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540After severe brain injury, one of the key challenges for medical doctors is to determine the patient’s prognosis. Who will do well? Who will not do well? Physicians need to know this, and families need to do this too, to address choices regarding the continuation of life supporting therapies. However, current prognostication methods are insufficient to provide a reliable prognosis. Functional Magnetic Resonance Imaging (MRI) holds considerable promise for improving the accuracy of prognosis in …Read more
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145In Loco Parentis Minimal Risk as an Ethical Threshold for Research upon ChildrenHastings Center Report 23 (2): 13-19. 1993.To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.
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102Unethical Author AttributionCambridge Quarterly of Healthcare Ethics 12 (1): 124-130. 2003.I am an M.D/Ph.D. student and work as a research assistant for the director of a division of the school of medicine who is an M.D. He assigned me to research a certain topic and gave me no guidelines or guidance as to how to do it. Nevertheless, I did the research and wrote it up. My supervisor liked the report and said that he thought it was so good that “I would like to offer you the opportunity to publish it and list you as the primary author.” Some bells went off when he so grandly offered t…Read more
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91Refuting the net risks test: a response to Wendler and Miller's "Assessing research risks systematically"Journal of Medical Ethics 33 (8): 487-490. 2007.Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (…Read more
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88Why the Debate over Minimal Risk Needs to be ReconsideredJournal of Medicine and Philosophy 39 (4): 387-405. 2014.Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a disagreement b…Read more
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88The research subject as wage earnerTheoretical Medicine and Bioethics 23 (4-5): 359-376. 2002.The practice of paying research subjects for participating inclinical trials has yet to receive an adequate moral analysis.Dickert and Grady argue for a wage payment model in whichresearch subjects are paid an hourly wage based on that ofunskilled laborers. If we accept this approach, what follows?Norms for just working conditions emerge from workplacelegislation and political theory. All workers, includingpaid research subjects under Dickert and Grady''s analysis,have a right to at least minimu…Read more
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86Protecting Communities in Research: Philosophical and Pragmatic ChallengesCambridge Quarterly of Healthcare Ethics 8 (4): 501-513. 1999.The issue of the protection of communities in clinical research first arose 10 years ago in studies conducted in technologically developing countries by scientists from technologically developed nations. The question was, which ethical standards ought to apply, those of the Western investigators or local standards?
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80Rehabilitating EquipoiseKennedy Institute of Ethics Journal 13 (2): 93-118. 2003.: When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that th…Read more
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79The publication of ethically uncertain research: attitudes and practices of journal editorsBMC Medical Ethics 13 (1): 4. 2012.Background: Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas. Methods: The Editor-in-chief of…Read more
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74Ethical Criteria for Human Challenge Studies in Infectious Diseases: Table 1Public Health Ethics 9 (1): 92-103. 2016.Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currentl…Read more
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64Ethics of neuroimaging after serious brain injuryBMC Medical Ethics 15 (1): 41. 2014.Patient outcome after serious brain injury is highly variable. Following a period of coma, some patients recover while others progress into a vegetative state (unresponsive wakefulness syndrome) or minimally conscious state. In both cases, assessment is difficult and misdiagnosis may be as high as 43%. Recent advances in neuroimaging suggest a solution. Both functional magnetic resonance imaging and electroencephalography have been used to detect residual cognitive function in vegetative and min…Read more
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63Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgeryBMC Medical Ethics 11 (1): 14-. 2010.Background: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying et…Read more
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60Trust based obligations of the state and physician-researchers to patient-subjectsJournal of Medical Ethics 32 (9): 542-547. 2006.When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the on…Read more
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60Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocolBMC Medical Ethics 19 (1): 90. 2018.Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. I…Read more
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59Equipoise and the duty of care in clinical research: A philosophical response to our criticsJournal of Medicine and Philosophy 32 (2). 2007.Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presentl…Read more
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58Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory MythsJournal of Law, Medicine and Ethics 24 (3): 252-259. 1996.Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo con…Read more
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58Assay Sensitivity and the Epistemic Contexts of Clinical TrialsPerspectives in Biology and Medicine 56 (1): 1-17. 2013.In February 2010, the World Medical Association hosted an international symposium on the ethics of placebo controls in clinical trials (WMA 2010). Despite years of debate, ethicists, clinical trialists, and policy makers remain divided over the ethical acceptability of using placebos in research when a proven, effective treatment is available. The protracted nature of this problem is due, at least in part, to a perceived conflict between the opposing demands placed on clinical research by scienc…Read more
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57This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?
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56A comparison of journal instructions regarding institutional review board approval and conflict-of-interest disclosure between 1995 and 2005Journal of Medical Ethics 35 (1): 74-78. 2009.OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. RESULTS: During the period, the proportion of jour…Read more
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54Will the real Charles Fried please stand up?Kennedy Institute of Ethics Journal 13 (4): 353-357. 2003.: In response to the preceding commentary by Jerry Menikoff in this issue of the Journal , the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by i…Read more
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53Evolving Ethical Issues in Selection of Subjects for Clinical ResearchCambridge Quarterly of Healthcare Ethics 5 (3): 334-345. 1996.Wittgenstein, in his famous critique of philosophy, noted that the influence of an idea can be such that it alters the way that we see the world. “It is like a pair of glasses on our nose through which we see whatever we look at,” he said. “It never occurs to us to take them off.” This view of the power of an idea suggests that the interpretation of an event, and what response this event calls for, can depend upon the view one has of the world. A person who is naive about medical facts may, for …Read more
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52Acknowledging awareness: informing families of individual research results for patients in the vegetative stateJournal of Medical Ethics 41 (7): 534-538. 2015.
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51Assessing Decision-Making Capacity in the Behaviorally Nonresponsive Patient With Residual Covert AwarenessAmerican Journal of Bioethics Neuroscience 4 (4): 3-14. 2013.
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49Fiduciary Obligation in Clinical ResearchJournal of Law, Medicine and Ethics 34 (2): 424-440. 2006.Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject
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49PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results. METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revi…Read more
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48Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation (review)BMC Medical Ethics 19 (1): 1-10. 2018.Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 3…Read more
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University of Western OntarioDepartment of Philosophy
Department of Epidemiology and BiostatisticsProfessor -
London, Ontario, Canada
Areas of Specialization
Biomedical Ethics |
Medical Research Ethics |