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  1. Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, & Therapeutic Optimism.Sam Horng & Christine Grady - 2003 - IRB: Ethics & Human Research 25 (1):11.
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  • First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine and Ethics 37 (1):38-50.
    The 21st-century translational science campaign could lead to an increase in first-in-human trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: the requirement for adequate preclinical research; study design safeguards; and choice of subject population. I also examine specific ethical considerations relevant to the three subject populations involved in (...)
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  • First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine and Ethics 37 (1):38-50.
    Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...)
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  • The Challenge of Incidental Findings.Susan M. Wolf - 2008 - Journal of Law, Medicine and Ethics 36 (2):216-218.
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  • Genetic Research as Therapy: Implications of “Gene Therapy” for Informed Consent.Larry R. Churchill, Myra L. Collins, Nancy M. P. King, Stephen G. Pemberton & Keith A. Wailoo - 1998 - Journal of Law, Medicine and Ethics 26 (1):38-47.
    In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that “the line between research and treatment is not always clear (...)
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  • Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
    Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...)
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  • Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field.Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline - 2012 - Journal of Law, Medicine and Ethics 40 (4):716-750.
    Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...)
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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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  • Ethical Responsibilities of Nanotechnology Researchers: A Short Guide. [REVIEW]Robert McGinn - 2010 - NanoEthics 4 (1):1-12.
    Little if any of the scholarly literature on nanotechnology (NT) and ethics is directed at NT researchers. Many of these practitioners believe that having clear ethical guidelines for the conduct of NT research is necessary. This work attempts to provide such guidelines. While no qualitatively new ethical issues unique to NT have yet been identified, the ethical responsibilities identified below merit serious attention by NT researchers. Thirteen specific ethical responsibilities arising at three levels are identified. They are derived by applying (...)
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  • Missing the Forest: Further Thoughts on the Ethics of Bystander Risk in Medical Research.Jonathan Kimmelman - 2007 - Cambridge Quarterly of Healthcare Ethics 16 (4):483.
    Developments in the last several years have sparked renewed interest in the ethics of research involving humans. Issues relating to the global extent of research and its guiding principles are of particular importance to researchers, health officials, and individual ethics committees who want a deeper and more encompassing inquire regarding the foundation and evolution of human research. This department of CQ launches a long overdue effort to explore these wider issues. Readers are invited to submit papers to Charles MacKay, 5011 (...)
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  • Genetic Research as Therapy: Implications of "Gene Therapy" for Informed Consent.Larry R. Churchill, Myra L. Collins, Nancy M. R. King, Stephen G. Pemberton & Keith A. Wailoo - 1998 - Journal of Law, Medicine and Ethics 26 (1):38-47.
  • Genetic Research as Therapy: Implications of "Gene Therapy" for Informed Consent.Larry R. Churchill, Myra L. Collins, Nancy M. R. King, Stephen G. Pemberton & Keith A. Wailoo - 1998 - Journal of Law, Medicine and Ethics 26 (1):38-47.