•  443
    Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions
    with Jacob M. Kolman, Nelda P. Wray, Carol M. Ashton, Anna F. Jarman, and Baruch A. Brody
    Journal of Law, Medicine and Ethics 40 (1): 99-121. 2012.
    Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.
  •  261
    Patient-Funded Trials: Opportunity or Liability?
    with Alex John London and Jonathan Kimmelman
    Cell Stem Cell 17 (2): 135-137. 2015.
    Patient-funded trials are gaining traction as a means of accelerating clinical translation. However, such trials sidestep mechanisms that promote rigor, relevance, efficiency, and fairness. We recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials, and we offer some basic criteria for evaluating PFT protocols
  •  116
    A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions
    with C. M. Ashton, N. P. Wray, A. F. Jarman, J. M. Kolman, and B. A. Brody
    Journal of Medical Ethics 37 (6): 368-373. 2011.
    Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other auth…Read more
  •  116
    Against Permitted Exploitation in Developing World Research Agreements
    Developing World Bioethics 16 (1): 36-44. 2016.
    This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntar…Read more
  •  112
    Research ethics: Ethics and methods in surgical trials
    with C. Ashton, N. Wray, A. Jarman, and J. Kolman
    Journal of Medical Ethics 35 (9): 579-583. 2009.
    This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards dem…Read more
  •  34
    Puberty-Blocking Treatment and the Rights of Bad Candidates
    American Journal of Bioethics 19 (2): 80-82. 2019.
  •  21
    Discharging the Duty to Conduct International Clinical Research
    American Journal of Bioethics 12 (11): 44-46. 2012.
    No abstract
  •  20
    The Social Value of Knowledge and International Clinical Research
    Developing World Bioethics 15 (2): 76-84. 2015.
    In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the…Read more
  •  19
    Ethicists have long recognized that two necessary features of ethical research are scientific validity and social value. Yet despite a significant literature surrounding the validity component of this dictate, until recently there has been little attention paid to unpacking what the social value component might require. This article introduces a framework for assessing the social value of research, and in particular, for determining whether a given research program is likely to have significant …Read more
  •  17
    Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits…Read more
  •  12
    Danielle M. Wenner Replies
    Hastings Center Report 49 (2): 47-47. 2019.
  •  12
    It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value re…Read more
  •  7
    A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting researc…Read more
  •  4
    Do Surgical Trials Meet the Scientific Standards for Clinical Trials
    with Baruch A. Brody, Anna Jarman, Jacob M. Kolman, Nelda Wray, and Carol Ashton
    Journal of the American College of Surgeons 215 (5): 722-730. 2012.
  •  3
    Licensing Domination: Foreign Will and Social Benefit
    American Journal of Bioethics 19 (9): 60-62. 2019.
    Volume 19, Issue 9, September 2019, Page 60-62.
  •  2
    Trials and Tribulations: The Professional Development of Surgical Trialists
    with Anna Jarman, Nelda Wray, and Carol Ashton
    American Journal of Surgery 204 (3): 339-346. 2012.
  • Nondomination and the Limits of Relational Autonomy
    International Journal of Feminist Approaches to Bioethics 13 (2): 28-48. 2020.
    Feminist theorists worry that liberal conceptions of autonomy are predicated on a problematic view of the individual as entirely self-sufficient and independent of her relationships with others. On one hand, they point out, agency cannot be separated from interdependence. Large swaths of our lives, especially during formative years, are spent dependent on others, and those relationships inform our preferences, our values, and our understandings of our selves. On the other hand, feminist theorist…Read more