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  1. Informed consent in pragmatic trials: results from a survey of trials published 2014–2019.Jennifer Zhe Zhang, Stuart G. Nicholls, Kelly Carroll, Hayden Peter Nix, Cory E. Goldstein, Spencer Phillips Hey, Jamie C. Brehaut, Paul C. McLean, Charles Weijer, Dean A. Fergusson & Monica Taljaard - 2022 - Journal of Medical Ethics 49 (1):34-40.
    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 include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...)
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  • Informed Consent in a Pragmatic Emergency Suicide Trial: Rejecting the Research–Practice Distinction.Kendra Parris & Kristin Canavera - 2019 - American Journal of Bioethics 19 (10):103-105.
    Volume 19, Issue 10, October 2019, Page 103-105.
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  • Stakeholders’ experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.Tiwonge K. Mtande, Carl Lombard, Gonasagrie Nair & Stuart Rennie - 2024 - Research Ethics 20 (1):64-78.
    Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share (...)
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  • Randomised controlled trials in medical AI: ethical considerations.Thomas Grote - 2022 - Journal of Medical Ethics 48 (11):899-906.
    In recent years, there has been a surge of high-profile publications on applications of artificial intelligence (AI) systems for medical diagnosis and prognosis. While AI provides various opportunities for medical practice, there is an emerging consensus that the existing studies show considerable deficits and are unable to establish the clinical benefit of AI systems. Hence, the view that the clinical benefit of AI systems needs to be studied in clinical trials—particularly randomised controlled trials (RCTs)—is gaining ground. However, an issue that (...)
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  • A Critical Examination of Informed Consent Approaches in Pragmatic Cluster-Randomized Trials.Cory E. Goldstein - 2022 - Dissertation, University of Western Ontario
    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 care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...)
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