Prescription Drug Use Related Software Study (CDER)

Data to Support Drug Product Communications

Appendix C - Informed Consent

Prescription Drug Use Related Software Study (CDER)

OMB: 0910-0695

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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.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorO'Donoghue, Amie
File Modified0000-00-00
File Created2022-07-01

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