•  4
    Beyond the Medical Model: Retooling Bioethics for the Work Ahead
    with Gail E. Henderson and Larry R. Churchill
    American Journal of Bioethics 21 (2): 53-55. 2021.
    The three important target articles make a strong case for regarding racism as a public health crisis. Each calls for advocacy by the bi...
  •  5
    The Future of Bioethics: It Shouldn't Take a Pandemic
    with Larry R. Churchill and Gail E. Henderson
    Hastings Center Report 50 (3): 54-56. 2020.
  •  1
    Pragmatism, Value, and Judgment in Medicine (review)
    Journal of Law, Medicine and Ethics 37 (1): 147-148. 2009.
  •  7
    Key Information in the New Common Rule: Can It Save Research Consent?
    Journal of Law, Medicine and Ethics 47 (2): 203-212. 2019.
    Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it …Read more
  •  20
    Who's Winning the IRB Wars? The Struggle for the Soul of Human Research
    Perspectives in Biology and Medicine 61 (3): 450-464. 2018.
    One of my favorite bioethics quotes is nearing 50 years old:Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be threatened by the erosion of th…Read more
  •  16
    Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial
    with Joseph E. Andrews, J. Brian Moore, Richard B. Weinberg, Mysha Sissine, Sabina Gesell, Jacquie Halladay, Wayne Rosamond, Cheryl Bushnell, Sara Jones, Paula Means, Diana Omoyeni, and Pamela W. Duncan
    Journal of Medical Ethics 44 (8): 560-566. 2018.
    Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the fea…Read more
  •  11
    Genetic Research as Therapy: Implications of “Gene Therapy” for Informed Consent
    with Larry R. Churchill, Myra L. Collins, Stephen G. Pemberton, and Keith A. Wailoo
    Journal of Law, Medicine and Ethics 26 (1): 38-47. 1998.
    In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that …Read more
  •  36
    Biodefense Research and the U.S. Regulatory Structure Whither Nonhuman Primate Moral Standing?
    with Rebecca L. Walker
    Kennedy Institute of Ethics Journal 21 (3): 277-310. 2011.
    Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease, suffering, and death arising, or potentially arising, from natural outbreaks or intentional deployment of some of the world’s most dreaded pathogens. Top priority research goals include finding vaccines to prevent, diagnostic tools to detect, and medicines for smallpox, plague, ebola, anthrax, tularemia, and viral hemorrhagic fevers, among many other pathogens (National Institute of Allergy and …Read more
  •  16
    Research Ethics: Reexamining Key Concerns
    Journal of Law, Medicine and Ethics 40 (4): 865-866. 2012.
  •  15
    Athletes Are Guinea Pigs
    with Richard Robeson
    American Journal of Bioethics 13 (10). 2013.
    No abstract
  •  18
    The ethics committee as greek chorus
    HEC Forum 8 (6): 346-354. 1996.
  • Not for Distribution
    Journal of Law, Medicine and Ethics 28 332-343. 2000.
  •  35
    Vulnerability to influence: A two-way street
    with Gail E. Henderson and Arlene M. Davis
    American Journal of Bioethics 4 (3). 2004.
    This Article does not have an abstract
  •  4
    The Stories We Tell Ourselves
    Hastings Center Report 33 (5): 48-48. 2003.
  •  26
    RAC Oversight of Gene Transfer Research: A Model Worth Extending?
    Journal of Law, Medicine and Ethics 30 (3): 381-389. 2002.
    Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.C…Read more
  •  6
    Ethical issues in regenerative medicine
    with Christine Nero Coughlin and Mark Furth
    “Regenerative medicine” describes a set of innovative approaches to the treatment of illness, injury, and disability, focusing on the growth, replacement, and repair of cells, organs, and tissues specific to the health needs of particular individuals. The extraordinary breadth of application of this approach is clear from an enumeration of just a few areas of regenerative medicine research, such as stem cells, including embryonic stem cells, pluripotent stem cells produced by genetic reprogrammi…Read more
  •  2
    Advance care planning and end-of-life decision-making
    with John C. Moskop
    In D. Micah Hester & Toby Schonfeld (eds.), Guidance for Healthcare Ethics Committees, Cambridge University Press. 2012.
  •  22
    An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial
    with Robert M. Nelson and Ken Kipnis
    American Journal of Bioethics 10 (10): 5-8. 2010.
    At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme?, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme? and saline in the field and, still without consent, randomized between PolyHeme? and blood after arrival at an eme…Read more
  •  49
    Protection of human subjects and scientific progress: Can the two be reconciled?
    with Kathleen Cranley Glass, David B. Resnik, Stephen Olufemi Sodeke, Halley S. Faust, Rebecca Dresser, C. D. Herrera, David Orentlicher, and Lynn A. Jansen
    Hastings Center Report 36 (1): 4-9. 2006.
  • The glass house : assessing bioethics
    In Lisa A. Eckenwiler & Felicia Cohn (eds.), The Ethics of Bioethics: Mapping the Moral Landscape, Johns Hopkins University Press. 2007.
  •  23
    Nanomedicine First-in-Human Research: Challenges for Informed Consent
    Journal of Law, Medicine and Ethics 40 (4): 823-830. 2012.
    First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also consi…Read more
  • Bioethics, Public Moral Argument, and Social Responsibility (edited book)
    with Michael J. Hyde
    Routledge. 2011.
    _Bioethics, Public Moral Argument, and Social Responsibility_ explores the role of democratically oriented argument in promoting public understanding and discussion of the benefits and burdens of biotechnological progress. The contributors examine moral and policy controversies surrounding biomedical technologies and their place in American society, beginning with an examination of discourse and moral authority in democracy, and addressing a set of issues that include: dignity in health care; th…Read more
  •  32
    What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011
    with Gail E. Henderson, Eric T. Juengst, Kristine Kuczynski, and Marsha Michie
    Journal of Law, Medicine and Ethics 40 (4): 1008-1024. 2012.
    In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of …Read more
  •  18
    Shaping Our Selves: On Technology, Flourishing, and a Habit of Thinking by Erik Parens
    Kennedy Institute of Ethics Journal 26 (1): 5-10. 2016.
    In Shaping Our Selves, Erik Parens offers both a personal history of bioethics and a cleverly clarifying lens to train on disputes in bioethics about emerging technologies. The question for readers is whether this lens, as useful as it is, leaves too much outside our field of vision. Parens, born in 1957, comes from the first wave of bioethics scholars—those of us who still mostly happened into bioethics as a field, before it was sufficiently well-established to be identified as a career pathway…Read more
  •  11
    Experimental Treatment Oxymoron or Aspiration?
    Hastings Center Report 25 (4): 6-15. 1995.