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  1. 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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  • 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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  • 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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  • A Randomised Controlled Trial to Compare Opt-in and Opt-Out Parental Consent for Childhood Vaccine Safety Surveillance Using Data Linkage.J. G. Berry, P. Ryan, M. S. Gold, A. J. Braunack-Mayer & K. 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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  • 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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  • Cluster Randomized Trials:Another Look.Ruth Macklin - 2014 - Hastings Center Report 44 (1):37-43.