Biosimilars Prescribing Survey

OMB Control # 0910-0695

Expiration Date: 02-28-2021

Paperwork Reduction Act Statement:  According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.  The time required to complete this information collection from eligibility to completion of the survey is estimated to average 23 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

Department of Health and Human Services (HHS)/ Food and Drug Administration (FDA) Biosimilars Survey

INFORMED CONSENT

You will be one of 500 healthcare providers in the United States to take part in this voluntary research study sponsored by the US Department of Health and Human Services and the Food and Drug Administration. In the survey, we will ask you about your experience prescribing and communicating with patients about prescribed medications. We will also ask you how you would make prescribing decisions in some hypothetical scenarios. The survey will take approximately 23 minutes.

This research is being conducted by Fors Marsh Group (FMG) on behalf of the U.S. Department of Health and Human Services. If you have questions about this survey, please contact Dr. Shane Mannis, Principal Investigator, by phone at 571-444-1109 or by email at pi@forsmarshgroup.com.

Possible Risks or Discomforts

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

Benefits

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

Incentive

In appreciation for your participation, you will receive an honorarium of

$___ [//INSERT BASED ON SPECIALTY//] for completing this survey.

Dermatology: up to $60.00

Gastroenterology: up to $45.00

Hematology: up to $80.00

Nephrology: up to $60.00

Oncology Cancer: up to $80.00

Rheumatology: up to $80.00

Nurse Practitioner - Physician Assistant: $25.00

Your Rights as a Participant

This study is 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 your honorarium when you complete the survey even if you choose not to answer some questions.

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 secure to the extent provided by law.

C1. If you have read the information above and agree to participate, please select “Yes” below. If not, select “No.” [Single punch]

Value	Label
01	Yes, I agree to participate. [Go to next section]
00	No, I do not agree to participate. [Go to C2]
-99	Refused [Go to C2]

C2. Are you sure you don’t want to participate? Your opinions are important to us. Please select “Yes” to continue this survey. Select “No” to exit. [Single punch]

Value	Value Label
01	Yes, I agree to participate. [Go to next section]
00	No, I do not agree to participate. [Terminate]
-99	Refused [Terminate]