Lázaro-Muñoz Brain Bioethics Lab
Brain Bioethics Lab
MGH Department of Neurosurgery
399 Revolution Drive STE 1140
Somerville,
MA
02145
Email: glazaromunoz@mgh.harvard.edu
Explore This Lab
About the Lab
The Lázaro-Muñoz Brain Bioethics Lab explores the ethical and social implications of integrating psychiatric genomics into clinical care, polygenic embryo screening, and neurotechnologies such as adaptive deep brain stimulation systems. Our research examines cutting-edge innovation in psychiatry and neurotechnology, anticipates potential ethical problems, and proposes solutions.
Lab Members
Gabriel Lázaro-Muño, PhD, JD
Assistant Professor of Psychiatry, Harvard Medical School
Departments of Neurosurgery and Psychiatry, Massachusetts General Hospital
glazaromunoz@mgh.harvard.edu
Dr. Lázaro-Muñoz’s research examines the ethical, legal, and social implications (ELSI) of emerging neuroscience and genomic technologies. His work uses embedded methods such as participant-observation, in-depth interviews with stakeholders, surveys, and ethical, legal, and policy analysis, with a focus on psychiatric genetics and emerging neurotechnologies like deep brain stimulation (DBS) across diverse populations. He collaborates closely with technology developers and stakeholders to anticipate ELSI issues and create actionable research insights to inform policy.
Over the past seven years, Dr. Lázaro-Muñoz has secured over $16 million in research funding and published over 100 manuscripts. His funding track record includes NIH support as a trainee (F31, K99/R00) and five R01 awards since becoming a faculty member. He has also contributed as a co-investigator on 10 externally funded studies. Previous grants have supported research on neurotechnologies, including adaptive DBS systems (R01MH114854) and DBS use in pediatric populations (R01MH121371).
Dr. Lázaro-Muñoz’s current studies, funded by the BRAIN Initiative, National Institute of Mental Health (NIMH), and the National Human Genome Research Institute (NHGRI), examine the ELSI of:
- Integrating psychiatric genomics (e.g., polygenic risk scores, pharmacogenetics) into clinical care (R01MH128676)
- Screening and selecting embryos for implantation using polygenic scores for conditions (e.g., psychiatric disorders, Alzheimer’s disease) and traits (e.g., intelligence, height; R01HG011711)
- Identifying policy solutions to ensure post-trial care and device maintenance for patients with treatment-resistant conditions who benefit from experimental neural devices in clinical trials (R01MH133657)
At the national level, Dr. Lázaro-Muñoz serves on the Genomics & Society Working Group, an advisory group of the NIH’s National Human Genome Research Institute. He has reviewed over 10 NIH grant review panels and serves as a reviewer for leading journals, including Cell, Nature Neuroscience, JAMA Neurology, JAMA Psychiatry, Genetics in Medicine, Brain Stimulation, and Neuromodulation. Dr. Lázaro-Muñoz is Co-Director of the Neurotech Justice Accelerator at Mass General Brigham (Neuro JAM), a Dana Center for Neuroscience & Society.
Internationally, Dr. Lázaro-Muñoz is a member of the International Brain Initiative (IBI) Neuroethics Working Group and the International Society of Psychiatric Genetics (ISPG) Ethics, Position, and Policy Committee, where he served as chair for three years. He has published in journals such as Nature Reviews Neuroscience, Neuron, Molecular Psychiatry, Biological Psychiatry, Brain Stimulation, Neuromodulation, JAMA Network Open, Genetics in Medicine, European Journal of Human Genetics, and Psychiatry Research. He has been cited in multiple media outlets, including Le Monde, LA Times, Scientific American, STAT News, National Public Radio, Huffington Post, Nature, MIT Technology Review, The Verge, Leaps Magazine, Nature, Nature Medicine, the Associated Press.
Dr. Lázaro-Muñoz received his PhD in Neuroscience from New York University, his JD and Master of Bioethics from the University of Pennsylvania, and his BA in Psychology from the University of Puerto Rico. His research interests span biotechnology translation into clinical care, neurotechnology, deep brain stimulation (DBS), brain-computer interfaces (BCI), post-trial management of neural devices, the effects of neuromodulation on personality and behavior, AI in neurotechnology, genomics, polygenic scores, psychiatric genetics, genetic legal issues; polygenic embryo screening (PES or PGT-P), neuroethics, and the ELSI of genomics.
Amanda Merner, PhD
Research Scientist, Brain Bioethics Lab
Department of Neurosurgery, Massachusetts General Hospital
amerner@mgh.harvard.edu
Dr. Merner received her doctorate in experimental psychology, specializing in affective neuroscience, from Case Western Reserve University. During her graduate training, she conducted research at the Center for Neurological Restoration at Cleveland Clinic, where she studied cognitive and emotional changes in patients who underwent DBS for neuropsychiatric conditions.
Dr. Merner completed her postdoctoral research fellowship in neuroethics in the Brain Bioethics Lab within the Department of Global Health and Social Medicine at Harvard Medical School. There, she integrated her training in psychology, neuroscience, and neuromodulation to inform her neuroethics research.
Dr. Merner’s current work focuses on the ethical, legal, social, and clinical implications of emerging genomic and neural technologies in psychiatry. She pursues two primary lines of research:
- Examining the impacts of DBS and other neuromodulation techniques on patients with neuropsychiatric conditions, as well as the post-trial obligations for participants in early-stage DBS trials for treatment-resistant psychiatric conditions.
- Investigating the potential impacts of integrating novel genomic technologies—particularly polygenic risk scores—into psychiatric and surgical care, with an emphasis on responsible management of genetic testing in psychiatry.
- Developing outcome metrics that are centered on patients' values and functional goals to ensure researchers and clinicians are measuring what is most meaningful to patients and their care partners.
Rémy Furrer, PhD
Postdoctoral Research Fellow, Brain Bioethics Lab
Department of Neurosurgery, Massachusetts General Hospital
rfurrer@mgh.harvard.edu
Dr. Furrer specializes in experimental research methods, design principles, and behavioral science, conducting innovative studies to address complex ethical challenges and biases in medical decision-making. He earned his PhD in psychology from the University of Virginia, where his interdisciplinary research spanned the disciplines of social psychology, cognitive science, and affective science.
After earning his PhD, Dr. Furrer pursued a postdoctoral fellowship in the Department of Global Health and Social Medicine at Harvard Medical School’s Center for Bioethics. His research examines the ethical and psychosocial implications of genomic and neurotechnologies, using mixed methods to explore how patients, healthcare professionals, and the public perceive, understand, and apply emerging biotechnologies, particularly polygenic risk scores (PRS) and polygenic embryo screening (PES).
Dr. Furrer employs experimental designs to develop and test human-centered strategies for effectively communicating complex health information. His work aims to enhance comprehension, support informed decision-making, and ultimately improve psychological and behavioral health outcomes.
Erika Versalovic, PhD
Postdoctoral Research Fellow, Brain Bioethics Lab
Department of Neurosurgery, Massachusetts General Hospital
eversalovic@mgh.harvard.edu
Focusing on qualitative research methods in neuroethics research, Dr. Versalovic completed her doctorate in philosophy at the University of Washington. Her dissertation examined storytelling practices in bioethics, exploring how medical research norms shape patient narratives and how they are understood.
Dr. Versalovic is particularly interested in using interview-based research methods to amplify patient voices in medical research. In the lab, she serves as project lead for an initiative to improve post-trial access and support for DBS trial participants. Her roles include developing research instruments, collecting and analyzing qualitative data, and facilitating discussion among stakeholder groups. Ultimately, the project works to advocate for improved policies to ensure trial participants have continued access to the devices after the trials end.
Most broadly, her research focuses on issues of just access and centering patient needs in the ways the neural technologies are being developed and deployed.
Our Research
Post-Trial Support for DBS Trials
Public and private research funders have heavily invested in implantable neurotechnologies to improve the management of treatment-resistant conditions and loss of function. These devices, including DBS for movement and psychiatric disorders such as obsessive-compulsive disorder and depression, are tested in individuals with severe, long-standing impairments and treatment-resistant conditions. However, even when participants experience significant symptom relief or functional improvement in these trials, there is currently no systemic way to ensure post-trial access to beneficial investigational devices.
The loss of access or maintenance for these devices after trials can lead to the recurrence of severe, treatment-resistant conditions. Former trial participants may face emotional distress from the loss and financial strain if device support and maintenance costs are not covered by insurers. This research aims to promote participant well-being and advance neuroscience by gaining insight into the experiences of participants following DBS trials, including their device access, clinical care, and social support needs.
To achieve this, we are interviewing former DBS trial participants, their care partners, and local clinicians to better understand their post-trial care needs. These findings will be shared with researchers, device manufacturers, insurers, and research sponsors to identify barriers and opportunities for interventions to improve post-trial care. Finally, we will convene public deliberation panels, bringing together representatives from each group to develop policy recommendations for continued DBS support.
PES: Informed Decision-Making
Preimplantation genetic testing (PGT) has long been used to prevent the implantation of embryos carrying rare monogenic disease-causing alleles or aneuploidies. However, advances in complex trait genetics, along with the ability to generate accurate genome-wide genotypes from single-cell input, now make it possible to screen embryos for common polygenic traits and disease risks. This polygenic embryo screening (PES) introduces key ethical considerations that differ from conventional PGT for monogenic diseases. Unlike PGT, PES allows screening for multiple common diseases simultaneously (e.g., diabetes, heart disease, cancer, mental health disorders) and could also screen against stigmatized conditions, such as psychiatric disorders. PES even allows selection for "desirable" traits like height and intelligence. Importantly, PES results are inherently probabilistic and subject to variability, with risk reported as a percentage for each condition.
Despite media coverage on the possibility of "designer babies" and the emergence of private PES services, little empirical research has been done to quantify the PES’s utility, assessed stakeholders perspectives, examined its ethical implications.
The inherent ambiguity of PES requires careful consideration by clinicians, patients, policymakers, and the public to fully understand its potential consequences. In a recent study (Karavani et al., Cell, 2019), we examined PES’s statistical limitations for selecting embryos based on polygenic risk scores (PRS) for quantitative traits. Our findings indicate that, given current technology, the average benefit from screening is modest, with extremely wide confidence intervals that create significant uncertainty for clinicians and patients considering PES. However, preliminary data suggest PES may hold greater predictive power for disease risk reduction.
While PRS research has grown exponentially in the last few years, little empirical data exists on the clinician and patient perspectives toward PRS’s clinical applications, especially with assisted reproductive technology. To build a framework for the ELSI of PES, we aim to assess the attitudes and perspectives of those most likely to use or be impacted by it.
PRS in Child and Adolescent Psychiatry: ELSI Implications
Recent research has identified over 500 genomic loci associated with various psychiatric disorders, including schizophrenia, depression, and autism spectrum disorders, making it possible to generate PRS to estimate individual’s risk for these conditions compared to the general population. As a prediction tool, psychiatric PRS may be most valuable when applied before the onset of illness, as about 75% psychiatric disorders or early symptoms occur by early adulthood. This makes PRS particularly useful for children and adolescents. PRS could improve early identification, allowing for better monitoring and timely interventions to potentially prevent or delay onset, reducing morbidity and the risk of suicide, which is the second leading cause of death in the U.S. in ages 10–24.
Despite its potential, PRS poses unique challenges in psychiatry. Our preliminary research has found that PRS is already being used in child and adolescent psychiatry, raising concerns due to the stigma surrounding mental illness and a history of misusing “predictors” of “undesirable” behaviors or mental illness in the U.S. Psychiatric PRS could be misapplied against patients with psychiatric disorders, as it is one of the first tools that can generate risk predictions on a personal level. There are also significant legal gaps in privacy protections and in preventing genetic discrimination.
To promote responsible use of psychiatric PRS in children and adolescents, we will use a mixed-methods approach that includes qualitative, quantitative, and legal analysis to:
- Gather perspectives from stakeholders (e.g., patients, parents/caregivers, clinicians) on whether and how psychiatric PRS should be used.
- Analyze the legal and regulatory landscape to identify necessary safeguards.
While some gaps apply to other genetic information, we will focus on policy solutions to address the likely uses and misuses of psychiatric PRS, particularly for individuals with or at risk of psychiatric disorders — a group that includes nearly 30% of the U.S. population.
The long-term goal of this research is to develop ethically justified and empirically informed guidelines that address the ethical challenges posed by the use of psychiatric PRS in children and adolescents.
Past Projects
Pediatric DBS: Neuroethics and Decision-Making
The BRAIN Initiative and other sponsors are investing in DBS and adaptive DBS (aDBS) systems due to their potential to improve management of refractory movement and psychiatric disorders. DBS is FDA-approved for adults with refractory movement disorders, such as Parkinson's disease and essential tremor, and is offered under FDA-humanitarian device exemptions (HDE) for adults with refractory dystonia and obsessive-compulsive disorder (OCD).
The use of DBS in children under 18 year has received little attention, though it is quickly increasing. DBS is already offered under an FDA-HDE for children aged 7 and older with refractory dystonia, making this movement disorder the most common indication for pediatric DBS (pDBS). As interest in DBS for psychiatric disorders in adults grows (e.g., OCD, anorexia, depression, Tourette syndrome), pDBS for similar conditions is also on the rise. We identified 97 publications reporting pDBS for movement disorders (e.g., dystonia, essential tremor) and psychiatric conditions (e.g., anorexia and TS) in pediatric patients (excluding epilepsy), 47 DBS trials on Clinicaltrials.gov that include minors, and at least 27 hospitals in the U.S. conducting pDBS.
This study will:
- Examine neuroethics issues within this setting
- Determine how these issues manifest
- Assess their impact from the perspective of stakeholders
- Develop ethically justified guidelines to manage these issues
- Explore ways to improve decision-making and informed consent processes
The long-term goal of this research is to develop empirically informed and ethically justified management plans for the neuroethics challenges presented by invasive neuromodulation in minors. This work aims to prevent ethical missteps and misuses of DBS in children. The first step is to identify pressing neuroethics issues and decisional needs related to pDBS from the perspective of key stakeholders and to develop a decision aid for those considering pDBS. This study will empirically examine neuroethics challenges associated with pDBS for neuropsychiatric and movement disorders. By identifying and understanding pDBS neuroethics issues, we hope to develop management plans that promote responsible research and translation of pDBS and maximize its social benefit. If pDBS is eventually considered safe and effective, addressing these neuroethics challenges will support broader adoption of this neurotechnology among the many patients who could benefit.
Neuroethics of aDBS Systems Targeting Neuropsychiatric and Movement Disorders
Adaptive deep brain stimulation (aDBS) systems can record neural activity and adjust brain stimulation in real time, and have emerged as a promising alternative to address significant limitations in conventional open- loop DBS treatment of the hundreds of thousands of individuals in the United States who suffer from treatment- resistant neuropsychiatric and movement disorders. However, neuromodulation using deep brain stimulation that can alter mood or motor outputs, has raised numerous ethical, legal, and social (“neuroethics”) concerns (e.g., dehumanization, changes in personal identity, threats to autonomy/agency, post-trial care, and device maintenance), and aDBS systems may exacerbate these concerns and raise novel neuroethics issues (e.g., privacy, use, and ownership of neural data). This study will promote the responsible research and translation of aDBS systems by empirically identifying and examining neuroethics issues raised by aDBS with researchers, patient-participants, their caregivers, and study decliners involved in ongoing aDBS clinical trials.