On Tech Ethics Podcast – Ethical and IRB Considerations for Virtual Reality Research

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1. Episode Introduction (00:00:30) Daniel opens the episode with a disclaimer, introduces guest Myra Luna-Lucero, and frames the discussion around virtual reality in research and the ethical and IRB issues it raises.
2. Myra Luna-Lucero’s Role in Research Compliance and Why VR Raises New Questions (00:01:00) Myra introduces her role as research compliance director at Teachers College and explains how VR has become a growing area of concern for IRBs because of evolving technological, physical, psychological, and privacy risks.
3. Examples of How VR Appears in Research Studies (00:05:37) Myra outlines the main ways VR is used in research and shares two examples—a PTSD exposure therapy study and a movement science study involving older adults—to show how IRBs evaluate risk and safeguards in immersive environments.
4. What Makes VR Ethically Different from Other Technologies (00:13:36) The conversation explores how immersion and embodiment distinguish VR from more traditional tools, with Myra explaining how virtual environments can feel real to participants and therefore create unique ethical and risk considerations.
5. The Physical and Psychological Risks of Immersive VR (00:18:17) Myra discusses the range of risks participants may face in VR, including cybersickness, loss of balance, eye strain, dizziness, panic, dissociation, and lingering emotional effects after the session ends.
6. How Informed Consent Should Work in VR Studies (00:23:08) Myra explains that consent, permission, and assent materials should clearly disclose the physical and psychological risks of VR, along with screening, check-ins, and debriefing procedures designed to protect participants.
7. Privacy, Data Governance, and the Role of IT in VR Review (00:27:40) The discussion turns to the data governance challenges created by VR systems, including motion tracking, behavioral data, storage practices, and the need for IRBs to collaborate with IT teams to assess privacy and confidentiality protections.
8. What IRBs Should Look for When Reviewing VR Protocols (00:29:57) Myra recommends that institutions create flexible guidance rather than rigid policy for VR studies and describes the core issues reviewers should evaluate, including data management, participant safeguards, and population-specific risks.
9. How Researchers Can Strengthen VR Study Design Before Submission (00:32:55) The conversation focuses on how researchers can improve their protocols by clearly describing risk levels, screening procedures, stopping rules, monitoring plans, consent transparency, and equitable subject selection.
10. Additional Issues When VR Intersects with AI and Third-Party Platforms (00:38:35) Myra discusses how AI features and third-party tools can intensify risk in VR studies, making it even more important to assess whether added technologies are necessary and whether they increase exposure or data collection concerns.
11. Recommended Resources and Practical Next Steps for IRBs (00:43:16) In closing, Myra encourages IRB professionals to experience or observe VR firsthand, talk with researchers and IT experts, and develop practical internal guidance to support more informed risk assessment.
12. Episode Closing (00:46:30) Daniel closes the episode by encouraging listeners to explore CITI Program’s other podcasts, courses, and webinars, including its new tech ethics training solution, and thanks the production team.

Daniel Smith: Welcome to On Tech Ethics with CITI Program. Today I’m going to speak with Myra Luna-Lucero, who is the research compliance director at Teachers College. In our conversation, we are going to discuss the use of virtual reality in research, including various ethical and IRB considerations.

Before we get started, I want to quickly note that this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws, regulations, and guidance that may be discussed in this podcast. In addition, the views expressed in this podcast are solely those of our guests. And on that note, welcome back to the podcast, Myra.

Myra Luna-Lucero: Thanks so much. Really happy to be here.

Daniel Smith: It’s great to have you again. So to start off our conversation today, can you just introduce your role at Teachers College and how VR has been showing up in research compliance work?

Myra Luna-Lucero: Absolutely. So as the research compliance director at Teachers College, my role is to oversee the ethical and regulatory review of human subjects, which honestly is one of my favorite topics. That includes ensuring risks are minimized, consent, ascent, and permission is meaningful, privacy and confidentiality is protected. And overall, research is equitable. So it’s a very busy job, but I enjoy those contributions and the contributions that the IRB team make to the research ecosystem.

Now, virtual reality. It’s a topic that landed on my desk many years ago. It’s been around for quite a while. Research lab members are often really excited to either test or use new technology or try novel ways to adapt it. So virtual reality’s been around and it’s been adapted to different disciplines like psychology, neuroscience, education research, and even in business settings. So it shows up as intervention tools and as a research environment.

But what we’ve been discovering and really thinking about now is how does VR and compliance meld together? And part of these issues that have been raised and the things we’ve been thinking about more deeply is the psychological and the physical risks of the use of VR, the data privacy and the platforms that are being used for gaining that data through the use of VR, the whole data stewardship consideration, informed consent, permission, or assent clarity in the context of using VR. So it’s not that VR is new and it’s not that it’s inherently high risk, but there have been a lot of technological changes and augmentations that has changed the texture of risk in the way an IRB really needs to be carefully analyzing and thinking about the use of virtual reality. And so we’re asking ourselves constantly when we see the use of any technology, but specifically virtual reality, is this minimal risk or do we need to think about it in a little bit more deeper ways and is this perhaps greater than minimal risk?

And so I just want to make a quick distinction here. I’m not a virtual reality expert, but I can say that this podcast is going to be geared towards thinking through virtual reality, but we can’t think of it in isolation. We have to think about all the technological components that could be involved in the use of VR, but it is very particular to the use of VR here, not augmented reality. And so I’m just going to make this little quick distinction. Virtual reality is the topic here, not augmented reality. Virtual reality is a tool used for simulation and interventions that puts the individual who is experiencing that by replacing the world. So that’s the best way to think of it, whereas augmented reality adds to your world. They’re still very important, very useful to think about the risks, how it impacts research compliance work, but we’re focusing on virtual reality as it replacing the world in the experience, not augmented reality, which adds to the world. So I think that’s important for folks who are listening and just thinking through what that means.

So in the virtual reality landscape and thinking about research compliance work and how it’s been showing up, one of the more urgent things we’ve been thinking about is again, is this project minimal risk? And now we have a lot of more immersive technology and artificial intelligence, AI that is adding to virtual reality spaces. So we have a lot of things to think about and as anybody knows who’s working in IRB, there’s already a lot of things to think about when you’re mitigating risk. But in the context of virtual reality, it’s the technology used, the hardware, the software, and then thinking about it in the context of any adjustments or improvements that are made to that virtual reality landscape using AI.

Daniel Smith: So as you mentioned, we’re going to focus a lot on the ethics and the risks around VR and how IRB members and others can think through those. But just to give our listeners a bit more of a real world understanding of what VR is, can you share one or two examples of research studies that incorporate VR?

Myra Luna-Lucero: Yeah, absolutely. And I think I’m going to step back for a little bit, Daniel, and just talk a little bit about the four ways that VR has been showing up. I said it’s been around for a while. It’s landed on my desk years ago, but it’s getting more sophisticated and more in depth in ways that get the IRB staff really thinking about risks. So it’s coming up in clinical intervention research, behavioral and social science research, in training simulation research, in environmental manipulation research. So if you kind of hold those four pillars in mind, you can think of how examples can come up in your own work or your own research landscape work and how virtual reality can impact clinical interventions or behavioral and social science research, et cetera.

So I’m going to focus on two examples that I think really get at research studies that incorporate virtual reality in this meaningful way, but we can think of it broadly that they’re showing up in many different areas, but these two examples I think really got our IRB staff thinking deeply. And so one example was using virtual reality exposure therapy research for individuals with post-traumatic stress disorder. So right away the thoughts are coming through my mind as an IRB reviewer and I’m thinking, ooh, okay, how is virtual reality being used in the context of an individual who may have trauma?

So participants in that space, the researcher had proposed that they would be immersed in a simulated trauma related environment. And so remember, virtual reality replaces the world. So this individual who is experiencing PTSD would be immersed in this environment, a simulated trauma related environment and then gradually with grounded psychological therapy steps given this desensitized triggers. So some major ethical considerations, right, psychological distress, that rings pretty true and the fact that it’s being intentionally elicited as part of the intervention. So this is going to be known to study subjects in the consenting procedures. The researcher is not using any deception. It’s going to be very plain forward language. They’re looking for individuals that meet these inclusion criteria and they’re very explicit in the consenting procedures and it’s going to be with adults competent to consent.

So we really had to evaluate whether these risks were reasonable in relation to the anticipated benefits and whether appropriate safeguards such as a clinician present, when to stop the study, how to stop the study were clearly in place. And we had to ask ourselves in the IRB, is this too risky or are we applying too much oversight? Is it reasonable what is being proposed here in this study and can we lean on an adult participant who is resilient and wants to face some of these challenges in their lives and maybe seize this study as an opportunity because they’re looking for a pathway. So is this really an opportunity for this individual who may be experiencing PTSD to engage now in the simulation to maybe have a potential benefit in the course of this study.

So we compound all of that thinking about the virtual reality as a software, as a hardware in the context of the study, the inclusion criteria, and then what is being proposed in this immersed simulated trauma related environment. Now, it took a lot of work. It took a lot of back and forth with the IRB and the researchers, but I think we landed in a very good space front facing consenting materials, clear language, debriefing scripts, resources, safeguards, and safeguards that were not only psychologically based, but safeguards that were physically based because again, the space is immersive and an individual may respond physically to something, right? Like you’ve maybe walked down the street and a piece of paper shifts a corner and you kind of jump a little bit because you might think it’s a little creature coming at you, but it’s a normal response. And when you’re in a virtual space, those physical responses may feel real and so we needed to have that physical contextual environmental space considered in the safeguard as well.

So a second example, and this one had us, again, thinking very deeply about not just the protection of the population, but the protection of the population in the context of virtual reality, going back to that virtual reality replacing your world, right? So it’s very experiential. So the second example was a movement science study. So they were interested in physical movement, moving arms, moving shoulders, where a researcher wanted to work with older adults, individuals who were 60 years or older and the study was designed to have movement activities based in this virtual reality space. Now we’re bringing up less psychological concerns in this particular context with older adults. Maybe we’re thinking more physical concerns because an individual may not have had experience with virtual reality before and it may be overwhelming in the experience in that landscape, but it’s also thinking about is that individual, perhaps an older adult going to experience different physical responses that maybe a healthy adult may not have as much of a concern for.

Now it’s not to say that we’re trying to be restrictive. Many people can do many things physically and psychologically, but it’s more just thinking through, are there additional safeguards? One for perhaps an individual who’s never experienced a virtual reality landscape before, but specifically for an individual that may have some mobility challenges based on whatever experiences they have in their lives, do we have to have additional safeguards for the physical movement in that virtual reality space? And so part of the inclusion criteria in that particular study was, do you feel comfortable physically moving? Is there any concerns about raising your arms or standing up or maybe they don’t stand up at all. Maybe they just stay seated the whole time, which again would increase the physical safety of that virtual reality space. Those are two examples that come to mind that really got us thinking in the IRB office really got us having to reach out to our colleagues in other departments like IT, the information technology department and really even general counsel, the risk assessment office.

We had conversations with the environmental health and safety office to talk through proximity and space and having no trip hazards. And we reached out to people who use virtual reality, researchers who’ve used virtual reality and said like, “What’s reasonable in these contexts?” What was very enriching to reach out to other people and really come up with some ways to help the researcher move forward with their work, protect that human subject in the engagement of that space and then check in the post-approval monitoring, like how did it go? Did it go okay? And then taking that information and maybe adapting it for additional safeguards as needed.

Daniel Smith: So in walking through those two examples, I think you touched on this a bit, but from an ethics standpoint, what makes VR different from other technologies?

Myra Luna-Lucero: Great, great question. So I think the best way to narrow that down is immersion and embodiment. So you really are not doing a 2D passive engagement, right? You’re watching TV, you know you are not the TV, you are your own separate person, you’re not really having that disassociation, you know that it’s a separate experience, but when you’re in a virtual reality environment, it can create a sense of presence, the feeling of actually being there. And there’s some discussions that I recall having with some of my colleagues and they were saying there was like a group of youth that physically went to the botanical garden and physically experienced something in that space.

And then there was another group that had the experience through a virtual reality setting. And then they asked the two groups, “What did you see? What did you hear? What did you experience?” And they were very similar, even though one was a physical space and one was a virtual reality environment, but the experience felt like being there. And so that means that the emotional and physical responses may feel similar to being there physically or maybe even amplified because there’s also the headset which feels closer to your ears and the eye viewer feels like maybe closer to your vision. So there’s a little bit maybe amplification to that.

There’s also the memory and encoding that may feel real and so participants may react psychologically or even physically as if they are actually there in an experience. And so it may also reduce that psychological distance. And so when we think about all of this, like the idea of being there but having that presence in a virtual reality space, it raises some ethical considerations. So is there an increase probability or magnitude of harm even if the stimulus is simulated? Okay, that’s a big question. I don’t think I can answer it all right here in this podcast, but these are some of the things we’re thinking about.

So if you physically went to a botanical garden and you physically saw a plant, is that different than maybe your virtual reality experience that you feel like you are there and then the sensations might be a little bit amplified because the speakers are closer to your ears and the vision might be more closer to your eyes, et cetera. Does that increase the risk? I don’t know. Got to think about that. Is there a harm consideration that we have to make in that virtual reality space? Now stepping back from the immersion and embodiment part of virtual reality, we also just have to think about the data being collected. So virtual reality as a software collects continuous streams of behavioral data, eye movement, head movement, gaze tracking, spatial mapping. So all of that information could be uniquely identifying. So just stepping back and just thinking about the hardware and software.

And so that raises privacy concerns that would differ from traditional data sets. So simply put the person in the virtual reality space may be feeling like they are in that experience, they’re feeling it as if it’s like being there and that separation may be challenging and we got to think about that in terms of harm. And then additionally, we have to think about what the data actually is being collected and how it’s being collected, where it’s being stored and any protections of that confidentiality and privacy, given how much behavioral data the virtual reality software and hardware can collect.

Daniel Smith: So I want to ask more about informed consent and then also get back to some of the issues with privacy and data governance that VR raises. But first as a kind of a follow-up question to my previous one about the unique ethical issues, I was wondering if you could talk some more about the unique risks, whether those be psychological, physical or otherwise that participants might be exposed to in immersive environments.

Myra Luna-Lucero: Such a great question. So if you’ve never experienced virtual reality yourself and I’ve had just a little tiny experience with it’s an experience that is unique and also really embodying of the environment. I know I’ve repeated this word immersive and I know I’ve repeated this word embodiment, but to actually do it to put the headset on is transformative. You are putting on a physical device and you are kind of tuning into that physical sensation and then you’re getting input and that input may be new.

And so in the very minor, small experience that I’ve had with virtual reality, I had the little jump scare, right? What is that? What am I experiencing? How am I experiencing it? Now I’ve had more exposure to virtual reality than that initial interaction, but the first time it was brief because it was so unfamiliar. And so there are literal physical risks to consider. The putting on of the headset, the physical wearing of the headset is a potential risk if an individual doesn’t like pressure on their head or if they have any kind of head discomfort or any kind of, say for example, glasses that they’re wearing or hearing aids that they’re wearing or any lenses that would impact the vision or the auditory input of the device, that’s part of it too. So there’s that and then there’s also that jump scare where you put it on, you see that first input. It’s kind of like, “Whoa, what is that?”

But thinking more deeply about the physical risks, there’s cyber-sickness. Wearing any kind of physical aids, glasses, contacts, hearing aids can impact the VR experience. You also could have this loss of balance. It really is a shift in the way you’re experiencing your day-to-day. You may feel like you might want to lean into something, and you could fall. Individuals who have a high risk for seizures or may be susceptible to seizures may have an experience in that way. There’s also the eye strain and there could be a long-term dizziness. Some individuals who’ve used virtual reality have reported that they felt fine in the moment. They got the debriefing about five minutes later and then they left and went on their way and then they had a little dizziness later, maybe even a sense of vertigo.

Now we can’t always correlate it to that virtual reality experience, but it is part of the consideration. One of the easiest ways that I try to think about if you’ve never experienced virtual reality, but maybe you’ve gone roller skating or maybe you’ve gone biking, right? The experience of riding a bike or the experience of rollerblading or roller skating and then you get off the bike or you take off the roller skates and you walk with your feet flat on the floor and you kind of have that like, “Oh, wait, where’s my wheels?” I have to walk now in a foot pace, not in a wheelbase, but you kind of have that little adjustment. That’s kind of as best as I could describe the experience with virtual reality, but just magnify it with lots of features and lots of technology and visual and auditory input.

Now, the psychological risks could be acute distress. We brought up earlier an example where PTSD if an individual just really is not ready to experience some of that simulation. They could have panic, they could have disassociation, there could be a potential risk for re-traumatization, any emotional after effects. And again, remember, virtual reality is like being there so it could persist beyond the session of the virtual reality experience. So we have to think about that as well. I think those are some ways to really think through virtual reality, how it may impact an individual physically or psychologically.

Alexa McClellan: I hope you’re enjoying this episode of On Tech Ethics. If you’re interested in hearing conversations about the research industry, join me, Alexa McClellan for CITI’s other podcast called On Research with CITI Program. You can subscribe wherever you listen to podcasts. Now back to the episode.

Daniel Smith: So then getting back to some of the informed consent considerations, how should researchers and IRBs be thinking about informed consent when it comes to studies involving VR?

Myra Luna-Lucero: Thanks so much for bringing back the informed consent. So I think we’re going to just kind of categorize this in three ways, the informed consent, the parent permission or guardian permission, and the ascent, because all of those populations may engage in a virtual reality space for human subjects research. So basically if the researcher is proposing the use of virtual reality in the context of human subjects research, disclosure is the best path forward to literally say you may experience disassociation, you may experience emotional after effects, they may include, for example, and it would be in context to the virtual reality environment, you may experience physical risk, cyber-sickness, loss of balance, and how the researcher is going to safeguard or to try and decrease that risk. I think also important in presenting that information to the potential participant is what is in the inclusion and exclusion criteria.

And we had a discussion with some of our researchers who were using virtual reality and they suggested perhaps they were not going to enroll study subjects who had never experienced virtual reality. Perhaps it was best for their population of recruitment for individuals who had some experience to virtual reality so it wasn’t that it was brand new to that individual. So another way to think about information presented in the consent form, guardian permission form or assent form is narrowing down that inclusion and exclusion criteria. It may not always be possible for the researcher to recruit somebody who’s already experienced virtual reality, but it is okay to include in the participant facing materials. If you’ve never experienced virtual reality, we’re going to do a demo or we’re going to do a little bit of an introduction to it before we collect the data. So it’s almost like a screening process to just get a feel for how this individual may be experiencing the device, may be experiencing the immersion or the embodiment of the virtual reality environment.

And so our approach is be explicit about any physical or psychological risks that an individual may experience in the context of this virtual reality space and then what safeguards be explicit in the participant facing materials of what the researcher is doing to try and decrease the chances of that risk coming to fruition and then also weaving in wherever possible, checking in how the individual’s doing, pausing to see if the individual wants to stop, maybe testing if the individual feels comfortable wearing the materials in this screening process before the actual data is collected.

And part of the suggestions in the timing of the studies in the participant facing materials is to segment it in three ways. Almost like a screening, as I was mentioning before, if that individual feels comfortable, that’s great. Then having the full data collection during the virtual reality experience and then having an actual pause. Say, “Are you okay? Doing good? Great. Let’s keep going.” And then at the end, the third part would be the debriefing and the debriefing isn’t like, “Okay, this is what happened, goodbye.” But actually putting time into the overall project for a debriefing that goes about 15 minutes after the data has been collected.

Now, why do we want to think about it that way? Because the after effects of a physical response may not happen right away. They may be a little bit later. And so just incorporating some of those checkpoints, screening to see how the individual responds initially to virtual reality, the device and the software, the actual data collection, having a pause and check-in, maybe even multiple check-ins during the data collection and then having a debriefing at the end that is about 15 minutes minimum or whatever is reasonable for that study, checking in with that individual and just saying, “Hey, how are you feeling? You’re seated, you’re doing good, great. You still feel good, great.” And then allowing that individual to check in with you later if they have any residual impact.

Daniel Smith: These are all really helpful consideration. So then going back to the discussion of privacy and data governance, can you also just expand a bit on the challenges that arise when VR systems collect detailed motion behavioral or biometric data?

Myra Luna-Lucero: Yes. And this is where I would call in our colleagues in the information technology office. They really have the technological language and know how to think through that data privacy and data confidentiality. And as you mentioned, data governance. I think one of the biggest challenges is that virtual reality as a device, you could purchase a device, but the software could be made by any number of programmers. And so is that software meeting the gold standard of data privacy and confidentiality? And we know how fluid data can be collected and how it can be transferred and how it can be used.

And so in that data stewardship plan, it’s also disclosing in the participant facing materials, this is the data that is going to be collected, this is the data that is not going to be collected as this has been maybe disabled on the device, or this is what the researchers will keep for analysis and there’s no other identifying information and then how long it will be stored either in the software system itself or with the researcher for data analysis.

So I think one of the biggest discussions we had with researchers who were using virtual reality is full disclosure to our IT office about what the software was and then getting advice from the tech experts about the software, like what company was actually being used to make this simulation and was that meeting the gold standard of the institution for data privacy and confidentiality and whatever advice the IT was giving that researcher that that be disclosed to the study subject about their data privacy and confidentiality. And so it’s not an easy path to walk because there is just a lot of considerations for the device itself, but I do highly recommend that IRBs lean on their tech experts to have those conversations with the researcher and that will help mold the data governance and the data stewardship plan.

Daniel Smith: And then I guess to kind of bring it all together for IRB members, can you talk about the main issues you look for when reviewing protocols involving VR?

Myra Luna-Lucero: Yeah. I have to pause for a second in this response because I find my interactions with researchers always fascinating because they’re doing such amazing work out in the field and they’re using such innovative ways to understand humans and environments and context. And so really I would just advise you can have a virtual reality guide and I would recommend a guide, not a policy. I recommend a guide because the technology itself is so immersive and so dynamic and virtual reality in essence really can change with artificial intelligence and with new use of the technology that a policy is a little bit less flexible than a guide. And so I recommend a guide and I would lean again on your IT office, on your general council office, on your environmental health and safety office, on researchers who have experience using virtual reality to work on this guide. So you all have these representations in the guide itself.

And once you have that guide, it gives you that grounding. So when you see a research study that is proposing the use of virtual reality, you can kind of go through that guide and say, okay, it’s meeting these minimum standards of what we expect. In other words, the virtual reality system is collecting eye tracking, hand movement, room mapping, voice recordings. And the researcher has had a data management plan that describes how they’re protecting the privacy and confidentiality of the individual for all of that data that the device is collecting. So that’s good. And then from there, you’re really just trying to put yourself in the study subjects shoes. It’s really thinking through, okay, in a magical world where everything is safe and everything is check-boxed and we’re doing really well, how might this individual or how might this particular population respond to the use of virtual reality in this context?

And so you go to the regulations and you think through adults competent to consent, parent permission for a child or guardian permission for child is sent, and really just thinking through how that maps out for that specific population. And I bring up the example that I mentioned before for the older adults, it was that consideration of that specific population in the use of virtual reality because it may be more likely that their exposure to virtual reality is minimal if not, they’ve never experienced it. So is there a screening process that becomes more important as a safeguard in that population or with that population because that would be safer for them to get used to it before actually collecting the full data to see if they feel comfortable with the device use?

Daniel Smith: And then on the flip side of that question, what steps can researchers take early in their study design to make their IRB submissions stronger?

Myra Luna-Lucero: Yeah, I love this question. I think I’m going to take this as a collaborative approach for the researcher and for the IRB reviewer because we both have a shared responsibility for the ethical engagement of research and for the protection of human subjects. And so I think together the researcher can create that strong protocol that follows the guide that maybe the IRB office has generated for the use of virtual reality, but really we can both be thinking about what is the risk, right? Really and can we all just ask ourselves, is the activity itself minimal risk? Is it minimal risk generally as an activity, but with this population, it’s greater than minimal risk because this population has unique characteristics.

So you can ask yourself that risk characterization between the researcher mapping out what that would look like, what they know are risks to allow the IRB to evaluate what those risks are would be really helpful. And so the question really is the immersive intensity of the virtual reality space accurately described? The researcher’s going to have that content knowledge of not only the simulation, the environment of the virtual reality space, the maybe intervention that they’re proposing. And so having them map out the risk characteristics make it more readily available for the IRB reviewer to walk through some of those risk mitigation plans.

The other is screening, and I mentioned it before, but I’m going to emphasize it again because that screening procedures could be essential, not just for the novice person who may be enrolled in the study because they’ve never experienced virtual reality before, but also for the researcher to be like, oh, this particular individual is having a little bit of a hard time with the device itself. They meet the inclusion and exclusion criteria, but this individual just may be a little bit off balance or they may have a little bit more physical activity in their reactions to the virtual reality space that may lead to potentially a fall or disorientation. So maybe we’re going to not enroll this individual, but we’ve had the screening procedure.

And so the question in that case would be, are vulnerable individuals appropriately identified and can we create a space in the screening procedure for the IRB to review what the researcher has proposed to help see if that individual can make it through the full study activities? Or is this something that needs to be a little bit more gradually introduced? And so I think also part of that is if the researcher can describe their pausing or their stopping rules, what their monitoring process is, you have the best intentions to enroll a study subject, they start going through activities and they get really excited about a part in the immersive environment and they stand up, but they’re supposed to be sitting down because it’s safer.

And so what would the researcher do to pause the study to say, “Well, let’s just pause for a second.” We’re going to metaphorically pull the plug, get the individual in a safer space. We’re going to now continue the study, et cetera, but there’s monitoring that way. And then if a study subject stands up and is looking a little wobbly, is there a person in the study team there to maybe hold that individual’s arm or guide them to a seated space? So what is that stopping rules and monitoring? That consent transparency, the permission and assent transparency is really important. And then we talked about privacy and confidentiality, what that governance looks like. If the researcher maps that out all in their proposal ahead of time, that means the IRB doesn’t have to ask those questions in the review because it’s already at the forefront. And then if there is any inclusion and exclusion criteria described for that virtual reality study, is that equitable selection of study subjects?

I’m going to pause for just a second and just say part of this I’ve been describing is that if deception is not being applied in the study, but sometimes researchers want to use deception so that does increase the risk. And so a researcher creating a strong protocol would be very front facing to the IRB in justifying any deception that’s being used. Why to what end? Does it answer the research question? What is the procedure for ensuring that individual gets a debriefing script or resources to explain when and how deception was used? And so that adds another layer if deception is used. And it’s not to say that when deception is not used, the study is easier to review, but it’s more to say that if deception is used, it just adds another risk assessment and risk layer for the IRB. So a researcher, again, should really be clear about risks, really clear about any screening procedures.

The researcher should have stopping rules, pausing rules, any kind of monitoring that they’re doing, ensuring that there’s consent, permission, or assent transparency in the activities of virtual reality, what their data governance is for privacy and confidentiality and that there’s equitable selection of subjects and then added if there is deception that there is justification for and how it is applied.

Daniel Smith: I think you’ve really covered a lot of ground here today in terms of covering the ethical considerations and the risks, but just for a few closing questions, on is are there any additional considerations when VR research intersects with AI as you mentioned earlier or third party platforms or anything else?

Myra Luna-Lucero: Yeah, I think sometimes I feel like I’m chasing the cart when it comes to technology and research. I try very hard to stay on top of the latest new emerging technology, but researchers are doing such innovative work that I’m like, “Oh, I didn’t know this AI scenario is now in virtual reality or I didn’t know that this can be done in this context.” So I do often get a wow factor and I think there’s a good realization in that and to hold space for that, it’s okay that the IRB doesn’t know everything about everything and it is also okay that we are not everywhere all the time. So it is absolutely appropriate for the IRB reviewer to say, “Hey, researcher, can you help me understand this?” I do it all the time. I’ll say, “Can you send me some resources? Can you send me some links?” Because I cannot as an IRB specialist make a determination unless I understand what the risk is and what’s happening.

Now, it’s important to recognize that the researcher has spent maybe even their lifetime studying this topic, they’re passionate about it, they’re excited about it and they can be that source of information sharing. And so you can take that information and help you assess what say AI or what new tool or what additional consideration is being put in this virtual reality space that may intensify or impact the risk. And I think some of those considerations and some common issues that come up is underestimating the psychological or physical intensity that an enrolled study subject will have in that immersive experience called virtual reality, right? Because again, it’s like being there. And so we want to really try to think about that intensity for the individual enrolled in the study. And so the study could be described as minimal risk, but the justification or clarification of what is minimal may not be fully unpacked.

So we need to be able to think through, okay, so virtual reality in a standard sense may be minimal risk, but if you add a AI component that could impact the risk and now it becomes greater than minimal risk. And then also you mentioned if there isn’t description of a third party data collection or any other software considerations that we need to make because the researcher may not mention that and then we may find that out later or there may be a data breach that we weren’t able to be responsive or responsible for at the onset of the study because it wasn’t disclosed. And so there’s also that consideration in addition to any precautions about the physical space. I want to just pause for that part because the virtual reality device out of the box, the physical user manual will describe must have a space, this number of feet that way, that number of feet this way.

And so if the researcher is in a research lab that they can’t make that space safe because they can’t meet the minimum user out of the box requirements for the device itself, that’s a concern. So that’s part of the physical safety precautions for some common issues that arise. And then also just thinking through that just because technology is emerging and just because it may be the latest AI use of this device in practice doesn’t mean the researcher has to do it. So I always try to ask the researcher, “Can you collect this information without using this additional potentially risky part? Or do you have to collect this data in order to answer your research questions?”

And sometimes that question is like, “Oh, well, no, I don’t have to do this. I can get the same information in a lower risk way.” Oh, okay, let’s just do it that way because that’s easier to protect the human subject because it’s less risky because it is minimal risk. And so asking that question is also important. It’s not to discourage the researcher from using the latest technology that may have the latest version of AI, but it’s moreover to just ask, is it necessary to answer your research questions? And sometimes the researcher may say, “Yeah, I don’t have to do that.” So then it decreases the risks and allows you to have a greater risk mitigation plan for that context.

Daniel Smith: And then as a final question for today, what resources or guidelines would you recommend for researchers or IRB members who want to deepen their understanding of the issues we’ve discussed today?

Myra Luna-Lucero: So I had the same conversation with my colleagues in the IRB office and I said, “We should all try virtual reality.” And there was a lot of mixed reviews about it. But I think if I were making the best recommendation, it would say try it. If you know of a research lab at your institution that is using virtual reality, even if you don’t put the device on itself and have that immersion experience, you could just ask them to demonstrate it. So you get that lived experience to see what the device looks like. You’ll see the cords, you’ll see the headset, you’ll see the computers, you’ll get a better, I think, sense of the space.

And if they’re doing a demo, if you don’t want to experience it yourself, but if they’re doing a demo, you can see how the physical movement in the space might look and that just helps inform you as an IRB person when you’re making that risk mitigation assessment. And then if the researcher’s adding AI, you can have a conversation with them on how that AI is adding to or adapting the environment. In real time, you can actually ask them, is there an algorithmic decision being made? Is there profiling that’s occurring in the use of AI in this case? Is there data being collected that’s used in this AI situation or AI context in virtual reality environments? So you can have those candid conversations, even if you don’t have the precise technological vocabulary to say it, even just simply asking the researcher, “Hey, what is this?”

And then hearing from them, what does it look like, you are, as an IRB reviewer, perhaps better able to assess, oh, okay, that looks like minimal risk because in the context it’s typical, or that is something that may be risky for this vulnerable population but may not be risky for say a healthy adult. And so I think trying to get past any ambiguity, trying to get past any uncertainty is primary goal. And again, if you don’t want to experience virtual reality yourself, having the time or even a conversation with an expert who does use virtual reality, and if you can see a demo of what virtual reality looks like, I think that helps decrease some of potential IRB oversight that would be misplaced or it helps increase oversight where you think it’s necessary, but it gives you that clearer sense.

I would also recommend having a deep conversation with your IT professionals and really taking seriously a guide. And even if it’s not a full-fledged, multi-page guide, but just this is what we expect in the IRB office of virtual reality use. This is how we want to protect that human subject in this context, data privacy, data confidentiality, physical security, psychological safeguards, et cetera, as we mentioned before, is a very good step forward so that when your IRB reviewers are looking at that IRB protocol from the researcher, they have that guide, they can make the reviewer checklist and then if questions come up particular to that population, they can respond accordingly per case.

Daniel Smith: I think that’s a wonderful place to leave our conversation for today. So thank you again, Myra.

Myra Luna-Lucero: Thank you so much. Pleasure being here.

Daniel Smith: If you enjoyed today’s conversation, I encourage you to check out CITI Program’s other podcasts, courses, and webinars. As technology evolves, so does the need for professionals who understand the ethical responsibilities of its development and use. That is why we developed our new Tech Ethics training solution. This new offering brings together practical, thoughtfully designed courses to help professionals navigate ethical and regulatory challenges with competence. The courses cover responsible AI, software as a medical device and clinical decision support systems, big data and data science, data management, software development and more. Check out the link in this episode’s description to learn more.

And I just want to give a last special thanks to our line producer, Evelyn Fornell, and production and distribution support provided by Raymond Longaray and Megan Stuart. And with that, I look forward to bringing you all more conversations on all things tech ethics.