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33Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristicsJournal of Medical Ethics 39 (2): 119-124. 2013.Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was u…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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When is informed consent required in cluster randomized trials in health research?Trials 1 (12): 202. 2011.
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Who is the research subject in cluster randomized trials in health research?Trials 1 (12): 118. 2011.
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10The Ethics of Biomedical Research: An International PerspectiveHastings Center Report 31 (1): 47. 2001.
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14Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providersJournal of Medical Ethics 44 (9): 593-598. 2018.The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators h…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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34Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation (review)BMC Medical Ethics 19 (1): 14. 2018.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. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were inc…Read more
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23Assessing Decision-Making Capacity in Patients with Communication ImpairmentsCambridge Quarterly of Healthcare Ethics 25 (4): 691-699. 2016.
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11The Quest for Legitimacy: Comment on Cox Macpherson's ‘to Strengthen Consensus, Consult the Stakeholders’Bioethics 18 (3): 293-300. 2004.
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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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13The Ottawa statement on the ethical design and conduct of cluster randomized trials: A short reportResearch Ethics 11 (1): 52-60. 2015.Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct, and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics com…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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18Placebo Orthodoxy in Clinical Research I: Empirical and Methodological MythsJournal of Law, Medicine and Ethics 24 (3): 243-251. 1996.The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo c…Read more
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10I 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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19The Ethical Analysis of RiskJournal of Law, Medicine and Ethics 28 (4): 344-361. 2000.The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time misman…Read more
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20Fiduciary Obligation in Clinical ResearchJournal of Law, Medicine and Ethics 34 (2): 424-440. 2006.Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absenc…Read more
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9The Balm of Gilead: Is the Provision of Treatment to Those Who Seroconvert in HIV Prevention Trials a Matter of Moral Obligation or Moral Negotiation?Journal of Law, Medicine and Ethics 34 (4): 793-808. 2006.Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and the Bill and Melinda Ga…Read more
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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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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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36A Misunderstanding Concerning FutilityAmerican Journal of Bioethics 15 (7): 59-60. 2015.It is a comment on Geppert about the concept of futility in cases of treatment-resistant anorexia nervosa.
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34The Ottawa statement on the ethical design and conduct of cluster randomized trials: A short reportResearch Ethics 10 (2): 77-85. 2014.Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics comm…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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University of Western OntarioDepartment of Philosophy
Department of Epidemiology and BiostatisticsProfessor -
London, Ontario, Canada
Areas of Specialization
Biomedical Ethics |
Medical Research Ethics |