Dietary Supplement Education Focus Groups (Formative Research) (CFSAN

IRB Participant Consent Form

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. The time required to complete this information collection is estimated to average 90 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].

Dietary Supplements Focus Groups

Consent Form

Purpose:

• This study is about dietary supplements.

• The U.S. Food and Drug Administration (FDA) is conducting this study to learn consumers’ views about and experiences with dietary supplements.

What is involved:

• You are being asked to be part of a discussion with 8-10 other people.

• We will ask you some questions about your experiences with dietary supplements.

• The focus group discussion will take approximately 90 minutes.

Confidentiality:

• Your name and information will be kept secure to the extent provided by law.

• We will video record the discussions

• Project staff from FDA may be observing the discussion.

• 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 Westat Project Director, Cynthia Robins, at 610.593.7389 or 240.367.4753.

• If you have any questions or complaints about your rights as a research subject, please contact FDA’s IRB, Human Subject Protection Program Management Staff, 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