Att D_ Informed Consent Form

Attachment D: Consent Form

INFORMED CONSENT FORM

Title of Information Collection:

Study Sponsor:

Alcohol Consumption Focus Groups

The Centers for Disease Control and Prevention (CDC)

Principal Investigator:

Sarah Evans, PhD

Telephone:

571-858-3757

Additional Contact(s): Study Staff

Caitlin Krulikowski, 571-858-3771

Address:

Fors Marsh Group

1010 N. Glebe Rd. Suite 510

Arlington, VA 22201

You are being asked to participate in an information collection. This form describes the purpose, procedures, benefits, risks, and precautions of the information collection. It also describes your right to withdraw at any time. A member of the project staff is available to read through this form with you and discuss all the information, if you wish.

Why is this information collection being done?

This information collection is being done to better understand how people make decisions about drinking alcohol. Fors Marsh Group (FMG) is conducting this project on behalf of the Centers for Disease Control and Prevention (CDC). The findings will inform the development of health education messages about alcohol use.

What do I need to know about this project?

1010 N. Glebe Road, Suite 510 | Arlington, Virginia 22201 | www.forsmarshgroup.com

Adults aged 21 to 64 are invited to participate. If you choose to participate, the project team will tell you when and where your assigned focus group is scheduled. During the session, you will be asked to share your thoughts with the moderator about your understanding, attitudes, and perceptions of alcohol use. The focus group will last about 90 minutes. There are no costs associated with your participation. You do not have to answer any questions that you don’t want to.

In accordance with the Paperwork Reduction Act of 1995, the questions asked as part of this project have been approved by the Federal government’s Office of Management and Budget (OMB) under OMB control number X. Without this approval, we could not ask these questions.

People from the project team (from FMG and/or our marketing partner SalterMitchell) will be observing the session—either in-person or via livestreaming. Members of the sponsoring agency may also observe the session, either in-person or via livestreaming. The observers will take notes and listen, but they won’t bother you. You will only be talking to the moderator and a small group of other participants.

What are the potential risks of being in the focus group?

There are minimal risks associated with this project. Loss of confidentiality is possible, but this risk is reduced by not linking your responses to your name or other identifying information. Instead, a code will be used, and the project team agrees to protect your privacy and confidentiality. You do not have to answer any questions that you do not want to answer.

Does participating in this project provide any benefit?

There is no direct benefit to you from participating in this project. The information from the focus groups will help us decide what ideas and messages might be useful in health education outreach about alcohol consumption.

Will it cost me anything to participate in the project?

There are no costs to participate in the project, other than possible transportation costs to and from the facility. Participants in the focus groups will receive $75 for their participation.

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Do I have to be in this project?

Your participation is voluntary, which means you can stop or withdraw at any time.

Who will see the results of this project or my information?

Everything you say during the focus group will be heard by the research team. We will be very careful to only let people working on the project see your information. There is a small risk that others might find out what you say, despite all of our best efforts. In the case of a breach of confidentiality, appropriate steps will be taken to notify participants.

The focus group will be audio-recorded and transcribed. It might also be livestreamed so that other members of the project team and/or members of the sponsoring agency who could not travel can watch remotely. You will be told at the start of the focus group whether it is being livestreamed. By signing this form, you consent to being audio-recorded and livestreamed during the focus group.

Your name and other personal information will not be linked to your responses and will not be shared with the sponsoring agency. This means that no one outside of the project team will be able to link what you said back to you. Everything you share will be kept private to the extent allowed by law. This means that we will not share anything you provide with anyone outside the project 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 of the 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 project team can access. We will collect some personal information from you, like your age and race, but we will not collect any information that could identify you personally. After three years, all of the collected information will be destroyed by securely shredding documents or permanently deleting electronic information.

Results from this project might appear in professional journals or scientific conferences or shared with other project teams. No individual participants will be identified or linked to the results. We will not disclose your identity in any report or presentation.

Who do I contact if I have questions about the project?

If you have questions or concerns about the project, you can contact Sarah Evans, the project director at Fors Marsh Group, by email at [email protected] or by phone at 571-858-3757.

You can ask questions about this consent form or the project (before you decide to start the project, at any time during the project, or after completion of the project). If you decide to start the project and then change your mind, you can stop participating at any time without penalty or loss of benefits.

If you have any questions or complaints about your rights as a participant, contact Chesapeake IRB by phone (toll free: 877-992-4724), by email ([email protected]), or by mail:

Study Subject Adviser
Chesapeake IRB
6940 Columbia Gateway Drive, Suite 110
Columbia, MD, 21046

Please reference the following number when contacting the Study Subject Adviser: Pro00019145

Please mark a box and sign below. By signing this form, you have not waived any of your legal rights.

Yes, I agree to participate in this project. I have read, understand, and had time to consider all of the information above. My questions have been answered, and I have no further questions.

No, I do not agree to participate in this project. I have read, understand, and had time to consider all of the information above. My questions have been answered, and I have no further questions.

Signature Date

If you would like a copy of this form for your records, please ask the project team.