UNIVERSITY OFNEVADA, RENO BIOMEDICALINSTITUTIONAL REVIEW BOARDCONSENT TO PARTICIPATE IN ARESEARCH STUDY
TITLE OFSTUDY: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) 682-8673Marian E. Berryhill, Ph.D. (775) 682-8692
Jacqueline Snow, Ph.D.(775) 682-8688Michael Crognale, Ph.D.(775) 682-8690
Jeffrey Hutsler, Ph.D. (775) 682-8694Michael 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 notpermit 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
Therisksinvolvedinneuroimaging 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.
Beyondtherisksdescribedabove,therearenoknownlong-termphysicalrisksassociatedwithneuroimaging studies.
Very occasionally, participation in neuroimaging experiments may reveal the presence of an anomaly (particularly if your child participates in an MRI scan). If inthecourseofthisresearchscanningprotocol weobserveananomalyinoneormoreoftheMRIimages,youwillbeinformedoftheobservation.
All brains are unique and ananomalydoesnotnecessarilyindicatethepresenceofanydisorder.BecauseourMRIscans are forresearchpurposesonly,theymaybeinadequateforthepurposeofclinicaldiagnosis.Additionally, asresearchers,wearenottrainedtoclinicallyinterpretMRIdata and cannot provide you with any diagnosis or medical advice.However,wefeelitisimportanttoinform youofanyobservations, which you may then use as you see fit. Allinformationcollectedaspartofthisstudywillbemadeavailableto you forfurtherexaminationbyamedicalprofessional.Ifyouprefernottobeinformedofanomalousfindings,youmustchoosenottoallow your child to participateinthestudy.
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 necessaryinorder to advance our understandingof human brain function, andeventuallyput this to usein thediagnosis,treatment andcureof 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
Therewill benocost toyouor your child forparticipatingin this researchstudy.
In theunlikely eventthat this research activityresults in an injury,treatment will be available including;firstaid, emergencytreatment, and follow-up care asneeded. Carefor suchinjuries will bebilled in theordinarymanner toyouor yourinsurance company.
Ifyou thinkyour child has suffereda researchrelatedinjury,you should immediatelycontacteither 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.
Thisisnotaclinicalstudy. TheMRIscanswillbeacquired forresearchpurposesonly, andarenotintendedtoofferanydiagnosisofanymedicalcondition.Thescansderivedfromthesesessionsmaynotbeadequateforsuchdiagnosis.However,if youwishtomake yourownarrangementstohavearadiologistexaminethesescans, a digital copywillbeprovidedto you at no extra cost.
DISCLOSURE OFFINANCIAL INTERESTS
Theexperimenters haveno financialinterests 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
Ifyouhave questions about this studyorwish to report aresearch-relatedinjury, please contacteither the primary investigator or any of the other investigators listed at the beginning of this document.
You mayaskaboutyourrights asa research subject oryoumayreport (anonymouslyifyou sochoose) anycomments,concerns, or complaints to theUniversityofNevada,RenoBiomedicalInstitutionalReviewBoard,telephonenumber (775) 327-2368, orbyaddressingaletterto theChairof theBoard,c/o UNR Office ofHumanResearchProtection, 205 Ross Hall / 331, UniversityofNevada, Reno, Reno,Nevada, 89557.
CLOSING STATEMENT
Ihave read () this consent form or have had it read to me( ).[Check one.]
has explained the studyto me andall of myquestionshave beenanswered.Iam 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.
IfIdo not permit my child to take part in this study,myrefusal to participate will involveno penaltyor loss of rights towhichIor my child am entitled.Imaywithdraw my childfrom this studyatanytime without penaltyor loss of otherbenefits to whichIor my child amentitled. If I change my mind later and decide to stop participating, there will be no negative consequences for me or my child.
Ihavebeen told myrightsas a researchsubject, andIvoluntarilyconsent to my child participatingin thisstudy.Ihavebeen told what thestudyis about andhow andwhyit is being done.All myquestionshave been answered.
Iwill receive a signed and dated copyof this consent form.
SignatureofParticipantDate
Signatureof InvestigatorDate
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