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Gene Transfer and the Ethics of First-in-Human Research. Lost in Translation
Kimmelman, J.
1ª Edición Octubre 2009
Inglés
Tapa blanda
218 pags
1000 gr
16 x 23 x 1 cm
ISBN 9780521690843
Editorial CAMBRIDGE
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Description
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.
• Each chapter provides a concise table of recommendations to enable quick
access to major findings and recommendations to the reader • Offers frameworks
for several key challenges posed in early phase clinical trials • Provides
careful analysis of numerous ethical challenges, and presents constructive solutions
Contents
Abbreviations; 1. Gene transfer lost in translation: an introduction; 2. What
is gene transfer?; 3. Safety, values, and legitimacy: the protean nature of
risk in translational trials; 4. Taming uncertainty: risk and gene transfer
clinical research; 5. Succor or suckers? Evaluating the benefits of trial participation;
6. Looking backward: a model of value for translational trials; 7. Over the
chasm: the initiation of first-in-human trials; 8. Tropic of cancers: gene transfer
in resource-poor settings; 9. Great expectations and hard times: managing expectations
in gene transfer; 10. Something in the sight adjusts itself: conclusion; Note
to readers; Index.
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