General consent form

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UNIVERSITY OF NEVADA, RENO BIOMEDICAL INSTITUTIONAL REVIEW
BOARD
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
TITLE OF STUDY: Neuroimaging of Human Cognitive, Perceptual and Motor Systems
INVESTIGATOR(S): Lars Strother, Ph.D., Primary Investigator (775) 384-7109
Gideon P. Caplovitz, Ph.D. (775) 682-8673
682-8692
Marian E. Berryhill, Ph.D. (775)
Jacqueline Snow, Ph.D. (775) 682-8688
8690
Michael Crognale, Ph.D. (775) 682-
Jeffrey Hutsler, Ph.D. (775) 682-8694
8691
Michael Webster, Ph.D. (775) 682-
Fang Jiang, Ph.D. (775) 784-6828
PROTOCOL #: B12-034
Introduction
Before you agree to participate in this research study, it is important that you read and
understand the following explanation of the study. It describes the why we are performing this
experiment, what we will be doing, why we are doing it and any possible risks or discomforts
that you may experience. As a participant, you have the right to change your mind about
participating. If, at any time, you want to stop the experiment you can.. We cannot make any
promises about the results of the study; every person is different. We can promise you that if you
decide to stop participating in the experiment it will not influence your normal medical care in
any way.
This consent may contain words that you do not understand. Please ask the investigator(s) to
explain any words or information that you do not understand.
It is very important that you tell the truth about your health history and let us know immediately
if you experience any kind of negative symptom or reaction. If you are not truthful, you may hurt
yourself by participating.
You do not have to be in this study. If you choose not to participate, you will not be affected in
any negative way.
Take as much time as you need to decide. If you say yes now but change your mind, you may
quit the study at any time. Just let the study doctor or one of the researchers know you do not
want to continue.
Purpose
You have been asked to participate in a study to learn more about what parts of the brain are
involved in different parts of thinking and sensation. Different parts of the brain have different
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jobs, such as vision, hearing and memory. “Neuroimaging” refers to several special techniques
that allow researchers and doctors to collect detailed photographs and videos of the brain in
action. These techniques are not invasive – you will not have any kind of surgery. I Instead a coil
or cap will be placed on your head and by tracking things like the level of oxygen in your blood
or the amount of electrical activity your brain is producing, we can determine what parts of your
brain are being used.Usually we will ask you to complete a task, like watching a movie or
playing a game, while you are connected to the neuroimaging machine. By watching your brain
activity while you complete the task, we can figure out what brain regions are involved in
specific tasks.
Why are we asking you to be in this study?
These neuroimaging techniques we are applying are relatively new, and are the best techniques
available for observing the brain in action. We are asking you to participate because you are a
healthy adult with a neurological characteristic that we are interested in studying. Since our aim
is to learn as much as possible about the brain and how it works, we are interested in participants
of all different backgrounds. Over the course of this study, we expect 200 people will participate.
You should not participate in this study if any of the following are true:

You are currently pregnant

You experience severe anxiety in enclosed spaces (claustrophobia)

(For MRI participants only) You have any ferrous-magnetic (iron) metals in your
body (including surgical pins, metal dental fillings, etc.

You are under the age of 18, or under the appointed care of a legal guardian
What happens if you agree to be in the study?
If you agree to be in this study you will be asked to attend (1-3) study sessions conducted at the
Psychology Department of the University of Nevada, Reno campus, or at the Renown Medical
Imaging Facility, part of Reno’s Renown hospital. You will be responsible for arranging travel to
and from each study session. If you need help arranging transportation because of a disability,
please bring this to our attention as soon as possible. We may be able to arrange disability access
parking or other forms of assistance.
Usually, your first session will start with some tasks to train you on what you will be doing
during the main experiment. Depending on the training and how long it takes, this visit may be
separate from the imaging session. In general, tasks consist of different ‘stimuli’ being presented
on a screen. These stimuli could be shapes, colors, sounds, video clips, etc. You will respond to
the stimulus by pressing a button or answering verbally. During both the training period and the
testing period, the task will be organized in several blocks with breaks to give you a short rest.
You can use these breaks to stretch and move a little bit; during the testing, it is important that
you try to stay completely still. If you feel uncomfortable or wish to stop the experiment, you
will be able to contact the researcher either by use of a nearby walkie-talkie or squeeze bulb that
sends an instant alert.
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During the imaging portion of the study, you will perform a task while we use an EEG or MRI
machine to track which brain areas you are using. Since the neuroimaging apparatus is very
sensitive, it is important to remain as still as possible to avoid ‘blurring’ the images. You may
have wires, foam pads or a metal coil placed on your head and neck during testing: these are part
of the imaging machinery. Too much movement can make these parts come lose, ruining the
image. If something is causing you to be uncomfortable, please immediately tell the researcher –
do not attempt to remove the machinery by yourself!
How long will you be in the study?
Each study visit may last between 45 – 120 minutes, depending on the tasks you will be doing.
You may be asked to complete testing on 1 – 3 different study visits.
DISCOMFORTS, INCONVENIENCES, AND/OR RISKS
Neuroimaging experiments are described as ‘minimal risk’ because there are almost zero
negative effects to participating. These techniques are used safely all over the world, both by
medical doctors and by researchers. If you feel pain or discomfort at any time during or after
participating in this experiment, please tell the researcher immediately!
Sometimes people feel anxious or uncomfortable during testing because they have to stay in a
small space. If you have claustrophobia or if small spaces make you feel trapped, you should not
participate. Also, because you have to stay very still during testing, you may feel some muscle
pain or soreness especially in your neck. Remember to try and stretch during the testing breaks.
Neuroimaging techniques are considered completely safe for both pregnant women and the fetus.
However, just to be completely safe you will not be allowed to participate in the study if you think
you may be pregnant. There are no known long-term risks associated with being in a
neuroimaging study.
Very rarely, it is possible that we may see something unusual in your brain during neuroimaging.
Everyone has a unique brain, so unusual features may not be a sign of any disease or disorder.
But, if we do see something unusual while you are participating in this study, you will be told
immediately. We are not doctors and the images we use are not meant to be used to identify
medical problems. We cannot give you any medical advice, but if you want to seek a doctor we
can provide you with all the neuroimaging information collected in the study. If you do not want
to know about any unusual findings you should not participate in this study.
BENEFITS
How the brain creates thoughts, behaviors and human mental ability is still mostly unknown. The
techniques we are using in this study allow us to understand what parts of the brain are needed
for certain abilities. Learning more about how the brain works will help us come up with new
ideas for treating brain injuries and diseases.
Your participation in this study will help find new information about how the brain works, but
you will not receive any kind of medical or health benefit from participating. Your choice to
participate will not affect your normal medical care in any way.
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CONFIDENTIALITY
Your personal privacy is important to us. To keep your identity safe, we will not keep any of
your personal information with the data we collect. Other individuals involved with research at
UNR may see the data collected from your participation in this study, but they will not have
access to any of your personal or medical information. Sometimes we may use the same data for
more than one study. In every situation, only the data we have collected will be discussed and
studied. Your personal information will never be made public, published, or shared with other
researchers. The investigators, Renown Regional Medical Center and the University of Nevada
Reno will treat your identity with professional standards of confidentiality and protect it
according to the law. The Department of Health and Human Service (HHS) and the University of
Nevada, Reno Biomedical Institutional Review Board may inspect your study records.
COSTS/COMPENSATION
There is no cost to participate in this research study.
In the unlikely event that this research activity results in an injury, treatment will be available,
including first aid, emergency treatment, and follow-up care as needed. Care for such injuries
will be billed in the ordinary manner to you or your insurance company.
If you think you have suffered a research related injury, you should immediately contact either
the primary investigator, or any of the other investigators listed below:
Lars Strother, Ph.D., Primary Investigator (775) 384-7109
Gideon P. Caplovitz, Ph.D. (775) 682-8673
Marian E. Berryhill, Ph.D. (775) 682-8692
Jacqueline Snow, Ph.D. (775) 682-8688
Michael Crognale, Ph.D. (775) 682-8690
Jeffrey Hutsler, Ph.D. (775) 682-8694
Michael Webster, Ph.D. (775) 682-8691
Fang Jiang, Ph.D. (775) 784-6828
Your participation may be compensated. If you are offered compensation for participating in the
study (cash, giftcard, etc.), you will receive that exact compensation even if you choose to stop
before completing the study. Finishing the study will not result in you getting a larger amount of
compensation. It is important that if you experience any distress or discomfort, you notify the
researchers immediately. Withdrawing from the study at any time will not result in a loss of the
financial compensation offered.
This is not a clinical study. Remember that we are not qualified to give any kind of medical
advice. The neuroimaging techniques we are using are only for our own research purposes and
may not be useful for medical purposes. If you would like to have your neuroimaging data
examined by a doctor, we can provide you with a digital copy at no cost to you. However, any
costs associated with bringing your data to a doctor are your responsibility.
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DISCLOSURE OF FINANCIAL INTERESTS
The experimenters have no financial interests to declare.
RIGHT TO REFUSE OR WITHDRAW
You may refuse to participate or withdraw from the study at any time. Your medical care will not
be affected in any way. Any compensation for participating in the study will be yours, no matter
when you decide to stop participating. If we change anything about the study you will be
informed immediately and we will ask for your consent again.
QUESTIONS
If you have questions about this study or wish to report a research-related injury, please contact
either the primary investigator or any of the other investigators listed at the beginning of this
document.
You may ask about your rights as a research subject or you may report (anonymously if you so
choose) any comments, concerns, or complaints to the University of Nevada, Reno Biomedical
Institutional Review Board, telephone number (775) 327-2368, or by addressing a letter to the
Chair of the Board, c/o UNR Office of Human Research Protection, 205 Ross Hall / 331,
University of Nevada, Reno, Reno, Nevada, 89557.
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CLOSING STATEMENT
I have read (
) this consent form or have had it read to me ( ). [Check one.]
has explained the study to me and all of my
questions have been answered. I am choosing to participate in a study about brain function. Some
camera machinery may be attached to my head to take pictures of my brain. I have been told
about the risks or discomfort I may experience. I have also been told about the possible benefits of
this study.
If I decide not to participate, or if I change my mind later and stop participating, there will be no
negative consequences for me. I will not lose any of the rights or benefits I am entitled to if I
withdraw.
I have been told my rights as a research subject, and I voluntarily consent to participate in this
study. I have been told what the study is about and how and why it is being done. All my
questions have been answered.
I will receive a signed and dated copy of this consent form.
Signature of Participant
Date
Signature of Investigator
Date
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