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  1. 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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  • Latent Variable Modeling and its Implications for Institutional Review Board Review: Variables That Delay the Reviewing Process.Dong-Sheng Tzeng, Yi-Chang Wu & Jane-Yi Hsu - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundTo investigate the factors related to approval after review by an Institutional Review Board, the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB.MethodsThe vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, total review time, and revision frequency. (...)
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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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  • Delaying and Withholding Interventions: Ethics and the Stepped Wedge Trial.Ariella Binik - 2019 - Journal of Medical Ethics 45 (10):662-667.
    Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: when the study (...)
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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 Issues in Field Trials of Genetically Modified Disease-Resistant Mosquitoes.David B. Resnik - 2012 - Developing World Bioethics 12 (3):37-46.
    Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these (...)
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  • Informed Consent in Cluster Randomised Trials: New and Common Ethical Challenges.Sapfo Lignou - 2018 - Journal of Medical Ethics 44 (2):114-120.
    Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct features of ‘population-based’ interventions, which have not (...)
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  • Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration.Adnan A. Hyder, Abbas Rattani, Carleigh Krubiner, Abdulgafoor M. Bachani & Nhan T. Tran - 2014 - American Journal of Bioethics 14 (2):28-37.
    Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...)
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  • Ethical Issues in Field Trials of Genetically Modified Disease-Resistant Mosquitoes.David B. Resnik - 2014 - Developing World Bioethics 14 (1):37-46.
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  • Cluster Randomized Trials:Another Look.Ruth Macklin - 2014 - Hastings Center Report 44 (1):37-43.