The Influence of Brand and Prinicple Display for Safe Consumer Use of OTC Drugs - Advancing the Science

Permission to Take Part in a Human Research Study

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Title of Research Study: The Influence of Brand and Priniciple Display for Safe
Consumer use of Over the Counter Drugs – Advancing the Science

Investigator: Dr. Michael Wolf PhD, MPH
Supported By: The US Food and Drug Administration (FDA)
Why am I being asked to take part in this research study?
We are asking you to take part in this research study because you are between 18 and 80
years old and may have had interactions with over the counter medicines.

What should I know about a research study?
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Someone will explain this research study to you.
Whether or not you take part is up to you.
You can choose not to take part.
You can agree to take part and later change your mind.
Your decision will not be held against you.
You can ask all the questions you want before you decide.

Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to any
of the research team by calling the number (312) 503-3272.
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You
may talk to them at (312) 503-9338 or [email protected] if:
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Your questions, concerns, or complaints are not being answered by the research
team.
You cannot reach the research team.
You want to talk to someone besides the research team.
You have questions about your rights as a research participant.
You want to get information or provide input about this research.

Why is this research being done?
This study is being done in order to understand how consumers identify and use over-thecounter medications .

How long will the research last?
This research consists of a one in-person interview that will last 45 minutes.

How many people will be studied?
We expect about 400 people will be in this research study.

What happens if I say “Yes, I want to be in this research”?
If you participate in this research you will be asked to participate in an interview with research
staff to be completed either now at this location or at a later time at Northwestern University
General Internal Medicine offices at 750 N Lake Shore Dr. In this interview you will be asked
Document Template Revision Date: May 25, 2016

Permission to Take Part in a Human Research Study

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about your experience and familiarity with over the counter medications. With your
permission, we will audio-record your answers to the questions asked for quality assurance
purposes and to supplement our notes. Audio recordings will be saved under a unique study
ID on secure Northwestern servers – your name will not be included. These recordings will be
destroyed at the end of the study.

What happens if I do not want to be in this research?
You can leave the research at any time and it will not be held against you. You may choose
not to participate in this research study.

What happens if I say “Yes”, but I change my mind later?
Your participation is voluntary. You can leave the research at any time and it will not be held
against you.
If you decide to leave the research, contact the investigator so that the investigator can
remove your information and interview responses from the study. We will keep all data
collected until the time you change your mind.

Is there any way being in this study could be bad for me?
There always exits the potential for loss of private information; however, there are procedures
in place to minimize this risk. You may also stop participation at any time or skip any question
that you feel uncomfortable answering .

Will being in this study help me in any way?
We cannot promise any benefits to you or others from your taking part in this research.
However, possible benefits include informing the researchers of how consumers choose over
the counter medications .

What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information to people who
have a need to review this information. We cannot promise complete secrecy. Organizations
that may inspect and copy your information include the IRB and other representatives of this
institution and the FDA.

What else do I need to know?
If you agree to take part in this research study, we will pay you $30 cash at the end of your
interview for your time and effort.

Optional Elements:
The following research activities are optional, meaning that you do not have to agree to them
in order to participate in the research study. Please indicate your willingness to participate in
these optional activities by placing your initials next to each activity.

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Permission to Take Part in a Human Research Study
I agree

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I disagree

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The researcher may audio record me for use in scholarly presentations or
publications. My identity may be shared as part of this activity, although the researcher
will attempt to limit such identification. I understand the risks associated with such
identification.

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The researcher may contact me in the future to see whether I am interested in
participating in other research studies by the principal investigator of this study.

Signature Block for Capable Adult
Your signature documents your permission to take part in this research.
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Signature of participant

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Date

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Printed name of participant
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Signature of person obtaining consent

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Date

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Printed name of person obtaining consent

Document Template Revision Date: May 25, 2016