1.

Record Nr.

UNINA9910792125203321

Autore

Kimmelman Jonathan

Titolo

Gene transfer and the ethics of first-in-human research : lost in translation / / Jonathan Kimmelman [[electronic resource]]

Pubbl/distr/stampa

Cambridge : , : Cambridge University Press, , 2010

ISBN

0-511-84765-3

1-107-20737-1

0-511-64185-0

0-511-63941-4

0-511-64049-8

0-511-63834-5

0-511-64236-9

Descrizione fisica

1 online resource (xi, 205 pages) : digital, PDF file(s)

Disciplina

615.8/95

Soggetti

Gene therapy - Moral and ethical aspects

Clinical trials - Moral and ethical aspects

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Title from publisher's bibliographic system (viewed on 05 Oct 2015).

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Introduction: 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.

Sommario/riassunto

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.