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Gene Transfer and the Ethics of First-in-Human Research
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  • Cited by 17
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    This book has been cited by the following publications. This list is generated based on data provided by CrossRef.

    Takashima, Kayo Inoue, Yusuke Tashiro, Shimon and Muto, Kaori 2018. Lessons for reviewing clinical trials using induced pluripotent stem cells: examining the case of a first-in-human trial for age-related macular degeneration. Regenerative Medicine, Vol. 13, Issue. 2, p. 123.

    Bubela, Tania Mansour, Yael and Nicol, Dianne 2017. The ethics of genome editing in the clinic: A dose of realism for healthcare leaders. Healthcare Management Forum, Vol. 30, Issue. 3, p. 159.

    Bubela, Tania Mansour, Yael and Nicol, Dianne 2017. L’éthique de la modification du génome en clinique : une dose de réalisme pour les leaders en santé. Healthcare Management Forum, Vol. 30, Issue. 3, p. 164.

    Addison, Courtney 2017. Spliced: Boundary-work and the establishment of human gene therapy. BioSocieties, Vol. 12, Issue. 2, p. 257.

    Satalkar, Priya Elger, Bernice Simone and Shaw, David 2016. Naming it ‘nano’: Expert views on ‘nano’ terminology in informed consent forms of first-in-human nanomedicine trials. Nanomedicine, Vol. 11, Issue. 8, p. 933.

    Viswanathan, Sowmya and Bubela, Tania 2015. Current practices and reform proposals for the regulation of advanced medicinal products in Canada. Regenerative Medicine, Vol. 10, Issue. 5, p. 647.

    King, Nancy M. P. 2014. Regenerative Medicine Ethics. p. 187.

    Gilbert, Frederic Harris, Alexander R. and Kapsa, Robert M. I. 2014. Controlling Brain Cells With Light: Ethical Considerations for Optogenetic Clinical Trials. AJOB Neuroscience, Vol. 5, Issue. 3, p. 3.

    Habets, Michelle GJL van Delden, Johannes JM and Bredenoord, Annelien L 2014. The social value of clinical research. BMC Medical Ethics, Vol. 15, Issue. 1,

    Hess, Pascale 2014. The Ethical Dilemmas of Experimental Invasive Brain Technologies. AJOB Neuroscience, Vol. 5, Issue. 3, p. 18.

    Caulfield, Timothy Evans, Jim McGuire, Amy McCabe, Christopher Bubela, Tania Cook-Deegan, Robert Fishman, Jennifer Hogarth, Stuart Miller, Fiona A. Ravitsky, Vardit Biesecker, Barbara Borry, Pascal Cho, Mildred K. Carroll, June C. Etchegary, Holly Joly, Yann Kato, Kazuto Lee, Sandra Soo-Jin Rothenberg, Karen Sankar, Pamela Szego, Michael J. Ossorio, Pilar Pullman, Daryl Rousseau, Francois Ungar, Wendy J. and Wilson, Brenda 2013. Reflections on the Cost of "Low-Cost" Whole Genome Sequencing: Framing the Health Policy Debate. PLoS Biology, Vol. 11, Issue. 11, p. e1001699.

    Master, Zubin and Resnik, David B. 2013. Hype and Public Trust in Science. Science and Engineering Ethics, Vol. 19, Issue. 2, p. 321.

    Resnik, David B. 2012. Responsible Conduct in Nanomedicine Research: Environmental Concerns beyond the Common Rule. The Journal of Law, Medicine & Ethics, Vol. 40, Issue. 4, p. 848.

    Kimmelman, Jonathan 2012. Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines. The Journal of Law, Medicine & Ethics, Vol. 40, Issue. 4, p. 841.

    Hess, Pascale 2012. Intracranial Stem Cell-Based Transplantation: Reconsidering the Ethics of Phase 1 Clinical Trials in Light of Irreversible Interventions in the Brain. AJOB Neuroscience, Vol. 3, Issue. 2, p. 3.

    Bubela, Tania Li, Matthew D Hafez, Mohamed Bieber, Mark and Atkins, Harold 2012. Is belief larger than fact: expectations, optimism and reality for translational stem cell research. BMC Medicine, Vol. 10, Issue. 1,

    Resnik, David B 2012. eLS.


Book 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.

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