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

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.

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.