-
38Ethical Considerations in the Conduct of Electronic Surveillance ResearchJournal 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
-
37Threats to the Common Good: Biochemical Weapons and Human Subjects ResearchHastings Center Report 33 (5): 17-25. 2003.The threat of biological and chemical terrorism highlights a growing tension in research ethics between respecting the interests of individuals and safeguarding and protecting the common good. But what it actually means to protect the common good is rarely scrutinized. There are two conceptions of the common good that provide very different accounts of the limits of permissible medical research. Decisions about the limits of acceptable medical research in defense of the common good should be car…Read more
-
37Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing AgenciesDeveloping World Bioethics 16 (1): 4-14. 2014.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
-
36A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective ReviewJournal of Law, Medicine and Ethics 40 (4): 930-944. 2012.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
-
34Learning health systems, clinical equipoise and the ethics of response adaptive randomisationJournal of Medical Ethics 44 (6): 409-415. 2018.To give substance to the rhetoric of ‘learning health systems’, a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation. However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holdi…Read more
-
33What Is Social and Global Justice to Bioethics or Bioethics to Social and Global Justice?Hastings Center Report 36 (4): 3-3. 2006.
-
32Cutting surgical practice at the joints: Individuating and assessing surgical proceduresIn Ethical Guidelines for innovative surgery, University Publishing Group. pp. 19-52in Angelique M. Rietsma and Jonathan D. Moreno eds., Ethical Guidelines for Innovative Surgery. (Hagerstown, MD: University Publishing Group) 19-52. [PDF].
-
29The decision to initiate invasive, first-in-human trials involving Parkinson’s disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable riskbenefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence…Read more
-
28The moral foundations of equipoise and its role in international researchAmerican Journal of Bioethics 6 (4). 2006.In “The Real Problem With Equipoise,” Chiong (2006) raises two distinct, but interrelated issues concerning the concept of equipoise. The first deals with the role of equipoise in evaluating intern...
-
26Dignity and the Value of Rejecting Profitable but Insulting OffersMind 124 (494): 409-448. 2015.In this paper we distinguish two competing conceptions of dignity, one recognizably Hobbesian and one recognizably Kantian. We provide a formal model of how decision-makers committed to these conceptions of dignity might reason when engaged in an economic transaction that is not inherently insulting, but in which it is possible for the dignity of the agent to be called into question. This is a modified version of the ultimatum game. We then use this model to illustrate ways in which the Kantian …Read more
-
26Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and PolicyHastings Center Report 49 (4): 31-41. 2019.Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series …Read more
-
25Justice in the Application of Science: Beyond Fair BenefitsAmerican Journal of Bioethics 10 (6): 54-56. 2010.There are now at least two different views that fall under the heading of the “fair benefits” approach (FBA) to international research. These views share a number of important commitments, such as...
-
25Response to Open Peer Commentaries on “The Ethics of Advertising for Health Care Services”American Journal of Bioethics 14 (4). 2014.No abstract
-
25To cite this Article: , 'Two Dogmas of Research Ethics and the Integrative Approach to Human-Subjects Research', Journal of Medicine and Philosophy, 32:2, 99 - 116 To link to this article: DOI: 10.1080/03605310701255727 URL: http://dx.doi.org/10.1080/03605310701255727..
-
25Equipoise, Research Stalemates, and the Limits of New DataAmerican Journal of Bioethics 11 (2). 2011.This Article does not have an abstract
-
25A Dilemma for Respecting Autonomy: Bridge Technologies and the Hazards of Sequential Decision-MakingJournal of Medicine and Philosophy 47 (2): 293-310. 2022.Respect for patient autonomy can apply at two levels: ensuring that patient care reflects their considered values and wishes and honoring patient preferences about how to make momentous decisions. Caregivers who seek to respect patient autonomy in the context of some end-of-life decisions face a dilemma. Because these decisions are fraught, patients may prefer to approach them sequentially, only making decisions at the time they arise. However, respecting patients’ preferences for a sequential a…Read more
-
24Equipoise and the Criteria for Reasonable ActionJournal of Law, Medicine and Ethics 34 (2): 441-450. 2006.Critics of clinical equipoise have long argued that it represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the tensions inherent in clinical research. In particular, the equipoise requirement is often attacked on the grounds that it is not sufficiently responsive to the interests of individual patients. In this paper, we outline a view of equipoise that not only withstands a stronger version of this objection, which was recently articulated by Deborah Hel…Read more
-
24First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately mini…Read more
-
24Self-Defeating Codes of Medical Ethics and How to Fix Them: Failures in COVID-19 Response and BeyondAmerican Journal of Bioethics 21 (1): 4-13. 2021.Statements of the core ethical and professional responsibilities of medical professionals are incomplete in ways that threaten fundamental goals of medicine. First, in the absence of explicit guida...
-
24Before participants can be enrolled in a clinical trial, an institutional review board must determine that the risks that the research poses to participants are ‘reasonable.’ This paper examines the two dominant frameworks for assessing research risks and argues that each approach suffers from significant shortcomings. It then considers what issues must be addressed in order to construct a framework for risk assessment that is grounded in a compelling normative foundation and might provide more …Read more
-
23Assessing the Moral Coherence and Moral Robustness of Social Systems: Proof of Concept for a Graphical Models ApproachScience and Engineering Ethics 22 (6): 1761-1779. 2016.This paper presents a proof of concept for a graphical models approach to assessing the moral coherence and moral robustness of systems of social interactions. “Moral coherence” refers to the degree to which the rights and duties of agents within a system are effectively respected when agents in the system comply with the rights and duties that are recognized as in force for the relevant context of interaction. “Moral robustness” refers to the degree to which a system of social interaction is co…Read more
-
21The Structure of Clinical Translation: Efficiency, Information, and EthicsHastings Center Report 45 (2): 27-39. 2015.The last two decades have witnessed a crescendo of allegations that clinical translation is rife with waste and inefficiency. Patient advocates argue that excessively demanding regulations delay access to life‐saving drugs, research funders claim that too much basic science languishes in academic laboratories, journal editors allege that biased reporting squanders public investment in biomedical research, and drug companies (and their critics) argue that far too much is expended in pharmaceutica…Read more
-
21Justice and the Human Development Approach to International ResearchHastings Center Report 35 (1): 24. 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.
-
21Undue inducements and reasonable risks: Will the dismal science lead to dismal research ethics?American Journal of Bioethics 5 (5). 2005.This Article does not have an abstract
-
20The high rates of attrition that occur in drug development are widely regarded as problematic, but the failure of well-designed studies benefits both researchers and healthcare systems by, for example, generating evidence about disease theories and demonstrating the limits of proven drugs. A wider recognition of these benefits will help the biomedical research enterprise to take full advantage of all the information generated during the drug development process
-
19Perspective: The Maltese Conjoined Twins: Two Views of Their SeparationHastings Center Report 31 (1): 48. 2001.
-
19Uncommon misconceptions and common moralityJournal of Medical Ethics 45 (12): 778-779. 2019.One of the fundamental challenges in any field of practical ethics is to articulate a framework for deliberation and decision making that is capable of providing warranted guidance about contentious ethical questions.1 Such a framework has to function effectively in the face of empirical uncertainty and what Rawls refers to as the fact of reasonable pluralism—the fact that individuals often differ in their ideals, ambitions, preferences and conceptions of the good life. One of the perennial ques…Read more
Areas of Specialization
Ethics of Artificial Intelligence, Misc |
Value Theory |
Biomedical Ethics |
Applied Ethics |
Normative Ethics |
Areas of Interest
Value Theory |
Biomedical Ethics |
Applied Ethics |
Normative Ethics |