Prescription Drug Use Related Software Study (CDER)

Appendix C: Informed Consent

Focus Groups on Prescription Drugs

Consent Form

Purpose:

• You are being asked to take part in a focus group for a research study for the U.S. Food and Drug Administration (FDA).

• Westat, an independent social science research firm, is conducting the study on behalf of FDA.

• The purpose of the focus groups is to gather thoughts and opinions on prescriptions.

What is involved:

• You are being asked to be part of a discussion with 5 to 6 other people.

• We will ask you some questions about new prescriptions drugs with technology. You will be asked to share your thoughts with the leader and the rest of the group.

• The focus group discussion will take approximately 60 minutes.

Confidentiality:

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

• We will audio and video record the discussions.

• Project staff from FDA and Westat 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.

• Study information will be kept in password protected files on secure servers at Westat and FDA locations. No information that can identify you will be given to FDA.

• The data collected in this study will be destroyed no later than three years after the project is completed.

Risks:

• This study is completely voluntary.

• You can stop participating at any time.

• There are no known risks for participation in this research activity.

Benefits:

• Other than the $75/250 token of appreciation for your participation, there are no other 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, Simani Price at simaniprice@westat.com or 301-610-5536.

You will receive [$75/250] as a token of appreciation for your participation in the discussion.