Gene Transfer And The Ethics Of First In Human Research

Author : Jonathan Kimmelman
Publisher : Cambridge University Press
ISBN 13 : 0521690846
Total Pages : 219 pages
Book Rating : 4.43/5 ( download)

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Download or read book Gene Transfer and the Ethics of First-in-Human Research written by Jonathan Kimmelman and published by Cambridge University Press. This book was released on 2010 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the ethical and policy dimensions of testing novel medical interventions in human beings for the first time.

Author : LeRoy Walters
Publisher : Oxford University Press, USA
ISBN 13 : 9780195059557
Total Pages : 240 pages
Book Rating : 4.57/5 ( download)

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Download or read book The Ethics of Human Gene Therapy written by LeRoy Walters and published by Oxford University Press, USA. This book was released on 1997 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: They start with the current techniques of gene addition, using non-reproductive (somatic) cells in an effort to cure or treat disease. Next they address the technical problems and moral issues facing attempts to prevent disease through genetically modifying early human embryos or sperm and egg cells. These changes would be passed on to future generations. Chapter 4, in many ways the most original part of this volume, confronts the issue of employing genetic means to improve human abilities and appearance.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030929665X
Total Pages : 78 pages
Book Rating : 4.56/5 ( download)

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Download or read book Oversight and Review of Clinical Gene Transfer Protocols written by Institute of Medicine and published by National Academies Press. This book was released on 2014-03-27 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309452880
Total Pages : 329 pages
Book Rating : 4.85/5 ( download)

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Download or read book Human Genome Editing written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-08-13 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309672988
Total Pages : 127 pages
Book Rating : 4.86/5 ( download)

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Download or read book Exploring Novel Clinical Trial Designs for Gene-Based Therapies written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-08-27 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

Author : Ana Smith Iltis
Publisher : Routledge
ISBN 13 : 1135991499
Total Pages : 232 pages
Book Rating : 4.94/5 ( download)

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Download or read book Research Ethics written by Ana Smith Iltis and published by Routledge. This book was released on 2006-01-16 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that occur when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging questions in human subjects research, namely financial conflicts of interest and the interpretation of scientific data.

Author : Larry V. McIntire
Publisher : National Academies Press
ISBN 13 : 0309052823
Total Pages : 297 pages
Book Rating : 4.25/5 ( download)

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Download or read book Biotechnology written by Larry V. McIntire and published by National Academies Press. This book was released on 1996-03-22 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnologyâ€"the manipulation of the basic building blocks of lifeâ€"is rapidly advancing in laboratories around the world. It has become routine to refer to DNA fingerprints and genetically engineered foods. Yet the "how to" of biotechnology is only the beginning. For every report of new therapies or better ways to produce food, there is a Jurassic Park scenario to remind us of the potential pitfalls. Biotechnology raises serious issues for scientists and nonscientists alike: Who will decide what is safe? Who will have access to our personal genetic information? What are the risks when advanced science becomes big business? In Biotechnology, experts from science, law, industry, and government explore a cross-section of emerging issues. This book offers straightforward explanations of basic science and provides insight into the serious social questions raised by these findings. The discussions explore five key areas: The state of the art in biotechnology-including an overview of the genetic revolution, the development of recombinant DNA technology, and the possibilities for applying the new techniques. Potential benefits to medicine and the environment-including gene therapy, the emerging area of tissue engineering and biomaterials, and the development of therapeutic proteins. Issues in technology transfer-focusing on the sometimes controversial relationship between university research centers and industry. Ethics, behavior, and values-exploring the ethical issues that surround basic research and applications of new technology, with a discussion of scientific misconduct and a penetrating look at the social impact of genetic discoveries. Government's role-including a comparison of U.S., European, and Japanese policies on pharmaceutical and biotechnology development. Biotechnology is here to stay, and this volume adds immeasurably to understanding its multiple aspects and far-reaching implications. This book will be of interest to scientists and industry leaders involved in biotechnology issues-and it will be welcomed by the concerned lay reader. Frederick B. Rudolph, Ph.D., is a professor of biochemistry and cell biology at Rice University and is executive director of the Institute of Biosciences and Bioengineering. Larry V. McIntire, Ph.D., is the E. D. Butcher Professor of Chemical and Biomedical Engineering at Rice University and is chair of the Institute of Biosciences and Bioengineering.

Author : Sorin Hostiuc
Publisher : Academic Press
ISBN 13 : 0128137657
Total Pages : 431 pages
Book Rating : 4.59/5 ( download)

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Download or read book Clinical Ethics at the Crossroads of Genetic and Reproductive Technologies written by Sorin Hostiuc and published by Academic Press. This book was released on 2018-08-07 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Ethics at the Crossroads of Genetic and Reproductive Technologies offers thorough discussions on preconception carrier screening, genetic engineering and the use of CRISPR gene editing, mitochondrial gene replacement therapy, sex selection, predictive testing, secondary findings, embryo reduction and the moral status of the embryo, genetic enhancement, and the sharing of genetic data. Chapter contributions from leading bioethicists and clinicians encourage a global, holistic perspective on applied challenges and the moral questions relating the implementation of genetic reproductive technology. The book is an ideal resource for practitioners, regulators, lawmakers, clinical researchers, genetic counselors and graduate and medical students. As the Human Genome Project has triggered a technological revolution that has influenced nearly every field of medicine, including reproductive medicine, obstetrics, gynecology, andrology, prenatal genetic testing, and gene therapy, this book presents a timely resource. Provides practical analysis of the ethical issues raised by cutting-edge techniques and recent advances in prenatal and reproductive genetics Contains contributions from leading bioethicists and clinicians who offer a global, holistic perspective on applied challenges and moral questions relating to genetic and genomic reproductive technology Discusses preconception carrier screening, genetic engineering and the use of CRISPR gene editing, mitochondrial gene replacement therapy, ethical issues, and more

Author : Mauro Giacca
Publisher : Springer Science & Business Media
ISBN 13 : 8847016436
Total Pages : 318 pages
Book Rating : 4.39/5 ( download)

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Download or read book Gene Therapy written by Mauro Giacca and published by Springer Science & Business Media. This book was released on 2010-11-01 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: I entered the gene therapy field in the mid-1990s, being fascinated by the immense potential of genes as drugs for the treatment of human disease. Since then, I have experienced the ups and downs of this discipline, and tried to contribute with my work and that of my laboratory to the development of innovative approaches to the treatment of cardiovascular disorders. During these years, I have had several opp- tunities to speak on gene therapy at lectures and academic lessons, and have often noticed that the field is very attractive to scientists of all disciplines. However, as yet no comprehensive book on the subject has been published. Indeed, most books in the field are either a collection of gene transfer laboratory protocols or deal with the subject in a rather superficial manner. Hence the idea to write a gene therapy textbook that is broad and comprehensive, but at the same time provides sufficient molecular and clinical detail to be of interest to students, professors, and specialists in the various disciplines that contribute to gene therapy. I have tried to keep the language plain and, whenever possible, non-technical. Since the book is intended to be a textbook in the field of gene therapy in both the basic science and clinical areas, whenever technical descriptions are required, they are provided.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309388708
Total Pages : 201 pages
Book Rating : 4.02/5 ( download)

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Download or read book Mitochondrial Replacement Techniques written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-04-17 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.