Brain Bioethics Lab
Email: glazaromunoz@mgh.harvard.edu
Overview
The Brain Bioethics Lab examines cutting-edge innovation in genomics and neurotechnology, anticipates potential challenges, and proposes solutions. Our research explores the ethical and social implications of integrating psychiatric genomics into clinical care, polygenic embryo screening, and neurotechnologies such as brain-computer interfaces (BCI) and deep brain stimulation (DBS) systems.
Research Projects
Post-Trial Support for Participants in Implantable Neural Device Trials
Funded by NIMH
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.
Polygenic Embryo Screening: Informed Decision-Making
Funded by NHGRI
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.
Genomic Tests for Substance Use Disorders
In 2023, more than 100,000 people died of an opioid overdose in the United States, and 2.5 million adults in the U.S. have an opioid use disorder (OUD). Paradoxically, people’s access to opioids often happens in the context of medical procedures and are prescribed by clinicians. Opioids are effective in treating moderate to severe pain and are often prescribed following surgical procedures such as back surgery. Iatrogenic harms associated with opioid use for medical purposes (e.g., OUD) pose an ethical and medical conundrum: How to properly balance the risks associated with opioid use with the potential medical benefits in terms of pain management and improved clinical outcomes? To help inform this decision, companies have developed genetic tests that use polygenic risk scores (PRS) to estimate a person’s genetic risk for developing an OUD. The FDA recently approved one such test, and tests for other substance use disorders (SUD) are in development.
A tool that can accurately estimate a person’s genetic risk for OUD, could help prevent opioid prescription, use, and save lives. However, the use of genetic tests to identify people at increased risk of OUD or any SUD is itself, ethically challenging. How reliable are these tests perceived to be, in which circumstances should they be ordered, how much genetic risk for OUD is too much to deny opioids to a patient in pain, how should OUD risk information be managed in the medical record, who could have access to OUD risk results, and how could this information be misused? Furthermore, OUD, other SUDs, and pain are stigmatized which may influence clinician and patient decision-making regarding ordering genetic tests for OUD and integrating results.
Little empirical research has examined the ethical and clinical implications of these novel tests in medicine. The proposed study examines key stakeholders’ (e.g., patients scheduled for surgery, patients with history of OUD, surgeons, pain management specialists, medical geneticists, legal experts) views, concerns, expectations, decision-making factors, and proposals for the responsible use of OUD genetic tests. The long-term goal of this research is to promote patient well-being and advance genomic science by generating data and analysis to inform the responsible use of genetic tests for SUDs in medicine.
The objective of this study is to empirically examine stakeholders’ views, concerns, expectations, and decision-making factors on whether and how to responsibly integrate genomic risk estimates for OUD in surgical care. In Aims 1 and 2, we will conduct semi-structured interviews with patients scheduled for surgery, patients with history of OUD, surgeons, pain management specialists, medical geneticists and other relevant clinicians to examine their views, concerns, expectations, decision-making factors, and proposals for the responsible use of PRS for OUD. In Aim 2, we will also experimentally examine which factors drive clinician decision-making regarding whether to order OUD genetic tests. Finally, in Aim 3, we will conduct a modified Delphi panel with stakeholders to identify the most pressing challenges and potential solutions for the responsible use of OUD genetic tests in medicine.
Polygenic Risk Scores in Child and Adolescent Psychiatry Funded by NIMH
Recent research has identified 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 judgments.
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.
Neurotech Justice Accelerator at Mass General Brigham, a Dana Center for Neuroscience & Society. Funded by the Dana Foundation
The Neurotech Justice Accelerator at MGB (NJAM) is training the next generation of neuroscience and society leaders to improve access to beneficial neurotechnology, promote end-user safety and wellbeing, and establish standards to promote responsible societal use of neurotechnology.
Research Team
Gabriel Lázaro-Muñoz, PhD, JD
Associate Professor of Psychiatry, Harvard Medical School; Lead Investigator, Brain Bioethics Lab
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 varied populations. He collaborates closely with technology developers and stakeholders to anticipate ELSI issues and create actionable research insights to inform policy.
Dr. Lázaro-Muñoz has secured over $25 million in research funding and published over 100 manuscripts. His funding track record includes seven NIH R01 awards to examine developments in genomics and neurotechnology. Previous grants have supported research on neurotechnologies, including adaptive or closed-loop DBS systems (R01MH114854) and DBS use in pediatric populations (R01MH121371).
Dr. Lázaro-Muñoz’s current work is funded by the BRAIN Initiative, National Institute of Mental Health (NIMH), and the National Human Genome Research Institute (NHGRI), the National Institute on Drug Abuse (NIDA) and the Dana Foundation.
- Post-trial Support: 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)
- Polygenic Embryo Screening: 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)\
- Opioid Use Disorder Genomics in Medicine: Genomic tests for substance use disorders in clinical care: Examining Challenges and Opportunities (R01DA062848)
- Psychiatric Genomics: Integrating psychiatric genomics (e.g., polygenic risk scores, pharmacogenetics) into clinical care (R01MH128676)
- Neurotech Justice Accelerator at MGB (NJAM), a Dana Center for Neuroscience and Society
At a 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 been a reviewer on more than 15 NIH grant review panels and is a member of the editorial board of Genetics in Medicine (editorial board). Dr. Lázaro-Muñoz is Co-Founder and Co-Director of the Neurotech Justice Accelerator at Mass General Brigham (NJAM), 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 the Today Show, Le Monde, ABC Australia, LA Times, Scientific American, STAT News, National Public Radio, Huffington Post, Nature, MIT Technology Review, The Verge, Nature, Nature Medicine, and 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 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
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
Rémy Furrer, PhD, is a behavioral scientist who examines the psychosocial implications of emerging biotechnologies by studying how people perceive, interpret, and respond to them. He is a postdoctoral research fellow in the Department of Neurosurgery at Massachusetts General Hospital and Harvard Medical School, where he uses randomized experiments, decision-making paradigms, interviews, and surveys to study how patients, clinicians, and the public engage with complex biomedical information. He earned his PhD in Psychology from the University of Virginia, where his interdisciplinary research spanned social psychology, cognitive science, and affective science, and then completed a postdoctoral fellowship at Harvard Medical School’s Center for Bioethics.
Dr. Furrer’s research explores how cognitive and emotional processes shape information processing, moral judgment, medical decision-making, and behavioral health outcomes. His current work focuses on the psychosocial implications of genomic and neurotechnologies, particularly polygenic risk scores (PRS) and polygenic embryo screening (PGT-P). Using mixed methods and experimental designs, he investigates how patients, clinicians, and the public understand these technologies and develops human-centered approaches to communicating complex health information.
His research has been published in journals including JAMA Network Open, Proceedings of the National Academy of Sciences, Journal of Personality and Social Psychology, Genetics in Medicine, Device, NPJ Genomic Medicine, and Emotion. He has also published op-eds in The Boston Globe and Psyche/Aeon. His work has also been featured in media outlets including The New York Times, The Washington Post, The Boston Globe, The Atlantic, CBS News, NBC’s Today, MIT Technology Review, STAT, Forbes, Vox, and Medscape, among others.
Erika Versalovic
Postdoctoral Research Fellow, Brain Bioethics Lab
Dr. Versalovic uses 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.