•  349
    Patient-Funded Trials: Opportunity or Liability?
    with Danielle M. Wenner 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
  •  212
    The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research…Read more
  •  194
    Cutting to the Core: Exploring the Ethics of Contested Surgeries
    with Michael Benatar, Leslie Cannold, Dena Davis, Merle Spriggs, Julian Savulescu, Heather Draper, Neil Evans, Richard Hull, Stephen Wilkinson, David Wasserman, Donna Dickenson, Guy Widdershoven, Françoise Baylis, Stephen Coleman, Rosemarie Tong, Hilde Lindemann, and David Neil
    Rowman & Littlefield Publishers. 2006.
    When the benefits of surgery do not outweigh the harms or where they do not clearly do so, surgical interventions become morally contested. Cutting to the Core examines a number of such surgeries, including infant male circumcision and cutting the genitals of female children, the separation of conjoined twins, surgical sex assignment of intersex children and the surgical re-assignment of transsexuals, limb and face transplantation, cosmetic surgery, and placebo surgery
  •  191
    The independence of practical ethics
    Theoretical Medicine and Bioethics 22 (2): 87-105. 2001.
    After criticizing three common conceptions of therelationship between practical ethics and ethical theory, analternative modeled on Aristotle's conception of the relationshipbetween rhetoric and philosophical ethics is explored. Thisaccount is unique in that it neither denigrates the project ofsearching for an adequate comprehensive ethical theory norsubordinates practical ethics to that project. Because the purpose of practical ethics, on this view, is tosecure the cooperation of other persons …Read more
  •  142
    IN BOTH THE EUDEMIAN ETHICS AND THE NICOMACHEAN ETHICS, Aristotle says that the aim of ethical inquiry is a practical one; we want to know what virtue is so that we may become good ourselves and thereby do well and be happy. By classifying ethical inquiry as a practical endeavor, Aristotle is rejecting a view that he attributes to Socrates according to which ethics is a kind of theoretical science. In theoretical sciences, such as geometry or astronomy, the knowledge of a particular subject matt…Read more
  •  102
    Sham Surgery and Genuine Standards of Care: Can the Two be Reconciled?
    with Joseph B. Kadane
    American Journal of Bioethics 3 (4): 61-64. 2003.
  •  91
    Amenable to reason: Aristotle's rhetoric and the moral psychology of practical ethics
    Kennedy Institute of Ethics Journal 10 (4): 287-305. 2000.
    : An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied et…Read more
  •  67
    There is considerable enthusiasm about the prospect that artificial intelligence (AI) will help to improve the safety and efficacy of health services and the efficiency of health systems. To realize this potential, however, AI systems will have to overcome structural problems in the culture and practice of medicine and the organization of health systems that impact the data from which AI models are built, the environments into which they will be deployed, and the practices and incentives that st…Read more
  •  65
    The Place of Philosophy in Bioethics Today
    with Jennifer Blumenthal-Barby, Sean Aas, Dan Brudney, Jessica Flanigan, S. Matthew Liao, Wayne Sumner, and Julian Savulescu
    American Journal of Bioethics 22 (12): 10-21. 2021.
    In some views, philosophy’s glory days in bioethics are over. While philosophers were especially important in the early days of the field, so the argument goes, the majority of the work in bioethics today involves the “simple” application of existing philosophical principles or concepts, as well as empirical work in bioethics. Here, we address this view head on and ask: What is the role of philosophy in bioethics today? This paper has three specific aims: (1) to respond to skeptics and make the …Read more
  •  63
    Justice and the human development approach to international research
    Hastings Center Report 35 (1): 24-37. 2005.
    : The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice
  •  63
    This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their sup…Read more
  •  52
    Advance care planning refers to the process of determining how one wants to be cared for in the event that one is no longer competent to make one's own medical decisions. Some have argued that advance care plans often fail to be normatively binding on caretakers because those plans do not reflect the interests of patients once they enter an incompetent state. In this article, we argue that when the core medical ethical principles of respect for patient autonomy, honest and adequate disclosure of…Read more
  •  52
    Editor's introduction: Theory and engagement in bioethics
    Theoretical Medicine and Bioethics 22 (2): 65-68. 2001.
  •  51
    This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a …Read more
  •  48
    Any view of equipoise faces perhaps the most radical and far-reaching objections from moral foundations. These objections hold that the equipoise requirement conflates the ethics of medical research and the ethics of clinical medicine. Once this conflation is recognized, this position holds, research can be given a new foundation on the imperative to avoid exploiting research participants. This article argues that what is novel in this critique is not as successful as its proponents claim and th…Read more
  •  44
    The Ethics of Advertising for Health Care Services
    with Yael Schenker and Robert M. Arnold
    American Journal of Bioethics 14 (3): 34-43. 2014.
    Advertising by health care institutions has increased steadily in recent years. While direct-to-consumer prescription drug advertising is subject to unique oversight by the Federal Drug Administration, advertisements for health care services are regulated by the Federal Trade Commission and treated no differently from advertisements for consumer goods. In this article, we argue that decisions about pursuing health care services are distinguished by informational asymmetries, high stakes, and pat…Read more
  •  38
    This Article does not have an abstract
  •  35
    Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinic…Read more
  •  34
    There is near universal agreement within the scientific and ethics communities that a necessary condition for the moral permissibility of cross-national, collaborative research is that it be responsive to the health needs of the host community. It has proven difficult, however, to leverage or capitalize on this consensus in order to resolve lingering disputes about the ethics of international medical research. This is largely because different sides in these debates have sometimes provided differe…Read more
  •  32
  •  31
    To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history…Read more
  •  31
    Addressing ethical challenges in HIV prevention research with people who inject drugs
    with Liza Dawson, Steffanie A. Strathdee, Kathryn E. Lancaster, Robert Klitzman, Irving Hoffman, Scott Rose, and Jeremy Sugarman
    Journal of Medical Ethics Recent Issues 44 (3): 149-158. 2018.
    Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in researc…Read more
  •  31
    Bringing science and advocacy together to address health needs of people who inject drugs
    with Liza Dawson, Steffanie A. Strathdee, Kathryn E. Lancaster, Robert Klitzman, Irving Hoffman, Scott Rose, and Jeremy Sugarman
    Journal of Medical Ethics Recent Issues 44 (3): 165-166. 2018.
    In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs, 1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process. 2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include ac…Read more
  •  30
    Ethical Considerations in the Conduct of Electronic Surveillance Research
    with Ashok J. Bharucha, David Barnard, Howard Wactlar, Mary Amanda Dew, and Charles F. Reynolds
    Journal of Law, Medicine and Ethics 34 (3): 611-619. 2006.
    The extant clinical literature indicates profound problems in the assessment, monitoring, and documentation of care in long-term care facilities. The lack of adequate resources to accommodate higher staff-to-resident ratios adds additional urgency to the goal of identifying more costeffective mechanisms to provide care oversight. The ever expanding array of electronic monitoring technologies in the clinical research arena demands a conceptual and pragmatic framework for the resolution of ethical…Read more
  •  30
    in Angelique M. Rietsma and Jonathan D. Moreno eds., Ethical Guidelines for Innovative Surgery. (Hagerstown, MD: University Publishing Group) 19-52. [PDF].
  •  29
    This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dog…Read more
  •  27
    Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies
    with Patrina Sexton, Katrina Hui, Donna Hanrahan, Mark Barnes, Jeremy Sugarman, and Robert Klitzman
    Developing World Bioethics 16 (1): 4-14. 2016.
    Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the researc…Read more