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
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
PROTOCOL #: B12-034
INTRODUCTION
Before you agree to allow your child to be in this study, please read this form carefully. The form may
use words you don’t understand. Please ask the study doctor or researchers to explain anything that you
do not understand.
It is important you are completely truthful about your child’s health. Doing otherwise may place your
child at risk of harm from participating in this research.
Your child does not have to be in this study. If you say no, your child’s usual medical care will not
change in any way.
Take as much time as you need to decide. If you say yes now but change your mind, your child may
quit the study at any time. Just let the study doctor or one of the researchers know you do not want your
child to continue.
PURPOSE
You are being asked to give permission for your child to participate in a study to learn more about what
parts of the brain are involved in different parts of cognition, including thinking, sensation 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 – your
child will not have any kind of surgery. Instead a coil or cap is placed on the head and by tracking
things like the level of oxygen in the blood or the amount of electrical activity the brain is producing,
we can determine what parts of your brain are being used. Your child will also probably be asked to
complete a task during the neuroimaging process. The task may involve looking at a set of pictures,
watching some short videos or playing a computer game. By looking at what the brain is doing while
your child completes a task, we can begin to figure out the unique roles of certain brain areas.
PARTICIPANTS
These neuroimaging techniques we are applying are relatively new and are providing researchers
unprecedented insight into how the brain works. We are asking you to permit your child to participate
because the developing brain possesses many unique characteristics that can influence cognitive ability
throughout the life span. Unlike most other body organs which are considered fully developed at birth,
there are critical periods of brain growth and development during infancy, childhood and adolescence.
By studying brain structure and activity throughout childhood, we can learn how the brain grows. We
also hope that this research can help us to understand developmental disorders such as autism spectrum
disorders. Since our aim is to learn as much as possible about cognition, we are interested in
participants of all different backgrounds. Over the course of this study, we anticipate enrolling 200
participants.
You should not permit your child to participate in this study if any of the following are true:

Your child experiences severe anxiety in enclosed spaces (claustrophobia)

(For MRI participants only) Your child has ferrous-magnetic metals in their body (including
surgical pins, metal dental fillings, etc.)
WHAT HAPPENS IF YOU AGREE
If you agree to allow your child to participate in this study they 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 require assistance arranging transportation due
to 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.
Typically, the first session your child participates in will be a training session, designed to familiarize
your child with the testing task. Depending on the training and how long it takes, it may occur as a
separate study session or during the same session in which we conduct the neuroimaging scan. In
general, tasks consist of different ‘stimuli’ being presented on a screen. These stimuli could be shapes,
colors, sounds, video clips, etc. Your child will be asked to respond to a specific stimulus by pressing a
button or choosing a response from a group of alternatives. During both the training period and the
testing period, the task will be organized in several blocks with automatic ‘breaks’ to allow your child
to rest, stretch, reposition, etc. There will be a walkie talkie or squeeze bulb within arm’s reach that
your child can use at any time to send an alert to the researcher if they feel uncomfortable, wish to stop
the experiment, or simply want reassurance. During testing, your child will always be visually
monitored by researchers for any signs of distress or discomfort. You may also choose to stay in the
room with your child if you feel that your presence would be comforting.
During the imaging portion of the study, your child will perform a task while we use an EEG or MRI
machine to track which brain areas are being activated. Since the neuroimaging apparatus is very
sensitive, it is important to remain as still as possible to avoid ‘blurring’ the images. Your child may
have wires, foam pads or a metal coil placed on their head and neck during testing: these are part of the
imaging machinery. Too much movement can make these parts come lose, ruining the image. It is very
important that if your child is uncomfortable they understand to ask a researcher for help adjusting the
machinery. Please do not try to remove the imaging apparatus yourself!
INVOLVEMENT
The study may take between 1 and 3 sessions to complete, and each session may last between 45-120
minutes.
DISCOMFORTS, INCONVENIENCES, AND/OR RISKS
The risks involved in neuroimaging experiments are minimal, and due to the noninvasive nature of
these procedures they are widely employed by researchers and physicians across the world.
Nonetheless, there are some minor adverse effects that your child might experience due to involvement
in this study.
Since it is necessary to remain very still and enclosed in a small space during the imaging process,
individuals with claustrophobia should not participate in this study. The noise of the apparatus, and the
unusual sensation of having electrodes against the skin often result in a little anxiety for first time
participants. This is normal, and we try to allow children some time to adjust to the test setting before
beginning the session. However, if your child has very high anxiety levels in new situations, you may
not wish to allow them in this study. Participants may also experience muscle stiffness and mild aches
or physical discomfort during the scanning session. We will remind your child to take advantage of the
breaks during testing to stretch and try to minimize discomfort.
Beyond the risks described above, there are no known long-term physical risks associated with
neuroimaging studies.
Very occasionally, participation in neuroimaging experiments may reveal the presence of an anomaly
(particularly if your child participates in an MRI scan). If in the course of this research scanning
protocol we observe an anomaly in one or more of the MRI images, you will be informed of the
observation.
All brains are unique and an anomaly does not necessarily indicate the presence of any disorder.
Because our MRI scans are for research purposes only, they may be inadequate for the purpose of
clinical diagnosis. Additionally, as researchers, we are not trained to clinically interpret MRI data and
cannot provide you with any diagnosis or medical advice. However, we feel it is important to inform
you of any observations, which you may then use as you see fit. All information collected as part of this
study will be made available to you for further examination by a medical professional. If you prefer not
to be informed of anomalous findings, you must choose not to allow your child to participate in the
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. This information is necessary in order to advance our
understanding of human brain function, and eventually put this to use in the diagnosis, treatment and
cure of brain disorders.
Your child’s participation in this experiment helps us gain new information about brain function that
will hopefully lead to new advances in treatment, however, there will be no immediate benefits or
therapies provided to you or your child as part of this experiment. We are researchers, not doctors, and
do not have the expertise or ability to provide any diagnoses or treatments. Participation in this study
lead to any type of direct medical aid for your child.
CONFIDENTIALITY
Your child’s personal privacy is important to us. To keep your and your child’s identity safe, we will
not keep any of the personal, identifiable information collected along with study data. 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 child’s 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. No personal information will ever be made public, published, or shared with
other researchers. The investigators, Renown Regional Medical Center and the University of Nevada
Reno will treat your child’s 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 will be no cost to you or your child for participating 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 your child has 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 child’s participation may be compensated. If financial compensation is offered for participation in
this study, that compensation will be given no matter when you choose to withdraw your child from the
study. It is important that if your child experiences any distress or discomfort, you notify the
researchers immediately. Stopping participation early will not result in any loss of compensation or
benefits.
This is not a clinical study. The MRI scans will be acquired for research purposes only, and are not
intended to offer any diagnosis of any medical condition. The scans derived from these sessions may
not be adequate for such diagnosis. However, if you wish to make your own arrangements to have a
radiologist examine these scans, a digital copy will be provided to you at no extra cost.
DISCLOSURE OF FINANCIAL INTERESTS
The experimenters have no financial interests to declare.
RIGHT TO REFUSE OR WITHDRAW
At any time during the course of the study you may withdraw consent for your child’s participation and
stop your involvement in this study. Withdrawing from the study will not affect the care your child
receives. 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.
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 allow my child to participate in a study about
brain function. Some camera machinery may be attached to my child’s head to take pictures of
their brain. I have been told about the risks or discomfort my child may experience as a result of
participating in this study. I have also been told about the possible benefits of this study.
If I do not permit my child to take part in this study, my refusal to participate will involve no
penalty or loss of rights to which I or my child am entitled. I may withdraw my child from this
study at any time without penalty or loss of other benefits to which I or my child am entitled. If
I change my mind later and decide to stop participating, there will be no negative consequences
for me or my child.
I have been told my rights as a research subject, and I voluntarily consent to my child
participating 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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