Appendix II
OMB No: 0910-0497 Expiration Date: 10/31/2020
Paperwork Reduction Act Statement: The public reporting burden for this collection of information has been estimated to average 120 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.
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’s consumer educational initiative on GMO foods, which are also known as genetically engineered or genetically modified foods.
What is involved: We will be asking you and the other participants your opinions about some educational concepts providing information on GMO foods, which are also known as genetically engineered or genetically modified 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 be used only 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 Hager Sharp’s secure servers and will be destroyed on project completion. There will also be observers from FDA, 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 FDA staff are required to follow the same data confidentiality guidelines just described.
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: You will receive $75.00 as a token of our appreciation for your participation and to help with any transportation and/or child care costs that may be related to your participation.
Questions: If you have questions about the project, you may call the Hager Sharp project director Christina Nicols at 202-842-3600. Please leave a message with your full name, that you are calling about the Foods Focus Group Study, and a phone number beginning with the area code. Someone will return your call as soon as possible.
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 Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Consent Form |
| Author | HAGERTY-HELLER_T |
| File Modified | 0000-00-00 |
| File Created | 2021-01-15 |