Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing)

Appendix V

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

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Nutrition Facts Label Campaign Focus Groups (Formative Research and Stimulus Testing) – Phase 2

Consent Form

Purpose:

• This study is about the new Nutrition Facts label.

• The U.S. Food and Drug Administration (FDA) is conducting this study to create educational materials about the Nutrition Facts label.

What is involved:

• You are being asked to be part of a focus group discussion.

• We will ask you some questions about how to make people aware of the new Nutrition Facts label.

• The focus group discussion will take approximately 90 minutes.

Confidentiality:

• Your name and information will be kept secure to the extent allowed by law.

• We will video record the discussions. We will keep the recordings secure and destroy them by 2022.

• What you say will not be connected with your name. We will report our results in a summary report. We may use quotes you say in our report, but we won’t use your name.

Risks:

• It is your choice to do this focus group discussion.

• You can stop participating at any time.

• There are no known risks for participation in this research activity.

Benefits:

• There are no direct benefits to you for participating in this study.

• You will be helping with an important research project.

Questions:

• If you have questions about the project you may call the RTI Project Director, Claudia Squire, at RTI at cms@rti.org and 919-541-6613.

• If you have any questions or complaints about your rights as a research subject, please contact FDA’s IRB, Research Involving Human Subjects Committee, at RIHSC@fda.hhs.gov and 301-796-9605.

You will receive $75 cash as a token of appreciation for your participation in the discussion.

If you agree to participate, please sign below.

I have read and understand the statements above. I consent to participate in this focus group.

____________________________________ _________________________________

Participant’s signature Date