Focus Groups of Salon Professionals and Consumers to Determine Reactions to Labeling Statements on Cosmetic Labels

Appendix IX_C: Consent Form for Retail Consumers

Hair Product Labeling 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 labeling on hair smoothing and straightening products.

What is involved: We will be asking you some questions about your experiences in using different types of hair smoothing or straightening products, as well as asking for your opinions of proposed labeling of such hair products. The focus group discussion will take approximately 90 minutes.

Confidentiality: All information collected in this study will only be used by the researchers and will be destroyed after reports are written. Your name will never be linked to your responses, though we may include quotes you provide in our report. Your name or any other personally identifying information will not be linked to any of your responses, though we may include quotes you provide in our reports. We will be recording the focus group discussion using both audio and visual recording equipment. We will be making anonymized transcriptions from the audio recording, which, along with transcriptions from other focus groups we are convening, will be grouped for the purpose of reporting and presentation. The recordings will be kept on Westat’s and FDA’s secure servers and will be destroyed on project completion or no later than December 2019.

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 at a letter point you may call the Westat Project Director Amanda Wilmot on XXX XXX XXXX. For questions about your rights and welfare as human subjects in this study, you may call the Westat Human Subjects Protections office at 1-888-920-7631. Please leave a message with your full name, that you are calling about the hair labeling study, and a phone number beginning with the area code. Someone will return your call as soon as possible.

You will receive $65 cash as a token of appreciation for your time and 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

June 2016