Gene Transfer and the Ethics of First-in-Human Research

Gene Transfer and the Ethics of First-in-Human Research
Author: Jonathan Kimmelman
Publisher: Cambridge University Press
Total Pages: 219
Release: 2010
Genre: Law
ISBN: 0521690846

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Examines the ethical and policy dimensions of testing novel medical interventions in human beings for the first time.

The Ethics of Human Gene Therapy

The Ethics of Human Gene Therapy
Author: LeRoy Walters
Publisher: Oxford University Press, USA
Total Pages: 240
Release: 1997
Genre: Gene therapy
ISBN: 9780195059557

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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.

Research Ethics

Research Ethics
Author: Ana Smith Iltis
Publisher: Routledge
Total Pages: 232
Release: 2006-01-16
Genre: Philosophy
ISBN: 1135991499

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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.

Exploring Novel Clinical Trial Designs for Gene-Based Therapies

Exploring Novel Clinical Trial Designs for Gene-Based Therapies
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 127
Release: 2020-08-27
Genre: Medical
ISBN: 0309672988

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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.

Oversight and Review of Clinical Gene Transfer Protocols

Oversight and Review of Clinical Gene Transfer Protocols
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 78
Release: 2014-03-27
Genre: Medical
ISBN: 030929665X

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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.

The Science and Ethics of Engineering the Human Germ Line

The Science and Ethics of Engineering the Human Germ Line
Author: Jon W. Gordon
Publisher: John Wiley & Sons
Total Pages: 304
Release: 2003-09-24
Genre: Science
ISBN: 0471478202

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With implications that go to the core of what it means to be human, the issues raised by genetic manipulation-especially cloning-have sparked a passionate debate among governmental, religious, and scientific quarters, as well as the media and the general public. Keeping to the actual science rather than speculation is of the utmost importance for an enlightened approach to this weighty discussion. In clear, lively prose, The Science and Ethics of Engineering the Human Germ Line: Mendel's Maze provides an authoritative treatment of the principles of science and bioethics that bear upon such technologies as germ-line insertion and cloning. It offers a realistic assessment of possible applications, limitations, and new developments likely to arise in these areas. Written by a top physician-investigator, this book progresses from the basics of building a living organism from inanimate parts through to recombinant DNA technology, assisted reproductive technologies, and gene transfer and germ-line engineering. Ethical considerations are woven into this material throughout, while a special section covers the intellectual role played by various social biases. As genetic and reproductive technologies spread from the laboratory to the clinic-and society takes further notice-students and practitioners of biology and medicine, as well as the interested general reader, will find The Science and Ethics of Engineering the Human Germ Line: Mendel's Maze to be an essential and accessible guide to these important subjects.

Human Genome Editing

Human Genome Editing
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 329
Release: 2017-08-13
Genre: Medical
ISBN: 0309452880

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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.

Gene Therapy and Ethics

Gene Therapy and Ethics
Author: Anders Nordgren
Publisher: Uppsala Univ. Lib.
Total Pages: 184
Release: 1999
Genre: Gene therapy
ISBN:

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The Ethics of Genetics in Human Procreation

The Ethics of Genetics in Human Procreation
Author: Hille Haker
Publisher: Routledge
Total Pages: 525
Release: 2018-04-27
Genre: Social Science
ISBN: 1351770853

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This title was first published in 2000: This third volume of proceedings of the European Network for Biomedical Ethics focuses on the ethical issues surrounding the debates on reproductive medicine and genetics in human procreation. Central issues include procreation and parenthood, moral protection of the human embryo and foetus, autonomy and recognition, social implications, moral reasoning in applied ethics, legal regulations of assisted procreation, genetic diagnosis and gene therapy. The legal regulation paper evaluates the central laws and guidelines of European countries.

Genetics and Ethics

Genetics and Ethics
Author: Gerard Magill
Publisher: Saint Louis University Press
Total Pages: 388
Release: 2004
Genre: Law
ISBN:

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Publisher description -- The sixteen original essays in this book provide a critical guide to many ethical issues at the heart of genetics technology--and our genetics future. Drawing on fields ranging from medicine and law to religion, health policy, and biotechnology, the essays address the core topics at the heart of current debates: legal, policy, and business dimensions of the genetics revolution; cultural and social implications of genetics; and practical and clinical issues. The essays serve as authoritative guides to current concerns in a wide range of areas, from the impact of genetics on aging and long-term care to the ethics of pharmacogenetics, prenatal screening, and research with children. An epilogue connects ethics discourse to debates on embryonic stem cell research and therapeutic cloning.