Consent Form - Physicians

Biosimilars Study Interviews

Consent Form – Physicians

Introduction and Purpose:

Thank you for agreeing to participate in a research study about biological drugs. The purpose of the study is obtain healthcare providers’ feedback on educational materials.

RTI International, a non-profit research organization in North Carolina, is conducting the study. We will be conducting interviews in Dallas, TX, and Irvine, CA. You are one of approximately 27 people being asked to participate in this study.

You are eligible to participate in this study because you are a physician who reported prescribing biological drugs recently.

Procedures:

If you agree to participate, you will take part in a one-on-one interview. During the interview, we’ll provide you with written materials and ask you to provide feedback on them. The interview will last about 60 minutes.

Benefits:

There is no direct benefit to you for participating. However, you may find the materials informative and may learn more about biological drugs.

Risks:

There are no known risks to participating in this study. While the questions we ask are not meant to be sensitive, there is always a chance that you may feel uncomfortable with some of the questions. You do not have to answer any question that you don’t want to answer.

Confidentiality:

We will keep the information you share in this interview confidential. The study team will not disclose your name or any of your comments, and your personal information (name, address, phone number) will not be linked to any of your responses.

With your permission, we will audio and video record the discussion to supplement our notes. Recordings will not include full names and will be stored on password protected computers that only project staff can access. All hardcopy forms will be kept in a locked file cabinet that only project staff can access.

Your answers will not be used against you for employment and/or legal retaliation. You will not be reprimanded for your comments, and your direct supervisor will not have access to your responses, the video streaming, or the audio/video recordings at any point in the study. The purpose of the recording is to ensure the study team accurately captures your comments.

Observation:

Several research team members will be observing the discussion online through video streaming. They will not record your name and will keep all of your comments confidential.

Reimbursement:

In appreciation for your time and travel, we will reimburse you $250 at the end of the interview.

Right to Refuse or Withdraw:

Your participation in this study is voluntary. You can choose not to talk about any topic, and you can withdraw from the interview for any reason at any time without penalty.

Persons to Contact:

If you have questions about the study, you can call the project director, Mr. Doug Rupert, at 1-800-334-8571, ext. 26495 (toll free). He can be reached between 8:00 AM and 4:00 PM Eastern Time Monday to Friday.

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.

Your Consent:

I have read this consent form. I had a chance to ask questions, and my questions were answered. I was given a copy of this consent form. I agree to participate in the study.

_________________________________ _________________

Signature of Participant Date

_________________________________ _________________

Signature of Person Obtaining Consent Date

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

OMB Control #0910-XXXX