�����������

Description:  Perceptual computing (PC), in combination with artificial intelligence and machine learning (AI/ML), is poised to revolutionize clinical approaches to diagnosis, personalized treatment (precision medicine), symptom and out- come monitoring, telemedicine/mobile health, and primary prevention across a wide range of disorders. PC tools are rapidly expanding but unresolved ethical and practical challenges stand in the way of responsible translation into clinical care. These challenges stem from the specific, novel features of PC metrics, which differ from traditional measures of emotional and social behavior in that they 1) represent objectively observed rather than subjectively elicited states and may involve collection of digital data that patients may not be aware of or wish to share with their clinicians; 2) collect data passively using digital devices that observe and register moment-to- moment emotional and behavioral information; 3) yield voluminous material (i.e. “big data”) that is difficult to scale into actionable information at the individual level; and 4) rest on data easy to collect and make inferences from, inviting engagement from commercial and other entities whose goals may be profit-driven rather than fiduciary, as in healthcare. Triangulated results from these aims will contribute concrete insights into what diverse stakeholders need to know in order to understand and translate PC metrics into actionable clinical knowledge and will contribute to NCAT’s aims by ensuring the success and predictable impacts of translating PC metrics into clinical care.
Role: MPI (Kostick, Kristin Marie; Herrington, John David; Storch, Eric A; Blumenthal-Barby, Jennifer) 
Funder: National Center for Advancing Translational Sciences (NCATS) - Ethical Issues in Translational Science, NIH
Grant: R01 TR004243
Associated Papers: 

• Sonig, A., Deeney, C., Hurley, M.E. et al. What patients and caregivers want to know when consenting to the use of digital behavioral markers. NPP—Digit Psychiatry Neurosci 2, 19 (2024).
• Sonig, A., Deeney, C., Hurley, M. et al. Ethical concerns of using computer perception technologies among pediatric patients. AI Ethics (2024).
• Kostick-Quenet, K., Estep, J., & Blumenthal-Barby, J. S. (2024). Ethical concerns for remote computer perception in cardiology: New stages for digital health technologies, artificial intelligence, and machine learning. Circulation: Cardiovascular Quality and Outcomes, 17 (5), e010717.
• Hurley, M. E., Sonig, A., Herrington, J., Storch, E. A., Lázaro-Muñoz, G., Blumenthal-Barby, J., & Kostick-Quenet, K. (2024). Ethical considerations for integrating multimodal computer perception and neurotechnology. Frontiers in Human Neuroscience, 18, 1332451.
• Kostick-Quenet, K. M., Herrington, J., & Storch, E. A. (2024). Personalized Roadmaps for Returning Results From Digital Phenotyping. The American Journal of Bioethics, 24(2), 102–105.
• Kostick Quenet, K., & Ayaz, S. S. (2024). Limitations of Patient-Physician Co-Reasoning in AI-Driven Clinical Decision Support Systems. The American Journal of Bioethics, 24(9), 97–99.
• Kostick-Quenet, K., Rahimzadeh, V., Anandasabapathy, S., Hurley, M., Sonig, A., & Mcguire, A. (2023). Integrating Social Determinants of Health into Ethical Digital Simulations. The American Journal of Bioethics, 23(9), 57–60.

Description:  Our NIH-funded project explores ethical and technical challenges of using digital phenotyping (DP) data, which holds promise for advancing personalized medicine but poses privacy risks, aiming to assess stakeholder perspectives on smart contracts (Aim 1) and design an optimal, patient-centered framework (Aim 2) to enhance data sharing control and modernize protections within the evolving DP data ecosystem.
Role: MPI (Kostick, Kristin Marie; Herrington, John David; Storch, Eric A) 
Funder: National Institute of Mental Health (NIMH), NIH
Grant: R01 MH125958-02S1
Associated Papers: 

• Deeney, C.,R., Sonig, A.,  Hurley, M., Tunç , B., Storch, E.A., Herrington, J.D., Blumenthal-Barby, J.S., Kristin Kostick-Quenet. “Stakeholder Perspectives on Trust and Transparency around Digital Health Data”. Under Review.
• Kostick-Quenet, K.M.,  Compagnucci, M.C., Aboy, M., Minssen, T., Patient-centric federated learning: automating meaningful consent to health data sharing with smart contracts, Journal of Law and the Biosciences, Volume 12, Issue 1, January-June 2025, lsaf003,
• Deeney, C. R., & Kostick-Quenet, K. (2023). Computational Ethics Tools to Audit Corporate Self-Governance in Data Processing. The American Journal of Bioethics, 23(11), 42–44.

Description: Esophageal cancer is the 6th leading cause of cancer mortality worldwide. In this renewal, we will build on our prior work developing a low cost, mobile high resolution microendoscope with artificial intelligence to evaluate its performance, acceptability, feasibility and clinical impact in diverse settings in the U.S. and Brazil. 
Role: Co-I (PI: Anandasabapathy, Sharmila; McGuire, Amy) 
Grant: R01CA181275 
Funder: National Cancer Institute (NCI), NIH

Description: Bipolar Disorder (BD) is marked by mood instability and high treatment resistance in depression, and this study aims to explore deep brain stimulation (DBS) in treatment-resistant BD using neural and behavioral monitoring to detect mood transitions, develop clinician-facing tools, and identify neural markers for improving intervention and future adaptive DBS systems.
Role: Co-I (MPI: Goodman, Wayne K; Herron, Jeffrey A.; Sheth, Sameer Anil) 
Funder: National Institute of Neurological Disorders and Stroke (NINDS), NIH
Grant: UH 3NS136631

Description:  This project unites Rice University’s Baker Institute for Public Policy and Baylor College of Medicine’s Center for Medical Ethics and Health Policy to establish a dynamic hub for ethical artificial intelligence in healthcare. Through a series of stakeholder focus groups across the Texas Medical Center, the team will map how AI tools are currently developed, deployed, and integrated in clinical practice, identifying pressing ethical and humanities questions. Findings will feed directly into a new joint undergraduate internship program that immerses Rice students in ethics‑oriented AI research and curriculum design, cultivating the next generation of clinicians and scholars fluent in both technology and humanistic care. Building on these efforts, the collaboration will lay the groundwork for a nationally recognized center dedicated to ethical AI, leveraging Houston’s unique concentration of biomedical expertise to set new standards for responsible innovation in medicine.
Role: MPI (Kostick-Quenet; Rahimzadeh; McGuire) 
Funder: Rice University Educational and Research Initiatives for Collaborative Health (ENRICH)
 

Description:  ����������� is conducting this OI Wellbeing Study as a part of the Brittle Bone Disorders Consortium which aims to improve the lives of people with osteogenesis imperfecta. This study addresses an under-researched aspect of health critical to the wellbeing of the OI community, namely psychological health. Participants meet with a researcher over a secure teleconference platform for about 1 hour and complete a series of questionnaires about mental health, physical health, quality of life, social wellbeing, and experience with health care professionals. This information may help develop psychological interventions personalized for people with OI.
Role: Co-I (PI: Brendan)
Funder: NIH
Grant: U54 AR068069-S1
Associated Papers: 

• Cho, H. E., Shepherd, W. S., Colombo, G. M., Wiese, A. D., Rork, W. C., Kostick, K. M., … Storch, E. A. (2024). Resilience and coping: a qualitative analysis of cognitive and behavioral factors in adults with osteogenesis Imperfecta. Disability and Rehabilitation, 47(3), 709–718.
• Morales, J. M., Wiese, A. D., Shepherd, W. S., Colombo, G. M., Guo, S., Qian, J., … Storch, E. A. (2024). Qualitative investigation of school experiences in children with osteogenesis imperfecta. Children’s Health Care, 1–28.
• Shepherd, W.S., Wiese, A.D., Cho, H.E. et al. Psychosocial Outcomes of Pain and Pain Management in Adults with Osteogenesis Imperfecta: A Qualitative Study. J Clin Psychol Med Settings 31, 614–627 (2024).
• Rork, W. C., Hertz, A. G., Wiese, A. D., Kostick, K. M., Nguyen, D., Schneider, S. C., Shepherd, W. S., Cho, H., Lee, B., Sutton, V. R., & Storch, E. A. (2023). A qualitative exploration of patient perspectives on psychosocial burdens and positive factors in adults with osteogenesis imperfecta. American Journal of Medical Genetics Part A, 191 (9), 2267–2275.

Description:  This project addresses the ethical, legal, and social implications (ELSI) of using synthetic datasets in machine learning (ML) by developing a computational checklist for ethical AI, conducting key informant interviews, and integrating ELSI documentation into predictive models through PREMIERE, ensuring responsible AI practices in biomedical research.
Role: Consultant (MPI: Bui, Alex; Wagner, Jennifer Kristin)
Funder: National Institute of Biomedical Imaging and Bioengineering; NIH
Grant: 3R01EB027650-03S1
Associated Papers:

• Susser, D., Schiff, D. S., Gerke, S., Cabrera, L. Y., Cohen, I. G., Doerr, M., Harrod, J., Kostick-Quenet, K., McNealy, J., Meyer, M. N., Price, W. N., II, & Wagner, J. K. (2024). Synthetic health data: Real ethical promise and peril. Hastings Center Report. Advance online publication.

Description:  Pediatric dystonia is a debilitating movement disorder characterized by involuntary muscle contractions that cause unwanted movements and postures. This progressive disease often results in development of musculoskeletal deformities, which can lead to significant impairments in gait, standing, and hand function thereby severely impacting quality of life.
Since 1999, pediatric deep brain stimulation (pDBS) for refractory dystonia has become increasingly common around the world, but there has been little systematic research (e.g., clinical trials) regarding its safety and effectiveness in minors and limited examination of the ethical challenges and implications of this practice.
The long-term goal of this study is to promote the responsible use of neurotechnologies in children by empirically examining pressing neuroethics issues and decisional and informational needs of using DBS in this vulnerable population. The objectives of this study are 1) to examine which neuroethics issues, if any, actually pose a problem in this setting, determine how these issues manifest, what is the magnitude of the problem from the perspective of stakeholders, and develop ethically-justified guidelines to help manage these issues and 2) to develop a decision aid for families considering pDBS for dystonia. A decision aid for the most common pDBS indication (dystonia) will promote informed decision making, responsible use of DBS in children, and facilitate the development of decision aids for other pediatric neurotechnologies or DBS applications.
Role: Co-I (MPI: Blumenthal-Barby, Jennifer; Lazaro-Munoz, Gabriel; Storch, Eric A.)
Funder: National Institute of Mental Health, NIH
Grant Number: RF1 MH121371
Associated Papers:

• Cenolli, I., Campbell, T. A., Dorfman, N., Hurley, M., Smith, J. N., Kostick-Quenet, K., … Lázaro-Muñoz, G. (2024). Deep Brain Stimulation for Childhood Treatment-Resistant Obsessive-Compulsive Disorder: Mental Health Clinician Views on Candidacy Factors. AJOB Empirical Bioethics, 16(1), 32–41.
• Smith, J. N., Dorfman, N., Hurley, M., Cenolli, I., Kostick-Quenet, K., Storch, E. A., … Blumenthal-Barby, J. (2024). Adolescent OCD Patient and Caregiver Perspectives on Identity, Authenticity, and Normalcy in Potential Deep Brain Stimulation Treatment. Cambridge Quarterly of ����������� Ethics, 33(4), 507–520. doi:10.1017/S0963180124000203
• Kristin M Kostick-Quenet, Lavina Kalwani, Laura N Torgerson, Katrina Munoz, Clarissa Sanchez, Eric A Storch, J. S. Blumenthal-Barby, Gabriel Lazáro-Muñoz; Deep Brain Stimulation for Pediatric Dystonia: Clinicians’ Perspectives on the Most Pressing Ethical Challenges. Stereotact Funct Neurosurg 16 October 2023; 101 (5): 301–313.
• Muñoz, K. A., Kostick, K., Torgerson, L., Zuk, P., Kalwani, L., Sanchez, C., Blumenthal-Barby, J., Storch, E. A., & Lázaro-Muñoz, G. (2021). Pressing ethical issues in considering pediatric deep brain stimulation for obsessive-compulsive disorder. Brain Stimulation, 14(6), 1566–1572.

Description:  The development and efficacy-testing of a holistic, personalized, electronically integrated clinical decision support system for left-ventricular assist device candidates will help to ensure that heart failure patients receive tailored treatments that lead to optimal and values-based outcomes. Our study involves utilization of an AI/machine learning system that predicts personalized risks using big data. Specifically, it applies the most advanced personalized risk prediction technologies and decision support available to make sure that evidence about cardiac outcomes is used by both patients and clinicians in the service of shared decision making that leads to more informed and value-concordant health decisions. The impact of this personalized approach to clinical decision making addresses the urgent need to better identify and respond to the specific and dynamic nature of patient needs in seeking treatment for advanced HF.
We will do this by updating and integrating a validated online risk prediction and communication tool, the Heart Mate 3 Risk Score calculator developed by Dr. Mandeep Mehra and colleagues at Brigham and Women's Hospital, with our efficacy-tested decision aid (Deciding Together) for LVAD. 
This five-year project builds on 6 years of research on the development, implementation and dissemination of LVAD decision support and a decade of research into accurate risk prediction models for LVAD.
Role: Co-I (PI: Blumenthal-Barby, Jennifer)
Funder: Agency for ����������� Research and Quality, NIH
Grant: R01-HS027784
Associated Papers: 

• Kostick-Quenet, K. M., Blumenthal-Barby, J., Mehra, M., Lang, B., Dorfman, N., Bhimaraj, A., Civitello, A., Jorde, U., Trachtenberg, B., Uriel, N., Kaplan, H., Gilmore-Szott, E., Volk, R., & Estep, J. (2022). Integrating personalized risk scores in decision making about left ventricular assist device (LVAD) therapy: Clinician and patient perspectives. The Journal of Heart and Lung Transplantation, 41(4, Supplement), S230.
• Kostick, K.M., Trejo, M., Bhimaraj, A. et al. A principal components analysis of factors associated with successful implementation of an LVAD decision support tool. BMC Med Inform Decis Mak 21, 106 (2021).

Description:  Adaptive deep brain stimulation (aDBS) systems can record neural activity and adjust stimulation in real time. These systems have emerged as a promising alternative to address significant limitations in conventional open-loop DBS treatment of neuropsychiatric and movement disorders. The BRAIN Initiative and others have made substantial investments in studies to accelerate the development of aDBS. However, neuromodulation using DBS that can alter mood or motor outputs, has raised num   erous ethical, legal, and social (neuroethics) concerns (e.g., dehumanization, threats to autonomy/agency, changes in personal identity). aDBS systems may exacerbate these concerns and raise novel neuroethics issues (e.g., privacy, use, and ownership of neural data). Although theoretical bioethics work has explored ethical implications of conventional open-loop DBS for treating various disorders, there is little empirical neuroethics research in this area, and there is a severe lack of neuroethics research about aDBS. These issues need to be empirically examined and addressed to responsibly research and translate aDBS to clinical care. The long-term goal of this research program is to develop an ethically-justified and empirically-informed policy framework for the responsible research and translation of aDBS systems. The objective of this proposal, which was the first step in pursuit of that goal, was to identify the most pressing neuroethics issues related to aDBS research and translation from the perspective of diverse stakeholders across multiple clinical research contexts. Identifying and understanding aDBS neuroethics issues can help develop management plans to promote the responsible research and translation of aDBS, and maximize its social utility.
Role: Co-I (MPI: Lazaro-Munoz, Gabriel; Goodman, Wayne K; Mcguire, Amy L)
Funder: National Institute of Mental Health (BRAIN Initiative), NIH
Grant Number: R01MH114854
Associated Papers: 

• Zuk, P., Sanchez, C. E., Kostick-Quenet, K., Muñoz, K. A., Kalwani, L., Lavingia, R., … Lázaro-Muñoz, G. (2022). Researcher Views on Changes in Personality, Mood, and Behavior in Next-Generation Deep Brain Stimulation. AJOB Neuroscience, 14(3), 287–299.
• Pham, M. T., Campbell, T. A., Dorfman, N., Torgerson, L. N., Kostick-Quenet, K., Blumenthal-Barby, J. S., Storch, E. A., & Lázaro-Muñoz, G. (2023). Participant perceptions of changes in psychosocial domains following participation in an adaptive deep brain stimulation trial. Brain Stimulation, 16  (5), 1053–1060.
• Lázaro-Muñoz, G., Pham, M. T., Muñoz, K. A., Kostick-Quenet, K., Sanchez, C. E., Torgerson, L., Robinson, J., Pereira, S., Outram, S., Koenig, B. A., Starr, P. A., Gunduz, A., Foote, K. D., Okun, M. S., Goodman, W., McGuire, A. L., & Zuk, P. (2022). Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost. Brain Stimulation, 15 (5), 1029–1036.
• Outram, S., Muñoz, K. A., Kostick-Quenet, K., Sanchez, C. E., Kalwani, L., Lavingia, R., Torgerson, L., Sierra-Mercado, D., Robinson, J. O., Pereira, S., Koenig, B. A., Starr, P. A., Gunduz, A., Foote, K. D., Okun, M. S., Goodman, W. K., McGuire, A. L., Zuk, P., & Lázaro-Muñoz, G. (2021). Patient, caregiver, and decliner perspectives on whether to enroll in adaptive deep brain stimulation research. Frontiers in Neuroscience, 15, 734182.
• Zuk, P., Sanchez, C. E., Kostick, K., Torgerson, L., Muñoz, K. A., Hsu, R., Kalwani, L., Sierra-Mercado, D., Robinson, J. O., Outram, S., Koenig, B. A., Pereira, S., McGuire, A. L., & Lázaro-Muñoz, G. (2020). Researcher perspectives on data sharing in deep brain stimulation. Frontiers in Human Neuroscience, 14, 578687.
• Muñoz, K. A., Kostick, K., Sanchez, C., Kalwani, L., Torgerson, L., Hsu, R., Sierra-Mercado, D., Robinson, J. O., Outram, S., Koenig, B. A., Pereira, S., McGuire, A., Zuk, P., & Lázaro-Muñoz, G. (2020). Researcher perspectives on ethical considerations in adaptive deep brain stimulation trials. Frontiers in Human Neuroscience, 14, 578695.

Description:  Despite largescale government and private investment in commercializing space travel, it remains too dangerous and too impractical for most civilians.
We are working to fill critical policy gaps that advance The Translational Research Institute for Space Health (TRISH) mission of translating responsible research on commercial space travel by developing an ethical framework for involving civilians in spaceflight research and formalizing an ethics review service for TRISH researchers. This will occur through a new collaborating partnership between TRISH and the Center for Medical Ethics and Health Policy (CMEHP) at ����������� called METEORS (Mission to enhance Ethics Education, Outreach, and Research in Space). Taken together, METEORS advances the TRISH mission by developing tools to enable the ethical translation of cutting-edge biomedical research and technology development and supports education on how to proportionately balance real human risks with tangible benefits of human space exploration missions moving forward.
Role: Co-I (MPI: Amy McGuire; Vasiliki Rahimzadeh) 
Funder: Translational Research Institute for Space Health (TRISH); Space Health Expeditionary Research Projects Assets (SHERPA) program

Description:  This study aims to assess the clinical utility, ethical implications, and clinician perspectives on polygenic embryo screening (PES) by combining statistical modeling of disease risk reduction with stakeholder interviews and surveys, providing an evidence-based framework to inform the ethical, legal, and social implications of PES.
Role: Co-I (MPI: Lencz, Todd; Carmi, Shai; Lazaro-Munoz, Gabriel)
Funder: National Human Genome Research Institute (NHGRI), NIH
Grant: R01 HG011711

Description:  This project explores ethical, legal, and policy challenges in translating psychiatric genomics research into clinical practice by studying the Genomics of Treatment-Resistant Psychosis (GTRP) study, using ethnographic observation, interviews, and legal analyses to provide evidence-based recommendations for improving consent processes, return of results, and the management of genomic findings in severely mentally ill patients.
Role: Co-I (PI: Lazaro-Munoz, Gabriel)
Funder: National Human Genome Research Institute, NIH
Grant Number: K99/R00 HG008689
Associated Papers: 

• Kostick, K. M., Brannan, C., Pereira, S., & Lázaro-Muñoz, G. (2019). Psychiatric genetics researchers' views on offering return of results to individual participants. American Journal of Medical Genetics Part B: Neuropsychiatric Genetics, 180(8), 589–600.
• Ward, Eric T. MD; Kostick, Kristin M. PhD, MA; Lázaro-Muñoz, Gabriel PhD, JD, MBE. Integrating Genomics into Psychiatric Practice: Ethical and Legal Challenges for Clinicians. Harvard Review of Psychiatry 27(1):p 53-64, 1/2 2019. | DOI: 10.1097/HRP.0000000000000203
• Kostick, K. M., Brannan, C., Pereira, S., & Lázaro-Muñoz, G. (2019). Psychiatric genomics researchers’ concerns about offering return of results to individual participants. European Neuropsychopharmacology, 29(S1), 1028. Elsevier.

Description: This is a research project studying disorders of consciousness (DOC) patients’ family members’ and clinical care team members’ views on consciousness and its moral significance. This research is investigating the following questions by interviewing family members and clinicians:

• What are the perceptions of consciousness regarding vegetative state (VS) and minimally conscious state (MCS) patients, as perceived by those patients' family members and clinicians. How do family members think about consciousness?
• How do VS/MCS patients' family members and clinicians perceive the significance of this consciousness. Is it better to be minimally conscious or not conscious at all? How does degree of consciousness factor into decision making about life support?

Role: Co-I (PI: Blumenthal-Barby, Jennifer) 
Funder: TIRR Memorial Hermann
Grant Number: BCM2015-01
Associated Papers: 

• Peterson A, Kostick KM, O’Brien KA, & Blumenthal-Barby J. Seeing minds in patients with disorders of consciousness. Brain Injury. Feb 23; 34(3) (2020): 390-398.
• Kostick KM, Halm A, O'Brien K, Kothari S, Blumenthal-Barby JS. Conceptualizations of consciousness and continuation of care among family members and health professionals caring for patients in a minimally conscious state. Disability and Rehabilitation. (2019) Dec 5:1-0.

Description:  As part of the Enhancing Life Project, this study, The Vortex of Expectations, examined an emerging field at the frontier of enhancing human life: longevity research. To better understand the strivings for human longevity, the study provided a richly textured, thick description of the needs, goods, cultural resources, and possible futures offered by longevity research and the cultural movements that coalesce around the technologies. This study asked what values, beliefs, social mechanisms, actors, and technologies are at work behind this much-heralded reimagining of anti-aging science. It was the first to explore these assumptions through interviews of the principal actors and observations of the communities of the longevity movement, providing ground level insights into the meaning of human enhancement through the social mechanisms, scientific advances, and future worlds imagined by the principal actors. The research featured both qualitative and quantitative approaches and had three major aims: Aim 1) Map the emerging landscape of the longevity movement. Conduct a content analysis of textual and visual materials related to the longevity field. Aim 2) Use semi-structured interviews and ethnographic observation to study the longevity movement. Participants will include scientists, futurists, technocrats, business leaders, philosophers, citizens, politicians, and allied professionals. Fieldwork would include meetings, technology events, and networking seminars. Analyze these data using grounded theory. Aim 3) Using the data gained from Aims 1 and 2, conduct a situational analysis of the longevity movement. Construct situational, social arena, and positional maps in the broader context of enhancing human life. Present results and widely publish findings.
Role: Senior Methodologist and Research Associate (PI: Lazáro-Muñoz)
Funder: John Templeton Foundation
Grant Number: 1RF1MH121371
Associated Papers: 

• Kostick, KM, Fowler, L., & Scott, C.. Engineering Eden: Does earthly pursuit of eternal life threaten the future of religion? Theology and Science, 17(2). (2019): 209-222.
• Kostick KM, Fowler LR, Scott CT. A matter of life and longer life. Journal of aging studies. 2019 Sep 1;50:100800. PMID: 31526498.