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

  • 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

  • Loss of access to legal abortion in America: history, implications, and action items for anesthesiologists. Anaesthesia, critical care & pain medicine Landau, R., Burgart, A. M., Sutton, C. D. 2022: 101125

    View details for DOI 10.1016/j.accpm.2022.101125

    View details for PubMedID 35803575

  • Poorly conducted science is unprofessional. Journal of vascular surgery Burgart, A. M., Pendergrast, T. 2020

    View details for DOI 10.1016/j.jvs.2020.07.080

    View details for PubMedID 32958318

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

Publications

  • A Bridge to Nowhere. The American journal of bioethics : AJOB Hollander, S., Char, D. 2023; 23 (6): 54-56

    View details for DOI 10.1080/15265161.2023.2201228

    View details for PubMedID 37220366

  • In Response. Anesthesia and analgesia Quiñónez, Z. A., Pyke-Grimm, K. A., Char, D. 2023; 136 (6): e29-e30

    View details for DOI 10.1213/ANE.0000000000006361

    View details for PubMedID 37205812

  • Caregiver and provider attitudes toward family-centred rounding in paediatric acute care cardiology. Cardiology in the young Gal, D. B., Rodts, M., Hills, B. K., Kipps, A. K., Char, D. S., Pater, C., Madsen, N. L. 2023: 1-6

    Abstract

    Family-centered rounding has emerged as the gold standard for inpatient paediatrics rounds due to its association with improved family and staff satisfaction and reduction of harmful errors. Little is known about family-centered rounding in subspecialty paediatric settings, including paediatric acute care cardiology.In this qualitative, single centre study, we conducted semi-structured interviews with providers and caregivers eliciting their attitudes toward family-centered rounding. An a priori recruitment approach was used to optimise diversity in reflected opinions. A brief demographic survey was completed by participants. We completed thematic analysis of transcribed interviews using grounded theory.In total, 38 interviews representing the views of 48 individuals (11 providers, 37 caregivers) were completed. Three themes emerged: rounds as a moment of mutual accountability, caregivers' empathy for providers, and providers' objections to family-centered rounding. Providers' objections were further categorised into themes of assumptions about caregivers, caregiver choices during rounds, and risk for exacerbation of bias and inequity.Caregivers and providers in the paediatric acute care cardiology setting echoed some previously described attitudes toward family-centered rounding. Many of the challenges surrounding family-centered rounding might be addressed through access to training for caregivers and providers alike. Hospitals should invest in systems to facilitate family-centered rounding if they choose to implement this model of care as the current state risks erosion of provider-caregiver relationship.

    View details for DOI 10.1017/S104795112300118X

    View details for PubMedID 37198962

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

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

  • Innovating for a Just and Equitable Future in Genomic and Precision Medicine Research. The American journal of bioethics : AJOB Dolan, D. D., Cho, M. K., Lee, S. S. 2023; 23 (7): 1-4

    View details for DOI 10.1080/15265161.2023.2215201

    View details for PubMedID 37353052

  • Re-envisioning community genetics: community empowerment in preventive genomics. Journal of community genetics Wand, H., Martschenko, D. O., Smitherman, A., Michelson, S., Pun, T., Witte, J. S., Scott, S. A., Cho, M. K., Ashley, E. A., Preventive Genomics Program Co-Design Working Group, Goldberg, E., Knepper, L., Michelson, S., Osborne, J., Sanders, V. 2023

    Abstract

    As genomic technologies rapidly develop, polygenic scores (PGS) are entering into a growing conversation on how to improve precision in public health and prevent chronic disease. While the integration of PGS into public health and clinical services raises potential benefits, it also introduces potential harms. In particular, there is a high level of uncertainty about how to incorporate PGS into clinical settings in a manner that is equitable, just, and aligned with the long-term goals of many healthcare systems to support person-centered and value-based care. This paper argues that any conversation about whether and how to design and implement PGS clinical services requires dynamic engagement with local communities, patients, and families. These parties often face the consequences, both positive and negative, of such uncertainties and should therefore drive clinical translation. As a collaborative effort between hospital stakeholders, community partners, and researchers, this paper describes a community-empowered co-design process for addressing uncertainty and making programmatic decisions about the implementation of PGS into clinical services. We provide a framework for others interested in designing clinical programs that are responsive to, and inclusive and respectful of, local communities.

    View details for DOI 10.1007/s12687-023-00638-y

    View details for PubMedID 36765027

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

  • 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

  • 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

  • Blurred Boundaries: Toward an Expanded Ethics of Research and Clinical Care AMERICAN JOURNAL OF BIOETHICS Halley, M. C., Olson, N. W. 2023; 23 (8): 5-9

    View details for DOI 10.1080/15265161.2023.2224148

    View details for Web of Science ID 001030455900003

Stephanie Harman
Clinical Associate Professor, Medicine - Primary Care and Population Health

Publications

  • "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

  • Top Ten Tips Palliative Care Clinicians Should Know About Their Work's Intersection with Clinical Ethics. Journal of palliative medicine Weaver, M. S., Boss, R. D., Christopher, M. J., Gray, T. F., Harman, S., Madrigal, V. N., Michelson, K. N., Paquette, E. T., Pentz, R. D., Scarlet, S., Ulrich, C. M., Walter, J. K. 2021

    Abstract

    Palliative care (PC) subspecialists and clinical ethics consultants often engage in parallel work, as both function primarily as interprofessional consultancy services called upon in complex clinical scenarios and challenging circumstances. Both practices utilize active listening, goals-based communication, conflict mediation or mitigation, and values explorations as care modalities. In this set of tips created by an interprofessional team of ethicists, intensivists, a surgeon, an attorney, and pediatric and adult PC nurses and physicians, we aim to describe some paradigmatic clinical challenges for which partnership may improve collaborative, comprehensive care.

    View details for DOI 10.1089/jpm.2021.0521

    View details for PubMedID 34807737

  • "Relax City Homecare team; protocols are ready for you" - A Quality Improvement Project Conducted on Behalf of the City Homecare Unit Team at the Trivandrum Institute of Palliative Sciences. Indian journal of palliative care Sunilkumar, M. M., Thampi, A., Lekshmi, S., Harman, S. M., Vallath, N. 2021; 27 (2): 204-210

    Abstract

    The city homecare unit (CHU) of the Trivandrum Institute of Palliative Sciences was dissatisfied with the quality of care provided to their patient population.This study aims to improve the average satisfaction score of CHU during their daily homecare services.The improvement project for the CHU activities was conducted with a prospective plan-do-study-act design, with stepwise application of improvement tools.The A3 quality improvement (QI) methodology, which uses tools for (i) analysing contributors (process mapping, cause-effect diagram); (ii) to derive key drivers (Pareto chart) and (iii) for measuring impact of interventions and sustainability (annotated run chart) was applied. The project was conducted as a mentored activity of the PC-PAICE program. The team's weekly average satisfaction score was recorded prospectively as the outcome parameter, with 0 representing total dissatisfaction and 10 representing total satisfaction. Accuracy of triaging and appropriateness of registration process were the process parameters selected. These were recorded as run charts across the project period of 9 months.The cause-effect tool and the impact effort tool were used to analyse the mapped CHU processes. Even though we identified 22 contributors to the problem, eight of them were found to be significant. Key drivers were determined based on these eight and applied to the CHU processes. Over the project period, the satisfaction scores of the CHU improved significantly from 5.82 to 7.6 that is, satisfaction levels were high on most days. The triaging and registration goals were achieved. The team also built its own capacity for QI.The application of the A3 methodology simplified and streamlined efforts and achieved the quality goal for the CHU team.

    View details for DOI 10.25259/IJPC_408_20

    View details for PubMedID 34511785

    View details for PubMedCentralID PMC8428877

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

  • 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

  • Variation in the design of Do Not Resuscitate orders and other code status options: a multi-institutional qualitative study. BMJ quality & safety Batten, J. N., Blythe, J. A., Wieten, S., Cotler, M. P., Kayser, J. B., Porter-Williamson, K., Harman, S., Dzeng, E., Magnus, D. 2020

    Abstract

    BACKGROUND: US hospitals typically provide a set of code status options that includes Full Code and Do Not Resuscitate (DNR) but often includes additional options. Although US hospitals differ in the design of code status options, this variation and its impacts have not been empirically studied.DESIGN AND METHODS: Multi-institutional qualitative study at 7 US hospitals selected for variability in geographical location, type of institution and design of code status options. We triangulated across three data sources (policy documents, code status ordering menus and in-depth physician interviews) to characterise the code status options available at each hospital. Using inductive qualitative methods, we investigated design differences in hospital code status options and the perceived impacts of these differences.RESULTS: The code status options at each hospital varied widely with regard to the number of code status options, the names and definitions of code status options, and the formatting and capabilities of code status ordering menus. DNR orders were named and defined differently at each hospital studied. We identified five key design characteristics that impact the function of a code status order. Each hospital's code status options were unique with respect to these characteristics, indicating that code status plays differing roles in each hospital. Physician participants perceived that the design of code status options shapes communication and decision-making practices about resuscitation and life-sustaining treatments, especially at the end of life. We identified four potential mechanisms through which this may occur: framing conversations, prompting decisions, shaping inferences and creating categories.CONCLUSIONS: There are substantive differences in the design of hospital code status options that may contribute to known variability in end-of-life care and treatment intensity among US hospitals. Our framework can be used to design hospital code status options or evaluate their function.

    View details for DOI 10.1136/bmjqs-2020-011222

    View details for PubMedID 33082165

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

  • An Interdisciplinary Reappraisal of Delirium and Proposed Subtypes JOURNAL OF THE ACADEMY OF CONSULTATION-LIAISON PSYCHIATRY Oldham, M. A., Slooter, A. C., Ely, W., Crone, C., Rosenthal, L. J., Ely, E., Maldonado, J. R. 2023; 64 (3): 248-261

    View details for Web of Science ID 000999622600001

  • A Retrospective Analysis of Guanfacine for the Pharmacological Management of Delirium. Cureus Jiang, S., Hernandez, M., Burke, H., Spurling, B., Czuma, R., Varghese, R., Cohen, A., Hartney, K., Sullivan, G., Kozel, F. A., Maldonado, J. R. 2023; 15 (1): e33393

    Abstract

    Background Delirium is a syndrome of acute brain failure that represents a change from an individual's baseline cognitive functioning characterized by deficits in attention and multiple aspects of cognition that fluctuate in severity over time. The symptomatic management of delirium's behavioral manifestations remains difficult. The alpha-2 agonists, dexmedetomidine and clonidine, are efficacious, but their potential cardiovascular adverse effects limit their utilization. Guanfacine is an oral alpha-2 agonist with a lower potential for such adverse outcomes; however, its use in delirium has not been studied. Methods A retrospective descriptive analysis of guanfacine for managing hyperactive or mixed delirium at Tampa General Hospital from January 2020 to October 2020 was conducted. The primary outcome was the time reduction in acute sedative administration. Secondary outcomes included renewed participation in physical therapy or occupational therapy (PT/OT), decreased opioid use, and an incidence of cardiovascular adverse effects. Results One hundred forty-nine patients were identified as having received guanfacine for managing delirium during the study period. All experienced a reduction in acute sedative use after the initiation of guanfacine. In 93 patients receiving PT/OT and no longer participating due to behavioral agitation, 74% had a documented renewal of services within four days. Of 112 patients on opioids, 70% experienced a 25% reduction in opioid administration within four days. No patients experienced consecutive episodes of hypotension that required a change in their clinical care. Two patients experienced a single episode of consecutive bradycardia that led to the discontinuation of guanfacine. Conclusions Based on our retrospective study, guanfacine is a well-tolerated medication for the management of delirium. Even in medically and critically ill patients, cardiovascular adverse events were rare with guanfacine. Patients treated with guanfacine experienced decreased acute sedative use for behavioral agitation. Additionally, patients treated with guanfacine received fewer opioids and were better able to participate in PT/OT. Future studies with prospective, randomized, placebo-controlled designs are warranted to evaluate this promising intervention for delirium further.

    View details for DOI 10.7759/cureus.33393

    View details for PubMedID 36751225

  • An Interdisciplinary Reappraisal of Delirium and Proposed Subtypes. Journal of the Academy of Consultation-Liaison Psychiatry Oldham, M. A., Slooter, A. J., Ely, E. W., Crone, C., Maldonado, J. R., Rosenthal, L. J. 2022

    Abstract

    An interdisciplinary plenary session entitled "Rethinking and Rehashing Delirium" was held during the 2021 Annual Meeting of the Academy of Consultation-Liaison Psychiatry to facilitate dialogue on the prevalent approach to delirium. Panel members included a psychiatrist, neurointensivist, and critical care specialist, and attendee comments were solicited with the goal of developing a statement. Discussion was focused on a reappraisal of delirium, and in particular its disparate terminology and history in relation to acute encephalopathy. The authors endorse a recent joint position statement that describes acute encephalopathy as a rapidly evolving (< 4 weeks) pathobiological brain process that presents as subsyndromal delirium, delirium, or coma, and suggest the following points of refinement: (1) to suggest that "delirium disorder" describe the diagnostic construct including its syndrome, precipitant(s), and unique pathophysiology, (2) to restrict the term "delirium" to describing the clinical syndrome encountered at the bedside, (3) to clarify that the disfavored term "altered mental status" may occasionally be an appropriate preliminary designation where the diagnosis cannot yet be specified further, and (4) to provide rationale for rejecting the terms acute brain injury, failure, or dysfunction. The final common pathway of delirium appears to involve higher-level brain network dysfunction, but there are many insults that can disrupt functional connectivity. We propose that future delirium classification systems should seek to characterize the unique pathophysiological disturbances ("endotypes") that underlie delirium and delirium's individual neuropsychiatric symptoms. We provide provisional means of classification, in hopes that novel subtypes might lead to specific intervention to improve patient experience and outcomes. This paper concludes by considering future directions for the field. Key areas of opportunity include interdisciplinary initiatives to harmonize efforts across specialties and settings, enhance underrepresented groups in research, integration of delirium and encephalopathy in coding, development of relevant quality and safety measures, and exploration of opportunities for translational science.

    View details for DOI 10.1016/j.jaclp.2022.07.001

    View details for PubMedID 35840003

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

  • Automating Justice: An Ethical Responsibility of Computational Bioethics. The American journal of bioethics : AJOB Rahimzadeh, V., Lawson, J., Baek, J., Dove, E. S. 2022; 22 (7): 30-33

    View details for DOI 10.1080/15265161.2022.2075051

    View details for PubMedID 35737496

  • Regulatory Angels and Technology Demons? Making Sense of Evolving Realities in Health Data Privacy for the Digital Age. The American journal of bioethics : AJOB Rahimzadeh, V. 2022; 22 (7): 68-70

    View details for DOI 10.1080/15265161.2022.2075981

    View details for PubMedID 35737504

  • Leveraging Algorithms to Improve Decision-Making Workflows for Genomic Data Access and Management. Biopreservation and biobanking Rahimzadeh, V., Lawson, J., Rushton, G., Dove, E. S. 2022

    Abstract

    Studies on the ethics of automating clinical or research decision making using artificial intelligence and other algorithmic tools abound. Less attention has been paid, however, to the scope for, and ethics of, automating decision making within regulatory apparatuses governing the access, use, and exchange of data involving humans for research. In this article, we map how the binary logic flows and real-time capabilities of automated decision support (ADS) systems may be leveraged to accelerate one rate-limiting step in scientific discovery: data access management. We contend that improved auditability, consistency, and efficiency of the data access request process using ADS systems have the potential to yield fairer outcomes in requests for data largely sourced from biospecimens and biobanked samples. This procedural justice rationale reinforces a broader set of participant and data subject rights that data access committees (DACs) indirectly protect. DACs protect the rights of citizens to benefit from science by bringing researchers closer to the data they need to advance that science. DACs also protect the informational dignities of individuals and communities by ensuring the data being accessed are used in ways consistent with participant values. We discuss the development of the Global Alliance for Genomics and Health Data Use Ontology standard as a test case of ADS for genomic data access management specifically, and we synthesize relevant ethical, legal, and social challenges to its implementation in practice. We conclude with an agenda of future research needed to thoughtfully advance strategies for computational governance that endeavor to instill public trust in, and maximize the scientific value of, health-related human data across data types, environments, and user communities.

    View details for DOI 10.1089/bio.2022.0042

    View details for PubMedID 35772014

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

Publications

Holly Tabor
Associate Professor of Medicine (General Medical Disciplines) and, by courtesy, of Epidemiology and Population Health

Publications

  • 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

  • Genomics Research with Undiagnosed Children: Ethical Challenges at the Boundaries of Research and Clinical Care. The Journal of pediatrics Halley, M. C., Young, J. L., Tang, C., Mintz, K. T., Lucas-Griffin, S., Maghiro, A. S., Ashley, E. A., Tabor, H. K. 2023: 113537

    Abstract

    To explore the perspectives of parents of undiagnosed children enrolled in genomic diagnosis research regarding their motivations for enrolling their children, their understanding of the potential burdens and benefits, and the extent to which their experiences ultimately aligned with or diverged from their original expectations.In-depth interviews were conducted with parents, audio-recorded and transcribed. A structured codebook was applied to each transcript, after which iterative memoing was used to identify themes.Fifty-four parents participated, including 17 (31.5%) whose child received a diagnosis through research. Themes describing parents' expectations and experiences of genomic diagnosis research included: 1) the extent to which parents' motivations for participation focused on their hope that it would directly benefit their child; 2) the ways in which parents' frustrations regarding the research process confused the dual clinical and research goals of their participation; and 3) the limited clinical benefits parents ultimately experienced for their children.Our results suggest that parents of undiagnosed children seeking enrollment in genomic diagnosis research are at risk of a form of therapeutic misconception - in this case, diagnostic misconception. These findings indicate the need to examine the processes and procedures associated with this research in order to appropriately communicate and balance the potential burdens and benefits of study participation.

    View details for DOI 10.1016/j.jpeds.2023.113537

    View details for PubMedID 37271495

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