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  1. Genetics and Bioethics: How Our Thinking has Changed Since 1969.LeRoy Walters - 2012 - Theoretical Medicine and Bioethics 33 (1):83-95.
    In 1969, the field of human genetics was in its infancy. Amniocentesis was a new technique for prenatal diagnosis, and a newborn genetic screening program had been established in one state. There were also concerns about the potential hazards of genetic engineering. A research group at the Hastings Center and Paul Ramsey pioneered in the discussion of genetics and bioethics. Two principal techniques have emerged as being of enduring importance: human gene transfer research and genetic testing and screening. This essay (...)
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  • Does Placebo Surgery-Controlled Research Call for New Provisions to Protect Human Research Participants?Dorothy E. Vawter, Karen G. Gervais & Thomas B. Freeman - 2003 - American Journal of Bioethics 3 (4):50-53.
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  • Therapeutic Optimism in the Consent Forms of Phase 1 Gene Transfer Trials: An Empirical Analysis.J. Kimmelman - 2005 - Journal of Medical Ethics 31 (4):209-214.
    Background: “Therapeutic misconception” arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicised investigational agents.Objective: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms have grown more optimistic in their (...)
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  • RAC Oversight of Gene Transfer Research: A Model Worth Extending?Nancy M. P. King - 2002 - Journal of Law, Medicine and Ethics 30 (3):381-389.
  • Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
  • Nanomedicine First-in-Human Research: Challenges for Informed Consent.Nancy M. P. King - 2012 - Journal of Law, Medicine and Ethics 40 (4):823-830.
    Risks of harm, translational uncertainty, ambiguities in potential direct benefit, and long-term follow-up merit consideration in first-in-human research. Some nanomedical technologies have additional characteristics that should be addressed, including: defining and describing nanomedical interventions; bystander risks; the therapeutic misconception; and a decision-making context that includes both common use of nanomaterials outside medicine and persistent unknowns about the effects of nanosize. This paper considers how to address these issues in informed consent to first-in-human nanomedicine research.
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