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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Alyssa Burgart (she/her)
Clinical Associate Professor, Anesthesiology, Perioperative and Pain Medicine Clinical Associate Professor (By courtesy), Pediatrics

Publications

  • 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

  • Violence in the pain clinic: the hidden pandemic. Regional anesthesia and pain medicine Fawzy, Y., Siddiqui, Z., Narouze, S., Potru, S., Burgart, A. M., Udoji, M. A. 2023

    Abstract

    Workplace violence is any physical assault, threatening behavior or other verbal abuse directed toward persons at work or in the workplace. The incidence of workplace violence in healthcare settings in general and more specifically the pain clinic is thought to be underestimated due to hesitancy to report, lack of support from management and healthcare systems, and lack of institutional policies as it relates to violence from patients against healthcare workers. In the following article, we explore risk factors that place clinicians at risk of workplace violence, the cost and impact of workplace violence, how to build a violence prevention program and lastly how to recover from violence in the practice setting.

    View details for DOI 10.1136/rapm-2022-104308

    View details for PubMedID 36754543

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

Publications

  • President Biden's Executive Order on Artificial Intelligence-Implications for Health Care Organizations. JAMA Mello, M. M., Shah, N. H., Char, D. S. 2023

    View details for DOI 10.1001/jama.2023.25051

    View details for PubMedID 38032634

  • Considerations for addressing bias in artificial intelligence for health equity. NPJ digital medicine Abràmoff, M. D., Tarver, M. E., Loyo-Berrios, N., Trujillo, S., Char, D., Obermeyer, Z., Eydelman, M. B., Maisel, W. H. 2023; 6 (1): 170

    Abstract

    Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these "Considerations" is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all.

    View details for DOI 10.1038/s41746-023-00913-9

    View details for PubMedID 37700029

    View details for PubMedCentralID 6941147

  • Case Report: Parental Separation by Proxy Using Video Conference Between Patient and Parent for Induction of Anesthesia. A&A practice Quinonez, Z. A., Brandford, E., Char, D. 2023; 17 (7): e01696

    Abstract

    Anesthetic induction in children can have significant psychological and behavioral impacts. Strategies like premedication or parental presence for induction may reduce distress. In children who require ongoing procedural care into adulthood, like those who receive heart transplants, transitioning from these strategies toward independence may require intermediate steps. The use of parental presence by video may aid in this transition. It might also be a reasonable approach for those children who have adverse reactions to medications commonly used for anxiolysis before procedures.

    View details for DOI 10.1213/XAA.0000000000001696

    View details for PubMedID 37409741

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

Publications

  • Moral Engagement and Disengagement in Health Care AI Development. AJOB empirical bioethics Nichol, A. A., Halley, M., Federico, C., Cho, M. K., Sankar, P. L. 2024: 1-10

    Abstract

    Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding their obligations to mitigate harms.We conducted 40 semi-structured interviews with developers of ML predictive analytics applications for health care in the United States.Participants varied widely in their perspectives on personal responsibility and included examples of both moral engagement and disengagement, albeit in a variety of forms. While most (70%) of participants made a statement indicative of moral engagement, most of these statements reflected an awareness of moral issues, while only a subset of these included additional elements of engagement such as recognizing responsibility, alignment with personal values, addressing conflicts of interests, and opportunities for action. Further, we identified eight distinct categories of moral disengagement reflecting efforts to minimize potential harms or deflect personal responsibility for preventing or mitigating harms.These findings suggest possible facilitators and barriers to the development of ethical ML that could act by encouraging moral engagement or discouraging 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 DOI 10.1080/23294515.2024.2336906

    View details for PubMedID 38588388

  • 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

  • The ELSI Virtual Forum, 30 Years of the Genome: Integrating and Applying ELSI Research. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics Moore, C. B., Dolan, D. D., Yarmolinsky, R., Cho, M. K., Soo-Jin-Lee, S. 2023; 51 (3): 661-671

    Abstract

    This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

    View details for DOI 10.1017/jme.2023.109

    View details for PubMedID 38088602

Carole Federico
Postdoctoral Scholar, 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

Henry T. (Hank) Greely
Deane F. and Kate Edelman Johnson Professor of Law and, Professor, by courtesy, of Genetics

Publications

  • Neuroscience and the Criminal Justice System ANNUAL REVIEW OF CRIMINOLOGY, VOL 2 Greely, H. T., Farahany, N. A., Petersilia, J., Sampson, R. J. 2019; 2: 451–71

    View details for DOI 10.1146/annurev-criminol-011518-024433

    View details for Web of Science ID 000456392800020

  • Neuroethics Guiding Principles for the NIH BRAIN Initiative. The Journal of neuroscience : the official journal of the Society for Neuroscience Greely, H. T., Grady, C., Ramos, K. M., Chiong, W., Eberwine, J., Farahany, N. A., Johnson, L. S., Hyman, B. T., Hyman, S. E., Rommelfanger, K. S., Serrano, E. E. 2018; 38 (50): 10586–88

    View details for DOI 10.1523/JNEUROSCI.2077-18.2018

    View details for PubMedID 30541767

  • The ethics of experimenting with human brain tissue. Nature Farahany, N. A., Greely, H. T., Hyman, S. n., Koch, C. n., Grady, C. n., Pașca, S. P., Sestan, N. n., Arlotta, P. n., Bernat, J. L., Ting, J. n., Lunshof, J. E., Iyer, E. P., Hyun, I. n., Capestany, B. H., Church, G. M., Huang, H. n., Song, H. n. 2018; 556 (7702): 429–32

    View details for DOI 10.1038/d41586-018-04813-x

    View details for PubMedID 29691509

Meghan Halley
Sr Research Scholar, School of Medicine - Biomedical Ethics

Publications

  • Career flexibility for PAs: What makes switching specialties successful? JAAPA : official journal of the American Academy of Physician Assistants Ward-Lev, E., Kuriakose, C., Navoa, J. J., Halley, M. 2024

    Abstract

    ABSTRACT: Switching specialties is common among physician associates/assistants (PAs) and important in combating burnout. Despite this, little is known about the PA experience with switching specialties. This study sought to identify factors associated with successfully switching specialties using semistructured interviews with PAs and hiring managers. Participants reported that switching specialties was initially challenging for managers and PAs because of insufficient onboarding and unrealistic expectations, but they also reported that they were generally satisfied with long-term outcomes. Our findings suggest that PAs hoping to switch specialties may want to focus on building a professional network, identifying areas where they can highlight relevant experience, and demonstrating their intent to remain in that role. Hiring managers could benefit from considering their hiring practices and tailoring onboarding expectations for new hires.

    View details for DOI 10.1097/01.JAA.0000000000000004

    View details for PubMedID 38595169

  • Moral Engagement and Disengagement in Health Care AI Development. AJOB empirical bioethics Nichol, A. A., Halley, M., Federico, C., Cho, M. K., Sankar, P. L. 2024: 1-10

    Abstract

    Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding their obligations to mitigate harms.We conducted 40 semi-structured interviews with developers of ML predictive analytics applications for health care in the United States.Participants varied widely in their perspectives on personal responsibility and included examples of both moral engagement and disengagement, albeit in a variety of forms. While most (70%) of participants made a statement indicative of moral engagement, most of these statements reflected an awareness of moral issues, while only a subset of these included additional elements of engagement such as recognizing responsibility, alignment with personal values, addressing conflicts of interests, and opportunities for action. Further, we identified eight distinct categories of moral disengagement reflecting efforts to minimize potential harms or deflect personal responsibility for preventing or mitigating harms.These findings suggest possible facilitators and barriers to the development of ethical ML that could act by encouraging moral engagement or discouraging 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 DOI 10.1080/23294515.2024.2336906

    View details for PubMedID 38588388

  • Recurring homozygous ACTN2 variant (p.Arg506Gly) causes a recessive myopathy. Annals of clinical and translational neurology Donkervoort, S., Mohassel, P., O'Leary, M., Bonner, D. E., Hartley, T., Acquaye, N., Brull, A., Mozaffar, T., Saporta, M. A., Dyment, D. A., Sampson, J. B., Pajusalu, S., Austin-Tse, C., Hurth, K., Cohen, J. S., McWalter, K., Warman-Chardon, J., Crunk, A., Foley, A. R., Mammen, A. L., Wheeler, M. T., O'Donnell-Luria, A., Bönnemann, C. G. 2024

    Abstract

    ACTN2, encoding alpha-actinin-2, is essential for cardiac and skeletal muscle sarcomeric function. ACTN2 variants are a known cause of cardiomyopathy without skeletal muscle involvement. Recently, specific dominant monoallelic variants were reported as a rare cause of core myopathy of variable clinical onset, although the pathomechanism remains to be elucidated. The possibility of a recessively inherited ACTN2-myopathy has also been proposed in a single series.We provide clinical, imaging, and histological characterization of a series of patients with a novel biallelic ACTN2 variant.We report seven patients from five families with a recurring biallelic variant in ACTN2: c.1516A>G (p.Arg506Gly), all manifesting with a consistent phenotype of asymmetric, progressive, proximal, and distal lower extremity predominant muscle weakness. None of the patients have cardiomyopathy or respiratory insufficiency. Notably, all patients report Palestinian ethnicity, suggesting a possible founder ACTN2 variant, which was confirmed through haplotype analysis in two families. Muscle biopsies reveal an underlying myopathic process with disruption of the intermyofibrillar architecture, Type I fiber predominance and atrophy. MRI of the lower extremities demonstrate a distinct pattern of asymmetric muscle involvement with selective involvement of the hamstrings and adductors in the thigh, and anterior tibial group and soleus in the lower leg. Using an in vitro splicing assay, we show that c.1516A>G ACTN2 does not impair normal splicing.This series further establishes ACTN2 as a muscle disease gene, now also including variants with a recessive inheritance mode, and expands the clinical spectrum of actinopathies to adult-onset progressive muscle disease.

    View details for DOI 10.1002/acn3.51983

    View details for PubMedID 38311799

Stephanie Harman
Clinical Associate 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

    View details for Web of Science ID 001058985600062

  • "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

Sandra Soo-Jin Lee, Ph.D
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

David Magnus, Ph.D.
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

Jose R. Maldonado, MD, FACLP, FACFE
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

    View details for DOI 10.1016/j.jaclp.2023.11.226

    View details for Web of Science ID 001161339100210

Nicole Martinez-Martin
Assistant Professor (Research) of Pediatrics (Biomedical Ethics)

Publications

  • Dimensions of Research-Participant Interaction: Engagement is Not a Replacement for Consent. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics Shearer, E., Martinez, N., Magnus, D. 2020; 48 (1): 183–84

    View details for DOI 10.1177/1073110520917008

    View details for PubMedID 32342787

  • What Are Important Ethical Implications of Using Facial Recognition Technology in Health Care? AMA journal of ethics Martinez-Martin, N. 2019; 21 (2): E180–187

    Abstract

    Applications of facial recognition technology (FRT) in health care settings have been developed to identify and monitor patients as well as to diagnose genetic, medical, and behavioral conditions. The use of FRT in health care suggests the importance of informed consent, data input and analysis quality, effective communication about incidental findings, and potential influence on patient-clinician relationships. Privacy and data protection are thought to present challenges for the use of FRT for health applications.

    View details for DOI 10.1001/amajethics.2019.180

    View details for PubMedID 30794128

  • Data mining for health: staking out the ethical territory of digital phenotyping NPJ DIGITAL MEDICINE Martinez-Martin, N., Insel, T. R., Dagum, P., Greely, H. T., Cho, M. K. 2018; 1

    View details for DOI 10.1038/s41746-018-0075-8

    View details for Web of Science ID 000453910600001

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

Publications

  • 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

  • Wrestling with Public Input on an Ethical Analysis of Scientific Research. The Hastings Center report Martschenko, D. O., Callier, S. L., Garrison, N. A., Lee, S. S., Turley, P., Meyer, M. N., Parens, E. 2023; 53 Suppl 1: S50-S65

    Abstract

    Bioethicists frequently call for empirical researchers to engage participants and community members in their research, but don't themselves typically engage community members in their normative research. In this article, we describe an effort to include members of the public in normative discussions about the risks, potential benefits, and ethical responsibilities of social and behavioral genomics (SBG) research. We reflect on what might-and might not- be gained from engaging the public in normative scholarship and on lessons learned about public perspectives on the risks and potential benefits of SBG research and the responsible conduct and communication of such research. We also provide procedural lessons for others in bioethics who are interested in engaging members of the public in their research.

    View details for DOI 10.1002/hast.1478

    View details for PubMedID 37079856

Kelly E. Ormond, MS, CGC
Adjunct Professor, Genetics
Thomas Raffin
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

Vasiliki Rahimzadeh
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

    View details for DOI 10.1080/15265161.2023.2237443

    View details for Web of Science ID 001058425800017

    View details for PubMedID 37647482

    View details for PubMedCentralID PMC10502902

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Audrey Shafer
Professor of Anesthesiology, Perioperative and Pain Medicine, Emeritum

Publications

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

Publications

  • "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

    View details for DOI 10.1018/j.jpeds.2023.113537

    View details for Web of Science ID 001029333600001

  • How are students learning to care for people with disabilities?: exploring the curriculum design of a sample of disability electives offered by US health professions schools. Disability and rehabilitation Clarke, L., Tabor, H. K., Gisondi, M. A. 2023: 1-11

    Abstract

    PURPOSE: There is an increased demand among health professions students for disability-focused training. We aimed to characterize the development and structure of a sample of disability electives offered at health professions schools in the United States.MATERIALS AND METHODS: A survey was developed to capture data on the curriculum design of disability electives offered at health professions schools across the United States. The primary outcome measures were elective development, elective structure, learner and instructor demographics, disability inclusion, and evaluation methodologies. A cross-sectional survey study was conducted, during which the survey was distributed to relevant professional societies focused on disability advocacy within healthcare.RESULTS: Data were collected on fifteen disability electives. Most electives were developed within the past four years, and many electives were initiated by students. The structure, duration, and evaluation methodology of electives were highly variable. Most electives took the form of a longer didactic-based course or a shorter clinical experience. All electives involved people with disabilities in some capacity.CONCLUSIONS: Disability electives fill an important gap in disability education at some health professions schools. Elective directors should have an increased focus on assessing student learning and ensuring that people with disabilities are involved in elective design and instruction.

    View details for DOI 10.1080/09638288.2023.2254694

    View details for PubMedID 37671804

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