Virtual Reality (VR), Augmented Reality (AR), and Extended Reality (XR)
Overview and Purpose
Human subjects research involving Virtual Reality (VR), Augmented Reality (AR), and Extended Reality (XR) requires careful review due to unique physical, psychological, privacy, and data security risks. Studies using devices that contact the body or collect physiological or behavioral data are subject to heightened review to ensure risks are minimized and reasonable in relation to anticipated benefits. The following guide is intended to help researchers conduct sounder, safer human subjects research using VR/AR/XR and wearable technology equipment.
Definitions
- Virtual Reality (VR): A fully immersive digital environment that replaces the user’s surrounding view.
- Augmented Reality (AR): A real-world experience where digital imagery is overlaid onto the physical environment.
- Extended Reality (XR): An umbrella term encompassing AR, VR, and mixed reality technologies, including wearable devices that track, analyze, and transmit personal data such as heart rate or sleep patterns.
IRB Review Considerations
Reviewers assess the equipment, physical environment, subject movement, duration of exposure, monitoring plans, and data handling procedures. Additional protections may be required for vulnerable populations or for studies involving prolonged or intensive immersion.
What Investigators Should Submit
- Clear description of all VR/AR/XR study procedures, equipment and software used in protocol application and IRB Form 4 (Link)
- Device specifications/manuals and manufacturer documentation /where equipment is being purchased
- Description of the physical setting and subject movement within the space
- Data privacy and security protections
- Prescreening questions that address the considerations listed below
- Consent language describing potential physical, sensory, and data-related risks associated with VR/AR/XR use
- Monitoring plan and clearly defined criteria for pausing or terminating participation
The IRB expects investigators to address all applicable prescreening considerations and risks listed on this page within their protocol submission. Protocols should clearly describe how subjects will be screened for these factors and how identified risks will be mitigated during the study. Failure to address these elements may delay IRB review or result in requests for modification prior to approval.
Prescreening Considerations
The conditions listed below should be used as exclusion criteria for subjects:
- History of motion sickness, migraines, dizziness, balance problems, or photosensitivity to strobe lights
- Epilepsy or other neurological conditions
- Implanted medical devices (e.g., pacemakers)
- Pregnancy or recent concussion
- Current illness, headache, nausea, or fatigue
- Visual impairments or mobility limitations relevant to the study
Common Risks to Subjects
The risks associated with VR/AR/XR studies depend on multiple factors. The equipment used, the nature of subject interaction, the duration of exposure, the type of content delivered, and individual differences can influence the likelihood that a subject will experience side effects during VR/AR/XR use.
When subjects engage in VR/AR/XR, their actions actively shape the virtual environment. Despite the growing use of immersive technologies, many individuals remain unaware of the range of risks that may be associated with this type of equipment. The consent form for your protocol should address the risks below:
- Cybersickness (e.g., dizziness, nausea, fatigue, visual disturbance)
- Neurological effects, including seizure risk triggered by visual stimuli
- Physical injury from tripping, falling, or collisions with objects
- Head or neck strain associated with wearable equipment
- Risk of contagion from shared head-mounted displays
- Loss of privacy or data security risks
Risk Mitigation Strategies
The following list explains practices that can mitigate risks associated with immersive technology studies.
- Ensure the physical environment is free of hazards prior to immersion.
- Prescreen subjects for medical, neurological, and short-term conditions that may increase risk.
- Inform subjects that participation is voluntary and that they may stop at any time without penalty.
- Conduct wellness checks and provide scheduled breaks during longer sessions.
- Continuously monitor subjects and use observers or spotters when subjects are mobile.
- Immediately pause or terminate the session if adverse symptoms occur.
- Clean and disinfect equipment between subjects to reduce infection risk.
When VR/AR/XR Technologies May Be Medical Devices
VR/AR/XR technologies may meet the definition of a medical device when they are intended for use in the diagnosis, treatment, mitigation, or prevention of disease or other conditions. Examples include surgical guidance systems, therapeutic VR experiences, and rehabilitation applications.
FDA Considerations
IRB approval does not constitute FDA approval or clearance of a device. Investigators are responsible for determining whether their VR/AR/XR technology meets the FDA definition of a medical device and for complying with all applicable FDA regulations. Form 4 may assist with device determination. For more information, please see FDA guidance, Augmented Reality and Virtual Reality Medical Devices: Questions to Consider.