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  1. A Critical Examination of Informed Consent Approaches in Pragmatic Cluster-Randomized Trials.Cory E. Goldstein - unknown
    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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  • 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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  • Social Science and Ethics Review: A Question of Practice Not Principle.Stuart G. Nicholls, Jamie Brehaut & Raphae Saginur - 2012 - Research Ethics 8 (2):71-78.
    In his article ‘The case against ethics review in the social sciences’, Schrag asserts that the social sciences should not be subject to ethical review. He recounts a number of examples where ethical review has seemingly failed. He further suggests some alternative models for dealing with ethical review in the social sciences. Finally, he concludes, and we concur, that there is a lack of empirical evidence as to the benefit of research ethics review.
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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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  • Cluster Randomized Trials:Another Look.Ruth Macklin - 2014 - Hastings Center Report 44 (1):37-43.
  • Thinking Clearly About the FIRST Trial: Addressing Ethical Challenges in Cluster Randomised Trials of Policy Interventions Involving Health Providers.Austin R. Horn, Charles Weijer, Spencer Phillips Hey, Jamie Brehaut, Dean A. Fergusson, Cory E. Goldstein, Jeremy Grimshaw & Monica Taljaard - 2018 - Journal of Medical Ethics 44 (9):593-598.
    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 have failed to sufficiently identify and address many of the (...)
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  • A Randomised Controlled Trial to Compare Opt-in and Opt-Out Parental Consent for Childhood Vaccine Safety Surveillance Using Data Linkage.Jesia G. Berry, Philip Ryan, Michael S. Gold, Annette J. Braunack-Mayer & Katherine M. Duszynski - 2012 - Journal of Medical Ethics 38 (10):619-625.
    Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent (...)
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  • Informed Consent and Community Engagement in Open Field Research: Lessons for Gene Drive Science.Jerome Amir Singh - 2019 - BMC Medical Ethics 20 (1):54.
    The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. (...)
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  • Government Policy Experiments and Informed Consent.Douglas MacKay & Averi Chakrabarti - 2019 - Public Health Ethics 12 (2):188-201.
    Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy research conducted (...)
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  • Ethical Oversight in Quality Improvement and Quality Improvement Research: New Approaches to Promote a Learning Health Care System.Kevin Fiscella, Jonathan N. Tobin, Jennifer K. Carroll, Hua He & Gbenga Ogedegbe - 2015 - BMC Medical Ethics 16 (1):63.
    Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.
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  • Exceptions to the Rule of Informed Consent for Research with an Intervention.Susanne Rebers, Neil K. Aaronson, Flora E. van Leeuwen & Marjanka K. Schmidt - 2016 - BMC Medical Ethics 17 (1):1-11.
    BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of (...)
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  • Response to Open Peer Commentaries on “Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside”.Sarah Jl Edwards - 2013 - American Journal of Bioethics 13 (9):W1 - W3.
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