Virtual Reality
Purpose
This guidance is intended to help investigators understand the ethical and regulatory considerations associated with using virtual reality for human subjects research.
What is Virtual Reality?
Virtual Reality (VR) research involves the use of computer-generated, immersive environments delivered through head-mounted displays (HMDs) or similar devices. Research subjects interact with simulated environments that may include visual, auditory, and sometimes haptic stimuli.
IRB Application Expectations
When submitting a study involving virtual reality, investigators should clearly describe the following:
Procedure Section
Q: What are you asking subjects to do?
Researchers should describe:
- What participants will see and do in the VR environment (e.g., movement, interaction, responding to scenarios, completing tasks)
- Any required physical actions (e.g., standing, turning, reaching, walking in place)
Q: When will participants do the procedures?
Clearly state when the study activities will occur in relation to enrollment and participation. This should include whether procedures take place immediately after consent, during a single session, or across multiple sessions/days.
Q: How long will it take participants to perform the activities described above?
Estimate the total time commitment required for participation, including all study components (e.g., consent, instructions, VR exposure, surveys, and debriefing).
Inclusion/Exclusion Criteria
Screening Scripts or Surveys
Participants will be screened for the following conditions, which may increase the risk of adverse reactions to VR exposure (e.g., motion sickness, dizziness, or disorientation):
- History of motion sickness or susceptibility to cybersickness
- Neurological or medical conditions
- Vestibular or balance disorders
- Vision-related conditions
- Current physical condition at time of participation
- Prior experience with VR and adverse reactions
Recruitment Materials
All recruitment materials must clearly state that the study involves the use of virtual reality (VR) equipment.
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Risks
Researchers should evaluate the probability, magnitude, duration, and reversibility of these risks based on the study design, VR content, and participant population.
- Physical
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Research subjects may experience temporary physical discomfort associated with VR use, including:
- Motion sickness (cybersickness)
- Dizziness or disorientation
- Eye strain or visual fatigue
- Headaches
- Nausea
- Loss of balance, slips, trips, or falls while standing or moving within the virtual environment
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
The following are suggested risk mitigation and safety monitoring measures:
- Clear the research area of hazards, including wires, rugs, furniture, and other obstacles.
- Ensure floors are dry and free from tripping hazards.
- Screen potential participants for conditions that may increase risk, such as severe motion sickness, vertigo, balance disorders, or neurological conditions.
- Inform participants that they may stop participation at any time without penalty.
- Instruct participants to immediately report any symptoms or discomfort.
- Continuously monitor participants during VR immersion.
- Conduct periodic welfare checks during longer sessions.
- Provide breaks as needed.
- Supervise participant movement and provide assistance when necessary.
- Assess participants for lingering symptoms following immersion and monitor until symptoms resolve.
- Clean and disinfect VR equipment between participants according to manufacturer recommendations and institutional policies.
- Psychological
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
Depending on the content and nature of the virtual environment, research subjects may experience:
- Anxiety
- Fear
- Emotional distress
- Psychological discomfort
- Temporary stress or embarrassment
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
The following are suggested risk mitigation:
- Clearly describe the VR experience during informed consent.
- Screen participants for factors that may increase susceptibility to distress when appropriate.
- Inform participants that they may discontinue participation at any time without penalty.
- Monitor participants throughout the VR experience for signs of distress.
- Stop the session immediately if significant discomfort is observed or reported.
- Conduct post-session check-ins to assess participant well-being.
- Social
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
- If data collected during the study reveal sensitive information, participants could experience embarrassment, stigmatization, or effects on personal relationships if confidentiality is breached.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
Researchers should:
- Limit collection of sensitive information to what is necessary for the research.
- Maintain participant confidentiality.
- Store data securely and restrict access to authorized study personnel.
- De-identify data whenever possible.
- Inform participants about confidentiality protections and any limitations to those protections.
- Legal
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
- Legal risks may arise if participants disclose illegal activities or other sensitive information during research activities and such information is subject to mandatory reporting requirements.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
Researchers should:
- Avoid collecting unnecessary sensitive or legally protected information.
- Inform participants of any limits to confidentiality, including mandatory reporting obligations where applicable.
- Restrict access to study data to authorized personnel.
- Utilize secure data management procedures.
- Privacy
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
- VR research may involve collection of behavioral, biometric, physiological, audio, video, movement-tracking, or other personal data. There is a potential risk that participant information could be inadvertently accessed, disclosed, or linked to identifiable individuals.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
Researchers should:
- Collect only information necessary to achieve study objectives.
- Use participant identification codes rather than direct identifiers whenever possible.
- Securely store study data on password-protected systems, limit access to authorized research personnel, use encryption when appropriate, clearly explain data handling practices during informed consent, and comply with all institutional data security requirements.
- Economic
Q: List the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects' participation in the research. Include for the IRB's consideration a description of the probability, magnitude, duration, and reversibility of the risks.
- A loss of confidentiality could potentially affect employment, insurance eligibility, or other economic opportunities if sensitive information were disclosed.
Q: Provides the measures you will use to minimize risks and to monitor subjects for safety (e.g., asking a subject at regular intervals to rate how they are feeling from 1 to 10, or to slowly crouch in order to check their balance.)
Researchers should:
- Implement strong confidentiality and data security protections.
- Limit collection of identifiable information.
- De-identify research data whenever possible.
- Restrict access to sensitive information to authorized personnel only.
Consent Documentation/Waivers
Consent language should clearly explain:
- All participants’ task will complete in the VR environment before participation begins (e.g., movement, interaction, and viewing virtual content).
- All potential VR-related risks, including motion sickness, dizziness, eye strain, headache, disorientation, and loss of balance.
- Any unanticipated adverse events that increase participant risk will be promptly reported to the IRB.
- That study does not provide routine or long-term medical treatment for research-related injuries.