Interview: Gabriel Lazaro-Muñoz

Dr. Lazaro-Muñoz is an Assistant Professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine. In his research, he studies the ethical and legal implications of emerging technology in neuroscience and genomics. Dr. Lazaro-Muñoz is serving as a panelist for a session taking place on the second day of the 2020 INS Annual Meeting, 'Life and Health Decisions with Experimental Brain Implants.'

What is your current position and field of research?

I am an assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Most of what I do is research, focusing broadly on neuroethics and the ethical, legal, and social implications of advances in genomics. I have a couple of grants from the NIH Brain Initiative investigating the development of closed-loop deep brain stimulation systems. We look at patient perspectives on the development of these tools and researchers perspectives on different issues. We also have a grant on pediatric DBS, which is something that has been growing quite a bit, particularly for movement disorders, like dystonia. However, there’s not a lot of systematic research in that area, so we’re looking at how clinicians, patients, and their caregivers make decisions about undergoing pediatric DBS. Ultimately, a lot of my research in neuroethics focuses on neurotechnology development and understanding the ethical challenges that researchers, caregivers, and participants might experience in these studies, and how to hopefully come up with solutions and ways to minimize some of the potential harms associated with developing these technologies while maximizing the benefits.

We also have a whole area of research mostly focused on psychiatric genetics. We do look at the ethical, social, and legal implications of genomics, but most of my research has focused on psychiatric genomics over the past few years. I work very closely with the researchers to understand their perspectives. We definitely always try to examine the perspectives of the participants and important stakeholders for any of these technologies, but my approach with a lot of this research has been to work very closely with the scientists developing this technology. This allows us to understand where they're trying to take these technologies, see the advances as they are happening, and ultimately see science as it’s happening. We think it's been a helpful approach to get a better picture of the capacities, limitations, and ethical concerns and considerations that come up with some of these technologies.

How has your background influenced your research approach?

My PhD is in neuroscience, so I guess I have that inclination towards understanding the science of what’s happening in the labs and where researchers want to take some of these technologies.

I’m also a lawyer, and so I’d like to understand the contexts and parameters –– in terms of regulations –– in which these technologies will be used. I try to understand what kind of protections are out there, where we could do better as a society in terms of providing more protections to participants, and what we can do to maximize the benefits of these technologies.

What kinds of connections do you find between your neuroethics research and your genetics research?

I think the common thread is the brain, whether it’s the genetics work, or work that’s more focused on neurotechnologies. We’ve also submitted some recent grants on artificial intelligence and a number of different issues related to polygenic conditions that look at behavioral genetics in addition to psychiatric genetics. Still, the common thread is the brain, but the focus of the research differs. Some will be focused on neurotech, and some will be focused on genomics advances and how we can potentially use what we’re learning in genetics and apply it to clinical practices.

For example, one thing that’s a pretty hot topic in genetics right now is polygenic risk scores. It’s one of the few genetic testing tools that can give you a sense of what level of risk someone might have in relation to the general population in terms of developing some kind of psychiatric disorder or certain behavioral traits. It's not like some types of cancer where you have particular genetic variants that contribute a great deal to your risk. When it comes to behaviors and psychiatric disorders, they are highly polygenic. You have hundreds of genomic regions that contribute to it. Previously, we hadn’t had the sample sizes necessary to be able to reliably identify risk. And the field is still in that process, but the idea is that you’ll be able to identify who is at an increased risk for specific psychiatric disorders or behavioral traits. That’s a huge area of research that I think is super interesting and obviously has very important issues related to neuroethics and the brain. Generally, it hasn’t been considered neuroethics, but I hope that we can start getting more neuroethicists involved in examining these issues.

What are some more traditional neuroethics issues in your research?

In terms of neurotechnologies, there’s a lot of buzz about Neuralink and about all these different companies developing brain implants. The idea is that you can stimulate a particular brain region and help manage some of the symptoms, and there’s been a lot of research for the use of these technologies with movement disorders, like Parkinson’s disease. However, there’s been a lot research and interest in using these devices for managing treatment-resistant depression, Tourette's syndrome, and obsessive compulsive disorder. Of course, there’s a lot of concerns that come with any kind of brain surgery intended to manage psychiatric conditions, especially given the history of psychosurgery. I think the field has made a great deal of progress in terms of controlling variables and being much more specific, but there’s still the concern of what kind of impact these devices have on the individuals, their behavior, and their personality.

Often, when we’ve interviewed these patients, we see that when it works, they feel such relief. There might be the risk of a change in personality or behavior – even if its low – but it’s also something where you have to balance the potential benefits in terms of managing the symptoms. It's a very difficult ethical analysis that has to be done when considering all of the aspects.

In fact, when you're working with DBS for psychiatric conditions, in part, personality and behavior is what you're trying to change: it’s the behaviors, emotional processing and responses to certain emotional stimuli. It’s a very complex issue, but that’s one big part of the research: understanding what the impact is on personality.

The other part I focus on quite a bit is science and health policy. For instance, what happens after these participants end their participation in the study? These are patients that have treatment-resistant conditions. They’ve tried many different treatment alternatives that haven’t worked and they have pretty severe presentations of these conditions, so they go into one of these trials. Of course, the intent of the trial is research: the goal is not to provide individual care, but to generate generalizable knowledge. But, some of these people are going to benefit from the stimulation. So what happens after the trials are over? Oftentimes, there’s no legal obligation for insurance providers to cover maintenance of these devices. So, there’s been a number of situations where the trial ends, a number of participants benefited from it, but then there’s no safety network there to ensure access to maintenance, and if you don’t have insurance covering any of the costs it can be quite expensive.

What’s an example of one of these neuroethical issues playing out in the wider world?

Post-trial obligations is something that we hear quite a bit in drug trials, and when it comes to something like brain interventions, there’s a lot of ethical implications dealing with the explantation, or removal, of the device. It’s not very common for a participant to request removal of the device, but it definitely happens and there’s a number of reasons why someone might want it removed. For instance, oftentimes you can’t get an MRI or you may not be able to participate in other trials. We’ve argued that there should be some funds available for this and that we need to plan for it as a community. Once the funding ends, there’s really no way for the researchers to cover the removal of the device, and there’s also very little planning unfortunately. This requires much more discussion among stakeholders to figure out how we are going to manage this.

What are you looking forward to about your panel, ‘Life and health decisions with experimental brain implants,’ at the annual meeting?

My hope is that, as a neuroethics community, we can tackle brain implant post-trial management of participants and devices and hopefully come up with some recommendations that we can provide for all the stakeholders involved. That involves a number of different players: public and private research sponsors, insurance providers, researchers, participants, caregivers, and policy makers. We’ve had a number of people looking at these issues, and it's unfortunate that, as a scientific community, we haven't been able to foresee some of these issues, address them, and create a safety network. But we have an opportunity to help push for that as a Society. Hopefully we can call some attention to these issues of continued access and post trial obligations. Hopefully we can come up with some guidelines of the things we need to keep in mind when putting together these studies to help maximize the potential benefit for participants.

My experience with a lot of the researchers is that they’re extremely thoughtful about many of these issues and they care about them. Most researchers think post-trial management of participants and devices is an issue that we need to manage, but now we need to start proposing more concrete guidelines of how to manage this problem and how to get stakeholders involved. Ultimately, these participants are sacrificing a great deal in order to help advance these technologies, and we need to push for more protections for them.

Why do you think people should attend the annual meeting?

It is really a wonderful meeting and I feel honored to be a speaker this year. The Program Committee does a wonderful job selecting speakers and identifying topics that are really fascinating and emerging. Every time I’ve been to the meeting, I’ve been so amazed at how much I learn.

Basically, neuroethics is my life’s work and it’s all I do, but I still learn a great deal from the INS meeting. Honestly, it’s one of my favorite meetings that I actually look forward to attending every year. If people have any kind of interest in the brain or ethical issues, I think it's a wonderful meeting to attend.

Our Digital Future: Building Networks Across Neuroscience, Technology and Ethics

The 2020 Annual Meeting of the International Neuroethics Society (INS) will convene virtually on Thursday and Friday, October 22-23, 2020. Sessions will address the many areas in which brain technologies and data concerning the brain are developed, deployed, utilized and regulated. We hope you will attend!