mbry-Riddle student Laurayna Pick, a freshman Aeronautical Science major, conducts virtual-reality flight training maneuvers at the Advanced Flight Simulation Center.

This page is intended to outline issues revolving around extended reality (XR) and related technology in research, such as found in virtual reality (VR), augmented reality (AR), mixed reality (MR) and wearable devices. The information below outlines definitions of those different technologies, risks to participants in using those technologies, risk mitigation for those technologies, frequent pre-screening characteristics and typical IRB-reviewed cautions in using those devices. The following guide is intended to help researchers conduct sounder, safer human subject research using VR/AR/MR and wearable technology equipment.

Definitions

VR refers to computer-generated environments that are designed to simulate a person’s physical presence in a specific environment that is designed to feel real. The purpose of VR is to allow a person to experience and manipulate the environment as if it were the real world. In contrast, augmented reality (AR) is technology that integrates digital information into the user’s real-world environment.

VR is created by tracking users’ natural movements (such as head rotation, arm movement or walking) and rendering a digital environment in response to these movements. Unlike AR, VR is intended to immerse users in a virtual space and replace or add cues from the real world with digital ones. By immersive, we mean that the user’s thoughts and actions are based solely on the computer-generated environment rather than on the user’s physical real world. Note that many inexperienced researchers use the label “VR” when they are not employing VR. They are using desktop monitors with 3D virtual worlds or video games that present a virtual environment but are not virtual reality because they do not embody the user within that environment.

A VR environment is experienced through sensory stimuli provided by a computer, and the human operator’s actions can influence what happens in the digital environment. At the current stage of development, users have to interact with this type of artificial environment by wearing a VR headset or haptic glove.

As the technology continues to improve, VR is expected to play an important technical role in the creation of immersive experiences.

AR is a type of interactive, reality-based display environment that takes the capabilities of computer-generated display, sound, text and effects to enhance the user’s real-world experience.

AR combines real and computer-based scenes and images to deliver a unified but enhanced view of the world. AR has many different implementation models and applications, but its primary objective is to provide a rich audiovisual experience. AR works by employing computerized simulation and techniques such as image and speech recognition, animation, head-mounted and hand-held devices, and powered display environments to add a virtual display on top of real images and surroundings.

MR is a hybrid environment that includes both real-world and digital elements. It uses technology that layers computerized objects, called holograms, on top of the user’s real world through the use of a head-mounted display or mobile device.

The term "mixed reality" is often used interchangeably with the term "augmented reality." In some business applications, however, AR is used to specifically describe a virtual overlay, such as a digital overlay on a car windshield (e.g., speedometer), while the term "mixed reality" is used to describe more advanced AR environments that allow virtual objects to be manipulated. MR is a type of hybrid system that involves both physical and virtual elements. Many experts describe MR as the sliding scale between a fully physical environment with no virtual elements and a completely virtual environment. In addition, many other MR projects experiment with adding virtual phenomena to the physical world. For example, some MR projects involve adding digital avatars, holograms, or other virtual images and displays to a physical installation to innovate human experience. Other types of mixed reality projects include building devices and technologies that simulate physical human senses that are more difficult to simulate, such as taste, touch and smell.

Wearable technology is any technology that is designed to be used while worn. Known mostly as "wearables," they are electronic devices that are physically worn by individuals in order to track, analyze and transmit personal data. These "smart" devices can track biometric data from heart rate to sleep patterns. They provide tactile feedback to an investigator in real-time. Common types of wearable technologies include smartwatches and smart glasses.

Technological Devices and the IRB

Studies that use technological devices that touch the skin (VR/AR/MR/wearables) are reviewed at least through the ‘Expedited’ review process where two IRB Board Members review the study to ensure the safety of the participant. Therefore, they will take more time to review than an ‘Exempt’ study. This includes studies that use VR headsets, tactor vests, bioharnesses and other physiological measuring equipment that is worn by the participant.

Common Risks for Devices

The risks of VR studies are contingent on several factors. The equipment used, the type of interaction, the length of treatment, the content delivered and individual differences (both ongoing conditions and temporary states) can affect a participant’s likelihood of experiencing side effects when using VR.

When you step into VR, your actions shape the environment. VR experiences are created by tracking users’ natural movements and rendering a digital environment in response. When social/behavioral studies are conducted in these immersive environments, understanding the unique risks depends on the equipment used, the type of interaction, duration, content delivered, data collected and individual considerations (both ongoing conditions and temporary states), all of which can affect a participant’s likelihood to experience side effects when using VR.

Many people are unaware of the various risks associated with this type of immersive equipment. These include:

  • Cybersickness
  • Triggering of seizures or other conditions due to visual effects are uncommon but can be a potential for people who have epilepsy or other neurological conditions.
  • Injury from tripping, falling or colliding with physical objects.
  • Contagions from sharing head-mounted displays. A contagion is a greater concern for VR studies than some other equipment uses because the equipment is placed on the face, near the eyes and nose in addition to using control input devices that are commonplace for many experiments.

Cybersickness is a common side effect of VR immersion.

Symptoms include:

  • Feeling dizzy or lightheaded
  • Sudden drowsiness or fatigue
  • Vision problems
  • Nausea and vomiting

Risk Mitigation for Devices

The following list explains practices that can mitigate risks associated with immersive technology studies.

  • The area should always be cleared of hazards and obstacles that could harm participants during immersion (e.g., tripping hazards such as wires or rugs). Tile floors should be kept dry. Researchers should know where the nearest restroom is and be prepared to accompany the participant if needed. It is recommended that spaces are equipped with a lined trash can or emesis bags in case of vomiting. Researchers may wish to keep ginger ale or saltines on hand to settle upset stomachs.
  • Before immersion, every participant should be prescreened for long-term (vision abnormalities, psychiatric disorders, being pregnant or heart conditions) and short-term conditions (have a cold, headache, nausea or dizziness) and excluded as appropriate.
  • Immediately before immersion, participants should be reminded that they can stop at any time and should tell the researcher immediately if they are feeling any symptoms.
  • During immersion, the researcher should conduct welfare checks on participants and schedule breaks for longer periods of immersion. Keep in mind children and adults with cognitive impairments may not recognize the bodily onset of cybersickness. Different approaches may be necessary depending on the age and background of the children.
  • If the participant reports any symptoms, the researcher should have the participant take a break from or terminate immersion.
  • During immersion, one researcher should always be watching and monitoring the participant. Sufficient precautions should be taken to ensure they do not harm themselves (e.g., running into walls, furniture or other participants). If the participant is moving around the room and their vision is obscured by a headset, the study may need a “catcher,” or someone to follow the person around the room. Wire headsets can present tripping hazards; wireless headsets mean there is one less constraint keeping participants from running into a wall.
  • After immersion, the researcher should ensure the participant is not feeling any side effects. If they are, researchers should render care and monitor the participant as needed.
  • Appropriate materials should be on hand to clean equipment to minimize the possibility of contagions.

Prescreening of Participants

Prescreening should be conducted before immersion. Researchers should consider:

  • Pre-existing conditions that may increase the likelihood of side effects.
  • States that may increase the likelihood of side effects, like having a cold or taking certain types of medications.
  • Visual impairments or physical mobility, as relevant to the study.

Optimally, screening for long-term conditions would happen before participants are on site for the study. Regardless of prescreening for long-term conditions, physical state should also be assessed immediately preceding immersion.

Longer-term conditions that may promote a greater likelihood of experiencing side effects include:

  • A history of motion sickness or nausea.
  • A history of migraines or headaches.
  • A history of balance issues or dizziness.
  • Epilepsy or neurological conditions where visual stimuli may trigger seizures or other issues.
  • Pregnancy, recent concussions or other conditions where dizziness, nausea or headaches are more likely.

Short-term conditions include:

  • Headache
  • Nausea
  • Dizziness or lightheadedness
  • Recent illness (flu, hangover, etc.)
  • Recent contagious condition (pink eye, head lice, flu, etc.)

Monitoring During Immersion

Any treatment over a few minutes in length should include wellness checks. Equipment or content that is more likely to evoke cybersickness should be considered when determining the frequency and timing of these checks. Additionally, if participants indicate a higher potential for cybersickness in their prescreening, these checks may need to be earlier or more frequent during immersion. Keep in mind some people may be so engaged in the experience that they do not recognize the onset of cybersickness before it’s too late.

If participants are feeling unwell, one of two courses of action should be taken. In most cases, the treatment should be terminated by the researcher immediately. Otherwise, participants should be asked if they wish to continue or if they wish to stop the immersive experience. If they wish to continue, a break is advised until their symptoms resolve. When they are back in immersion, they should be reminded to speak up the moment they do not feel well. The frequency of wellness checks should also be increased by the experimenter.

If participants are feeling unwell, the researcher should take appropriate steps to address the situation as symptoms could get worse after leaving the study. Participants who are feeling dizzy, for example, could fall down the stairs or faint. Participants who are experiencing dizziness or lightheadedness should be encouraged to sit down or perhaps close their eyes and put their heads down. If they are experiencing nausea or an upset stomach, have them sit close to the trash can or offer an emesis bag. You may wish to offer them saltines or ginger ale. Inform them that you would like them to stay until their symptoms subside and offer them a comfortable place to wait. Of course, you cannot force them to stay; if they wish to leave, express your concern but allow them to leave.

IRB Concerns

IRB reviewers will be looking at what equipment the researchers plan on using and what the physical space of the study will be. Will participants be wearing a headset, or is it projection-based? Will participants be walking around a space or seated? Will other equipment be incorporated (controllers, backpacks, sensor trackers)? Are they in a controlled lab setting or elsewhere? What is the space like? It is also imperative for researchers to screen participants for conditions that may make them very prone to negative side effects.

This is an outline of various considerations that should be addressed when immersive technology is employed in research and what the IRB typically looks for when these forms of technology are used. Please take the best precautions for safeguarding the welfare of the participants in using immersive technology in your research.