Focus Groups with Nutrition Educators (CFSAN)

OMB Control No. 0910-0497 Expiration Date: 10/31/2020

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Focus Groups with Nutrition Educators

Consent Form

About this study

The U.S. Food and Drug Administration (FDA) contracted RTI International to conduct this research study to learn how FDA can better support nutrition educators. You are being asked to take part in this study. If you agree, you will participate in a focus group discussion. Focus groups are a form of research used to gather thoughts and opinions on a certain topic.

What will I do during the study?

The focus group discussion leader will ask you some questions about your experiences as a nutrition educator. There will be about 5-8 other educators in the focus group with you. You will be asked to share your thoughts with the leader and the rest of the group. The discussion will take about 90 minutes. There are no costs to you to participate in this study.

Who will see the results of this study?

The study team will know your name but will do their best to make sure no one outside the study knows you were part of the study. During the group, the discussion leader, you, and other participants will only use first names. Your name or any other information about you will not be linked to any of your responses. The study team may include quotes that you provide in their reports, but they will not attribute the quote to your name, and these quotes will not be linked to any of your information. You will not be identified in any published or presented materials. Your data will only be used for this study, and not for other studies.

The focus group will be live-streamed so that other researchers who could not attend in person can watch and listen to the discussion. The discussion will also be recorded using audio and video recorders. These recordings will help the team document everything that was talked about during the focus groups. The recordings will be used to prepare transcripts. The transcripts will be combined with transcripts from the other focus groups that are part of this study for the final report. Your information RTI collects will be separated from the information that identifies you and it will be combined with information from other people taking part in the study. FDA will not have access to any record of your full name or contact information. All data collected for the focus group will be stored in a locked file cabinet or on a password-protected computer for a period of three years, after which they will be destroyed.

All information collected in this study will be kept secure to the extent permitted by law. This means that the study team will not share anything you tell us with anyone outside the study unless it is required to protect you or if required by law.

Could anything bad happen to me during this study?

There are no known risks for participation in this discussion. We do not expect that any of the topics discussed during the focus group will make you uncomfortable or upset you; however, if they do, you do not have to participate in that part of the discussion.

Participation and Withdrawal: Do I have to be in this study? What if I want to stop participating?

This study is completely voluntary. You may decide not to answer any questions that you do not want to answer. You may leave the discussion at any point without penalty. You will receive the full token of appreciation for your participation in the focus group even if you choose not to answer some questions.

What good comes from my participation?

There are no direct benefits to you for participating in this study. However, you will be helping with an important research project. The information that FDA learns from this project may help other nutrition educators, and the populations they serve.

What if I have questions?

If you have questions about the study, you may contact the project manager, Jenna Brophy, by e-mail at jbrophy@rti.org or by phone at 919-541-8881. If you have any questions or complaints about your rights as a research subject, please contact RTI’s Office of Research Protection at 1-866-214-2043.

You will receive $50 as a ‘thank you’ for participating.

If you agree to participate, please sign below.

I have read and understand the statements above, and my questions so far have been answered. I understand that my participation in this research study is voluntary. I consent to participate in this focus group.

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Participant’s signature Date