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27An 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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44Ethical 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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21Informed 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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12A Critical Examination of Informed Consent Approaches in Pragmatic Cluster-Randomized TrialsDissertation, University of Western Ontario. 2022.This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine car…Read more
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28Is it unethical to publish data from Chinese transplant research?Journal of Medical Ethics 46 (10): 689-690. 2020.Non-consensual organ procurement from prisoners in China raises serious questions regarding the ethics of Chinese transplant research. In their article, published in this issue of JME, Higgins and colleagues address these questions through the lens of publication ethics. They argue that, ‘while there are potentially compelling justifications for use [of unethical research] under some circumstances, these justifications fail when unethical practices are ongoing’.1 Consequently, they recommend non…Read more
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Accommodating quality and service improvement research within existing ethical principlesTrials 19 (1): 334. 2018.Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation…Read more
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Stepped-wedge trials should be classified as research for the purpose of ethical reviewClinical Trials 16 (6): 580-588. 2019.
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39Ethical issues raised by cluster randomised trials conducted in low-resource settings: identifying gaps in the Ottawa Statement through an analysis of the PURE Malawi trialJournal of Medical Ethics 45 (6): 388-393. 2019.The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. TheOttawa Statement on the Ethical Design and Conduct of Cluster Randomised Trialsis the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in theOttawa Statementrelevant to cluster trials conducted in low-resource settings. Our method is (1) to analys…Read more
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60Ethical 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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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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28It Does Not Matter Whether Research Interventions Are Usual CareAmerican Journal of Bioethics 20 (1): 47-48. 2020.
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21A 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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31Thinking 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
Cory E. Goldstein
Ottawa Hospital Research Institute
University of Ottawa
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Ottawa Hospital Research InstitutePost-doctoral Fellow
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Areas of Specialization
Medical Research Ethics |
Public Health |
Areas of Interest
Medical Research Ethics |
Public Health |