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  1. Translational Research Beyond Approval: A Two-Stage Ethics Review.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):W1-W3.
    Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research. Whether or not T1 has these features, translational research beyond approval is unlikely to and, (...)
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  • Valuing risk: The ethical review of clinical trial safety.Jonathan Kimmelman - 2004 - Kennedy Institute of Ethics Journal 14 (4):369-393.
    : Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially (...)
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  • The Diverse Ethics of Translational Research.Neema Sofaer & Nir Eyal - 2010 - American Journal of Bioethics 10 (8):19-30.
    Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1 ). Whether or not T1 has these features, translational research beyond approval (...)
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