Youth Assent

Attachment 8_Focus Group Youth Assent Form

YOUTH Assent FORM

for FOCUS GROUPS

TITLE OF INFORMATION COLLECTION: Asthma Control Initiative Communication Messaging and Materials Development

Sponsor: The Centers for Disease Control and Prevention’s (CDC) Air Pollution and Respiratory Health Branch (APRHB)

Principal Investigator: Brian Griepentrog, Ph.D.

Telephone: 571-858-3757 (24 Hours)

Address: Fors Marsh Group, LLC (FWA00011194)

1010 N. Glebe Road

Suite 510

Arlington, VA 22201

You are being asked to take part in this research study because you have asthma. This form explains the study. After reading this form, which explains the research, you may decide if you would like to participate in the study or not. Your participation is voluntary. If you decide to start the study and then change your mind, you can withdraw at any time.

You may ask the research team questions about the study at any time. They will explain anything you do not understand.

You must sign this form before you can take part in the study. If you would like a copy for your records, you may request a copy from the research team.

About This Study

Fors Marsh Group (FMG) is a research company contracted by the Centers for Disease Control and Prevention (CDC) to investigate youth’s reactions to and their understanding of asthma management. We plan to conduct focus groups with youth across the country. During the focus group, which will last about 90 minutes, you will be asked to share your thoughts about asthma management.

There will be an onsite research staff observing the focus group in a separate room. The focus group will be audio-recorded and transcribed for study-related purposes, but no personally identifiable information will be tied to you or made available to researchers.

Study Benefits

There is no direct benefit to you. Your feedback will help us to decide how asthma management interventions and communication can be improved.

Incentive

You will receive an incentive of $45 as a token of appreciation for your participation and your caregiver will receive a $30 gift card to cover transportation costs. You will receive the incentive for your time even if you choose not to answer some of the questions during the discussion.

Anticipated Risks

FMG will be very careful to allow only members of the research team to see your information. Despite all of our best efforts, there is a small risk that others might find out what you say in the focus group. If this does happen, appropriate steps will be taken to notify participants. Remember that you can stop participating in this study at any time.

Because this is a group session, participants might share private thoughts that they do not want shared with others outside of the group. We ask that you respect everyone’s privacy and do not share what is discussed with people outside of the group. We will ask the other group members to do the same thing.

If you have any questions about this research study, you may call Brian Griepentrog of Fors Marsh Group at 571-858-3757.

Privacy

Everything you say during the focus group can be heard by the research team.

The focus group will be audio-recorded and transcribed for note-taking purposes. By signing this form, you agree to be audio-recorded during the focus group.

Your identity will not be linked to your responses. This means that no one outside of the research team will be able to link what you have said back to you. Everything you share will be kept private to the extent allowed by law. Therefore, we will not share anything you provide with anyone outside of the study unless it is required to protect you or if required by law. However, if you show a direct threat of harm to yourself or others, we have the right to take action out of concern for you and concern for others.

All information we collect—including anything you say in the focus group, information collected during screening, audio files, and transcripts—will be stored on a password-protected computer and/or in locked cabinets that only the research team can access. We will collect some personal information from you, such as your age, gender, and race, but it will only be used for eligibility and scheduling purposes. After three years, all collected data will be destroyed by securely shredding documents or permanently deleting electronic information.

Results from this study may appear in professional journals or at scientific conferences. No individual participants will be identified or linked to the results. We will not disclose your identity in any report or presentation. Results also may be used in future research or shared with other researchers. Other researchers will not have your name or any identifying information.

Participation and Withdrawal

Participation in this study is voluntary. You may withdraw at any time by contacting Brian Griepentrog of Fors Marsh Group at [email protected] or 571-858-3757.

You do not have to answer any questions that you do not want to answer. You will receive the incentive for your time in the focus group even if you choose not to answer some questions.

We advise you to keep a copy of this consent form for future reference. If you would like a copy for your records, you may request a copy from the research team, and they will provide you with a copy.

If you have any questions or complaints about your rights as a research subject, please contact the CDC IRB at [email protected].

Consent – Please complete and sign.

I, __________________________________, have read this form and agree to participate in this study.

[PRINT NAME]

_______________________________________________ __________________

[SIGNATURE] [DATE]

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