Appendix A - Consent Form

Pretest and Main Study Consent Form

Thank you for your participation in our online survey. Your opinions are very important to us. Your personal information will not be linked to your answers or used in any report.

You are one of about 3,000 people in the United States who is being asked to take part in this voluntary research survey. The survey is examining how people understand information about prescription drugs. During the survey, you will be shown prescription drug information and you will be asked your opinions about it. The survey will take approximately 20 minutes. Please do not take this survey on a mobile device.

This survey is being conducted by Fors Marsh Group on behalf of the Food and Drug Administration (FDA). If you have questions about this survey, please contact Dr. Brian Griepentrog, Principal Investigator, by phone at 571-858-3757 or by email at pi@forsmarshgroup.com.

Possible Risks or Discomforts

We do not expect that any of the survey questions will make you uncomfortable or upset you; however, if they do, you can refuse to answer any question. If you skip a question, you can continue with the rest of the survey.

Benefits

Your responses are very important because they will help researchers understand how people view prescription drug information. There is no direct benefit to you for your participation.

Incentive

You will receive e-Rewards Currency as a token of appreciation for your time in completing this survey.

Rights as a Participant

This study is completely voluntary. You can stop at any time. You also do not have to answer any questions that you do not want to. You will receive e-Rewards Currency for your time when you complete the survey even if you choose not to answer some questions.

The Research Involving Human Subjects Committee (RIHSC) at FDA has reviewed this research. RIHSC is an institutional review board (IRB), a group of people who are responsible for ensuring that the rights of participants in research are protected. If you have questions about your rights as a study participant or concerns about how you are treated in the study, you may contact RIHSC at 301-796-9605 or RIHSC@fda.hhs.gov.

Privacy and Confidentiality

Some demographic information, like your age, gender, and race/ethnicity, will be gathered, but no personal information, like your name, will be collected. Your identity will not be linked to your responses. We will be very careful to only let people working on the study see the responses you provide, which will not be linked back to any personal information that can be used to identify you. Your personal information will be kept private to the extent allowed by law.

Do you want to participate in the study?

1. Yes

2. No