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  1. 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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  • Justifying surgery's last taboo: the ethics of face transplants.Michael Freeman & Pauline Abou Jaoudé - 2007 - Journal of Medical Ethics 33 (2):76-81.
    Should face transplants be undertaken? This article examines the ethical problems involved from the perspective of the recipient, looking particularly at the question of identity, the donor and the donor’s family, and the disfigured community and society more generally. Concern is expressed that full face transplants are going ahead.
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  • Innovation in Human Research Protection: The AbioCor Artificial Heart Trial.E. Haavi Morreim, George E. Webb, Harvey L. Gordon, Baruch Brody, David Casarett, Ken Rosenfeld, James Sabin, John D. Lantos, Barry Morenz, Robert Krouse & Stan Goodman - 2006 - American Journal of Bioethics 6 (5):W6-W16.
    Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...
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  • On the ethics of facial transplantation research.Osborne P. Wiggins, John H. Barker, Serge Martinez, Marieke Vossen, Claudio Maldonado, Federico V. Grossi, Cedric G. Francois, Michael Cunningham, Gustavo Perez-Abadia, Moshe Kon & Joseph C. Banis - 2004 - American Journal of Bioethics 4 (3):1 – 12.
    Transplantation continues to push the frontiers of medicine into domains that summon forth troublesome ethical questions. Looming on the frontier today is human facial transplantation. We develop criteria that, we maintain, must be satisfied in order to ethically undertake this as-yet-untried transplant procedure. We draw on the criteria advanced by Dr. Francis Moore in the late 1980s for introducing innovative procedures in transplant surgery. In addition to these we also insist that human face transplantation must meet all the ethical requirements (...)
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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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  • About face: Downplaying the role of the press in facial transplantation research.E. Haavi Morreim - 2004 - American Journal of Bioethics 4 (3):27 – 29.
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  • Facing the ethical questions in facial transplantation.George J. Agich & Maria Siemionow - 2004 - American Journal of Bioethics 4 (3):25 – 27.
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