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15I 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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15The 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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15An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled TrialKennedy Institute of Ethics Journal 28 (1): 85-118. 2018.Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framewor…Read more
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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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14Structuring the Review of Human Genetics Protocols Part-III: Gene Therapy StudiesIRB: Ethics & Human Research 21 (2): 1. 1999.
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14Informed 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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14A 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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14Research Governance Lessons from the National Placebo InitiativeHealth Law Review 17 (2-3): 26-32. 2009.
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13When argument failsAmerican Journal of Bioethics 2 (2). 2002.This Article does not have an abstract
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13Caregiver 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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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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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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12Key messages The research environment has changed since clinical equipoise was first proposed 30 years ago New trial designs—such as umbrella and basket trials, adaptive platform trials, and cluster randomised trials—raise new ethical challenges for evaluating the state of scientific uncertainty and communicating about risks with patients and participants Clinical equipoise needs to evolve We propose the design of specific guidelines to provide ethics committees and trialists with instructions f…Read more
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12The 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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12The 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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12Ottawa Statement does not impede randomised evaluation of government health programmesJournal of Medical Ethics 46 (1): 31-33. 2020.In this issue of JME, Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees, Watson et al argue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics …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 |