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49Revisiting equipoise: A response to GiffordKennedy Institute of Ethics Journal 17 (3): 227-246. 2007.: The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "…Read more
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46Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children wi…Read more
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45An Ethics of Welfare for Patients Diagnosed as Vegetative With Covert AwarenessAmerican Journal of Bioethics Neuroscience 6 (2): 31-41. 2015.
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45The 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.Must treatment be provided to subjects who acquire HIV during the course of a prevention study? An analysis of ethical foundation, regulation, and recent argumentation provides no basis for the obligation. We outline an alternative approach to the problem based on moral negotiation
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42PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the …Read more
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41Informing Study Participants of Research Results: An Ethical ImperativeIRB: Ethics & Human Research 25 (3): 12. 2003.
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41As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities,…Read more
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39Reporting 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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39The 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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38Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Indust…Read more
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38Why should we include women and minorities in randomized controlled trials?Journal of Clinical Ethics 10 (2): 100. 1999.
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37A 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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37Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of…Read more
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37Structuring the Review of Human Genetics Protocols Part II: Diagnostic and Screening StudiesIRB: Ethics & Human Research 19 (3/4): 1. 1997.
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37Research bystanders, justice, and the state: Reframing the debate on third‐party protections in health researchBioethics 36 (8): 865-873. 2022.Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, and ethicists argue that protections should be afforded these “research bystanders.” The standard rationale for extending protections to research bystanders contends that they are sufficiently like research participants that the ethical principle…Read more
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35Ethical 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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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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34Informed consent for functional MRI research on comatose patients following severe brain injury: balancing the social benefits of research against patient autonomyJournal of Medical Ethics 45 (5): 299-303. 2019.Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient’s participation in research compatible w…Read more
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34Case notes and charting of bioethical case consultationsHEC Forum 5 (3): 176-195. 1993.In summary, the usual elements of a typical health care ethics consultation note might reasonably accommodate the needs and expectations of relevant parties, and would therefore include: 1. identification of the relevant ethical issues, questions, or dilemmas; 2. reference to any relevant facts--medical, nursing, social, psychological, spiritual, legal, political, etc.; 3. a prioritized list of recommendations to improve coordinated care; 4. a clear and concise articulation of relevant arguments…Read more
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34Placebo 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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University of Western OntarioDepartment of Philosophy
Department of Epidemiology and BiostatisticsProfessor -
London, Ontario, Canada
Areas of Specialization
Biomedical Ethics |
Medical Research Ethics |