Informed Consent (Pretest)

Healthcare Professional Survey of Prescription Drug Promotion II

[Main Survey]

INFORMED CONSENT FORM

[Consent Screen 1]

[DISPLAY]

The Food and Drug Administration is conducting this study to understand health care providers’ attitudes regarding pharmaceutical promotion as it relates to public health.  Your responses, and those of your colleagues nationwide, will provide valuable insight into matters affecting the medical community. This survey will take between 15-20 minutes to complete and your responses will be kept confidential.

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

OMB Control #0910-xxxx. Expires xx/xx/20xx.

[Consent Screen 2]

[DISPLAY]

This survey is being conducted by Westat, an independent social science research firm, on behalf of the U.S. Department of Health and Human Services. Westat is working with WebMD to conduct this survey but is not affiliated with WebMD in any way. If you have questions about this survey, please contact the project director, Dr. Simani Price, at 301-610-5536. She can be reached between 9 AM and 5 PM Eastern Time Monday to Friday.

Privacy and Confidentiality

This survey will ask you for some general demographic information (for example, age, gender, race/ethnicity). However, no personal information, such as 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 your responses, which will not be linked back to any personal information that can be used to identify you. Your information will be kept private to the extent allowed by law.

Possible Risks or Discomforts

There are no anticipated risks to participating in the survey. However, you can skip any questions you do not wish to answer and continue with the survey. While we will be very careful to let only members of the research team see your information, there is a small risk that others might find out what you say, despite all our best efforts. In the case of a breach of confidentiality, appropriate steps will be taken to notify participants.

Benefits

Your responses are very important because they will help researchers understand how people make decisions about medications. There is no direct benefit to you for your participation.

Incentive

In appreciation for your time, you will receive $(50/60) for completing this survey.

Rights as a Participant

If you have any questions about your rights as a participant, you may wish to contact Westat Human Subjects Protections office at 1-888-920-7631. You may also contact RIHSC at 301-796-9605 or RIHSC@fda.hhs.gov. 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.

[Consent Screen 3]

Consent1. If you have read the previous screens and agree to participate, please click the Yes button. If not, click the No button.

• Yes, I agree to participate. [CONTINUE WITH NEXT SECTION]

• No, I do not agree to participate. [GO TO NEXT QUESTION]

Consent2. Are you sure you don't want to participate? Your opinions are important to us. Please select the Yes button to continue this survey. Select the No button to exit.

• Yes, I agree to participate. [CONTINUE WITH NEXT SECTION]

• No, I do not agree to participate. [END SURVEY]