Appendix III
OMB No: 0910-0497 Expiration Date: 10/31/2020
Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0497 and the expiration date is 10/31/2020. The time required to complete this information collection is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to [email protected].
Foods Focus Group Study
Consent Form
Purpose: You are being asked to take part in a research study being conducted on behalf of the U.S. Food and Drug Administration (FDA). The research involves participation in a focus group discussion, the findings from which will be used to inform the FDA about consumers’ perspectives on bioengineered or genetically modified (GMO) foods.
What is involved: We will be asking some questions about what you and the other focus group participants know about GMO foods and what you believe to be the risks and benefits of these products; and we will ask for your opinion on some materials about GMO foods. The focus group discussion will take approximately 90 minutes.
Voluntary: Your participation in this study is completely voluntary. You are free to ask questions or withdraw from participation at any time without penalty.
Confidentiality: All information collected in this study will only be used by the researchers and will be destroyed after reports are written. Although we may include quotes from you or other participants in our report, we will never link your name or any identifying information to the quote. We will be recording the focus group discussion using both audio and visual recording equipment. We will be making anonymized transcripts from all of the focus groups for the purpose of analysis and reporting. The recordings will be kept on Westat’s and FDA’s secure servers and will be destroyed on project completion or no later than January 31, 2020. There will also be observers from FDA, USDA and EPA, both here at the focus group facility as well as off site. Off-site staff will be observing the focus group through a livestreaming service. All staff involved in this project are required to follow the same guidelines just described for data to be secured to the extent provided for by law.
Risks: There are no known risks for participation in this research activity. You may decide not to answer any questions that you do not want to answer, and you may leave the discussion at any point without penalty.
Benefits: There are no direct benefits to you for participating in this study. However, you will be helping with an important research project.
Questions: If you have questions about the project, you may call the Westat Project Director Dr. Cynthia Robins at (301)738-3524. For questions about your rights and welfare as a human subject in this study, you may call the Westat Human Subjects Protections office at (888) 920-7631. Please leave a message with your full name, that you are calling about the GMO Foods study, and a phone number beginning with the area code. Someone will return your call as soon as possible.
You will receive a cash 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.
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Participant’s signature Date
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