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  1. Ethical Issues Posed by Cluster Randomized Trials in Health Research.Charles Weijer, Jeremy M. Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Andrew D. McRae & Ray Saginur - 2011 - Trials 1 (12):100.
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  2. When is Informed Consent Required in Cluster Randomized Trials in Health Research?Andrew D. McRae, Ariella Binik, Charles Weijer, Angela White, Jeremy M. Grimshaw, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Raphael Saginur, Merrick Zwarenstein & Monica Taljaard - 2011 - Trials 1 (12):202.
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  3.  29
    Ethical Issues in Pragmatic Randomized Controlled Trials: A Review of the Recent Literature Identifies Gaps in Ethical Argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):1-10.
    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, 36 articles were included and reviewed using content analysis. Results Our (...)
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    Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):14.
    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 included and reviewed using content analysis. Our review identified four (...)
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  5. Who is the Research Subject in Cluster Randomized Trials in Health Research?Andrew D. McRae, Ariella Binik, Charles Weijer, Jeremy M. Grimshaw, Monica Taljaard, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Ray Saginur & Merrick Zwarenstein - 2011 - Trials 1 (12):118.
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    Stakeholder Views Regarding Ethical Issues in the Design and Conduct of Pragmatic Trials: Study Protocol.Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):90.
    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. Interest in, and the number of, pragmatic trials has grown substantially (...)
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    A Recruitment Strategy for Cluster Randomized Trials in Secondary Care Settings.Anne E. Walker, Marion K. Campbell, Jeremy M. Grimshaw & the Tempest Group - 2000 - Journal of Evaluation in Clinical Practice 6 (2):185-192.
  8. Accommodating Quality and Service Improvement Research Within Existing Ethical Principles.Cory E. Goldstein, Charles Weijer, Jamie Brehaut, Marion Campbell, Dean A. Fergusson, Jeremy M. Grimshaw, Karla Hemming, Austin R. Horn & Monica Taljaard - 2018 - Trials 19 (1):334.
    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 in QSI research entails no more than minimal risk, is consent required? The (...)
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    The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: A Short Report.Charles Weijer, Monica Taljaard, Jeremy M. Grimshaw, Sarah Jl Edwards & Martin P. Eccles - 2014 - Research Ethics 10 (2):77-85.
    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 committee review, the identification of research participants, obtaining informed consent, the (...)
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    The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: A Short Report.Charles Weijer, Monica Taljaard, Jeremy M. Grimshaw, Sarah J. L. Edwards & Martin P. Eccles - 2015 - Research Ethics 11 (1):52-60.
    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 committee review, the identification of research participants, obtaining informed consent, the (...)
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