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  1. (1 other version)Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
    The biomedical literature and popular media are full of upbeat reports about the health benefits we can expect from medical innovations using nanotechnology. Some particularly enthusiastic reports portray nanotechnology as one of the innovations that will lead to a significantly extended human life span. Extreme enthusiasts predict that nanotechnology “will ultimately enable us to redesign and rebuild, molecule by molecule, our bodies and brains….”Nanomaterials have special characteristics that could contribute to improved patient care. But the same characteristics that make nanotechnology (...)
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  • (1 other version)Building an Ethical Foundation for First-in-Human Nanotrials.Rebecca Dresser - 2012 - Journal of Law, Medicine and Ethics 40 (4):802-808.
    Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
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  • The social value of clinical research.Michelle Gjl Habets, Johannes Jm van Delden & AnneLien L. Bredenoord - 2014 - BMC Medical Ethics 15 (1):66.
    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used (...)
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  • Predicting harms and benefits in translational trials: ethics, evidence, and uncertainty.Jonathan Kimmelman & Alex John London - unknown
    First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns on claims (...)
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  • Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems.James A. Anderson & Jonathan Kimmelman - 2010 - Kennedy Institute of Ethics Journal 20 (1):75-98.
    Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study—first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two (...)
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  • A Taxonomy of Value in Clinical Research.David J. Casarett, Jason H. T. Karlawish & Jonathan D. Moreno - 2002 - IRB: Ethics & Human Research 24 (6):1.
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