WORK CHAT: AN INTERACTIVE VIRTUAL WORKDAY
(Screening Consent Form)
Principal Investigator:
Matthew J. Smith, Ph.D., School of Social Work, University of Michigan
KEY INFORMATION ABOUT THE RESEARCHERS AND THIS STUDY
Thank you for your interest in participating in the Work Chat Study! This form contains information that will help you decide whether to complete the screening questionnaire to join the study.
Things you should know:
- The purpose of the main study is to see if a virtual reality computer program (Work Chat) can help people who have autism spectrum disorder improve their social skills.
- You will be asked a series of screening questions to determine your eligibility. Some of these screening questions include a 10-minute reading assessment that must be done over Zoom.
- If you meet certain criteria and are eligible, you will move forward to the main study and receive a consent form with more details.
Taking part in this research study is up to you. You do not have to participate in this screening survey. If you choose to take part, you can change your mind at any time.
PURPOSE OF THE STUDY
People may have a hard time keeping a job. We created a virtual reality computer program to improve social skills for people with a form of autism. We want to test the virtual reality computer program, called "Work Chat: An Interactive Virtual Workday", to see if it helps people to become more socially skilled at work.
The National Institute of Mental Health funded this study.
WHO CAN PARTICIPATE IN THE STUDY?
You are being asked to participate in the study because of the following:
1) You are at least 18 years old
2) You have a diagnosis on the autism spectrum
INFORMATION ABOUT STUDY PARTICIPATION SCREENING FORM
If you agree to complete the screening questionnaire, you will be sent some surveys asking about your diagnosis, basic demographic questions, and other related questions. You will also be asked to complete a reading assessment over the phone that should last approximately 10 minutes. These surveys will be completed online. In total, you may spend up to 60 minutes completing the screening surveys.
If you are eligible to participate in the main study, we will reach out to let you know the next steps and provide you with a Consent Form with more details about the main study. If you are not eligible, we will inform you and keep your information on file unless you specify otherwise.
INFORMATION ABOUT STUDY RISKS AND BENEFITS
There is a rare confidentiality risk that the University of Michigan computer server system could be broken. We will tell you how we manage these risks down below.
ENDING THE STUDY
You are free to withdraw your screening questions or leave the study at any time. If you decide to end participation, please tell one of the persons listed in Section 9. "Contact Information". If you choose to tell the researchers why you are leaving the study, your reasons may be kept as part of the study record. The researchers will keep the information collected about you for the research unless you ask us to delete it from our records. If the researchers have already used your information in a research analysis it will not be possible to remove your information.
FINANCIAL INFORMATION
There is no compensation for completing the screening questionnaire and assessments. If you are eligible for the main study, you can earn up to $215 for participating.
RESEARCH FUNDING AND DISCLOSURES
The institution and investigators are receiving a grant from the National Institute of Health to support this research. Dr. Matthew Smith, the principal investigator and the person responsible for the conduct of this research study is an inventor of the Work Chat: An Interactive Virtual Work Day program. The program is sold by SIMmersion LLC and Dr. Smith has a financial interest in the program. SIMmersion LLC is a sponsor of this study. SIMmersion LLC and Dr. Smith may one day benefit financially from the results of the study. SIMmersion, LLC personnel will also have access to study data. Research can lead to new discoveries (e.g., tests, apps, software, devices). Researchers, their organizations, such as U-M, research sponsors, and other entities, including companies, may potentially benefit from the use of the discoveries or data. You will not have rights to these discoveries or any proceeds from them.
PROTECTING AND SHARING RESEARCH INFORMATION
We plan to share the results of this screening survey and the main study with the public. We will not include any information that would identify you. We will protect your privacy by completing all research visits in a private or semi-private research room. To keep this information safe, the researchers will enter research data on a computer protected by a password. To protect your confidentiality, your name will not be in any written or published materials. Research data will be stored with an ID number. All research records that are reviewed, stored, and analyzed will be kept in a secured area at the University of Michigan School of Social Work. The researchers will keep this information for future research studies.
You will have the option to be contacted to see if you would like to share your name or other information with a news outlet or to complete an interview for a press release - this is not required to participate and is optional.
We will keep your participation in this research study confidential. However, it is possible that other people may become aware of your participation in this study. For example, the following people or groups may inspect and copy records pertaining to this research:
- The Office of Human Research Protections in the U.S. Department of Health and Human Services
- The University of Michigan Institutional Review Board
- The University of Michigan Human Subjects Protection Office
- The National Institute of Health, the study sponsor.
Some of these records could contain information that personally identifies you. Reasonable efforts will be made to keep the personal information in your research record private and confidential but absolute confidentially cannot be guaranteed.
A description of this study will be posted on a public website, http://ClincalTrials.gov , and summary results of this study will be posted on this website at the conclusion of the research, as required by the National Institutes of Health (NIH), the study sponsor. No information that can identify you will be posted.
This research holds a Certificate of Confidentiality from the National Institutes of Health.
This means that we cannot be forced to disclose any research information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, except as described below.
As the researchers are mandatory reporters, we will report to the appropriate authorities in specific cases, such as if we learn of abuse, neglect or endangerment of any vulnerable person.
Please note that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then we will not use the Certificate to withhold that information.
More detailed information about Certificates may be found at the NIH CoC webpage: https://humansubjects.nih.gov/coc/index
We will store your data to use for future research studies as mentioned above. Your name and any other identifying information will be secured and stored separately from your research data at the School of Social Work. If you agree to be contacted for future research studies, we will keep your name and contact information until you tell us you would like it removed. Dr. Smith, the Principal Investigator, and research study team members will have access to your research data for future research studies. Research data may be shared with other investigators but will never contain any information that could identify you.
CONTACT INFORMATION
Please contact the researchers listed below to:
- Obtain more information about the study
- Ask a question about the study procedures or treatments
- Report an illness, injury, or another problem (you may also need to tell your regular doctors)
- Leave the study before it is finished
- Express a concern about the study
Principal Investigator: Dr. Matthew Smith
Email: mattjsmi@umich.edu
Telephone: 734-764-9322
Study Coordinator: Brittany Ross
Email: rossbrit@umich.edu
Telephone: 734-764-2368
If you have questions about your rights as a research participant, or wish to obtain information, ask questions or discuss any concerns about this study with someone other than the researcher(s), please contact the following:
University of Michigan
Health Sciences and Behavioral Sciences Institutional Review Board (IRB-HSBS) 2800 Plymouth Road Building 520, Room 1169 Ann Arbor, MI 48109-2800 Telephone: 734-936-0933 or toll free (866) 936-0933 Fax: 734-936-1852
E-mail: irbhsbs@umich.edu
You can also contact the University of Michigan Compliance Hotline at 1-866-990-0111
YOUR CONSENT
Before making the decision to participate in this research you should have:
- Reviewed the information in this form
- Had the opportunity to ask any questions you may have
- Agree that your data will be kept for future research (if you would not like your data to be retained, you must write a letter to the Principal Investigator requesting so)
- Understand that you may not be eligible to participate in the main study after completing the screening surveys
You will receive a copy of the signed and dated form to keep for yourself. You may contact the researcher or research staff if you think of a question later.
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