000 02170nam a2200169 4500
020 _a9780521690843
082 _a615.895
_bK571G
100 _aKimmelman, Jonathan.
_917787
245 _aGene Transfer and the Ethics of First-in-Human Research
_bLost in translation
_cby Jonathan Kimmelman.
260 _aCambridge, UK
_bCambridge University Press
_c2010.
300 _axi, 205 p.
_bill.,24 cm.
504 _aIncludes bibliographical references and index.
505 _aIntroduction: gene transfer lost in translation -- What is gene transfer? -- Safety, values, and legitimacy: the protean nature of risk in translational trials -- Taming uncertainty: risk and gene-transfer clinical research -- Succor or suckers? Benefit, risk, and the therapeutic misconception -- Looking backward: a model value for translational trials -- The chasm: the ethics of initiating first-in-human clinical trials -- Tropic of cancers: gene transfer in resource-poor settings -- Great expectations and hard times: expectation management in gene transfer -- Something in the sight adjusts itself: conclusions.
520 _a"Human gene transfer is widely regarded as one of the most promising technologies for the treatment of a variety of disorders, but it presents practitioners with a variety of difficult ethical questions. Gene Transfer and the Ethics of First-in-Human Research examines the ethical and policy dimensions of testing interventions in human beings for the first time. The book discusses the difficult ethical challenges that arise from attempting to translate laboratory discoveries into clinical applications. These range from which available techniques to use, when to initiate human testing, questions of consent, expectation in public arenas, how to define acceptable risk, and the inclusion of vulnerable or disadvantaged subjects in early phase trials. This book is relevant to ethicists, legal practitioners, policy makers, geneticists and clinicians involved in clinical trials of new medical interventions"--Provided by publisher.
650 _aGene therapy
_aClinical trials
_aGene Transfer Techniques
_aHuman Experimentation
_aPublic Policy.
_917788
942 _cBK
999 _c13137
_d13137