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16The existing EELS literature has usefully identified the scope of ethical issues posed by pharmacogenetic and pharmacogenomic research. The time has come for in-depth examination of particular ethical issues. The involvement of racial and ethnic communities in pharmacogenetic and pharmacogenomic research is contentious precisely because it touches upon the science and politics of studying racial and ethnic difference. To date, the ethics literature has not seriously taken account of the fact tha…Read more
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16What questions can a placebo answer?Monash Bioethics Review 34 (1): 23-36. 2016.The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction—describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a…Read more
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16Informed consent in pragmatic trials: results from a survey of trials published 2014–2019Journal of Medical Ethics 49 (1): 34-40. 2022.ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not inc…Read more
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16Monitoring informed consent in an oncology study posing serious risk to subjectsIRB: Ethics & Human Research 20 (6): 1-6. 1998.
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16The notions of individual and collective ethics were first explicitly defined in the biostatistical literature in 1971 to motivate a mathematical solution to a posed ethical dilemma. This paper reviews key antecedents to these concepts and traces explicit references to them over time, primarily in the biostatistical literature. Following a historical exposition of these texts, a critical thematic analysis shows the following: the normative force of these concepts has not been adequately argued. …Read more
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15A Stepwise Approach to Ethically Assess Pragmatic Cluster Randomized Trials: Implications for Informed Consent for Suicide Prevention Implementation ResearchAmerican Journal of Bioethics 19 (10): 101-103. 2019.Volume 19, Issue 10, October 2019, Page 101-103.
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15[Demarcating Research and Treatment Interventions: A Case Illustration]: CommentaryIRB: Ethics & Human Research 14 (4): 5. 1992.
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15Caregiver reactions to neuroimaging evidence of covert consciousness in patients with severe brain injury: a qualitative interview studyBMC Medical Ethics 22 (1): 1-13. 2021.BackgroundSevere brain injury is a leading cause of death and disability. Diagnosis and prognostication are difficult, and errors occur often. Novel neuroimaging methods can improve diagnostic and prognostic accuracy, especially in patients with prolonged disorders of consciousness (PDoC). Yet it is currently unknown how family caregivers understand this information, raising ethical concerns that disclosure of neuroimaging results could result in therapeutic misconception or false hope.MethodsTo…Read more
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14Family experiences with non-therapeutic research on dying patients in the intensive care unitJournal of Medical Ethics 48 (11): 845-851. 2022.Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient. We interviewed 33 family members involved in surrogate research consent decisions for dying patients …Read more
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14Research Governance Lessons from the National Placebo InitiativeHealth Law Review 17 (2-3): 26-32. 2009.
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14Structuring the Review of Human Genetics Protocols Part-III: Gene Therapy StudiesIRB: Ethics & Human Research 21 (2): 1. 1999.
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13This presentation addresses these questions: • “Upon what ethical grounds may the physician offer RCT enrollment to a patient?” • Which is the preferred moral basis of the RCT?
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13I Need a Placebo like I Need a Hole in the HeadJournal of Law, Medicine and Ethics 30 (1): 69-72. 2002.In this issue of the Journal of Law, Medicine & Ethics Peter Clark provides a comprehensive and sound ethical analysis of clinical trials examining the treatment of advanced Parkinson's disease with fetal tissue transplantation. These studies raise profound questions about how clinical trials of surgical interventions ought to be conducted. At stake is not only the ethical basis of such trials, but differing views as to the proper role of science in medicine and its limitations.Experience with t…Read more
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13Controlled Donation After Circulatory Determination of Death: A Scoping Review of Ethical Issues, Key Concepts, and ArgumentsJournal of Law, Medicine and Ethics 49 (3): 418-440. 2021.Controlled donation after circulatory determination of death (cDCDD) is an important strategy for increasing the pool of eligible organ donors.
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13Rules of the Road for Patient-Driven Consent ProcessesAmerican Journal of Bioethics 20 (5): 36-37. 2020.Volume 20, Issue 5, June 2020, Page 36-37.
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13When argument failsAmerican Journal of Bioethics 2 (2). 2002.This Article does not have an abstract
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13The three claims put forward by Dr. Roger Poisson to rationalize his enrollment of ineligible subjects in clinical trials do not justify research fraud. None the less, certain lessons for the conduct of clinical research can be learned from the affair: experimental therapies should be made available to technically ineligible subjects when no effective therapy exists for their disease; further research must investigate the possible benefits of clinical-trial participation; broadly based, pragmati…Read more
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13The Ethics of Biomedical Research: An International PerspectiveHastings Center Report 31 (1): 47. 2001.
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12Uses of equipoise in discussions of the ethics of randomized controlled trials of COVID-19 therapiesBMC Medical Ethics 22 (1): 1-8. 2021.BackgroundEarly in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns …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 |