Publications

SCBE faculty and fellows publish often in leading journals. SCBE is also home to the editorial office of the American Journal of Bioethics (AJOB).

 

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Clinical Associate Professor, Anesthesiology, Perioperative and Pain Medicine Clinical Associate Professor (By courtesy), Pediatrics

Publications

  • Chemical Restraints for Obstetric Violence: Anesthesiology Professionals, Moral Courage, and the Prevention of Forced and Coerced Surgeries. The American journal of bioethics : AJOB Burgart, A., Sutton, C. 2024; 24 (2): 4-7

    View details for DOI 10.1080/15265161.2024.2299629

    View details for PubMedID 38295250

  • Physician Unionization: Opportunities and Challenges for Anesthesiologists in the United States. Anesthesia and analgesia Hendrix, J. M., Burgart, A. M., Baker, E. B., Wolman, R. L., Kras, J. F. 2023

    Abstract

    Physician unionization is gaining traction in the United States, with <10% of practicing physicians now members, up from historically weak support. Factors that drive interest in unions include a decreased number of independent practitioners, an increase in workloads, and the erosion of autonomy. Approximately 56% of anesthesiologists are considered employees and may be eligible for union membership. Physician unions may provide higher wages, better working conditions, and legal protection. However, they also raise concerns about patient care and professionalism. This article discusses the legal and regulatory framework governing the unionization of physicians, benefits, challenges, and potential future developments. Continued analysis and debate are necessary to determine the optimal role of physician unions in the health care industry.

    View details for DOI 10.1213/ANE.0000000000006852

    View details for PubMedID 38091478

  • Recommendations for the use of pediatric data in artificial intelligence and machine learning ACCEPT-AI. NPJ digital medicine Muralidharan, V., Burgart, A., Daneshjou, R., Rose, S. 2023; 6 (1): 166

    Abstract

    ACCEPT-AI is a framework of recommendations for the safe inclusion of pediatric data in artificial intelligence and machine learning (AI/ML) research. It has been built on fundamental ethical principles of pediatric and AI research and incorporates age, consent, assent, communication, equity, protection of data, and technological considerations. ACCEPT-AI has been designed to guide researchers, clinicians, regulators, and policymakers and can be utilized as an independent tool, or adjunctively to existing AI/ML guidelines.

    View details for DOI 10.1038/s41746-023-00898-5

    View details for PubMedID 37673925

    View details for PubMedCentralID PMC10482936

Associate Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric)

Publications

  • Whether Designated as Research or Not, Who Resolves Ethical Considerations Emerging with Healthcare AI? The American journal of bioethics : AJOB Char, D. 2024; 24 (10): 93-95

    View details for DOI 10.1080/15265161.2024.2388752

    View details for PubMedID 39283381

  • Ethical Considerations in the Design and Conduct of Clinical Trials of Artificial Intelligence. JAMA network open Youssef, A., Nichol, A. A., Martinez-Martin, N., Larson, D. B., Abramoff, M., Wolf, R. M., Char, D. 2024; 7 (9): e2432482

    Abstract

    Importance: Safe integration of artificial intelligence (AI) into clinical settings often requires randomized clinical trials (RCT) to compare AI efficacy with conventional care. Diabetic retinopathy (DR) screening is at the forefront of clinical AI applications, marked by the first US Food and Drug Administration (FDA) De Novo authorization for an autonomous AI for such use.Objective: To determine the generalizability of the 7 ethical research principles for clinical trials endorsed by the National Institute of Health (NIH), and identify ethical concerns unique to clinical trials of AI.Design, Setting, and Participants: This qualitative study included semistructured interviews conducted with 11 investigators engaged in the design and implementation of clinical trials of AI for DR screening from November 11, 2022, to February 20, 2023. The study was a collaboration with the ACCESS (AI for Children's Diabetic Eye Exams) trial, the first clinical trial of autonomous AI in pediatrics. Participant recruitment initially utilized purposeful sampling, and later expanded with snowball sampling. Study methodology for analysis combined a deductive approach to explore investigators' perspectives of the 7 ethical principles for clinical research endorsed by the NIH and an inductive approach to uncover the broader ethical considerations implementing clinical trials of AI within care delivery.Results: A total of 11 participants (mean [SD] age, 47.5 [12.0] years; 7 male [64%], 4 female [36%]; 3 Asian [27%], 8 White [73%]) were included, with diverse expertise in ethics, ophthalmology, translational medicine, biostatistics, and AI development. Key themes revealed several ethical challenges unique to clinical trials of AI. These themes included difficulties in measuring social value, establishing scientific validity, ensuring fair participant selection, evaluating risk-benefit ratios across various patient subgroups, and addressing the complexities inherent in the data use terms of informed consent.Conclusions and Relevance: This qualitative study identified practical ethical challenges that investigators need to consider and negotiate when conducting AI clinical trials, exemplified by the DR screening use-case. These considerations call for further guidance on where to focus empirical and normative ethical efforts to best support conduct clinical trials of AI and minimize unintended harm to trial participants.

    View details for DOI 10.1001/jamanetworkopen.2024.32482

    View details for PubMedID 39240560

  • What Do We Do with Physicians When Autonomous AI-Enabled Workflow is Better for Patient Outcomes? The American journal of bioethics : AJOB Abramoff, M. D., Char, D. 2024; 24 (9): 93-96

    View details for DOI 10.1080/15265161.2024.2377111

    View details for PubMedID 39225989

Professor (Research) of Pediatrics (Center for Biomedical Ethics) and of Medicine (Primary Care and Population Health)

Publications

  • A Justice-First Approach to Ambient Intelligence in Healthcare AMERICAN JOURNAL OF BIOETHICS Herington, J., Cho, M. K. 2025: 1-12

    Abstract

    Ambient intelligence systems (AIS) are increasingly deployed to provide persistent, artificially intelligent, monitoring and documentation of healthcare. AIS pose many ethical issues, including risks to the privacy of third parties, pernicious biases in predictive analytics, and intractable conflicts between the interests of patients, family members and care providers. In this paper we argue that these risks cannot be effectively navigated by applying a traditional bioethical framework. The traditional bioethical framework focuses heavily on protecting the autonomy and interests of a patient within the context of a single decision. An AIS, on the other hand, occupies a physical space and thus implicates multiple stakeholders, with interests that may conflict, in a setting where individually opting out of the interaction may be impractical or infeasible. Hence, we argue that, like many questions arising in the context of public health ethics, they should be dealt with through a "justice-first" approach to ethical theorizing.

    View details for DOI 10.1080/15265161.2025.2497972

    View details for Web of Science ID 001484833600001

    View details for PubMedID 40340546

  • An ecosystem approach to governing commercial actors in healthcare AI POLICY STUDIES Waeiss, Q., Cho, M. K. 2025
  • Design and implementation of an action plan for justice, equity, diversity, and inclusion within the Clinical Genome Resource. American journal of human genetics Popejoy, A. B., Ritter, D. I., Azzariti, D., Berg, J. S., Bulkley, J. E., Cho, M., Gonzaga-Jauregui, C., Klein, T. E., Martschenko, D. O., Oni-Orisan, A., Ramos, E. M., Rehm, H. L., Riggs, E. R., Wright, M. W., Yudell, M., Plon, S. E., Morales, J. 2025

    Abstract

    How might members of a large, multi-institutional research and resource consortium foster justice, equity, diversity, and inclusion as central to its mission, goals, governance, and culture? These four principles, often referred to as JEDI, can be aspirational-but to be operationalized, they must be supported by concrete actions, investments, and a persistent long-term commitment to the principles themselves, which often requires self-reflection and course correction. We present here the iterative design process implemented across the Clinical Genome Resource (ClinGen) that led to the development of an action plan to operationalize JEDI principles across three major domains, with specific deliverables and commitments dedicated to each. Active involvement of consortium leadership, buy-in from its members at all levels, and support from NIH program staff at pivotal stages were essential to the success of this effort. The ClinGen JEDI action plan that resulted from our process is a living document and roadmap whose target goals and deliverables will continue to evolve. Here, we offer a transparent account of how a large, multi-site biomedical research consortium achieved this, as well as the challenges and opportunities we encountered on this first step in our journey toward enacting JEDI principles in our sphere of influence. We hope that others seeking to engage in this work will gain valuable insights from our process, experience, and lessons learned.

    View details for DOI 10.1016/j.ajhg.2024.12.009

    View details for PubMedID 39793579

Social Science Research Scholar, School of Medicine - Biomedical Ethics

Publications

  • Not in my AI: Moral engagement and disengagement in health care AI development. Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing Nichol, A. A., Halley, M. C., Federico, C. A., Cho, M. K., Sankar, P. L. 2023; 28: 496-506

    Abstract

    Machine learning predictive analytics (MLPA) are utilized increasingly in health care, but can pose harms to patients, clinicians, health systems, and the public. The dynamic nature of this technology creates unique challenges to evaluating safety and efficacy and minimizing harms. In response, regulators have proposed an approach that would shift more responsibility to MLPA developers for mitigating potential harms. To be effective, this approach requires MLPA developers to recognize, accept, and act on responsibility for mitigating harms. In interviews of 40 MLPA developers of health care applications in the United States, we found that a subset of ML developers made statements reflecting moral disengagement, representing several different potential rationales that could create distance between personal accountability and harms. However, we also found a different subset of ML developers who expressed recognition of their role in creating potential hazards, the moral weight of their design decisions, and a sense of responsibility for mitigating harms. We also found evidence of moral conflict and uncertainty about responsibility for averting harms as an individual developer working in a company. These findings suggest possible facilitators and barriers to the development of ethical ML that could act through encouragement of moral engagement or discouragement of moral disengagement. Regulatory approaches that depend on the ability of ML developers to recognize, accept, and act on responsibility for mitigating harms might have limited success without education and guidance for ML developers about the extent of their responsibilities and how to implement them.

    View details for PubMedID 36541003

  • Stronger regulation of AI in biomedicine. Science translational medicine Trotsyuk, A. A., Federico, C. A., Cho, M. K., Altman, R. B., Magnus, D. 2023; 15 (713): eadi0336

    Abstract

    Regulatory agencies need to ensure the safety and equity of AI in biomedicine, and the time to do so is now.

    View details for DOI 10.1126/scitranslmed.adi0336

    View details for PubMedID 37703349

  • Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials. Contemporary clinical trials Federico, C. A., Heagerty, P. J., Lantos, J., O'Rourke, P., Rahimzadeh, V., Sugarman, J., Weinfurt, K., Wendler, D., Wilfond, B. S., Magnus, D. 2022: 106703

    Abstract

    Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.

    View details for DOI 10.1016/j.cct.2022.106703

    View details for PubMedID 35176501

Deane F. and Kate Edelman Johnson Professor of Law and, Professor, by courtesy, of Genetics

Publications

  • Life scientists react to Trump's election victory NATURE Clark, A., Topol, E., Greely, H., Karim, S., Karim, Q., Laxminarayan, R. 2024; 635 (8040): 812-814

    View details for Web of Science ID 001376888000001

    View details for PubMedID 39587290

  • Toward a framework for risk mitigation of potential misuse of artificial intelligence in biomedical research NATURE MACHINE INTELLIGENCE Trotsyuk, A. A., Waeiss, Q., Bhatia, R., Aponte, B. J., Heffernan, I. L., Madgavkar, D., Felder, R., Lehmann, L., Palmer, M. J., Greely, H., Wald, R., Goetz, L., Trengove, M., Vandersluis, R., Lin, H., Cho, M. K., Altman, R. B., Endy, D., Relman, D. A., Levi, M., Satz, D., Magnus, D. 2024
  • The NIH BRAIN Initiative: Integrating Neuroethics and Neuroscience. Neuron Ramos, K. M., Grady, C., Greely, H. T., Chiong, W., Eberwine, J., Farahany, N. A., Johnson, L. S., Hyman, B. T., Hyman, S. E., Rommelfanger, K. S., Serrano, E. E., Churchill, J. D., Gordon, J. A., Koroshetz, W. J. 2019; 101 (3): 394–98

    Abstract

    The NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is focused on developing new tools and neurotechnologies to transform our understanding of the brain, and neuroethics is an essential component of this research effort. Coordination with other brain projects around the world will help maximize success.

    View details for DOI 10.1016/j.neuron.2019.01.024

    View details for PubMedID 30731065

Assistant Professor (Research) of Pediatrics (Stanford Center for Biomedical Ethics)

Publications

  • Sustainability in translational genomics research with undiagnosed patients: What is it, why do we need it, and how do we do it? Genetics in medicine : official journal of the American College of Medical Genetics Young, J. L., Tang, C., Liang, L., Ashley, E., Tabor, H. K., Halley, M. C. 2025: 101458

    Abstract

    Genomics research enrolling undiagnosed patients can provide answers for one-third of participants and more can be diagnosed through future reanalysis. The long-term value for participants has raised questions of the "sustainability" of these studies, but the meaning, goals and best practices for sustainability remain unclear.We conducted semi-structured interviews with researchers leading studies enrolling undiagnosed patients in the United States and Canada and utilized thematic content analysis to summarize key themes.Researchers lacked consensus regarding what "sustainability" was actually intended to sustain, variably referencing study procedures, personnel, data access, and participant recontact. However, the primary driver of sustainability was widely shared as the perceived obligation to continue to search for answers for undiagnosed participants. Proposed sustainability strategies included diversifying funding sources, developing centralized data infrastructure, and building collaborations across disciplines and institutions. Researchers also emphasized the need to address ethical concerns, to integrate research with clinical care, and for leadership from research funders to guide these efforts.While genomics researchers perceived continued obligations to undiagnosed participants, they also lacked a shared understanding of the goals of sustainability and called for coordinated efforts to develop centralized infrastructure that integrated research and clinical care.

    View details for DOI 10.1016/j.gim.2025.101458

    View details for PubMedID 40411343

  • Exploring how claims of 'suffering' are operationalized in pediatric critical care. Journal of pain and symptom management Grekov, K., Batten, J., Tate, T., Anand, K. J., Magnus, D., Halley, M. C. 2025

    Abstract

    Identifying when a child is suffering can be incredibly challenging. Understanding how the term 'suffering' is used in pediatric critical care - and specifically end of life care - is critical for clinical decision-making, communication, and goal-setting between healthcare providers and families. To gain insight into this complex question, we employed ethnographic methods to explore the underlying meanings and goals associated with the use of this term by clinicians, patients, and families in the Pediatric Intensive Care Unit (PICU).To explore how the term 'suffering' is operationalized by clinicians and families in Pediatric Intensive Care Units (PICUs) and its implications for decision-making.This study was conducted in three specialized PICUs within a large tertiary children's hospital. This exploratory qualitative study used ethnographic methods, including narrative literature review, analysis of verbatim transcripts of 30 care conferences and 50 ethnographic observations involving physicians, nurses, and families. Analyses employed an iterative, interpretive approach to identify key themes across data sources.This study identified three main themes: 1) 'Suffering' was rarely defined, 2) Discussions of patient 'suffering' included collateral impacts on providers and families, in addition to impacts on patient experience; and 3) Physicians used 'suffering' to pivot goals of care, while parents used it variably.These findings suggest that 'suffering' is often invoked in the PICU with little specificity, is used to signal provider or caregiver distress, and is used with the intention to shift goals of care in a manner not always consistent with family values or interpretations. Recognizing the implicit messages conveyed through language may support families and healthcare providers to better communicate their goals and preferences, fostering collaborative decision-making and enhancing patient outcomes in the PICU and during end-of-life care.

    View details for DOI 10.1016/j.jpainsymman.2025.05.005

    View details for PubMedID 40389182

  • "Learning from those who know the system inside and out": Experiences of physician mothers who are informal caregivers. Families, systems & health : the journal of collaborative family healthcare Semere, W., Ponce, A. N., Linos, E., Jagsi, R., Mangurian, C., Halley, M. C. 2024

    Abstract

    For physicians, the added responsibility of being an informal caregiver (IC, providing regular care for seriously ill loved ones) can create challenges such as increased rates of burnout that have received little attention. In this study, we explored physician mothers' informal caregiving experiences and probed their perspectives on how health systems can better support their needs.From September 14, 2021, to October 31, 2021, we distributed an online survey to a national sample of physician mothers who self-identified as ICs; survey questions examined their caregiving responsibilities and perspectives on workplace changes needed to support them.Of 23 respondents, 48% were caregivers for a child, and 74% coresided with their care recipient; 26% spent on average 40 hr per week caregiving and 44% were ICs for 5 years or more. Main caregiving responsibilities included communicating with health care providers (91%) and managing and/or attending medical appointments (70%). Three central themes emerged from open-ended questions: (a) "It's an exhausting and unrecognized burden"; (b) "Our health care system is difficult to navigate, even for physicians"; and (c) "Flexible work schedules, no penalties." Within these themes, respondents described feeling unrecognized and unsupported as ICs in their workplaces.Physician mothers who are ICs fill critical, demanding roles as health care leaders and caregivers at home. Balancing these dual roles presents significant challenges that can have adverse effects, leaving physician-mother ICs vulnerable to burnout and attrition. Targeted support strategies including flexible staffing models, expanded telehealth, and paid informal caregiving leave may improve experiences for physician ICs more generally. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

    View details for DOI 10.1037/fsh0000945

    View details for PubMedID 39666478

Clinical Professor, Medicine - Primary Care and Population Health

Publications

  • Education About Specialty Palliative Care Among Non-Healthcare Workers: A Systematic Review. Journal of pain and symptom management Smith, G. M., Singh, N., Hui, F., Sossenheimer, P. H., Hannah, J. M., Romano, P., Wong, H. C., Heidari, S. N., Harman, S. M. 2023

    Abstract

    Despite the expansion of palliative care (PC) services, the public has little knowledge and holds misperceptions about PC, creating barriers to accessing timely specialty PC.To systematically review the evidence regarding the efficacy of educational interventions to improve knowledge and attitudes about PC among non-healthcare workers.We searched five databases (PubMed/MEDLINE, Embase, CIANHL, Web of Science, and Scopus) for studies investigating educational interventions about specialty PC in adults who identified as patients, caregivers, or members of the public. We included studies that were available in English and had a comparator group. We excluded studies that only sampled health professionals or children. We used the Mixed Methods Appraisal Tool to assess quality and risk of bias.Of 12,420 records identified, we screened 5,948 abstracts and assessed 526 full texts for eligibility. 21 articles were extracted for analysis, representing 20 unique educational interventions. Common methodologies included quasi-experimental (9, 45%), randomized controlled trial (4, 20%), and non-randomized trial (2, 10%). Common components of the educational interventions included video presentations (9, 45%), written materials (8, 40%), and lectures (4, 20%). Content included definition (14, 70%) and philosophy (14, 70%) of PC, distinctions between PC and hospice (11, 55%), and eligibility for PC (11, 55%). Fourteen (70%) interventions showed statistically significant positive differences in either knowledge or attitudes about PC.While educational interventions can positively impact knowledge and attitudes about PC among non-healthcare workers, more research is needed to inform the design, delivery, and evaluation of interventions to increase knowledge and attitudes about PC.

    View details for DOI 10.1016/j.jpainsymman.2023.09.023

    View details for PubMedID 37797678

  • Designing Code Status Orders that Convey Patient Preferences for Emergency Intubation: A Qualitative Assessment Batten, J., Blythe, J., Shearer, E., Dzeng, E., Cotler, M., Porter-Williamson, K., Kayser, J., Harman, S., Magnus, D., Wieten, S. LIPPINCOTT WILLIAMS & WILKINS. 2023: 170
  • "No Escalation of Treatment" Designations: A Multi-Institutional Exploratory Qualitative Study. Chest Batten, J. N., Blythe, J. A., Wieten, S. E., Dzeng, E., Kruse, K. E., Cotler, M. P., Porter-Williamson, K., Kayser, J. B., Harman, S. M., Magnus, D. 2022

    Abstract

    BACKGROUND: No Escalation of Treatment (NoET) designations are used in intensive care units internationally to limit treatment for critically ill patients. However, they are the subject of debate in the literature and have not been qualitatively studied.QUESTION: How do physicians understand and perceive NoET designations, especially with regards to their utility and associated challenges? What mechanisms do hospitals provide to facilitate the use of NoET designations?STUDY DESIGN AND METHODS: Qualitative study at seven United States hospitals, employing semi-structured interviews with thirty physicians and review of relevant institutional records (e.g., hospital policies, screenshots of ordering menus in the electronic health record).RESULTS: At all hospitals, participants reported the use of NoET designations, which were understood to mean that providers should withhold new or higher-intensity interventions ("escalations") but not withdraw ongoing interventions. Three hospitals provided a specific mechanism for designating a patient as NoET (e.g., a DNR/Do-Not-Escalate code status order); at the remaining hospitals, a variety of informal methods (e.g., verbal handoffs) were used. We identified five functions of NoET designations: (1) Defining an intermediate point of treatment limitation, (2) Helping physicians navigate pre-arrest clinical decompensations, (3) Helping surrogate decision makers transition toward comfort care, (4) Preventing patient harm from invasive measures, and (5) Conserving critical care resources. Across hospitals, participants reported implementation challenges related to the ambiguity in meaning of NoET designations.INTERPRETATION: Despite ongoing debate, NoET designations are used in a varied sample of hospitals and are perceived as having multiple functions, suggesting they may fulfill an important need in the care of critically ill patients, especially at the end of life. The use of NoET designations can be improved through the implementation of a formal mechanism that encourages consistency across providers and clarifies the meaning of "escalation" for each patient.

    View details for DOI 10.1016/j.chest.2022.08.2211

    View details for PubMedID 36007596

Sr Research Scholar, Pediatrics - Center for Biomedical Ethics

Publications

  • Excavating the Personal Genome: The Good Biocitizen in the Age of Precision Health HASTINGS CENTER REPORT Lee, S. 2020; 50: S54–S61

    Abstract

    The rise of genomic technologies has catalyzed shifts in the health care landscape through the commercialization of genome sequencing and testing services in the genomics marketplace. The development of consumer genomics into a growing array of information technologies aimed at collecting, curating, and broadly sharing personal data and biological materials reconstitutes the meaning of health and reframes patients into biocitizens. In this context, the good biocitizen is expected to assume personal responsibility for health through consumption of genomic information and acquiescence to public and private efforts at data surveillance and aggregation. These shifts raise fundamental questions about how competing interests of the public, the state, and corporate entities will be reconciled and what trade-offs are demanded for the promise of precision health.

    View details for DOI 10.1002/hast.1156

    View details for Web of Science ID 000543918300008

    View details for PubMedID 32597530

  • Obligations of the "Gift": Reciprocity and Responsibility in Precision Medicine. The American journal of bioethics : AJOB Lee, S. S. 2020: 1–15

    Abstract

    Precision medicine relies on data and biospecimens from participants who willingly offer their personal information on the promise that this act will ultimately result in knowledge that will improve human health. Drawing on anthropological framings of the "gift," this paper contextualizes participation in precision medicine as inextricable from social relationships and their ongoing ethical obligations. Going beyond altruism, reframing biospecimen and data collection in terms of socially regulated gift-giving recovers questions of responsibility and care. As opposed to conceiving participation in terms of donations that elide clinical labor critical to precision medicine, the gift metaphor underscores ethical commitments to reciprocity and responsibility. This demands confronting inequities in precision medicine, such as systemic bias and lack of affordability and access. A focus on justice in precision medicine that recognizes the sociality of the gift is a critical frontier for bioethics.

    View details for DOI 10.1080/15265161.2020.1851813

    View details for PubMedID 33325811

  • Integrating stakeholder feedback in translational genomics research: an ethnographic analysis of a study protocol's evolution. Genetics in medicine : official journal of the American College of Medical Genetics Kraft, S. A., McMullen, C. n., Lindberg, N. M., Bui, D. n., Shipman, K. n., Anderson, K. n., Joseph, G. n., Duenas, D. M., Porter, K. M., Kauffman, T. L., Koomas, A. n., Ransom, C. L., Jackson, P. n., Goddard, K. A., Wilfond, B. S., Lee, S. S. 2020

    Abstract

    This study describes challenges faced while incorporating sometimes conflicting stakeholder feedback into study design and development of patient-facing materials for a translational genomics study aiming to reduce health disparities among diverse populations.We conducted an ethnographic analysis of study documents including summaries of patient advisory committee meetings and interviews, reflective field notes written by study team members, and correspondence with our institutional review board (IRB). Through this analysis, we identified cross-cutting challenges for incorporating stakeholder feedback into development of our recruitment, risk assessment, and informed consent processes and materials.Our analysis revealed three key challenges: (1) balancing precision and simplicity in the design of study materials, (2) providing clinical care within the research context, and (3) emphasizing potential study benefits versus risks and limitations.While involving patient stakeholders in study design and materials development can increase inclusivity and responsiveness to patient needs, patient feedback may conflict with that of content area experts on the research team and IRBs who are tasked with overseeing the research. Our analysis highlights the need for further empirical research about ethical challenges when incorporating patient feedback into study design, and for dialogue with genomic researchers and IRB representatives about these issues.

    View details for DOI 10.1038/s41436-020-0763-z

    View details for PubMedID 32089547

Thomas A. Raffin Professor of Medicine and Biomedical Ethics and Professor (Teaching) of Medicine (Primary Care and Population Health)

Publications

  • A Qualitative Analysis of Physician Communication During Brain Death Conversations: Dead With a Heartbeat. Neurology. Clinical practice Rao, A., Shen, J. X., Fisher, P. G., Magnus, D. 2025; 15 (4): e200484

    Abstract

    In recent decades, many legal cases have resulted from physicians ineffectively communicating to a family that their loved one is brain dead (brain dead/death by neurologic criteria [BD/DNC]). Although the definition of BD/DNC has recently undergone revision, little research has been conducted to establish optimal approaches in communicating BD/DNC status to families. The aim of this study was to characterize what highly experienced physicians perceive to be the best communication practices and language choices during BD/DNC conversations.In this qualitative study, we conducted semistructured, in-depth interviews with physician leaders in the field of BD/DNC between September 2023 and January 2024. All interviews were conducted through Zoom. Twenty expert physician participants were recruited from multiple institutions across the United States through convenience sampling. Participants were current or former attending physicians whose practices at academic institutions involved communication with families about BD/DNC in either the pediatric or adult setting. Participants completed a Qualtrics form containing questions about their demographic background and practice characteristics, including an estimate of the number of times they communicated BD/DNC to patient families. Semistructured interviews were conducted with each of the participants and included hypothetical scenarios and views about best practices.Using 20 qualitative interview transcripts, we identified multiple areas of agreement and disagreement among expert physicians regarding best practices in communicating BD/DNC status. While physicians concurred on specific language to use and avoid, they differed on whether to use the word "coma," on when to introduce the possibility of brain death, and on whether to analogize with cardiac death. There was strong agreement on the utility of visualization through imaging and family attendance at BD/DNC testing. Finally, physicians were in consensus that multiple family meetings with the same providers are crucial for successful BD/DNC communication.This study described main convergences and divergences in physician language during BD/DNC conversations and used qualitative data to present a "train journey" theory of ideal physician communication with families. By investigating and improving physician communication styles during BD/DNC conversations, the medical community may ameliorate the legal and medical fallout that results from clinical miscommunication.

    View details for DOI 10.1212/CPJ.0000000000200484

    View details for PubMedID 40510874

    View details for PubMedCentralID PMC12153502

  • The Unsuccessful Effort to Revise the Uniform Determination of Death Act. JAMA Truog, R. D., Magnus, D. C. 2023

    Abstract

    This Viewpoint summarizes the major issues that led to the decision to draft a revision of the Uniform Determination of Death Act, the alternatives that were considered, why there was failure to reach consensus, and what this means for the future.

    View details for DOI 10.1001/jama.2023.24475

    View details for PubMedID 38060232

  • Stronger regulation of AI in biomedicine. Science translational medicine Trotsyuk, A. A., Federico, C. A., Cho, M. K., Altman, R. B., Magnus, D. 2023; 15 (713): eadi0336

    Abstract

    Regulatory agencies need to ensure the safety and equity of AI in biomedicine, and the time to do so is now.

    View details for DOI 10.1126/scitranslmed.adi0336

    View details for PubMedID 37703349

John and Terry Levin Family Professor of Medicine and Professor, by courtesy, of Emergency Medicine and of Medicine

Publications

  • Wishing That Your Patient Would Die: Reasons and Reactions. The primary care companion for CNS disorders Sher, Y., Hussain, F., Hoover, B. J., Gunther, M., Fishman, D. O., Zein, M., Maldonado, J. R., Stern, T. A. 2025; 27 (1)

    Abstract

    The Psychiatric Consultation Service at Massachusetts General Hospital sees medical and surgical inpatients with comorbid psychiatric symptoms and conditions. During their twice-weekly rounds, Dr Stern and other members of the Consultation Service discuss diagnosis and management of hospitalized patients with complex medical or surgical problems who also demonstrate psychiatric symptoms or conditions. These discussions have given rise to rounds reports that will prove useful for clinicians practicing at the interface of medicine and psychiatry.Prim Care Companion CNS Disord 2025;27(1):24f03823.Author affiliations are listed at the end of this article.

    View details for DOI 10.4088/PCC.24f03823

    View details for PubMedID 40048280

  • Investigating Sepsis-Associated Delirium Through Optical Neuroimaging: A New Frontier in Critical Care Research CHEMOSENSORS Jiang, S., Gunther, M., Maldonado, J. R., Efron, P. A., Dekosky, S. T., Jiang, H. 2024; 12 (12)
  • Pimavanserin for Delirium Management in the Setting of Parkinson's Disease: A Case Report. Journal of the Academy of Consultation-Liaison Psychiatry Gunther, M., Jiang, S., Maldonado, J. R. 2024

    View details for DOI 10.1016/j.jaclp.2024.07.007

    View details for PubMedID 39069171

Assistant Professor (Research) of Pediatrics (Biomedical Ethics) and, by courtesy, of Psychiatry and Behavioral Sciences (Child and Adolescent Psychiatry and Child Development)

Publications

  • Rationales and Approaches to Protecting Brain Data: a Scoping Review NEUROETHICS Jwa, A. S., Martinez-Martin, N. 2024; 17 (1)
  • Re-thinking the Ethics of International Bioethics Conferencing. The American journal of bioethics : AJOB Brown, T. E., Martinez-Martin, N., Cabrera, L. Y. 2024; 24 (4): 55-57

    View details for DOI 10.1080/15265161.2024.2308128

    View details for PubMedID 38529987

  • Peer review of GPT-4 technical report and systems card. PLOS digital health Gallifant, J., Fiske, A., Levites Strekalova, Y. A., Osorio-Valencia, J. S., Parke, R., Mwavu, R., Martinez, N., Gichoya, J. W., Ghassemi, M., Demner-Fushman, D., McCoy, L. G., Celi, L. A., Pierce, R. 2024; 3 (1): e0000417

    Abstract

    The study provides a comprehensive review of OpenAI's Generative Pre-trained Transformer 4 (GPT-4) technical report, with an emphasis on applications in high-risk settings like healthcare. A diverse team, including experts in artificial intelligence (AI), natural language processing, public health, law, policy, social science, healthcare research, and bioethics, analyzed the report against established peer review guidelines. The GPT-4 report shows a significant commitment to transparent AI research, particularly in creating a systems card for risk assessment and mitigation. However, it reveals limitations such as restricted access to training data, inadequate confidence and uncertainty estimations, and concerns over privacy and intellectual property rights. Key strengths identified include the considerable time and economic investment in transparent AI research and the creation of a comprehensive systems card. On the other hand, the lack of clarity in training processes and data raises concerns about encoded biases and interests in GPT-4. The report also lacks confidence and uncertainty estimations, crucial in high-risk areas like healthcare, and fails to address potential privacy and intellectual property issues. Furthermore, this study emphasizes the need for diverse, global involvement in developing and evaluating large language models (LLMs) to ensure broad societal benefits and mitigate risks. The paper presents recommendations such as improving data transparency, developing accountability frameworks, establishing confidence standards for LLM outputs in high-risk settings, and enhancing industry research review processes. It concludes that while GPT-4's report is a step towards open discussions on LLMs, more extensive interdisciplinary reviews are essential for addressing bias, harm, and risk concerns, especially in high-risk domains. The review aims to expand the understanding of LLMs in general and highlights the need for new reflection forms on how LLMs are reviewed, the data required for effective evaluation, and addressing critical issues like bias and risk.

    View details for DOI 10.1371/journal.pdig.0000417

    View details for PubMedID 38236824

    View details for PubMedCentralID PMC10795998

Daphne O. Martschenko
Assistant Professor (Research) of Pediatrics (Stanford Center for Biomedical Ethics)

Publications

  • Increasing equity in science requires better ethics training: A course by trainees, for trainees. Cell genomics Patel, R. A., Ungar, R. A., Pyke, A. L., Adimoelja, A., Chakraborty, M., Cotter, D. J., Freund, M., Goddard, P., Gomez-Stafford, J., Greenwald, E., Higgs, E., Hunter, N., MacKenzie, T. M., Narain, A., Gjorgjieva, T., Martschenko, D. O. 2024: 100554

    Abstract

    Despite the profound impacts of scientific research, few scientists have received the necessary training to productively discuss the ethical and societal implications of their work. To address this critical gap, we-a group of predominantly human genetics trainees-developed a course on genetics, ethics, and society. We intend for this course to serve as a template for other institutions and scientific disciplines. Our curriculum positions human genetics within its historical and societal context and encourages students to evaluate how societal norms and structures impact the conduct of scientific research. We demonstrate the utility of this course via surveys of enrolled students and provide resources and strategies for others hoping to teach a similar course. We conclude by arguing that if we are to work toward rectifying the inequities and injustices produced by our field, we must first learn to view our own research as impacting and being impacted by society.

    View details for DOI 10.1016/j.xgen.2024.100554

    View details for PubMedID 38697124

  • Including multiracial individuals is crucial for race, ethnicity and ancestry frameworks in genetics and genomics. Nature genetics Martschenko, D. O., Wand, H., Young, J. L., Wojcik, G. L. 2023

    View details for DOI 10.1038/s41588-023-01394-y

    View details for PubMedID 37202500

  • The Value of Intersectionality for Genomic Research on Human Behavior. Genetics in medicine : official journal of the American College of Medical Genetics Matthews, L. J., Martschenko, D. O., Sabatello, M. 2023: 100860

    View details for DOI 10.1016/j.gim.2023.100860

    View details for PubMedID 37092536

Adjunct Professor, Genetics
The Colleen and Robert Haas Professor in Medicine and Biomedical Ethics, Emeritus

Publications

  • Advertising, patient decision making, and self-referral for computed tomographic and magnetic resonance imaging ARCHIVES OF INTERNAL MEDICINE Illes, J., Kann, D., Karetsky, K., Letourneau, P., Raffin, T. A., Schraedley-Desmond, P., Koenig, B. A., Atlas, S. W. 2004; 164 (22): 2415-2419

    Abstract

    Self-referred imaging is one of the latest health care services to be marketed directly to consumers. Most aspects of these services are unregulated, and little is known about the messages in advertising used to attract potential consumers. We conducted a detailed analysis of print advertisements and informational brochures for self-referred imaging with respect to themes, content, accuracy, and emotional valence.Forty print advertisements from US newspapers around the country and 20 informational brochures were analyzed by 2 independent raters according to 7 major themes: health care technology; emotion, empowerment, and assurance; incentives; limited supporting evidence; popular appeal; statistics; and images. The Fisher exact test was used to identify significant differences in information content.Both the advertisements and the brochures emphasized health care and technology information and provided assurances of good health and incentives to self-refer. These materials also encouraged consumers to seek further information from company resources; virtually none referred to noncomplying sources of information or to the risks of having a scan. Images of people commonly portrayed European Americans. We found statistical differences between newspaper advertisements and mailed brochures for references to "prevalence of disease" (P<.001), "death" (P<.003), and "radiation" (P<.001). Statements lacking clear scientific evidence were identified in 38% of the advertisements (n = 15) and 25% of the brochures (n = 5).Direct-to-consumer marketing of self-referred imaging services, in both print advertisements and informational brochures, fails to provide prospective consumers with comprehensive balanced information vital to informed autonomous decision making. Professional guidelines and oversight for advertising and promotion of these services are needed.

    View details for Web of Science ID 000225701900003

    View details for PubMedID 15596630

  • Discovery and disclosure of incidental findings in neuroimaging research 33rd Annual Meeting of the Society-for-Neuroscience Illes, J., Kirschen, M. P., Karetsky, K., Kelly, M., Saha, A., Desmond, J. E., Raffin, T. A., Glover, G. H., Atlas, S. W. JOHN WILEY & SONS INC. 2004: 743–47

    Abstract

    To examine different protocols for handling incidental findings on brain research MRIs, and provide a platform for establishing formal discussions of related ethical and policy issues.Corresponding authors identified from a database of peer-reviewed publications in 1991-2002 involving functional MRI (fMRI), alone or in combination with other imaging modalities, were invited to participate in this web-based survey. The survey asked questions regarding knowledge and handling of incidental findings, as well as characteristics of the scanning environment, training required, IRB protocol requirements, and neuroradiologist involvement.Seventy-four investigators who conduct MRI studies in the United States and abroad responded. Eighty-two percent (54/66) reported discovering incidental findings in their studies, such as arteriovenous malformations, brain tumors, and developmental abnormalities. Substantial variability was found in the procedures for handling and communicating findings to subjects, neuroradiologist involvement, personnel permitted to operate equipment, and training.Guidelines for minimum and optimum standards for detecting and communicating incidental findings on brain MRI research are needed.

    View details for DOI 10.1002/jmri.20180

    View details for Web of Science ID 000224762700001

    View details for PubMedID 15503329

    View details for PubMedCentralID PMC1506385

  • Chylothorax after heart/lung transplantation JOURNAL OF HEART AND LUNG TRANSPLANTATION Ziedalski, T. M., Raffin, T. A., Sze, D. Y., Mitchell, J. D., Robbins, R. C., Theodore, J., Faul, J. L. 2004; 23 (5): 627-631

    Abstract

    Chylothorax is a potentially serious complication of lung and heart-lung transplantation. This article describes the clinical course of chylothorax in 3 heart-lung allograft recipients. We discuss management options, including dietary modifications, octreotide infusion, thoracic duct ligation and embolization, and surgical pleurodesis. In addition, we describe the novel use of aminocaproic acid to reduce lymph flow. We propose a multidisciplinary approach for the management of chylothorax that includes both medical and surgical options.

    View details for Web of Science ID 000221393700018

    View details for PubMedID 15135382

Member, Maternal & Child Health Research Institute (MCHRI)

Publications

  • Benefits of sharing neurophysiology data from the BRAIN Initiative Research Opportunities in Humans Consortium NEURON Rahimzadeh, V., Jones, K., Majumder, M. A., Kahana, M. J., Rutishauser, U., Williams, Z. M., Cash, S. S., Paulk, A. C., Zheng, J., Beauchamp, M. S., Collinger, J. L., Pouratian, N., McGuire, A. L., Sheth, S. A., NIH Res Opportunities Humans ROH C 2023; 111 (23): 3710-3715

    Abstract

    Sharing human brain data can yield scientific benefits, but because of various disincentives, only a fraction of these data is currently shared. We profile three successful data-sharing experiences from the NIH BRAIN Initiative Research Opportunities in Humans (ROH) Consortium and demonstrate benefits to data producers and to users.

    View details for DOI 10.1016/j.neuron.2023.09.029

    View details for Web of Science ID 001135333000001

    View details for PubMedID 37944519

  • Ethically cleared to launch? Science (New York, N.Y.) Rahimzadeh, V., Fogarty, J., Caulfield, T., Auñón-Chancellor, S., Borry, P., Candia, J., Cohen, I. G., Covington, M., Lynch, H. F., Greely, H. T., Hanlon, M., Hatt, J., Low, L., Menikoff, J., Meslin, E. M., Platts, S., Ravitsky, V., Ruttley, T., Seidler, R. D., Sugarman, J., Urquieta, E., Williams, M. A., Wolpe, P. R., Donoviel, D., McGuire, A. L. 2023; 381 (6665): 1408-1411

    Abstract

    Rules are needed for human research in commercial spaceflight.

    View details for DOI 10.1126/science.adh9028

    View details for PubMedID 37769066

  • Integrating Social Determinants of Health into Ethical Digital Simulations AMERICAN JOURNAL OF BIOETHICS Kostick-Quenet, K., Rahimzadeh, V., Anandasabapathy, S., Hurley, M., Sonig, A., Mcguire, A. 2023; 23 (9): 57-60
This profile is not available
Professor of Anesthesiology, Perioperative and Pain Medicine, Emeritum

Publications

Professor of Medicine (Primary Care & Population Health) and, by courtesy, of Pediatrics (Stanford Center of Biomedical Ethics) and of Epidemiology

Publications

  • Telemedicine Experiences of Adults with Intellectual and/or Developmental Disabilities During the COVID-19 Pandemic: Lessons for Future Accessibility. Journal of general internal medicine Cvitanovic, M., Steinberg, J., Hing, K. L., Seay-Morrison, T., Srinivasan, M., Young, A., Respicio, K., Digre, S., Vega, C., Hui, F., Taylor, S., Clarke, L., Walls, S. C., Rosas, L. G., Tabor, H. K. 2025

    Abstract

    Telemedicine has experienced dramatic increases in availability and use, particularly during the COVID-19 pandemic. However, it is largely unknown whether adults with intellectual and/or developmental disabilities (AIDD) can utilize telemedicine and have access to high-quality telemedicine care. Few studies have asked AIDD about their experiences with telemedicine. Existing studies have primarily focused on specialty care for IDD diagnoses, pediatric populations, or care in non-US settings.Characterize the experiences of AIDD with telemedicine using a community-based participatory research (CBPR) approach.A Community Advisory Board of AIDD and non-AIDD co-designed the study and focus group guide. Six virtual focus groups were conducted, four with AIDD and two with caregivers of AIDD (CAIDD), to solicit their experiences with and perspectives about telemedicine during the COVID-19 pandemic.Twenty-one AIDD and 13 CAIDD, recruited through community organizations and snowball sampling.Content analysis of focus group transcripts using consensus coding amongst three coders.Most AIDD in the study had participated in telemedicine. Positive experiences/benefits included (1) convenience and privacy; (2) minimizing IDD-specific in-person challenges; and (3) reducing COVID-19 risks and facilitating triage. Negative experiences and challenges included (1) IDD-specific communication challenges; (2) concerns about the need for "hands-on stuff"; and (3) challenges with technology access and abilities. Participants had mixed experiences with tele-mental healthcare. Some worried about challenges arising from a post-pandemic return to in-person care for AIDD.Participants found telemedicine beneficial, specifically in ways that mitigate existing barriers AIDD experience accessing and managing healthcare visits. While some of these benefits also exist for non-AIDD populations, they have specific potential to reduce health disparities for AIDD, even outside of a pandemic context. CBPR approaches centering AIDD voices are needed to validate and extend these results and to develop and test solutions.

    View details for DOI 10.1007/s11606-025-09482-x

    View details for PubMedID 40274742

    View details for PubMedCentralID 7891688

  • Historical and Religious Influences on the Stigma of Cutaneous Disease: The Black Death as a Case Study. Journal of the American Academy of Dermatology Schwartz, B. L., Bailey, E. E., Tabor, H. K. 2024

    View details for DOI 10.1016/j.jaad.2024.12.010

    View details for PubMedID 39709079

  • "Like not having an arm": a qualitative study of the impact of visitor restrictions on cancer care during the COVID-19 pandemic. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer Holdsworth, L. M., Siden, R., Wong, B. O., Verano, M., Lessios, A. S., Tabor, H. K., Schapira, L., Aslakson, R. 2024; 32 (5): 288

    Abstract

    Visitor restriction policies to prevent the spread of COVID-19 among patients and clinicians were widespread during the pandemic, resulting in the exclusion of caregivers at key points of cancer care and treatment decision-making. The aim of this study was to explore how visitor restrictions impacted cancer treatment decision-making and care from patient and physician perspectives.Sixty-seven interviews, including 48 cancer patients and 19 cancer and palliative care physicians from four academic cancer centers in the USA between August 2020 and July 2021.Visitor restrictions that prevented caregivers from participating in clinic appointments and perioperative hospital care created challenges in cancer care that spanned three domains: practical, social, and informational. We identified eight themes that characterized challenges within the three domains across all three groups, and that these challenges had negative emotional and psychological consequences for both groups. Physicians perceived that patients' negative experiences due to lack of support through the physical presence of caregivers may have worsened patient outcomes.Our data demonstrate the tripartite structure of the therapeutic relationship in cancer care with caregivers providing critical support in the decision-making and care process to both patients and physicians. Caregiver absences led to practical, psychosocial, and informational burdens on both groups, and likely increased the risk of burnout among physicians. Our findings suggest that the quality of cancer care can be enhanced by engaging caregivers and promoting their physical presence during clinical encounters.

    View details for DOI 10.1007/s00520-024-08473-8

    View details for PubMedID 38622350

    View details for PubMedCentralID PMC11018646

This profile is not available