•  2
    Background Genome scientists and Ethical, Legal, and Social Implications of genetics (ELSI) scholars commonly inhabit distinct research cultures – utilizing different research methods, asking different research questions, and valuing different types of knowledge. Collaborations between these two communities are frequently called for to enhance the ethical conduct of genomics research. Yet, little has been done to qualitatively compare genome scientists’ and ELSI scholars’ perspectives on collabo…Read more
  •  8
    Understanding the Gap: A Cross-Sectional Survey of ELSI Scholars’ Dissemination Practices and Translation Goals
    with Deanne Dunbar Dolan, Rachel H. Lee, and Sandra Soo-Jin Lee
    AJOB Empirical Bioethics 15 (2): 147-153. 2024.
    Background Researchers engaged in the study of the ethical, legal, and social implications (ELSI) of genetics and genomics are often publicly funded and intend their work to be in the public interest. These features of U.S. ELSI research create an imperative for these scholars to demonstrate the public utility of their work and the expectation that they engage in research that has potential to inform policy or practice outcomes. In support of the fulfillment of this “translational mandate,” the …Read more
  •  14
    Spotlighting Structural Constraints on Decisions About Participation in Genomic and Precision Medicine
    with Deanne Dunbar Dolan and Sandra Soo-Jin Lee
    AJOB Empirical Bioethics 15 (2): 87-92. 2024.
    Public investments in genomic and precision medicine have begun to yield clinically useful interventions, most recently, for example, two new, FDA-approved gene therapies for sickle cell disease (F...
  •  14
    Moral Engagement and Disengagement in Health Care AI Development
    with Ariadne A. Nichol, Meghan Halley, Carole Federico, and Pamela L. Sankar
    AJOB Empirical Bioethics. forthcoming.
    Background Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding the…Read more
  •  22
    The ELSI Virtual Forum, 30 Years of the Genome: Integrating and Applying ELSI Research
    with Caroline B. Moore, Deanne Dunbar Dolan, Rachel Yarmolinsky, and Sandra Soo-Jin-Lee
    Journal of Law, Medicine and Ethics 51 (3): 661-671. 2023.
    This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.
  • Developing a new paradigm for integrating ethics and biomedical research: proposal for a benchside consultation program
    with H. T. Greely, D. Magnus, and J. Maienschein
    American Society for Bioethics and Humanities/Canadian Bioethics Society Joint Meeting. forthcoming.
  •  20
    Innovating for a Just and Equitable Future in Genomic and Precision Medicine Research
    with Deanne Dunbar Dolan and Sandra Soo-Jin Lee
    American Journal of Bioethics 23 (7): 1-4. 2023.
    From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...
  •  46
    Focusing on Cause or Cure? Priorities and Stakeholder Presence in Childhood Psychiatry Research
    with Lauren C. Milner
    AJOB Empirical Bioethics 5 (1): 44-55. 2014.
    Background: Biomedical research is influenced by many factors, including the involvement of stakeholder groups invested in research outcomes. Stakeholder involvement in research efforts raises questions of justice as stakeholders’ specific interests and motivations play a role in directing research resources that ultimately produce knowledge, shaping how different conditions (and affected individuals) are understood and treated by society. This issue is highly relevant to child psychiatry resear…Read more
  •  20
    A Pilot Survey on the Licensing of DNA Inventions
    with Michelle R. Henry, Meredith A. Weaver, and Jon F. Merz
    Journal of Law, Medicine and Ethics 31 (3): 442-449. 2003.
    Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to …Read more
  •  89
    Thinking about the human neuron mouse
    with Henry T. Greely, Linda F. Hogle, and Debra M. Satz
    American Journal of Bioethics 7 (5). 2007.
    No abstract
  •  52
    Response to open Peer commentaries on "thinking about the human neuron mouse"
    with Henry T. Greely, Linda F. Hogle, and Debra M. Satz
    American Journal of Bioethics 7 (5). 2007.
    This Article does not have an abstract
  •  42
    Racial and Ethnic Categories in Biomedical Research: There is No Baby in the Bathwater
    Journal of Law, Medicine and Ethics 34 (3): 497-499. 2006.
    There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social…Read more
  •  13
  •  63
    Response to Open Peer Commentaries on “Strangers at the Beachside: Research Ethics Consultation”
    with Sara L. Tobin, Henry T. Greely, Jennifer McCormick, Angie Boyce, and David Magnus
    American Journal of Bioethics 8 (3): 4-6. 2008.
    Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for co…Read more
  •  15
    Research ethics: The “how” and “whys” of research: life scientists’ views of accountability
    with J. M. Ladd, M. D. Lappe, J. B. McCormick, and A. M. Boyce
    Journal of Medical Ethics 35 (12): 762-767. 2009.
    Objectives: To investigate life scientists’ views of accountability and the ethical and societal implications of research. Design: Qualitative focus group and one-on-one interviews. Participants: 45 Stanford University life scientists, including graduate students, postdoctoral fellows and faculty. Results: Two main themes were identified in participants’ discussions of accountability: the “how” of science and the “why” of science. The “how” encompassed the internal conduct of research including …Read more
  •  21
    Resource Allocation in COVID-19 Research: Which Trials? Which Patients?
    with Sarah Wieten and Alyssa Burgart
    American Journal of Bioethics 20 (7): 86-88. 2020.
    Volume 20, Issue 7, July 2020, Page 86-88.
  •  38
    “What Is the FDA Going to Think?”: Negotiating Values through Reflective and Strategic Category Work in Microbiome Science
    with Pamela L. Sankar, Angie M. Boyce, and Katherine W. Darling
    Science, Technology, and Human Values 40 (1): 71-95. 2015.
    The US National Institute of Health’s Human Microbiome Project aims to use genomic techniques to understand the microbial communities that live on the human body. The emergent field of microbiome science brought together diverse disciplinary perspectives and technologies, thus facilitating the negotiation of differing values. Here, we describe how values are conceptualized and negotiated within microbiome research. Analyzing discussions from a series of interdisciplinary workshops conducted with…Read more
  •  17
    To Understand Inequity, Bioethics Needs to Sort Things Out
    Hastings Center Report 53 (2): 2-2. 2023.
    Bioethics is reexamining how to implement diversity, equity, inclusion, and justice concerns into scholarship. However, bioethicists should question the categories used to define diversity. The act of categorization is value laden, and classification systems confer power and benefits and generate harms. For example, what conditions count as disabilities? We should consider the equity implications of offering only “male” and “female” options for self‐identification in health records. However, we …Read more
  •  35
    Epistemic Rights and Responsibilities of Digital Simulacra for Biomedicine
    with Nicole Martinez-Martin
    American Journal of Bioethics 23 (9): 43-54. 2022.
    Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...
  •  21
    Bridging the AI Chasm: Can EBM Address Representation and Fairness in Clinical Machine Learning?
    with Nicole Martinez-Martin
    American Journal of Bioethics 22 (5): 30-32. 2022.
    McCradden et al. propose to close the “AI chasm” between algorithms and clinically meaningful application using the norms of evidence-based medicine and clinical research, with the rat...
  •  53
    Digital Contact Tracing, Privacy, and Public Health
    with Nicole Martinez-Martin, Sarah Wieten, and David Magnus
    Hastings Center Report 50 (3): 43-46. 2020.
    Digital contact tracing, in combination with widespread testing, has been a focal point for many plans to “reopen” economies while containing the spread of Covid‐19. Most digital contact tracing projects in the United States and Europe have prioritized privacy protections in the form of local storage of data on smartphones and the deidentification of information. However, in the prioritization of privacy in this narrow form, there is not sufficient attention given to weighing ethical trade‐offs …Read more
  •  33
    The Invisibility of Asian Americans in COVID-19 Data, Reporting, and Relief
    with Jennifer L. Young
    American Journal of Bioethics 21 (3): 100-102. 2021.
    Without proper recognition of the dual pandemics of COVID-19 and racism that Asian Americans and other racial minorities in the United States are facing, we cannot successfully address structural b...
  •  19
    Partial Entrustment in Pragmatic Clinical Trials
    American Journal of Bioethics 20 (1): 24-26. 2020.
  •  52
    Trustworthiness in Untrustworthy Times: Response to Open Peer Commentaries on Beyond Consent
    with Stephanie A. Kraft, Katherine Gillespie, Nina Varsava, Kelly E. Ormond, Benjamin S. Wilfond, and Sandra Soo-Jin Lee
    American Journal of Bioethics 18 (5). 2018.
  •  102
    Beyond Consent: Building Trusting Relationships With Diverse Populations in Precision Medicine Research
    with Stephanie A. Kraft, Katherine Gillespie, Meghan Halley, Nina Varsava, Kelly E. Ormond, Harold S. Luft, Benjamin S. Wilfond, and Sandra Soo-Jin Lee
    American Journal of Bioethics 18 (4): 3-20. 2018.
    With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several fa…Read more
  •  32
    Defining the Scope and Improving the Quality of Clinical Research Ethics Consultation: Response to Open Peer Commentaries About the National Collaborative
    with Kathryn M. Porter, Marion Danis, Holly A. Taylor, and Benjamin S. Wilfond
    American Journal of Bioethics 18 (2): 13-15. 2018.
  •  64
    The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative
    with Kathryn M. Porter, Marion Danis, Holly A. Taylor, and Benjamin S. Wilfond
    American Journal of Bioethics 18 (1): 39-45. 2018.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 ch…Read more
  •  51
    Adrift in the gray zone: IRB perspectives on research in the learning health system
    with Sandra Soo-Jin Lee, Maureen Kelley, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N. Meyer, Douglas Diekema, Alexander M. Capron, Benjamin S. Wilfond, and David Magnus
    AJOB Empirical Bioethics 7 (2): 125-134. 2016.
  •  23
    Fairness and Transparency in an Expanded Access Program: Allocation of the Only Treatment for SMA1
    with Alyssa M. Burgart and Julie Collier
    American Journal of Bioethics 17 (10): 71-73. 2017.