Attachment 4A. CDC BYB FG Informed Consent_English_v3

DRAFT

Project Title: CDC Bring Your Brave

Attachment Title: Focus Group Participant Consent Form - English

Attachment Number: #4a

focus group

participant Consent form

Sponsor / Study Title:

Centers for Disease Control and Prevention (CDC) / CDC Bring Your Brave

Principal Investigator:

Memi Miscally

Telephone:

571-858-3757 (24 hours)

Additional Contact(s): Study Staff

Sam Evans

Address:

Fors Marsh

4250 Fairfax Dr., Ste 520

Arlington, VA 22203

We’re pleased you have accepted our invitation to participate. You will be discussing a number of topics in this focus group session. 

What is the key information?

You are being asked to participate in a study collecting information about early onset breast cancer. 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 study staff is available to read through this form with you and discuss all the information if you wish.

This information collection is being done to develop campaign materials for a national health program. Fors Marsh Group (FMG) is conducting this project on behalf of the Centers for Disease Control and Prevention (CDC).

CDC has the authority to collect this data.

What do I need to know about this study?

If you agree to be part of the study, you will be asked to participate in a remote (online) focus group where you will discuss your thoughts and experiences related to early onset breast cancer. The entire session will take about 90 minutes.

Your participation is voluntary, which means you can stop or withdraw at any time. You may choose to not participate, or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled.

Your part in the study may stop at any time for any reason, such as if the sponsor decides to stop the study.

What are the potential risks of being in this study?

There are minimal risks associated with this project. There is a possible risk of data breach. This risk is minimized by protections described in the “Who will see the results of this project or my information?” section below.

Does participating in this project provide any benefits?

Although you may not directly benefit from being in this study, others may benefit because the findings of this study may be used to develop campaign and communication materials related to early onset breast cancer.

Are there alternatives to participating?

The only alternative is to not participate in this study.

Will it cost me anything to participate in the project?

There are no costs to participate in the project. You will be given an incentive of $150 in the form of an electronic gift card to participate in the focus group.

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

Everything you say during the focus group will be heard by other participants and the study staff. 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 data breach, appropriate steps will be taken to notify participants. The focus group will be audio- and video-recorded. By consenting to this study, you consent to being audio- and video-recorded during your focus group.

Your name and other personal information (for example, contact and demographic information) will not be linked to your responses and will not be shared with the sponsoring agency or distributed for future studies. This means that no one outside of the project team will be able to link what you said back to you. The Investigator and the sponsor or persons working on behalf of the sponsor will be able to inspect and copy study-related records which identify you by name. Data will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. 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, and audio files 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.

Whom to contact about this study:

During the study, if you have questions, concerns or complaints about the study, please contact the Investigator at the telephone number listed on the first page of this consent document. If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this study.

If you have any questions, concerns, or complaints regarding this study, contact [email protected].

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