9780521690843

Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation

by
  • ISBN13:

    9780521690843

  • ISBN10:

    0521690846

  • Edition: 1st
  • Format: Paperback
  • Copyright: 2009-12-07
  • Publisher: Cambridge University Press
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Summary

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.

Author Biography

Jonathan Kimmelman is Assistant Professor, Biomedical Ethics unit/social studies of Medicine, McGill University, Montreal, Quebec, Canada.

Table of Contents

Acknowledgmentsp. viii
List of abbreviationsp. x
Introduction: gene transfer lost in translationp. 1
What is gene transfer?p. 8
Safety, values, and legitimacy: the protean nature of risk in translational trialsp. 31
Taming uncertainty: risk and gene-transfer clinical researchp. 51
Succor or suckers? Benefit, risk, and the therapeutic misconceptionp. 72
Looking backward: a model of value for translational trialsp. 89
The chasm: the ethics of initiating first-in-human clinical trialsp. 110
Tropic of cancers: gene transfer in resource-poor settingsp. 132
Great Expectations and Hard Times: expectation management in gene transferp. 153
Something in the sight adjusts itself: conclusionsp. 178
Epiloguep. 192
Indexp. 193
Table of Contents provided by Ingram. All Rights Reserved.

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