•  664
    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.
    There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Foo…Read more
  •  422
    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
  •  348
    Against Permitted Exploitation in Developing World Research Agreements
    Developing World Bioethics 16 (1): 36-44. 2015.
    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
  •  316
    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
  •  284
    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
  •  60
    Puberty-Blocking Treatment and the Rights of Bad Candidates
    American Journal of Bioethics 19 (2): 80-82. 2019.
  •  44
    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
  •  36
    Nondomination and the Limits of Relational Autonomy
    International Journal of Feminist Approaches to Bioethics 13 (2): 28-48. 2020.
    Relational autonomy theorists attempt to accommodate social embeddedness within a conception of autonomy. These attempts are conceptually messy, at best, and category errors, at worst. Rejecting the liberal conception of autonomy due to feminist concerns is more helpfully answered by the neorepublican notion of freedom as nondomination. The conception of freedom as nondomination captures the values that motivate the relational turn in moral and political theory and does so in a conceptually neat…Read more
  •  34
    Within bioethics as well as in broader clinical practice, support for transgender and gender‐questioning adolescent access to pubertal suppression has often relied heavily on the desire to prevent risky, self‐destructive, and suicidal behavior. We argue that framing justifications for access to puberty suppression in this way can actually be harmful to both individual patients as well as to the broader trans population. This justification for access to care makes such access precarious, limits i…Read more
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  •  31
    Danielle M. Wenner Replies
    Hastings Center Report 49 (2): 47-47. 2019.
    The author replies to a letter to the editor from Felicitas Sofia Holzer concerning Wenner’s article “The Social Value Requirement in Research: From the Transactional to the Basic Structure Model of Stakeholder Obligations,” in the Hastings Center Report’s January‐February 2019 issue.
  •  26
    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
  •  26
    Discharging the Duty to Conduct International Clinical Research
    American Journal of Bioethics 12 (11): 44-46. 2012.
    Pratt, Zion, and Loff (2012) correctly point out that most international clinical research (ICR) is not intended to address the vast inequities in access to health care between developed and develo...
  •  23
    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
  •  23
    The Social Value of Knowledge and International Clinical Research
    Developing World Bioethics 15 (2): 76-84. 2013.
    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
  •  18
    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
  •  18
    Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California
    with Emily A. Largent, Govind Persad, Michelle M. Mello, Daniel B. Kramer, Brownsyne Tucker Edmonds, and Monica Peek
    American Journal of Public Health 1 (1). 2021.
    California has focused on health equity in the state’s COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California’s 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier’s test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 …Read more
  •  13
    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.
  •  6
    Reproductive Justice Beyond Borders: Global Feminist Solidarity in the Post- Roe Era
    with Gabriela Arguedas-Ramírez
    Journal of Law, Medicine and Ethics 51 (3): 606-611. 2023.
    The global impact of Dobbs v. Jackson Women’s Health Organization and the backlash towards reproductive justice that it represents warrant a global feminist response informed by broad theoretical and geopolitical lenses. We consider how a solidaristic, transnational feminist movement might learn from Latin American feminist movements that have been successful in uniting broad coalitions in the fight for reproductive justice as situated within far-reaching political goals. The success of such a g…Read more
  •  5
    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.
  •  4
    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.