Gene transfer and the ethics of first-in-human research : lost in translation

"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. "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

Human gene transfer is widely regarded as a promising approach for treating a variety of disorders, but its development presents a number of difficult ethical challenges.

Gene Transfer and the Ethics of First-in-Human Research uses the example of gene transfer to examine the ethical and policy dimensions of testing novel interventions in human beings for the first time. The book argues that many ethical frameworks devised for randomized controlled trials translate awkwardly to early phase human studies of novel therapies. Major issues discussed include: when to initiate human testing, how to obtain valid consent, managing public expectations, defining acceptable risk, and recruiting economically disadvantaged persons in early phase trials.

This book is relevant to ethicists, legal practitioners, policy makers, geneticists, and researchers involved in clinical trials of novel medical interventions.

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 Gene transfer lost in translation : an introduction 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? : evaluating the benefits of trial participation Looking backward : a model of value for translational trials Over the chasm : the initiation of first-in-human trials Tropic of cancers : gene transfer in resource-poor settings Great expectations and hard times : managing expectations in gene transfer Something in the sight adjusts itself. This book examines the ethical and policy dimensions of testing interventions in human beings for the first time. It discusses numerous distinctive ethical challenges encountered in attempting to translate preclinical findings into clinical applications. It is relevant to ethicists, legal practitioners, policy makers, clinical researchers and geneticists.