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  1. Rethinking Risk Assessment for Emerging Technology First-in-Human Trials.Anna Genske & Sabrina Engel-Glatter - 2016 - Medicine, Health Care and Philosophy 19 (1):125-139.
    Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to the (...)
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  • The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment.Susan M. Wolf - 2012 - Journal of Law, Medicine and Ethics 40 (4):712-715.
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  • Concepts of Risk in Nanomedicine Research.Linda F. Hogle - 2012 - Journal of Law, Medicine and Ethics 40 (4):809-822.
    Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration foreground procedures for minimizing risk for human subjects and require (...)
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  • Concepts of Risk in Nanomedicine Research.Linda F. Hogle - 2012 - Journal of Law, Medicine and Ethics 40 (4):809-822.
    Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and (...)
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  • Nanomedicine First-in-Human Research: Challenges for Informed Consent.Nancy M. P. King - 2012 - Journal of Law, Medicine and Ethics 40 (4):823-830.
    First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form (...)
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  • An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials.Laura Fleege & Frances Lawrenz - 2012 - Journal of Law, Medicine and Ethics 40 (4):751-762.
    Nanotechnology not only offers the promise of new enhancements to existing materials but also allows for the development of new materials and devices. The potential applications of nanotechnology range from medicine to agriculture to health and environmental science and beyond. Nanotechnology is growing at such a rate that Lux Research in 2007 estimated that nanotechnology will be incorporated into 15% of global manufactured goods by 2014. The U.S. National Nanotechnology Initiative defines nanotechnology as the following: “ Research and technology development (...)
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  • An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials.Laura Fleege & Frances Lawrenz - 2012 - Journal of Law, Medicine and Ethics 40 (4):751-762.
    As part of “Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight,” an empirical search was conducted to identify publicly available resources that guided understanding about human subjects issues in nanomedicine or nanotechnology including policy statements, guidance documents, or consent forms. The authors conducted 5,083 internet searches and analyzed 175 documents. Results show that very little guidance is publicly available and most documents focused on occupational and environmental concerns.
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  • The Clinical Research of Nanomedicine: A New Ethical Challenge?Urban Wiesing & Jens Clausen - 2014 - NanoEthics 8 (1):19-28.
    Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical research have (...)
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