D2D Participants
STUDY00006717
Version Date 09August2022
Approved for use by UMN IRB Effective on 8/17/2022
Title of Research Study: D2D Neuropsychometrics: Development of a Neurocognitive Computational Assessment Suite at the Minnesota State Fair Investigator Team Contact Information: For questions about research appointments, the research study, research results, or other concerns, call the study team at:
Investigator Name: Sophia Vinogradov, M.D.
Investigator Departmental Affiliation:
Department of Psychiatry & Behavioral Sciences
Phone Number: 612-273-9816
Email Address: svinogra@umn.edu
Study Staff: Wendy Schlinsog
Phone Number: 612-625-1838
Email Address: onr-compas@umn.edu
Supported By: Office of Naval Research. This is a collaborative research study between the University of Minnesota, the Minneapolis Veterans Affairs Health Care System, and Posit Science Inc., the developers of the software used in this study.
Dr. Sophia Vinogradov, the Principal Investigator, and Dr. Melissa Fisher, a Co-Investigator, have business interests with Posit Science Corporation, the company that develops the software that we are studying. They help consult with Posit Science on their software design. However, they do not have a financial relationship with Posit Science.
Key Information about This Research Study The following is a short summary to help you decide whether to be a part of this research study. More detailed information is listed later on in this form.
What is research? The goal of research is to learn new things in order to help people in the future. Investigators learn things by following the same plan with a number of participants, so they do not usually make changes to the plan for individual research participants. You, as an individual, may or may not be helped by volunteering for a research study.
Why am I being invited to take part in this research study? We are asking you to take part in this research study because you are a visitor of the Minnesota State Fair who is between the age of 18 and 50 and can use an iPad for audio and visual tasks unassisted.
What should I know about a research study?
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. Please contact the study staff listed above if you have any questions about the research. Why is this research being done? In this research study, we are testing a set of computerized cognitive measures, and performance on these measures in healthy individuals. We will take those results and compare them with the results of individuals living with Post Traumatic Stress Disorder and Traumatic Brain Injury to see if there is a difference in how each group performs on the tasks.
How long will the research last? We expect the study activities to take you about 15 to 20 minutes to complete.
What will I need to do to participate? If you agree to participate, we will ask you to complete the following activities on an iPad:
Provide us with demographic information. Provide a brief medical history (1-2 minutes). We will ask about the presence of psychiatric illness and neurological conditions in your family and any medications you are currently taking. Complete 2 brief measures of quality of life and functioning. Log in to BrainHQ with an ID and password provided to you by study staff, and complete three to four measures from the BrainHQ cognitive battery (10-12 minutes). There will be two different groups of questions and games, and you will have a 1 in 2 chance of being assigned to each group. Experience may differ based on which group you are placed in.
You will be asked to provide some demographic information, including a brief medical history, and to complete 2 brief measures of quality of life and functioning. Then you will be automatically redirected to the BrainHQ website where you will login with an ID and password provided to you by study staff. If you have any difficulty logging in, please be sure to let a study team member know.
After logging in, you will play a series of short games that test various aspects of cognitive functioning, such as memory, decision making, visual processing, and more. Some of the games involve sound, so please use the provided over-the-ear headphones when playing the games.
Before each game starts, there will be a short training round that will show you how to complete the assessment. If you need to have these instructions repeated, you can click the “I” symbol on the lower right hand screen.
We ask that you do not participate in this study if you have used any illicit substances or alcohol within the past 8 hours, or if you are otherwise under the influence of any substances. Following these conditions will provide us with accurate results
If you have technical difficulty, let a staff member know so they can help you.
Is there any way that being in this study could be bad for me? The primary risks that you face by participating in this study are:
Fatigue or frustration: Some people may become frustrated or tired when completing the assessments. Many of the BrainHQ games are challenging, and they get harder over time. They are designed so that no one will perform perfectly. Please do your best and do not worry about how you are performing. Embarrassment: Some of the questions asked are sensitive in nature and may be embarrassing for some people to answer. For example, we will ask about your relationships with others, your health status, and drug use. You do not have to answer any questions that you do not want to answer, but we ask that you answer as many as you feel comfortable. Please answer truthfully—if you are uncomfortable answering any question, please leave the question blank. Randomization risks: Since you will be placed randomly into one of the two groups, it is possible that the games you play may be more frustrating than other games. Loss of privacy: Participation in research involves a loss in privacy. However, we are committed to keeping your information secure, private, and confidential. Email Risks: To participate in this study, you must disclose your email address to study staff. Study staff will send you a copy of your consent using email, and may use it to send updates to the study in the future. Sending emails has risks to your privacy, and these risks are increased when emails are sent without a technology known as encryption. In order to participate in this study, you must be willing to send and receive unencrypted emails with the study team. Will being in this study help me in any way? There are no benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research. However, the possible benefits to others include improving mental health research and treatment.
What happens if I do not want to be in this research? There are no known alternatives, other than deciding not to participate in this research study.
How many people will be studied? We expect about 500 people from the State Fair will be in this research study.
What happens if I say “Yes”, but I change my mind later? Participation in this study is voluntary. Your decision whether or not to participate in this study will not affect your current or future relations with the University of Minnesota Department of Psychiatry or the MVAHS. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
What happens to the information collected for the research? Efforts will be made to limit the use and disclosure of your personal information. We cannot promise complete confidentiality. Organizations that may inspect and copy your information include the Institutional Review Board (IRB) and other representatives of this institution.
Information collected through self-report measures will be stored on secure databases hosted by the University of Minnesota. Cognitive Assessment Battery data will be collected and stored on secure servers hosted by Posit Science. Posit Science uses HIPAA-compliant data practices for their servers, and has signed contracts with the University of Minnesota to ensure protection of your identity. This data will be owned and stored indefinitely on Posit Science servers for future use and you will not be told how your data will be used. Posit Science may choose to share your data with other researchers in the future. However, Posit Science will not have your identifying information, and no one will be able to identify you from any publications or presentations they may make in the future.
When data collection is complete, the data will be extracted and stored on University of Minnesota secure servers. Researchers at the University of Minnesota can continue to use your de-identified data to answer other research questions in the future. We will not include your name or identifying information in any publications or presentations. By signing this consent form, you agree that your data can be used for future research purposes.
If you agree below, the researchers at the University of Minnesota can continue to use your de identified data to answer other research questions in the future. If you agree, this means your data may be shared outside of the study team.
Whom do I contact if I have questions, concerns or feedback about my experience?
This research has been reviewed and approved by an IRB within the Human Research Protections Program (HRPP). To share feedback privately with the HRPP about your research experience, call the Research Participants’ Advocate Line at 612-625-1650 or go to https://research.umn.edu/units/hrpp/research-participants/questions-concerns. You are encouraged to contact the HRPP if:
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. Will I be compensated for my participation? To thank you for participating in our research study, you will receive one of four different prizes. All prizes say “University of Minnesota Citizen Scientist.” You will be able to spin a prize wheel at the end of your participation to determine which item you can take. If we ran out of the item you landed on, you can pick a different item. The possible items include a ball cap, a can coozie, a water bottle, and an apron.
Optional Elements: The following research activities are optional, meaning that you do not have to agree to them to participate in the research study.
The investigators may contact me for future research opportunities.
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Please indicate your willingness to participate in these optional activities by placing your initials here.
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Your signature documents your permission to take part in this research. A pdf copy of this consent form will be e-mailed to you.
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Date of Signature
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Now M-D-Y H:M
Printed name of Participant:
First and Last Name
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Email address:
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