Appendix A - Informed Consent

Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug

Appendix A - Informed Consent

OMB: 0910-0900

Document [docx]
Download: docx | pdf

Physician Survey of Research Data about Prescription Drugs

Informed Consent

NOTE: do not display headings in all caps.


The Food and Drug Administration is conducting this study to better understand physicians’ opinions and preferences about the type of information that is provided about prescription drugs. Your responses, and those of your colleagues nationwide, will provide valuable insight into matters affecting the medical community. Please answer honestly and give us your best guess on answers you do not know. This survey will take 15-20 minutes to complete and your responses will be kept confidential.

OMB STATEMENT PLACEHOLDER

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 SERMO to conduct this survey but is not affiliated with SERMO 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 not collect any personal information, such as your name. 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 might be used to identify you. Your information will be kept secure to the extent allowed by law. Study information will be kept in password protected files on secure servers at Westat and FDA locations. The data collected in this study will be destroyed no later than three years after the project is completed.

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 $[46/62] for completing this survey.

Rights as a Participant

This study is voluntary. You do not have to answer any questions that you do not want to and can withdraw from the study at any time. The Institutional Review Board (IRB) at Westat has reviewed this research study. If you have any questions about your rights as a participant or concerns about how you are treated in the study, you may wish to contact Westat Human Subjects Protections office at 1-888-920-7631.

Documentation of Informed Consent

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.

  • No, I do not agree to participate



OMB Control # Expires XX/XX/XXXX


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorAikin, Kathryn J
File Modified0000-00-00
File Created2022-08-08

© 2024 OMB.report | Privacy Policy