Consent Form

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Thank you for completing the screening questionnaire. Your opinions are very important to us. Please read this information carefully. If there is anything you do not understand, please click here to email us. The research team will be happy to answer your questions.

INFORMED CONSENT FORM

TITLE OF INFORMATION COLLECTION: Prescription Drug Promotion

Sponsor: The Food and Drug Administration (FDA)

Principal Investigator: Sarah Evans, PhD

Telephone: 571-858-3757 (24 Hours)

Address: Fors Marsh Group, LLC (FWA00011194)

1010 N. Glebe Road

Suite 510

Arlington, VA 22201

You are being asked to take part in this study, because you are a practicing physician. After reading this form, which explains the study, you may decide if you would like to participate in the study or not. Your participation is completely voluntary. If you decide to start the study and then change your mind, you can withdraw at any time.

You may ask the research team questions about the study at any time. They will explain anything you do not understand.

You must complete and submit this form before you can take part in the study. If you would like a copy for your records, you can print a copy now, or you may request a copy from the research team, and they will provide you with a copy.

About this study

Fors Marsh Group is a research company partnering with the U.S. Food and Drug Administration (FDA) to investigate physicians’ reactions to and understanding of information in prescription drug promotion. We plan to conduct remote in-depth interviews with physicians across the country.

After signing this form, you will be directed to a webpage to sign up for an interview time through Doctor Directory’s online scheduling tool. During the telephone interview, which will last about 60 minutes, you will be asked to share your thoughts with the moderator about various professional prescription drug promotions. You will need access to your computer during the interview, and you will be provided a link to access and view materials. You will not need a webcam, and there will be no video recording. There are no costs associated with your participation in this study. You may skip any questions you do not want to answer.

People from FDA and the study team will be observing the session via livestreaming; however, you only will be interacting with the moderator.

Study Benefits:

There is no direct benefit to you. Your feedback will help us to decide how professional prescription drug promotions can be improved.

Incentive:

You will receive an incentive as a token of appreciation for your participation. Doctor Directory will issue a company check to you upon completion of the interview. You will receive the incentive for your time even if you choose not to answer some questions during the discussion.

Anticipated Risks:

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 of our best efforts. In the case of a breach of confidentiality, appropriate steps will be taken to notify participants. Remember that you can stop participating in this study at any time.

Privacy:

Everything you say during the interview can be heard by the research team.

The interview will be audio recorded and transcribed for note-taking purposes. It also will be livestreamed so that other researchers can observe. By signing this form, you consent to being audio recorded and livestreamed during the interview.

Your identity will not be linked to your responses. This means that no one outside of the research team will be able to link what you said back to you. Everything you share will be kept private to the extent allowed by law. Therefore, we will not share anything you provide with anyone outside the study unless it is required to protect you or if required by law. However, if you show a direct threat of harm to yourself or others, we have the right to take action out of concern for you and concern for others.

All information we collect, including anything you say in the interview, information collected during screening, audio files, and transcripts will be stored on a password-protected computer and/or in locked cabinets that only the research team can access. We will collect some personal information from you, such as your age, gender, and race, but it will only be used for eligibility and scheduling purposes. After 3 years, all collected data will be destroyed by securely shredding documents or permanently deleting electronic information.

Results from this study may appear in professional journals or at scientific conferences. No individual participants will be identified or linked to the results. We will not disclose your identity in any report or presentation. Results also may be used in future research or shared with other researchers. Other researchers will not have your name or any identifying information.

Participation and Withdrawal:

Participation in this study is completely voluntary. You may withdraw at any time by contacting Sarah Evans of Fors Marsh Group at [email protected] or 571-858-3757.

You do not have to answer any questions that you do not want to. You will receive the incentive for your time in the interview even if you choose not to answer some questions.

We advise you to keep a copy of this consent form for future reference. If you would like to do so, print a copy now.

Please read the statement below. Then, using the mouse, please click on the statement that describes whether you want to participate in this study. After checking the box that best represents your willingness to participate, please click “Submit.”

By checking “yes” below, you are consenting to participate. If you check “no” below, you are not consenting to participate, and you will not continue on to the scheduling tool.

Consent. I have read and understand the information provided above, and the study’s purpose and procedures are clear to me.

[SINGLE PUNCH]

Yes, I agree to participate in this study. 01

No, I do not wish to participate in this study. 02

[SUBMIT BUTTON]

[IF Consent=01 (“Yes, I agree to participate in this study.”), CONTINUE TO DOCTOR DIRECTORY’S SCHEDULING TOOL.]