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  1. Reconstruing Genetic Research as Research.M. Therese Lysaught - 1998 - Journal of Law, Medicine and Ethics 26 (1):48-54.
  • 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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  • 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.
    Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...)
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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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  • To Research (or Not) That is the Question: Ethical Issues in Research When Medical Care is Disrupted by Political Action: A Case Study From Eldoret, Kenya.Darlene R. House, Irene Marete & Eric M. Meslin - 2016 - Journal of Medical Ethics 42 (1):61-65.
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  • 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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