Informed Consent for Studies with Adults

TITLE OF RESEARCH STUDY: FW-HTF-P: Immersive Virtual Reality Instructional Modules for Active Shooter Events
RESEARCH TEAM: Dr. Sharad Sharma, Professor in the Department of Information Science, Office Phone: 940-565-2605, Email: sharad.sharma@unt.edu

As a member of the UNT community, you may know Dr. Sharad Sharma, the Principal Investigator for this study. Your employment status and/or your relationship with the research team will not be affected by your decision to take part in this study. You are being asked to participate in a research study. Taking part in this study is voluntary. The investigators will explain the study to you and will any answer any questions you might have. It is your choice whether or not you take part in this study. If you agree to participate and then choose to withdraw from the study, that is your right, and your decision will not be held against you.

The goal of this effort is to conduct data collection, preliminary experiments, and a pilot study for improving preparedness for an active shooter event using collaborative immersive virtual reality (VR) environment. We have developed occupants training virtual reality instructional (VRI) module of active shooter response for a building and using run, hide and fight mode. We will conduct a pilot study for security personnel training and building occupants training in immersive (oculus rift and corner cave) and non-immersive (desktop) environment. A presence questionnaire (PQ) and system usability scale (SUS) framework will be incorporated to evaluate the effectiveness of our immersive training module. These PQ measures six aspects that are realism, possibility to act, quality of interface, possibility to examine, self-evaluation of performance and sounds. It will include gathering user data using 7 point Likert scale. Your questionnaire responses will help us verify the effectiveness of these modules.

You are being asked to take part in a research study about improving preparedness for an active shooter event using collaborative immersive virtual reality (VR) environment.

This research is being funded by NSF (National Science Foundation)

Your participation in this research study involves evaluating the VRI (virtual reality instructional) modules. You will be asked to play the VRI modules for 30- 45 minutes. Afterwards, you will be given a questionnaire assessing your experience with the modules. You may also ask questions and provide feedback regarding the modules. More details will be provided in the next section. You might want to participate in this study if you would like to know and learn the safety procedures during active shooter events, and help improve preparedness for an active shooter event using collaborative immersive virtual reality (VR) environment. You may choose to participate in this research study if you are above 18 years of age. Evaluation sessions will be held in a classroom/Lab setting. The reasonable foreseeable risks or discomforts to you if you choose to take part is the psychological and physiological stress associated with immersion in a simulated high stress situation including simulated explosions, gunshots and potentially running from/confronting an active shooter, particularly if the immersive version is being used. Participants who have been diagnosed with PTSD or who have experienced gun related trauma should consult a physician before considering taking part in this study. A synopsis of the potential for emotional health safety and other risks associated with using the immersive headset (According to Oculus VR Headset Safety Center) are mentioned in the possible risks/discomforts section later. You can compare these risks to the potential benefits of learning and training for active shooter response. You will not receive compensation for participation.

DETAILED INFORMATION ABOUT THIS RESEARCH STUDY: The following is more detailed information about this study, in addition to the information listed above.
PURPOSE OF THE STUDY: The goal of this effort is to conduct data collection, preliminary experiments, and a pilot study for improving preparedness for an active shooter event using collaborative immersive virtual reality (VR) environment. We have developed occupants training virtual reality instructional (VRI) module of active shooter response for a building and using run, hide and fight mode. We will conduct a pilot study for security personnel training and building occupants training in immersive (oculus rift and corner cave) and non-immersive (desktop) environment. It will be evaluated by security personnel at the UNT police department as well as by faculty, staff, and visitors for building occupant. A presence questionnaire (PQ) and system usability scale (SUS) framework will be incorporated to evaluate the effectiveness of our immersive training module. These PQ measures six aspects that are realism, possibility to act, quality of interface, possibility to examine, self-evaluation of performance and sounds. It will include gathering user data using 7 point Likert scale. Our vision is for the immersive VRI modules to ultimately become a platform for emergency training that is deployed across institutions of higher education (IHE). If practice makes perfect, then active shooter response training drills and exercises are the path to perfection when it comes to implementing emergency operation plans (EOP) and translating them into action. This will result in potentially increasing their effectiveness in the event of an actual emergency or, at least their effectiveness in implementing the current plan. Moreover, best practice in emergency management calls for an evaluation and improvement cycle after each exercise to improve not only how the plan was followed, but also if EOP is designed correctly in the first place. Staff roles and responsibilities may change substantively in the wake of a drill or exercises.
TIME COMMITMENT: Participation in this study is expected to last 30-45 minutes in total (Activity + Survey).
STUDY PROCEDURES: You will be shown the VRI modules prior to your evaluation of them. You will then be asked to play the VRI modules for 30-45 minutes. Afterwards, you will be given a questionnaire assessing your experience with the modules. You may also ask questions and provide feedback regarding the modules.

POSSIBLE BENEFITS: Our vision is for the immersive VRI modules to ultimately become a platform for emergency training that is deployed across institutions of higher education (IHE). If practice makes perfect, then active shooter response training drills and exercises are the path to perfection when it comes to implementing emergency operation plans (EOP) and translating them into action. This will result in potentially increasing their effectiveness in the event of an actual emergency or, at least their effectiveness in implementing the current plan. Moreover, best practice in emergency management calls for an evaluation and improvement cycle after each exercise to improve not only how the plan was followed, but also if EOP is designed correctly in the first place. Staff roles and responsibilities may change substantively in the wake of a drill or exercises

POSSIBLE RISKS/DISCOMFORTS: While this study should not directly harm the participants, it is a computer simulation of an active shooter event, including simulated explosions, gunshots and potentially running from/confronting an active shooter. You might experience psychological and physiological stress associated with immersion in a simulated high stress situation, particularly if the immersive version is being used. Participants who have been diagnosed with PTSD or who have experienced gun related trauma should consult a physician before considering taking part in this study. According to Oculus VR Headset Safety Center the following health and safety warnings are mentioned. 1) Content Selection. VR is an immersive experience that can be intense. If you have a history of discomfort when exposed to violent or anxiety provoking content or experiences or are new to virtual reality, start with content rated comfortable content first. 2) Use Only When Unimpaired: A comfortable VR experience requires an unimpaired sense of motion and balance. Do not use the headset when you are experiencing any of the following (as it may increase your susceptibility to adverse symptoms): Tired, Need sleep, Under the influence of alcohol or drugs, Hung-over, Have digestive problems, Under emotional stress or anxiety, and When suffering from cold, flu, headaches, migraines, or earaches 3) Pre-Existing Medical Conditions: Consult with your physician before using the headset if you are pregnant, elderly, have pre-existing binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition or using any Medical Devices. 4) Discomfort: Immediately discontinue using the headset if any of the following symptoms are experienced: Seizures, Loss of awareness, Eye strain, Eye or muscle twitching, Involuntary movements, Altered, blurred, or double vision or other visual abnormalities, Dizziness, Disorientation, Impaired balance, Impaired hand-eye coordination, Excessive sweating, Increased salivation, Nausea, Lightheadedness, Discomfort or pain in the head or eyes, Drowsiness, Fatigue, and any symptoms similar to motion sickness. 5) Contagious Conditions: To avoid transferring contagious conditions (like pink eye), do not share the headset with persons with contagious conditions, infections or diseases, particularly of the eyes, skin or scalp. The headset and controller(s) will be cleaned between each use with skin-friendly non-alcohol, non-abrasive antibacterial wipes and with a dry microfiber cloth for the lenses 6) Skin Irritation: The headset is worn next to your skin and scalp. Stop using the headset if you notice swelling, itchiness, skin irritation, loss of hair or other skin reactions. Similarly, with the hand-controller, please stop use if you observe any skin irritation or reaction. If symptoms persist, contact a doctor.

The following procedures will be incorporated for protecting against or minimizing the potential risks stated above. • The headset and controller(s) will be cleaned between each use with skin-friendly non-alcohol, non-abrasive antibacterial wipes and with a dry microfiber cloth for the lenses.
• If participants experience any discomfort when completing the research activity, they may choose to stop participating at any time.
• Participating in this research study may involve increased risk of exposure to COVID-19 due to in-person interactions with the research team. The study team will follow local regulations and institutional policies, including using personal protective equipment (masks) and social distancing guidelines while those regulations and policies are in effect. If you have any questions or concerns, please discuss them with your research team.
• The researchers will try to prevent any problem that could happen, but the study may involve risks to the participant, which are currently unforeseeable. Consent form includes the following statement: UNT does not provide medical services, or financial assistance for emotional distress or injuries that might happen from participating in this research. If you need to discuss your discomfort further, please contact a mental health provider, or you may contact the researcher who will refer you to appropriate services. If your need is urgent, helpful resources include UNT Mental Health Emergency line at 940-565-2741.

You might experience mental fatigue and/or eye strain during this research study. However, you can contact UNT Mental Health Emergency line at 940-565-2741 if needed. Remember that you have the right to withdraw any study procedures at any time without penalty, and may do so by informing the research team. Participating in research may involve a loss of privacy and the potential for a breach in confidentiality. Study data will be physically and electronically secured by the research team. As with any use of electronic means to store data, there is a risk of breach of data security.
Participating in this research study may involve increased risk of exposure to COVID-19 due to in-person interactions with the research team. The study team will follow local regulations and institutional policies, including using personal protective equipment (masks) and social distancing guidelines while those regulations and policies are in effect. If you have any questions or concerns, please discuss them with your research team. If you experience excessive discomfort when completing the research activity, you may choose to stop participating at any time without penalty. The researchers will try to prevent any problem that could happen, but the study may involve risks to the participant, which are currently unforeseeable. UNT does not provide medical services, or financial assistance for emotional distress or injuries that might happen from participating in this research. If you need to discuss your discomfort further, please contact a mental health provider, or you may contact the researcher who will refer you to appropriate services. If your need is urgent, helpful resources include Denton County MHMR crisis hotline at 1-800-762-0157; UNT Mental Health Emergency line at 940-565-2741; Family Violence Shelter of Denton County Crisis Line at 940-382-7273; National Suicide Prevention Hotline at 1-800-273-8255, or 988; UNT Survivor Advocate for students effected by Violence or Sexual Assault at 940-565-2648.

COMPENSATION: There is no compensation for participation.

CONFIDENTIALITY: Efforts will be made by the research team to keep your personal information private, including research study and disclosure will be limited to people who have a need to review this information. All paper and electronic data collected from this study will be stored in a secure location on the UNT campus and/or a secure UNT server for at least three (3) years past the end of this research. The data will be stored in password protected computer in PI’s campus office. Research records will be labeled with a code and the master key linking names with codes will be maintained in a separate and secure location. Participation in the online survey at the end of the study involves the potential for the loss of confidentiality similar to a person’s everyday use of the internet. The results of this study may be published and/or presented without naming you as a participant. The data collected about you for this study may be used for future research studies that are not described in this consent form. If that occurs, an IRB would first evaluate the use of any information that is identifiable to you, and confidentiality protection would be maintained. While absolute confidentiality cannot be guaranteed, the research team will make every effort to protect the confidentiality of your records, as described here and to the extent permitted by law. In addition to the research team, the following entities may have access to your records, but only on a need-to-know basis: the U.S. Department of Health and Human Services, the FDA (federal regulating agencies), the reviewing IRB, and sponsors of the study.

This research uses a third-party software called Qualtrics and is subject to the privacy policies of this software noted here: https://www.qualtrics.com/privacy-statement/

CONTACT INFORMATION FOR QUESTIONS ABOUT THE STUDY: If you have any questions about the study you may contact Dr. Sharad Sharma, Professor in Data Science at Department of Information Science (Office: Room E292C, UNT Discovery Park, Email: sharad.sharma@unt.edu). Any questions you have regarding your rights as a research subject, or complaints about the research may be directed to the Office of Research Integrity and Compliance at 940-565-4643, or by email at untirb@unt.edu.