Phase 1 - Main Study Completes (Consumers)

Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials

Appendix A - Informed Consent

Phase 1 - Main Study Completes (Consumers)

OMB: 0910-0902

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Appendix A – Consent Form (Pretests and Main Studies)

What is the Research About?

Thank you for your interest in this research study. The research involves looking at a website or advertisement for a prescription drug and completing an online questionnaire. Viewing the website or advertisement and completing the survey will take approximately 20 minutes.

What is the Purpose of This Study?

The purpose of the study is to learn more about prescription drug advertisements. You are one of about <IF STUDY 1 PRETEST: “252”, IF STUDY 1 MAIN STUDY: “900”, IF STUDY 2 PRETEST: “432”, IF STUDY 2 MAIN STUDY: “720”> people in the United States who are being asked to take a survey about a new prescription drug.

Who is Leading the Study?

RTI International, an independent nonprofit research organization, is conducting this study on behalf of, and funded by, a federal agency. RTI is working with Dynata to conduct this survey but is not affiliated with Dynata in any way.

Do I Have to Take Part in this Study?

Your participation in this study is completely voluntary, and you have the right to stop at any time or to refuse to answer any question. If you decide to participate and later change your mind, you will not be contacted again or asked for further information.

What Are the Possible Risks?

We do not expect that any of the survey questions will make you uncomfortable, but if they do, you can refuse to answer any question. There is also a potential risk of loss of confidentiality. Every effort will be made to protect your information, but this cannot be guaranteed.

Will I Benefit from Taking Part in This Study?

There are no direct benefits to you for participating in this study. However, you will be helping with an important research project.

Will I Receive Any Payment for Taking Part in this Study?

Upon completion of the survey, you will receive [IF CONSUMER points equivalent to the amount] [IF HCP dollar amount] mentioned in the study invitation from Dynata.

Who Will See the Information I Give?

Many precautions have been taken to protect your information. All information collected in this survey will be kept confidential to the extent provided by law. You will never be identified by name. The information obtained from all of the surveys will be combined into a summary report so that details of individual questionnaires cannot be linked to a specific participant. When we analyze the results, your responses will be combined with responses from other people taking part in the study. You will not be identified in any published or presented materials. The information collected in this study may be used or shared for future research studies.

Will I Be Contacted in the Future about This Study?

You will not be contacted in the future about this research after your participation ends.

What If I Have Questions?

If you have questions about this survey, please contact your panel provider through your member website for assistance. You will need to mention the Project # [SurveyNumber], and someone will direct your questions to the appropriate researchers at RTI. If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection toll-free at 1-866-214-2043.

If you have read the information above and agree to participate, please click the Yes button. If not, click the No button.

  • Yes, I agree to participate. [CONTINUE AND RANDOMLY ASSIGN PARTICIPANT TO EXPERIMENTAL CONDITION]

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



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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSullivan, Helen W (CDER)
File Modified0000-00-00
File Created2021-10-04

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