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).

 

Associate Professor of Medicine (Primary Care and Population Health) and of Anesthesiology, Perioperative and Pain Medicine at the Stanford University Medical Center

Publications

  • Opportunities for Palliative Care in Patients with Burn Injury-A Systematic Review Cook, A., Langston, J., Jaramillo, J., Edwards, K., Wong, H., Aslakson, R. ELSEVIER SCIENCE INC. 2020: 256
  • Opportunities for Palliative Care in Patients with Burn Injury-A Systematic Review Cook, A., Langston, J., Jaramillo, J., Edwards, K., Wong, H., Aslakson, R. ELSEVIER SCIENCE INC. 2020: 449
  • Surgical and Perioperative Palliative Care: Updates from 2019 Berlin, A., Woodrell, C. D., Aslakson, R. A., Arnheim, M. ELSEVIER SCIENCE INC. 2020: 444–45
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine

Publications

  • Parents Demand and Teenager Refuses Epidural Anesthesia. Pediatrics Berkowitz, I., Burgart, A., Truog, R. D., Mancuso, T. J., Char, D., Lantos, J. D. 2020

    Abstract

    A 15-year-old girl is scheduled to undergo an upper lobectomy to debulk metastatic Ewing sarcoma. The anesthesiologist recommended placement of a thoracic epidural catheter to provide postoperative analgesia. The patient did not want a needle to be placed near her spine. She was terrified that the procedure would be painful and that it might paralyze her. Although the anesthesiologist reassured her that sedation and local anesthesia would make the procedure comfortable, she remained vehemently opposed to the epidural procedure. The parents spoke privately to the anesthesiologist and asked for placement of the epidural after she was asleep. They firmly believed that this would provide optimal postoperative analgesia and thus would be in her best interest. Experts discuss the pros and cons of siding with the patient or parents.

    View details for DOI 10.1542/peds.2019-3295

    View details for PubMedID 32398328

  • Donor heart selection during the COVID-19 pandemic: A case study JOURNAL OF HEART AND LUNG TRANSPLANTATION Chen, C., Chen, S. F., Hollander, S. A., Rosenthal, D., Maeda, K., Burgart, A., Almond, C. S., Chen, S. 2020; 39 (5): 497–98
  • Machine Learning Implementation in Clinical Anesthesia: Opportunities and Challenges. Anesthesia and analgesia Char, D. S., Burgart, A. 2020

    View details for DOI 10.1213/ANE.0000000000004656

    View details for PubMedID 31922996

Assistant Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric) at the Stanford University Medical Center

Publications

  • Machine Learning Implementation in Clinical Anesthesia: Opportunities and Challenges. Anesthesia and analgesia Char, D. S., Burgart, A. 2020

    View details for DOI 10.1213/ANE.0000000000004656

    View details for PubMedID 31922996

  • Lessons learnt about Autonomous AI: Finding a safe, efficacious and ethical path through the development process. American journal of ophthalmology Abramoff, M. D., Tobey, D., Char, D. S. 2020

    Abstract

    Artificial Intelligence (AI) describes systems capable of making decisions of high cognitive complexity; Autonomous AI systems in healthcare are AI systems that make clinical decisions without human oversight. Ensuring that autonomous AI provides these benefits requires evaluation of the Autonomous AI's effect on patient outcome, design, validation, data usage and accountability, from a bioethics and accountability perspective.Case study with literature review and bioethical analysis.Online library search for articles with AI and ethics as subject. Definition of terminology. Review of bioethical principles, and derivation of evaluation rules for Autonomous AI. Case study with an FDA de novo authorized Autonomous AI system.Preliminary evaluation rules derived from bioethical principles include patient outcome, validation, reference standard, design, data usage, and accountability for medical liability. Application of the rules explains successful FDA de novo authorization.Physicians need to become competent in understanding the limitations and risks as well as the potential benefits of autonomous AI, and understand its design, safety, efficacy and equity, validation, liability, and how its data was obtained. The Autonomous AI evaluation rules introduced here can support this process.

    View details for DOI 10.1016/j.ajo.2020.02.022

    View details for PubMedID 32171769

  • The opioid crisis should lead pediatric anesthesiologists to a broader vision of opioid stewardship. Paediatric anaesthesia Burgart, A. M., Char, D. 2019; 29 (11): 1078–80

    View details for DOI 10.1111/pan.13730

    View details for PubMedID 31677337

Professor (Research) of Pediatrics (Center for Biomedical Ethics) and of Medicine (General Medical Disciplines)

Publications

  • Partial Entrustment in Pragmatic Clinical Trials AMERICAN JOURNAL OF BIOETHICS Richardson, H. S., Cho, M. K. 2020; 20 (1): 24–26
  • Partial Entrustment in Pragmatic Clinical Trials. The American journal of bioethics : AJOB Richardson, H. S., Cho, M. K. 2020; 20 (1): 24–26

    View details for DOI 10.1080/15265161.2019.1687791

    View details for PubMedID 31896335

  • Perspectives on Precision Health Among Racial/Ethnic Minority Communities and the Physicians That Serve Them. Ethnicity & disease Rosas, L. G., Nasrallah, C., Park, V. T., Vasquez, J. J., Duron, Y., Garrick, O., Hattin, R., Cho, M., David, S. P., Evans, J., McClinton-Brown, R., Martin, C. 2020; 30 (Suppl 1): 137–48

    Abstract

    Background: In order for precision health to address health disparities, engagement of diverse racial/ethnic minority communities and the physicians that serve them is critical.Methods: A community-based participatory research approach with mixed methods was employed to gain a deeper understanding of precision health research and practice among American Indian, African American, Latino, Chinese, and Vietnamese groups and physicians that serve these communities. A survey assessed demographics and opinions of precision health, genetic testing, and precision health research. Focus groups (n=12) with each racial/ethnic minority group and physicians further explored attitudes about these topics.Results: One hundred community members (American Indian [n=17], African American [n=13], Chinese [n=17], Latino [n=27], and Vietnamese [n=26]) and 14 physicians completed the survey and participated in the focus groups. Familiarity with precision health was low among community members and high among physicians. Most groups were enthusiastic about the approach, especially if it considered influences on health in addition to genes (eg, environmental, behavioral, social factors). Significant concerns were expressed by African American and American Indian participants about precision health practice and research based on past abuses in biomedical research. In addition, physician and community members shared concerns such as security and confidentiality of genetic information, cost and affordability of genetic tests and precision medicine, discrimination and disparities, distrust of medical and research and pharmaceutical institutions, language barriers, and physician's specialty.Conclusions: Engagement of racial/ethnic minority communities and the providers who serve them is important for advancing a precision health approach to addressing health disparities.

    View details for DOI 10.18865/ed.30.S1.137

    View details for PubMedID 32269455

Postdoctoral Research Fellow, Biomedical Ethics
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
  • 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., Koch, C., Grady, C., Pașca, S. P., Sestan, N., Arlotta, P., Bernat, J. L., Ting, J., Lunshof, J. E., Iyer, E. P., Hyun, I., Capestany, B. H., Church, G. M., Huang, H., Song, H. 2018; 556 (7702): 429–32

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

    View details for PubMedID 29691509

Research Scholar, School of Medicine - Biomedical Ethics

Publications

  • Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. Journal of general internal medicine Halley, M. C., Petersen, J., Nasrallah, C., Szwerinski, N., Romanelli, R., Azar, K. M. 2020

    Abstract

    BACKGROUND: Group-based lifestyle change programs based on the Diabetes Prevention Program (DPP) are associated with clinically significant weight loss and decreases in cardiometabolic risk factors. However, these benefits depend on successful real-world implementation. Studies have examined implementation in community settings, but less is known about integration in healthcare systems, and particularly in large, multi-site systems with the potential for extended reach.OBJECTIVE: To examine the barriers and facilitators to successful DPP implementation in a large multi-site healthcare system.DESIGN: Semi-structured interviews, based on the RE-AIM framework, were conducted in person for 30-90min each.PARTICIPANTS: Past and present DPP lifestyle coaches in the healthcare system identified using purposive sampling.APPROACH: Thematic analysis of qualitative data to identify key factors influencing the success of DPP implementation. An iterative consensus process was used to model the relationships among factors.KEY RESULTS: We conducted 33 interviews across 20 clinic sites serving 12 counties. Participants described six key factors as potential barriers or facilitators to implementation, including (1) Broader Context, including the surrounding physical and sociodemographic context; (2) Institutional Context, including finances, infrastructure, and personnel; (3) Program Provision, including curriculum, administration, cost, goals, and visibility; (4) Recruitment Process, including screening and referrals; (5) Lifestyle Coaches, including their characteristics, behaviors, and morale; and (6) Cohort, including group attrition/retention and interpersonal dynamics. These factors were both highly interconnected in their impact on implementation and widely variable across sites within the healthcare system, as illustrated in our multi-level conceptual framework.CONCLUSIONS: This study identified key factors that could serve as barriers or facilitators in the implementation of DPP in large healthcare systems, from the perspective of lifestyle coaches. With further examination, the conceptual model presented here may be used for planning and managing the implementation of group-based behavioral interventions in these settings.

    View details for DOI 10.1007/s11606-020-05744-y

    View details for PubMedID 32291720

  • Differing views regarding diet and physical activity: adolescents versus parents' perspectives. BMC pediatrics Azar, K. M., Halley, M., Lv, N., Wulfovich, S., Gillespie, K., Liang, L., Goldman Rosas, L. 2020; 20 (1): 137

    Abstract

    BACKGROUND: Today, approximately one in five United States adolescents age 12 to 19years is obese and just over a third are either overweight or obese. This study examines how parents and peers influence diet and physical activity behaviors of older adolescents (14-18years) with overweight or obesity to inform weight management interventions.METHODS: Adolescent participants included 14 to 18-year-olds with a Body Mass Index (BMI) greater than the 85th percentile for their age and sex who were receiving care in a large healthcare system in Northern California. Adolescents and their parents participated in separate focus groups and interviews (if not able to attend focus groups) that were held at the same time in the same location. We used qualitative thematic analysis to identify common themes discussed in the adolescent and parent focus groups as well as paired analysis of adolescent-parent dyads.RESULTS: Participants included 26 adolescents and 27 parents. Adolescent participants were 14 to 18years old. Half were female and the participants were almost evenly distributed across year in school. The majority self-identified as White (56%) and Asian (36%).Three themes were identified which included 1) parents overestimated how supportive they were compared to adolescents' perception 2) parents and adolescents had different views regarding parental influence on adolescent diet and physical activity behaviors 3) parents and adolescents held similar views on peers' influential role on lifestyle behaviors.CONCLUSION: Parents' and adolescents' differing views suggest that alignment of parent and adolescent expectations and behaviors for supporting effective weight management could be incorporated into interventions.

    View details for DOI 10.1186/s12887-020-02038-4

    View details for PubMedID 32220230

  • Association between financial links to indoor tanning industry and conclusions of published studies on indoor tanning: systematic review. BMJ (Clinical research ed.) Adekunle, L., Chen, R., Morrison, L., Halley, M., Eng, V., Hendlin, Y., Wehner, M. R., Chren, M., Linos, E. 2020; 368: m7

    Abstract

    OBJECTIVE: To assess whether an association exists between financial links to the indoor tanning industry and conclusions of indoor tanning literature.DESIGN: Systematic review.DATA SOURCES: PubMed, Embase, and Web of Science, up to 15 February 2019.STUDY SELECTION CRITERIA: Articles discussing indoor tanning and health were eligible for inclusion, with no article type restrictions (original research, systematic reviews, review articles, case reports, editorials, commentaries, and letters were all eligible). Basic science studies, articles describing only indoor tanning prevalence, non-English articles, and articles without full text available were excluded.RESULTS: 691 articles were included in analysis, including empiric articles (eg, original articles or systematic reviews) (357/691; 51.7%) and non-empiric articles letters (eg, commentaries, letters, or editorials) (334/691; 48.3%). Overall, 7.2% (50/691) of articles had financial links to the indoor tanning industry; 10.7% (74/691) articles favored indoor tanning, 3.9% (27/691) were neutral, and 85.4% (590/691) were critical of indoor tanning. Among the articles without industry funding, 4.4% (27/620) favored indoor tanning, 3.5% (22/620) were neutral, and 92.1% (571/620) were critical of indoor tanning. Among the articles with financial links to the indoor tanning industry, 78% (39/50) favored indoor tanning, 10% (5/50) were neutral, and 12% (6/50) were critical of indoor tanning. Support from the indoor tanning industry was significantly associated with favoring indoor tanning (risk ratio 14.3, 95% confidence interval 10.0 to 20.4).CONCLUSIONS: Although most articles in the indoor tanning literature are independent of industry funding, articles with financial links to the indoor tanning industry are more likely to favor indoor tanning. Public health practitioners and researchers need to be aware of and account for industry funding when interpreting the evidence related to indoor tanning.SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019123617.

    View details for DOI 10.1136/bmj.m7

    View details for PubMedID 32019742

Clinical Associate Professor, Medicine - Primary Care and Population Health

Publications

Sr Research Scholar, Pediatrics - Center for Biomedical Ethics Senior Research Scholar, School of Medicine - Biomedical Ethics

Publications

  • Higher Breast Cancer Risk Among Immigrant Asian American Women Than Among US-Born Asian American Women PREVENTING CHRONIC DISEASE Morey, B. N., Gee, G. C., von Ehrenstein, O. S., Shariff-Marco, S., Canchola, A. J., Yang, J., Allen, L., Lee, S., Bautista, R., La Chica, T., Tseng, W., Chang, P., Gomez, S. 2019; 16
  • Ethics of inclusion: Cultivate trust in precision medicine. Science (New York, N.Y.) Lee, S. S., Fullerton, S. M., Saperstein, A., Shim, J. K. 2019; 364 (6444): 941–42

    View details for DOI 10.1126/science.aaw8299

    View details for PubMedID 31171685

  • "I don't want to be Henrietta Lacks": diverse patient perspectives on donating biospecimens for precision medicine research. Genetics in medicine : official journal of the American College of Medical Genetics Lee, S. S., Cho, M. K., Kraft, S. A., Varsava, N., Gillespie, K., Ormond, K. E., Wilfond, B. S., Magnus, D. 2018

    Abstract

    PURPOSE: To determine whether patients distinguish between biospecimens and electronic health records (EHRs) when considering research participation to inform research protections.METHODS: We conducted 20 focus groups with individuals who identified as African American, Hispanic, Chinese, South Asian, and non-Hispanic white on the collection of biospecimens and EHR data for research.RESULTS: Our study found that many participants did not distinguish between biospecimens and EHR data. However, some participants identified specific concerns about biospecimens. These included the need for special care and respect for biospecimens due to enduring connections between the body and identity; the potential for unacceptable future research, specifically the prospect of human cloning; heightened privacy risks; and the potential for unjust corporate profiteering. Among those who distinguished biospecimens from EHR data, many supported separate consent processes and would limit their own participation to EHR data.CONCLUSION: Considering that the potential misuse of EHR data is as great as, if not greater than, for biospecimens, more research is needed to understand how attitudes differ between biospecimens and EHR data across diverse populations. Such research should explore mechanisms beyond consent that can address diverse values, perspectives, and misconceptions about sources of patient information to build trust in research relationships.

    View details for PubMedID 29887604

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

Publications

  • Making Medical Treatment Decisions for Unrepresented Patients in the ICU An Official American Thoracic Society/American Geriatrics Society Policy Statement AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE Pope, T. M., Bennett, J., Carson, S. S., Cederquist, L., Cohen, A. B., DeMartino, E. S., Godfrey, D. M., Goodman-Crews, P., Kapp, M. B., Lo, B., Magnus, D. C., Reinke, L. F., Shirley, J. L., Siegel, M. D., Stapleton, R. D., Sudore, R. L., Tarzian, A. J., Thornton, J., Wicclair, M. R., Widera, E. W., White, D. B., Amer Thoracic Soc, Amer Geriatrics Soc 2020; 201 (10): 1182–92

    Abstract

    Background and Rationale: ICU clinicians regularly care for patients who lack capacity, an applicable advance directive, and an available surrogate decision-maker. Although there is no consensus on terminology, we refer to these patients as "unrepresented." There is considerable controversy about how to make treatment decisions for these patients, and there is significant variability in both law and clinical practice.Purpose and Objectives: This multisociety statement provides clinicians and hospital administrators with recommendations for decision-making on behalf of unrepresented patients in the critical care setting.Methods: An interprofessional, multidisciplinary expert committee developed this policy statement by using an iterative consensus process with a diverse working group representing critical care medicine, palliative care, pediatric medicine, nursing, social work, gerontology, geriatrics, patient advocacy, bioethics, philosophy, elder law, and health law.Main Results: The committee designed its policy recommendations to promote five ethical goals: 1) to protect highly vulnerable patients, 2) to demonstrate respect for persons, 3) to provide appropriate medical care, 4) to safeguard against unacceptable discrimination, and 5) to avoid undue influence of competing obligations and conflicting interests. These recommendations also are intended to strike an appropriate balance between excessive and insufficient procedural safeguards. The committee makes the following recommendations: 1) institutions should offer advance care planning to prevent patients at high risk for becoming unrepresented from meeting this definition; 2) institutions should implement strategies to determine whether seemingly unrepresented patients are actually unrepresented, including careful capacity assessments and diligent searches for potential surrogates; 3) institutions should manage decision-making for unrepresented patients using input from a diverse interprofessional, multidisciplinary committee rather than ad hoc by treating clinicians; 4) institutions should use all available information on the patient's preferences and values to guide treatment decisions; 5) institutions should manage decision-making for unrepresented patients using a fair process that comports with procedural due process; 6) institutions should employ this fair process even when state law authorizes procedures with less oversight.Conclusions: This multisociety statement provides guidance for clinicians and hospital administrators on medical decision-making for unrepresented patients in the critical care setting.

    View details for DOI 10.1164/rccm.202003-0512ST

    View details for Web of Science ID 000535260100009

    View details for PubMedID 32412853

    View details for PubMedCentralID PMC7233335

  • 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

  • Using Implementation Science to Enact Specific Ethical Norms: The Case of Code Status Policy. The American journal of bioethics : AJOB Shearer, E., Magnus, D. 2020; 20 (4): 6–7

    View details for DOI 10.1080/15265161.2020.1735874

    View details for PubMedID 32208071

Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology-Adult) and, by courtesy, of Emergency Medicine and of Medicine at the Stanford University Medical Center and, by courtesy, of Law

Publications

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
Professor (Teaching) of Genetics

Publications

  • Clinical Genetics Lacks Standard Definitions and Protocols for the Collection and Use of Diversity Measures. American journal of human genetics Popejoy, A. B., Crooks, K. R., Fullerton, S. M., Hindorff, L. A., Hooker, G. W., Koenig, B. A., Pino, N., Ramos, E. M., Ritter, D. I., Wand, H., Wright, M. W., Yudell, M., Zou, J. Y., Plon, S. E., Bustamante, C. D., Ormond, K. E., Clinical Genome Resource (ClinGen) Ancestry and Diversity Working Group 2020

    Abstract

    Genetics researchers and clinical professionals rely on diversity measures such as race, ethnicity, and ancestry (REA) to stratify study participants and patients for a variety of applications in research and precision medicine. However, there are no comprehensive, widely accepted standards or guidelines for collecting and using such data in clinical genetics practice. Two NIH-funded research consortia, the Clinical Genome Resource (ClinGen) and Clinical Sequencing Evidence-generating Research (CSER), have partnered to address this issue and report how REA are currently collected, conceptualized, and used. Surveying clinical genetics professionals and researchers (n = 448), we found heterogeneity in the way REA are perceived, defined, and measured, with variation in the perceived importance of REA in both clinical and research settings. The majority of respondents (>55%) felt that REA are at least somewhat important for clinical variant interpretation, ordering genetic tests, and communicating results to patients. However, there was no consensus on the relevance of REA, including how each of these measures should be used in different scenarios and what information they can convey in the context of human genetics. A lack of common definitions and applications of REA across the precision medicine pipeline may contribute to inconsistencies in data collection, missing or inaccurate classifications, and misleading or inconclusive results. Thus, our findings support the need for standardization and harmonization of REA data collection and use in clinical genetics and precision health research.

    View details for DOI 10.1016/j.ajhg.2020.05.005

    View details for PubMedID 32504544

  • Informed Consent in the Genomics Era. Cold Spring Harbor perspectives in medicine Rego, S., Grove, M. E., Cho, M. K., Ormond, K. E. 2019

    Abstract

    Informed consent, the process of gathering autonomous authorization for a medical intervention or medical research participation, is a fundamental component of medical practice. Medical informed consent assumes decision-making capacity, voluntariness, comprehension, and adequate information. The increasing use of genetic testing, particularly genomic sequencing, in clinical and research settings has presented many new challenges for clinicians and researchers when obtaining informed consent. Many of these challenges revolve around the need for patient comprehension of sufficient information. Genomic sequencing is complex-all of the possible results are too numerous to explain, and many of the risks and benefits remain unknown. Thus, historical standards of consent are difficult to apply. Alternative models of consent have been proposed to increase patient understanding, and several have empirically demonstrated effectiveness. However, there is still a striking lack of consensus in the genetics community about what constitutes informed consent in the context of genomic sequencing. Multiple approaches are needed to address this challenge, including consensus building around standards, targeted use of genetic counselors in nongenetics clinics in which genomic testing is ordered, and the development and testing of alternative models for obtaining informed consent.

    View details for DOI 10.1101/cshperspect.a036582

    View details for PubMedID 31570382

  • The clinical application of gene editing: ethical and social issues. Personalized medicine Ormond, K. E., Bombard, Y., Bonham, V. L., Hoffman-Andrews, L., Howard, H., Isasi, R., Musunuru, K., Riggan, K. A., Michie, M., Allyse, M. 2019

    Abstract

    Gene-editing techniques have progressed rapidly in the past 5years. There are already ongoing human somatic gene-editing clinical trials for multiple diseases. And there has been one purported scenario of human germline gene editing in late 2018. In this paper, we will review the current state of the technology, discuss the ethical and social issues that surround the various forms of gene editing, as well as review emerging stakeholder data from professionals, the 'general public' and individuals and families dealing with genetic diseases potentially treatable by gene editing.

    View details for DOI 10.2217/pme-2018-0155

    View details for PubMedID 31331245

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

Postdoctoral Research Fellow, Biomedical Ethics

Publications

  • Pros and cons of prosent as an alternative to traditional consent in medical research. Journal of medical ethics Rahimzadeh, V. N. 2020

    Abstract

    In their recent article, Porsdam Mann et al propose to share biomedical research data more widely, securely and efficiently using blockchain technologies.1 They present compelling arguments for how the blockchain presents both a technological innovation, and a deontologically grounded policy innovation to traditional research consent. Their proposal can be read in conversation with a rich body of evidence to suggest current consent processes are problematic on at least one of tripartite bases in biomedical research: that it be fully informed. This response attempts to further the author's discussion of social justice discourse in, and of their proposed prosent model to enhance engagement among under-represented and vulnerable populations in research, specifically. Motivating this response is the view that advancing technological capabilities is no doubt necessary, but on its own insufficient to reinvigorate distributive, procedural and social justice as guiding principles for con/prosent processes. I offer three pros and cons to consider in effort to deepen the model's commitments to social justice to historically marginalised groups in the biomedical research enterprise.

    View details for DOI 10.1136/medethics-2020-106443

    View details for PubMedID 32571849

Adjunct Clinical Associate Professor, Pediatrics - Center for Biomedical Ethics
Professor of Anesthesiology, Perioperative and Pain Medicine at the Palo Alto Veterans Affairs Health Care System

Publications

Associate Professor of Medicine (General Medical Disciplines) and, by courtesy, of Health Research and Policy (Epidemiology) at the Stanford University Medical Center

Publications

  • Patient and family social media use surrounding a novel treatment for a rare genetic disease: a qualitative interview study. Genetics in medicine : official journal of the American College of Medical Genetics Iyer, A. A., Barzilay, J. R., Tabor, H. K. 2020

    Abstract

    PURPOSE: Advances in gene therapy and precision medicine have led to a growing number of novel treatments for rare genetic diseases. Patients/families may lack access to up-to-date, accurate, and relevant information about these treatments. Social media offers one potentially important resource for these communities. Our goal was to understand how patients/families with spinal muscular atrophy (SMA)-a rare genetic condition-used social media to share, consume, and evaluate information about the novel treatment nusinersen (Spinraza) following the drug's approval.METHODS: We conducted qualitative, semistructured interviews with 20 SMA patients or parents of patients, deriving themes and subthemes through content and thematic network analysis. Participants also completed a demographic survey.RESULTS: Participants described leveraging social media to learn about nusinersen treatment, make informed treatment decisions, and advocate for/access treatment. They also described critically evaluating the trustworthiness of nusinersen-related information on social media and the privacy risks of social media use.CONCLUSION: Patients/families used social media to navigate the new and dynamic landscape of nusinersen treatment for SMA, while attempting to mitigate misinformation and privacy risks. As new treatments become available, providers and patients/families may benefit from proactively discussing social media use, so as to maximize important benefits while minimizing risks.

    View details for DOI 10.1038/s41436-020-0890-6

    View details for PubMedID 32601388

  • De novo EIF2AK1 and EIF2AK2 Variants Are Associated with Developmental Delay, Leukoencephalopathy, and Neurologic Decompensation. American journal of human genetics Mao, D., Reuter, C. M., Ruzhnikov, M. R., Beck, A. E., Farrow, E. G., Emrick, L. T., Rosenfeld, J. A., Mackenzie, K. M., Robak, L., Wheeler, M. T., Burrage, L. C., Jain, M., Liu, P., Calame, D., Küry, S., Sillesen, M., Schmitz-Abe, K., Tonduti, D., Spaccini, L., Iascone, M., Genetti, C. A., Koenig, M. K., Graf, M., Tran, A., Alejandro, M., Lee, B. H., Thiffault, I., Agrawal, P. B., Bernstein, J. A., Bellen, H. J., Chao, H. T. 2020

    Abstract

    EIF2AK1 and EIF2AK2 encode members of the eukaryotic translation initiation factor 2 alpha kinase (EIF2AK) family that inhibits protein synthesis in response to physiologic stress conditions. EIF2AK2 is also involved in innate immune response and the regulation of signal transduction, apoptosis, cell proliferation, and differentiation. Despite these findings, human disorders associated with deleterious variants in EIF2AK1 and EIF2AK2 have not been reported. Here, we describe the identification of nine unrelated individuals with heterozygous de novo missense variants in EIF2AK1 (1/9) or EIF2AK2 (8/9). Features seen in these nine individuals include white matter alterations (9/9), developmental delay (9/9), impaired language (9/9), cognitive impairment (8/9), ataxia (6/9), dysarthria in probands with verbal ability (6/9), hypotonia (7/9), hypertonia (6/9), and involuntary movements (3/9). Individuals with EIF2AK2 variants also exhibit neurological regression in the setting of febrile illness or infection. We use mammalian cell lines and proband-derived fibroblasts to further confirm the pathogenicity of variants in these genes and found reduced kinase activity. EIF2AKs phosphorylate eukaryotic translation initiation factor 2 subunit 1 (EIF2S1, also known as EIF2α), which then inhibits EIF2B activity. Deleterious variants in genes encoding EIF2B proteins cause childhood ataxia with central nervous system hypomyelination/vanishing white matter (CACH/VWM), a leukodystrophy characterized by neurologic regression in the setting of febrile illness and other stressors. Our findings indicate that EIF2AK2 missense variants cause a neurodevelopmental syndrome that may share phenotypic and pathogenic mechanisms with CACH/VWM.

    View details for DOI 10.1016/j.ajhg.2020.02.016

    View details for PubMedID 32197074

  • Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors. Annals of internal medicine Matheny Antommaria, A. H., Gibb, T. S., McGuire, A. L., Wolpe, P. R., Wynia, M. K., Applewhite, M. K., Caplan, A., Diekema, D. S., Hester, D. M., Lehmann, L. S., McLeod-Sordjan, R., Schiff, T., Tabor, H. K., Wieten, S. E., Eberl, J. T. 2020

    Abstract

    The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies.To characterize the development of ventilator triage policies and compare policy content.Survey and mixed-methods content analysis.North American hospitals associated with members of the Association of Bioethics Program Directors.Program directors.Characteristics of institutions and policies, including triage criteria and triage committee membership.Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations.The results may not be generalizable to institutions without academic bioethics programs.Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation.

    View details for DOI 10.7326/M20-1738

    View details for PubMedID 32330224

Postdoctoral Research Fellow, Biomedical Ethics

Publications

  • Waiting and "weighted down": the challenge of anticipatory loss for individuals and families with Li-Fraumeni Syndrome. Familial cancer Werner-Lin, A., Young, J. L., Wilsnack, C., Merrill, S. L., Groner, V., Greene, M. H., Khincha, P. P. 2020

    Abstract

    Li-Fraumeni Syndrome (LFS) is characterized by risk of multiple primary malignancies in diverse sites, pediatric onset, near complete penetrance by age 70years, limited options for prevention, and substantial uncertainty regarding disease manifestation and prognosis. Forty-five families, including 117 individuals aged 13-81years, enrolled in the US National Cancer Institute's Li-Fraumeni Syndrome Study completed 66 interviews regarding their LFS experiences. An interdisciplinary team used modified grounded theory to examine family distress regarding expectations of loss and change due to likely cancer diagnoses, and the consequences of this likelihood across physical, social, and emotional domains. Disease-free periods were characterized by fearful anticipation of diagnosis or recurrence, uncertainty regarding post-treatment quality of life, and planning for shifts in family dynamics to enable caregiving. The chronicity of waiting for these changes incited dread and inhibited effective coping with the pragmatic, emotional, and existential challenges of the syndrome. Consequently, families reported high burden on roles and resources and limited guidance to prepare for, or achieve resolution with, grief. Anticipatory loss, the experience of bereavement prior to an expected change, distinguishes hereditary cancer risk from a sporadic diagnosis. Such grief is often incomplete in impact or meaning, subjected to rapid or profound change as conditions worsen, and poorly understood. In this study, losses were compounded by profound uncertainty, a chronic feature of LFS, which compromised mourning. Long-term engagement of mental health providers with bereavement training, in partnership with genetics providers, can provide invaluable educational and psychological support to families as they navigate these implacable challenges.

    View details for DOI 10.1007/s10689-020-00173-6

    View details for PubMedID 32222840

  • Health behavior change is related to management of cancer worry for families with Li-Fraumeni syndrome: "If you just change your diet, you're going to get cured" Wilsnack, C., Sleight, A., Young, J., Greene, M. H., Khincha, P. P., Groner, V., Werner-Lin, A. WILEY. 2020: 99–100
  • Couples coping with screening burden and diagnostic uncertainty in Li-Fraumeni syndrome: Connection versus independence JOURNAL OF PSYCHOSOCIAL ONCOLOGY Young, J. L., Pantaleao, A., Zaspel, L., Bayer, J., Peters, J. A., Khincha, P. P., Bremer, R. C., Loud, J. T., Greene, M. H., Achatz, M., Savage, S. A., Werner-Lin, A. 2019; 37 (2): 178–93

    Abstract

    Li-Fraumeni Syndrome (LFS) is an inherited tumor predisposition syndrome with lifetime cancer risks approaching 100% and evolving risk-management strategies. This study evaluated couples' coping with LFS-related burdens.Constructivist grounded theory and anticipatory loss frameworks guided design and analysis.Twenty-six individuals enrolled in the NCI LFS Family Study completed semi-structured interviews with their partner during annual screening visits. An interdisciplinary team completed open and focused coding to identify patterns of coping and adaptation.Couples described living with ambiguous danger, a state of chronic apprehension resulting from LFS-associated uncertainties. Most couples communicated openly and alternated shouldering the burden, while others engaged in protective buffering to shield each other from distress and sustain the appearance of normalcy.Optimally, coping reduces shared psychosocial distress, yet some strategies may inadvertently increase disconnection.Mental health support is critical for both partners coping with LFS, together and separately.

    View details for DOI 10.1080/07347332.2018.1543376

    View details for Web of Science ID 000465227200005

    View details for PubMedID 30591002