Informed Consent
University of Nevada, Reno
Parent Permission Form
Title of Study:
Translating cognitive neuroscience to inform the use of behavioral assessments in child development
Principal Investigator:
Ann M. Weber, Ph.D., Primary Investigator, (775) 682-7089
Co-Investigators:
Jacqueline Snow, Ph.D. (775) 682-8688
Lars Strother, Ph.D. (775) 384-7109
Study ID Number:
IRBNet ID: 1945003-1
Sponsor:
NIH COBRE
SUMMARY OF KEY ELEMENTS
This is a consent form to enroll your child in a behavioral research study. The main purpose of study is to learn how different parts of the brain are involved in the early development of children’s motor, communication, and social skills. If you decide that you and your child would like to participate in our research, your child would take part in a brain imaging process using fNIRS, which is a safe and non-invasive technique that has been used for over 25 years to investigate natural brain activity. All information that we receive from you, including names and any other information, will be strictly confidential and kept in a secured location. Your participation and that of your child is your choice alone.
Introduction
Please read this form carefully before you agree to allow your child to be in this study. The form may use words you don’t understand. Please ask the study 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.
Why are we doing this study?
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 early childhood development, such as emerging motor, communication, and social skills. “Neuroimaging” refers to several special techniques that allow researchers 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 cap is placed on the head and by tracking things like the level of oxygen in the blood, we can determine what parts of the brain are being used. Your child will also probably be asked to complete a task during the neuroimaging process. The task may involve picking up objects, holding a crayon, looking at a set of pictures, or watching short videos. 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. Benefits of research cannot be guaranteed; however, we hope that the results of the research can help shed light on the brain mechanisms that underlie the emergence of children’s earliest developmental skills.
Why are we asking your child to be in this study?
The neuroimaging techniques that we are applying are providing researchers new 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, language, and motor 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 in early childhood, we can learn how brain activity changes as children age and learn new skills.
How many people will be in this study?
Over the course of this study, we anticipate enrolling 65 participants from friends, colleagues, students, and staff at the University of Nevada, Reno as well as families attending local daycare centers in Reno.
What will your child be asked to do if you agree to allow your child to be in the study?
If you agree to allow your child to participate in this study they will be asked to attend 1-2 study sessions conducted at the Psychology Department of the University of Nevada, Reno campus. 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.
During the imaging portion of the study, your child will be asked to perform everyday behavioral tasks while we use a fNIRS machine to track which brain areas are being activated. Your child will need to wear a head cap with attached optical wires during testing: these are part of the imaging machinery. We will ask your help in placing the fNIRS head cap on your child’s head. During the fNIRS data collection, your child will sit on your lap, at a table. We ask that you refrain from interacting with your child unless your child becomes fussy. An assessor will sit across from your child to administer such tasks as asking your child to pick up a small object (for example, a cheerio); scribble using crayon and paper, or point to pictures on a page or a tablet. A second assessor will stand out of view and record events by taking notes. Audio-visual equipment will also be set up in one or two locations and will be used to capture your child’s actions so that we can mark the timing when your child started to reach, to scribble, or to point, for example.
Since the neuroimaging apparatus is very sensitive, it is important that you and your child remain as still as possible to avoid ‘blurring’ the images. Too much movement can make the head cap come lose, ruining the image or creating noise in the imaging signal. It is very important that if your child is uncomfortable that you ask for help adjusting the head cap.
How long will your child be in the study?
We expect that most participants will visit our testing site once. However, if your child becomes fussy, or is crying or sleepy, we may ask you to reschedule if possible. The expected length of the in-person visit is up to 1 hour.
What if you agree to have your child be in the study now, but change your mind later?
You and your child do not have to stay in the study. You may withdraw your child from the study at any time without repercussion simply by informing the researchers.
What if the study changes while your child is in it?
If anything about the study changes or if we want to use your child’s information in a different way, we will tell you and your child, and ask if your child will remain in the study. We will also tell you about any important new information that may affect your willingness allow your child to stay in the study.
Is there any way being in this study could be bad for your child?
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, your child may experience some mild discomfort from wearing the neuroimaging head cap or feel boredom or fussiness due to the length of the imaging process or the behavioral tasks they are asked to complete.
What happens if your child becomes injured because of her/his participation in the study?
In the event that this research activity results in an injury, treatment will be available. This includes 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 the primary investigator: Ann M. Weber, Ph.D., by email at annweber@unr.edu or by phone 775-682-7089.
Will being in this study help your child in any way?
Your child’s participation in this research helps us gain new information about brain function that will hopefully lead to advances in educational programs for caregivers. However, there will be no immediate benefits or therapies provided to you or your child as part of this research. We are researchers, not doctors, and do not have the expertise or ability to provide any diagnoses or treatments.
Who will pay for the costs of your child’s participation in this research study?
No costs are associated with participation in this study.
Will you (or your child) be paid for your child’s participation in this study?
We would like to compensate you for your time and your child’s participation in this study by offering you a $30 Amazon gift card. Compensation will be given even if 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.
Who will know that your child is in this study and who will have access to the information we collect about your child?
Only the study researchers at the University of Nevada, Reno will have access to your child’s study records.
How will we protect private information about you and your child, and the information we collect about your child?
We will treat your identity and that of your child with professional standards of confidentiality and will protect your and your child’s private information to the extent allowed by law. To keep your and your child’s identity safe, we will not keep any of the personal, identifiable information collected along with study data.
Your child’s identifying information might be removed and the de-identified information used for future research or distributed to another investigator without additional informed consent from you. They will not have access to any of your child’s personal information; 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.
We will not use your name or your child’s name or other information that could identify you or your child in any reports or publications that result from this study unless you give your consent by signing the Photo/Video Release Form.
The researchers and the University of Nevada, Reno will not use obtained data for commercial purposes.
Do the researchers have monetary interests tied to this study?
The researchers and/or members of their families have no financial interests related to this study to declare.
Who can you contact if you have questions about the study or want to report an injury?
At any time, if you have questions about this study or wish to report an injury that may be related to your child’s participation in this study, contact the primary investigator: Ann M. Weber, Ph.D., by email at annweber@unr.edu or by phone 775-682-7089.
Who can you contact if you want to discuss a problem or complaint about the research or ask about your child’s rights as a research participant?
You may discuss a problem or complaint or ask about your child’s rights as a research participant by calling the University of Nevada, Reno Research Integrity Office at (775) 327-2368. You may also use the online Contact the Research Integrity Office form available from the Contact Us page of the University’s Research Integrity Office website.
Agreement to be in the study
If you agree to allow your child to be in this study, you must sign this permission form. We will give you a copy of the form to keep.
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Child’s Name Printed
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Name of Parent/Guardian Printed Date
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Signature of Parent/Guardian Date
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Signature of Person Obtaining Consent Date