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.

This guide is intended to help researchers conduct safe, ethical human subjects research using VR, AR, XR, and wearable technologies.

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 studies involving prolonged or intensive immersion.

What Investigators Should Submit

• Clear description of all VR/AR/XR study procedures, equipment, and software used in the protocol application and IRB Form 4.
• Device specifications, manuals, manufacturer documentation, and purchasing information.
• Description of the physical setting and subject movement within the space.
• Data privacy and security protections.
• Prescreening questions addressing the considerations listed below.
• Consent language describing potential physical, sensory, and data-related risks.
• Monitoring plan with clearly defined criteria for pausing or terminating participation.

Important: The IRB expects investigators to address all applicable prescreening considerations and risks within their protocol submission. Protocols should explain how participants will be screened and how identified risks will be mitigated. Failure to address these elements may delay IRB review or result in requests for modification.

Prescreening Considerations

Consider using the following conditions as exclusion criteria when appropriate:

• History of motion sickness, migraines, dizziness, balance problems, or photosensitivity.
• Epilepsy or other neurological conditions.
• Implanted medical devices (for example, 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, and XR studies depend on the equipment used, the level of subject interaction, the duration of exposure, the type of content presented, and individual participant characteristics.

When subjects engage in immersive technologies, their actions actively shape the virtual environment. Despite the growing use of these technologies, many participants remain unaware of the associated risks. Consent forms should address the following potential risks:

• Cybersickness (dizziness, nausea, fatigue, visual disturbances).
• Neurological effects, including seizure risk triggered by visual stimuli.
• Physical injury from tripping, falling, or collisions.
• Head or neck strain associated with wearable equipment.
• Risk of infection from shared head-mounted displays.
• Privacy and data security risks.

Risk Mitigation Strategies

The following practices help reduce participant risk:

• Ensure the physical environment is free of hazards before immersion.
• Prescreen participants for medical and neurological conditions.
• Inform participants they may withdraw at any time without penalty.
• Conduct wellness checks and provide scheduled breaks during longer sessions.
• Continuously monitor participants and use observers or spotters when participants are mobile.
• Pause or terminate participation immediately if adverse symptoms occur.
• Clean and disinfect equipment between participants.

When VR/AR/XR Technologies May Be Medical Devices

VR, AR, and XR technologies may meet the FDA definition of a medical device when they are intended for use in the diagnosis, treatment, mitigation, or prevention of disease or other medical 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. IRB Form 4 may assist with device determination.

For additional guidance, see Augmented Reality and Virtual Reality Medical Devices: Questions to Consider.

Information adapted with permission from Embry-Riddle Aeronautical University.