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

  • 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

  • A conjunctural analysis of the origins of 'embedded ELSI' in U.S. genomic medicine JOURNAL OF RESPONSIBLE INNOVATION Karabin, J., Adsit-Morris, C., Lee, S., Fullerton, S. M., Cho, M. K., Reardon, J. 2024; 11 (1)
  • 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
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

  • "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

  • Telehealth Is Effective in the Evaluation of Individuals With Undiagnosed Rare Disorders: An Undiagnosed Diseases Network Study. American journal of medical genetics. Part A Tan, Q. K., McConkie-Rosell, A., Mahoney, R., Spillmann, R. C., Schoch, K., Chanprasert, S., Acosta, M. T., Toro, C., Rosenfeld, J. A., Orengo, J. P., Scott, D. A., Granadillo, J. L., Sisco, K., Wegner, D. J., Tekin, M., Bivona, S., Peart, L., Rodan, L., Bonner, D., Wheeler, M. T., Bernstein, J. A., Ruzhnikov, M., Adams, D. R., Hisama, F. M., Shashi, V. 2024: e63956

    Abstract

    Patients with undiagnosed and/or rare disorders frequently manifest dysmorphic and neurological features. There is a lack of information on the effectiveness of telehealth in the evaluation of these disorders. We thus compared an unassisted virtual physical examination (PE) with an in-person PE in undiagnosed individuals and also assessed participant telehealth satisfaction. Twenty-six individuals enrolled in the Undiagnosed Diseases Network study underwent an in-home synchronous virtual PE, and a subsequent in-person PE, by the same clinician. The participants completed surveys on telehealth usability and provider empathy. On PE, general appearance and craniofacial features showed near perfect agreement (κ = 0.81-1.00) between the telehealth and in-person evaluations. Specific components of the neurological examination demonstrated substantial agreement (speech, gait, coordination; κ > 0.61), whereas others had moderate agreement (muscle tone, strength; κ = 0.41-0.60), and a few had none to slight agreement (skin; κ < 0.20). Some systems could not be examined in the virtual PE. Importantly, features relevant to diagnosis or management were missed on the virtual PE in only 2/26 individuals. The participants were satisfied with the quality of the telehealth interaction, as well as empathy demonstrated by providers in the virtual interface. Telehealth is effective for PEs in undiagnosed diseases and is acceptable to affected individuals.

    View details for DOI 10.1002/ajmg.a.63956

    View details for PubMedID 39629753

  • Health-related quality of life in patients with diverse rare diseases: An online survey. Genetics in medicine open Rao, A., Yabumoto, M., Ward-Lev, E., Miller, E. G., Naik, H., Halley, M. C. 2024; 2: 101889

    Abstract

    Rare diseases substantially contribute to population morbidity and mortality. Understanding rare disease health-related quality of life (HRQL) is essential for evaluating platform-based interventions that aim to tackle multiple rare diseases at a time. However, most HRQL studies focus on single or select group of rare diseases, often in a single country. Our study aimed to identify patient- and disease-specific correlates of HRQL across diverse rare diseases.We conducted an international online survey of rare disease patients and caregiver proxies affected by a systematically identified sample of rare diseases. We calculated EQ-5D scores and conducted multivariate linear regression to examine sociodemographic and disease predictors of EQ-5D-5L visual analog scale (VAS) and utility scores (United States only).A total of 1053 individuals affected by 103 different rare diseases participated, including 660 patients and 393 caregiver proxies. Disability status and disease prevalence correlated with poorer HRQL across models (P < .05). Increased pain and decreased ability to perform usual activities also correlated with lower VAS for both adult patients and caregiver proxies (P < .05). Being unemployed approached significance as a correlate of both lower caregiver proxy VAS and lower patient utility scores.Our results suggest that across rare diseases, lower HRQL is associated with a reduced rare disease prevalence and disability status, among other predictors. Understanding the key correlates of HRQL is essential for developing interventions for improving health care delivery and quality of life for rare disease patients and families.

    View details for DOI 10.1016/j.gimo.2024.101889

    View details for PubMedID 39669621

    View details for PubMedCentralID PMC11613748

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

  • 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

  • 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

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

Publications

  • 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

  • Revise the UDDA to Align the Law with Practice through Neuro-Respiratory Criteria. Neurology Omelianchuk, A., Bernat, J., Caplan, A., Greer, D., Lazaridis, C., Lewis, A., Pope, T., Ross, L. F., Magnus, D. 1800

    Abstract

    Although the Uniform Determination of Death Act (UDDA) has served as a model statute for 40 years, there is a growing recognition that the law must be updated. One issue being considered by the Uniform Law Commission's Drafting Committee to revise the UDDA is whether the text "all functions of the entire brain, including the brainstem" should be changed. Some argue that the absence of diabetes insipidus indicates that some brain functioning continues in many individuals who otherwise meet the "accepted medical standards" like the American Academy of Neurology's. The concern is that the legal criteria and the medical standards used to determine death by neurological criteria are not aligned. We argue for the revision of the UDDA to more accurately specify legal criteria which align with the medical standards: brain injury leading to permanent loss of a) the capacity for consciousness, b) the ability to breathe spontaneously, and c) brainstem reflexes. We term these criteria "neuro-respiratory criteria" and show that they are well-supported in the literature for physiological and social reasons justifying their use in the law.

    View details for DOI 10.1212/WNL.0000000000200024

    View details for PubMedID 35078943

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

Publications

  • Dextroamphetamine as Adjunctive Pharmacotherapy for Aggression Secondary to Korsakoff Syndrome: 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.2024.02.006

    View details for PubMedID 38417703

  • Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study. Nature medicine Schiff, N. D., Giacino, J. T., Butson, C. R., Choi, E. Y., Baker, J. L., O'Sullivan, K. P., Janson, A. P., Bergin, M., Bronte-Stewart, H. M., Chua, J., DeGeorge, L., Dikmen, S., Fogarty, A., Gerber, L. M., Krel, M., Maldonado, J., Radovan, M., Shah, S. A., Su, J., Temkin, N., Tourdias, T., Victor, J. D., Waters, A., Kolakowsky-Hayner, S. A., Fins, J. J., Machado, A. G., Rutt, B. K., Henderson, J. M. 2023

    Abstract

    Converging evidence indicates that impairments in executive function and information-processing speed limit quality of life and social reentry after moderate-to-severe traumatic brain injury (msTBI). These deficits reflect dysfunction of frontostriatal networks for which the central lateral (CL) nucleus of the thalamus is a critical node. The primary objective of this feasibility study was to test the safety and efficacy of deep brain stimulation within the CL and the associated medial dorsal tegmental (CL/DTTm) tract.Six participants with msTBI, who were between 3 and 18 years post-injury, underwent surgery with electrode placement guided by imaging and subject-specific biophysical modeling to predict activation of the CL/DTTm tract. The primary efficacy measure was improvement in executive control indexed by processing speed on part B of the trail-making test.All six participants were safely implanted. Five participants completed the study and one was withdrawn for protocol non-compliance. Processing speed on part B of the trail-making test improved 15% to 52% from baseline, exceeding the 10% benchmark for improvement in all five cases.CL/DTTm deep brain stimulation can be safely applied and may improve executive control in patients with msTBI who are in the chronic phase of recovery.ClinicalTrials.gov identifier: NCT02881151 .

    View details for DOI 10.1038/s41591-023-02638-4

    View details for PubMedID 38049620

    View details for PubMedCentralID 8126422

  • Reliability and Validity of the Spanish Adaptation of the Stanford Proxy Test for Delirium (S-PTDsv) in Two Clinical Communities Infante-Reyes, S., Behn, A., Gonzalez, M., Pintor, L., Franco, E., Araya, P., Maldonado, J. ELSEVIER SCIENCE INC. 2023: S111-S112
Assistant Professor (Research) of Pediatrics (Biomedical Ethics) and, by courtesy, of Psychiatry and Behavioral Sciences (Child and Adolescent Psychiatry and Child Development)

Publications

  • 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

  • Rationales and Approaches to Protecting Brain Data: a Scoping Review NEUROETHICS Jwa, A. S., Martinez-Martin, N. 2024; 17 (1)
  • 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)

Publications

  • 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

  • Genomics Research with Undiagnosed Children: Ethical Challenges at the Boundaries of Research and Clinical Care JOURNAL OF PEDIATRICS Halley, M. C., Young, J. L., Tang, C., Mintz, K. T., Lucas-Griffin, S., Maghiro, A., Ashley, E. A., Tabor, H. K., Undiagnosed Diseases Network 2023; 261
This profile is not available