FDA Unified Consumer Communications Program

Visual Identity Focus Groups

Consumer Consent Form

Introduction and Purpose:

Thank you for agreeing to participate in a research study about the U.S. Department of Health and Human Services’ communications. The purpose of the study is to gather your thoughts and opinions on materials related to the visual identity of a federal agency.

Sensis is conducting the study. We will be conducting focus groups in Philadelphia, Atlanta, Los Angeles, and Chicago. You are one of approximately 64 people being asked to participate in this study.

We have invited you to participate in a discussion with other consumers to share your knowledge and thoughts about this topic.

Procedures:

If you agree to participate, you will take part in a group discussion (6-8 people) about your understanding of the public health issues and your reactions to some communication materials. The discussion will last about 90 minutes.

Benefits:

There is no direct benefit to you for participating. However, you may find the discussion informative and may learn more about the topic.

Risks:

There are no known risks to participating in this study. While the questions we ask are not meant to be sensitive, there is always a chance that you may feel uncomfortable with some of the questions. You do not have to answer any question that you don’t want to answer.

Confidentiality:

We will try to keep the information you share in this focus group confidential. The study team will not disclose your name or any of your comments, and your personal information (name, address, phone number) will not be linked to any of your responses. We also will ask the other participants not to disclose anything that was discussed in the group. However, we cannot control what other participants say after the group is finished.

With your permission, we will audio record the discussion to supplement our notes. Recordings will not include full names and will be stored on password protected computers that only project staff can access. All hardcopy forms will be kept in a locked file cabinet that only project staff can access.

Your answers will not be used against you for employment and/or legal retaliation. You will not be reprimanded for your comments, and your direct supervisor will not have access to your responses, or the audio recordings taken at any point in the study. The purpose of the recording is to ensure the study team accurately captures your comments.

Reimbursement:

In appreciation for your time and travel, we will reimburse you $100 at the end of the focus group.

Right to Refuse or Withdraw:

Your participation in this study is voluntary. You can choose not to talk about any topic, and you can withdraw from the group for any reason at any time without penalty.

Persons to Contact:

If you have questions about the study, you can call the project director, Natalie Barg ([email protected] or 202-629-3815). She can be reached between 8:00 AM and 7:00 PM Eastern Time Monday to Friday.

Your Consent:

I have read this consent form. I had a chance to ask questions, and my questions were answered. I was given a copy of this consent form. I agree to participate in the study.

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Signature of Participant Date

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Signature of Person Obtaining Consent Date

DHHS research authorized by Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)). Confidentiality protected by 5 U.S.C. 552(a) and (b) and 21 CFR part 20.

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