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

Focus Groups as Used by the Food and Drug Administration

Appendix V - NFL Consent Form

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

OMB: 0910-0497

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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 [email protected] 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 [email protected] 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

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleConsent Form
AuthorHAGERTY-HELLER_T
File Modified0000-00-00
File Created2021-01-15

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