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  1. Inequalities and Fairness in Cluster Trials.Erin Conrad & Sarah Jl Edwards - 2011 - Research Ethics 7 (2):58-65.
    Cluster randomized controlled trials (cluster RCTs) randomize whole clusters of individuals in testing two or more competing interventions. Here we will present the ethical problems raised by cluster RCTs concerning their effect on inequality. We argue that some inequalities generated by cluster RCTs are larger in scope than those generated from individual RCTs. We also argue that any cluster RCT-generated inequalities, which divide groups rather than individuals, are more problematic in type than the inequalities created in individual RCTs. These concerns (...)
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  • Ethics of Clinical Science in a Public Health Emergency: Drug Discovery at the Bedside.Sarah Jl Edwards - 2013 - American Journal of Bioethics 13 (9):3-14.
    Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to (...)
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  • Alternative consent models for comparative effectiveness studies: Views of patients from two institutions.Nancy Kass, Ruth Faden, Rachel E. Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner & James Pitcavage - 2016 - AJOB Empirical Bioethics 7 (2):92-105.
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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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  • 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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