for any reason.

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 child’s identity will not be known in the results of the study. Everything your child shares will be kept private to the extent allowed by law. Only the authorized study staff will have access to your child’s responses. Your child’s answers will be combined with everyone else’s responses and shared with RTI and the FDA but will otherwise be kept private. We will not share your child’s name or personal identifiable information with RTI or the FDA. We will not share their individual survey responses with anyone outside of the Ipsos, FDA and RTI staff. However, your child’s 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 child’s answers are shared.

There is no guarantee that the information they send online will not be seen by others, but we will do everything we can to keep their information private.

There is no cost to you or your child for participating. Your child may be asked to take another survey at a later time. If asked to take another survey at a later time, your child will receive panel points for each additional survey they complete. It is up to you and your child to decide whether you would like to participate in future surveys. If your child is under the age of majority, we will ask your permission and your child’s assent before asking your child to take any future survey.

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 allow your child 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 child’s privacy. We cannot provide information that could identify them to anyone who is not connected with the study. We cannot share your child’s information in legal proceedings, even if there is a court order, unless you and your child agree. We may share your child’s information if:

• You and 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 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 or your child from sharing personal information or talking about this study with others. You and your child can tell others that your child is in this study.

I understand the study purpose and process.

Do you agree to allow your child to participate in this study?

Yes, I agree to allow my child to participate in this study.

No, I do not want my child to participate in this study.

Please click next and have your child take the survey as soon as possible.

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