Risk and Benefit Perception Scale Development Focus Groups

Measures Study Focus Groups

Consent Form

Introduction and Purpose:

Thank you for agreeing to participate in a research study about prescription drugs. The purpose of the study is to learn more about how people find information and make decisions about prescription drugs.

RTI International, a non-profit research organization in North Carolina, is conducting the study. We will be conducting focus groups in Bethesda, MD; Raleigh, NC; Portland, OR; and Denver, CO. You are one of approximately 90 people being asked to participate in this study.

You are eligible to participate in this study because you have recently begun taking one or more prescription drugs.

Procedures:

If you agree to participate, you will take part in a group discussion (8-10 people) about prescription drug decisions. The discussion will last about two hours.

Benefits:

There is no direct benefit to you for participating. However, you may find the discussion informative and may learn how other people make decisions about prescription 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 try to keep the information you share in this focus group 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. We also will ask the other participants not to disclose anything that was discussed in the group. However, we cannot control what other participants say after the group is finished.

With your permission, we will audio-tape 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. At the end of the project, we will destroy the recordings. All hardcopy forms will be kept in a locked file cabinet that only project staff can access.

Observation:

Some project staff may observe the discussion behind a one way mirror. 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 $75 at the end of the focus group.

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 group 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.

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Signature of Participant Date

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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 #0910-0497 Expires 06/30/2014