•  121
    ELSI Priorities for Brain Imaging
    with Judy Illes, Raymond De Vries, and Pam Schraedley-Desmond
    American Journal of Bioethics 6 (2). 2006.
    As one of the most compelling technologies for imaging the brain, functional MRI (fMRI) produces measurements and persuasive pictures of research subjects making cognitive judgments and even reasoning through difficult moral decisions. Even after centuries of studying the link between brain and behavior, this capability presents a number of novel significant questions. For example, what are the implications of biologizing human experience? How might neuroimaging disrupt the mysteries of human na…Read more
  •  111
    Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations
    with Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness, and Benjamin S. Wilfond
    Journal of Law, Medicine and Ethics 36 (2): 219-248. 2008.
    No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researche…Read more
  •  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
  •  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
  •  72
    Engineering Values Into Genetic Engineering: A Proposed Analytic Framework for Scientific Social Responsibility
    with Pamela L. Sankar
    American Journal of Bioethics 15 (12): 18-24. 2015.
    Recent experiments have been used to “edit” genomes of various plant, animal and other species, including humans, with unprecedented precision. Furthermore, editing the Cas9 endonuclease gene with a gene encoding the desired guide RNA into an organism, adjacent to an altered gene, could create a “gene drive” that could spread a trait through an entire population of organisms. These experiments represent advances along a spectrum of technological abilities that genetic engineers have been working…Read more
  •  71
    Strangers at the benchside: Research ethics consultation
    with Sara L. Tobin, Henry T. Greely, Jennifer McCormick, Angie Boyce, and David Magnus
    American Journal of Bioethics 8 (3). 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
  •  66
    “Don't Want No Risk and Don't Want No Problems”: Public Understandings of the Risks and Benefits of Noninvasive Prenatal Testing in the United States
    with Megan Allyse, Lauren Carter Sayres, Taylor Goodspeed, and Marsha Michie
    AJOB Empirical Bioethics 6 (1): 5-20. 2015.
  •  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
  •  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
  •  59
    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.
    The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because “race” has some correlation with biological and genetic characteristics, there has been a call not to “throw the baby out with the bathwater” by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as …Read more
  •  54
    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
  •  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
  •  53
    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.
  •  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
  •  51
    Disease Genes Are Not Patentable: A Rebuttal of McGee
    with Jon F. Merz
    Cambridge Quarterly of Healthcare Ethics 7 (4): 425-428. 1998.
    Dr. McGee presents a cogent argument for the patentability of the diagnosis of gene forms that are found to be associated with disease or other phenotypic manifestations. We're convinced he's wrong. An analogy will help explain why
  •  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.
  •  46
    Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making
    with Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Emily Rosenthal, Steven Joffe, Benjamin Wilfond, and Sandra Soo-Jin Lee
    American Journal of Bioethics 15 (9): 4-17. 2015.
    We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to i…Read more
  •  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
  •  43
    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
  •  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
  •  37
    No abstract
  •  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...
  •  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...
  •  32
    The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on “Patient Perspectives on the Learning Health System”
    with Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Steven Joffe, Benjamin Wilfond, and Sandra Soo-Jin Lee
    American Journal of Bioethics 16 (2): 7-9. 2016.
  •  32
    Understanding Incidental Findings in the Context of Genetics and Genomics
    Journal of Law, Medicine and Ethics 36 (2): 280-285. 2008.
    Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic v…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.
  •  31
    Understanding Incidental Findings in the Context of Genetics and Genomics
    Journal of Law, Medicine and Ethics 36 (2): 280-285. 2008.
    Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, “incidental” or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent …Read more
  •  27
    Reporting Race and Ethnicity in Genetics Research: Do Journal Recommendations or Resources Matter?
    with Pamela Sankar, Keri Monahan, and Kamila Nowak
    Science and Engineering Ethics 21 (5): 1353-1366. 2015.
    Appeals to scrutinize the use of race and ethnicity as variables in genetics research notwithstanding, these variables continue to be inadequately explained and inconsistently used in research publications. In previous research, we found that published genetic research fails to follow suggestions offered for addressing this problem, such as explaining the basis on which these labels are assigned to populations. This study, an analysis of genetic research articles using race or ethnicity terms, e…Read more
  •  24
    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.