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Author: Jörg Niewöhner
Publisher: Elsevier
ISBN: 0080470939
Category : Science
Languages : en
Pages : 275
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Book Description
This book presents work that has been conducted as part of the research project "Discourse on ethical questions of biomedicine" of the interdisciplinary Working Group Bioethics and Science Communication at the Max-Delbrueck-Center for Molecular Medicine (MDC)in Berlin-Buch, Germany. This book offers ground-breaking ideas on how the daily interworking of cutting-edge biomedical research assess the broader social context and its communication to stakeholders and the public. Editors cover three aspects: Scientific, Ethical and Legal, and Perception and Communication. This work establishes an international and interdisciplinary network of excellent researchers at the beginning of their careers, who brilliantly integrate their work into the different perspectives on gene therapy from the natural and social sciences, as well as the humanities and law.* Discusses biological and cellular barriers limiting the clinical application of nonviral gene deliverysystems* Addresses such questions as: Does patent granting hinder the development of Gene Therapy products?* Offers insight in the future of public perception of gene therapy in Europe* Provides details on how to communicate risks in gene therapy
Author: Jörg Niewöhner
Publisher: Elsevier
ISBN: 0080470939
Category : Science
Languages : en
Pages : 275
Get Book Here
Book Description
This book presents work that has been conducted as part of the research project "Discourse on ethical questions of biomedicine" of the interdisciplinary Working Group Bioethics and Science Communication at the Max-Delbrueck-Center for Molecular Medicine (MDC)in Berlin-Buch, Germany. This book offers ground-breaking ideas on how the daily interworking of cutting-edge biomedical research assess the broader social context and its communication to stakeholders and the public. Editors cover three aspects: Scientific, Ethical and Legal, and Perception and Communication. This work establishes an international and interdisciplinary network of excellent researchers at the beginning of their careers, who brilliantly integrate their work into the different perspectives on gene therapy from the natural and social sciences, as well as the humanities and law.* Discusses biological and cellular barriers limiting the clinical application of nonviral gene deliverysystems* Addresses such questions as: Does patent granting hinder the development of Gene Therapy products?* Offers insight in the future of public perception of gene therapy in Europe* Provides details on how to communicate risks in gene therapy
Author: J?rg Niew?hner
Publisher: Elsevier Science Limited
ISBN: 9780444528063
Category : Medical
Languages : en
Pages : 252
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Book Description
This book presents work that has been conducted as part of the research project "Discourse on ethical questions of biomedicine" of the interdisciplinary Working Group Bioethics and Science Communication at the Max-Delbrueck-Center for Molecular Medicine (MDC)in Berlin-Buch, Germany. This book offers ground-breaking ideas on how the daily interworking of cutting-edge biomedical research assess the broader social context and its communication to stakeholders and the public. Editors cover three aspects: Scientific, Ethical and Legal, and Perception and Communication. This work establishes an international and interdisciplinary network of excellent researchers at the beginning of their careers, who brilliantly integrate their work into the different perspectives on gene therapy from the natural and social sciences, as well as the humanities and law. * Discusses biological and cellular barriers limiting the clinical application of nonviral gene delivery systems * Addresses such questions as: Does patent granting hinder the development of Gene Therapy products? * Offers insight in the future of public perception of gene therapy in Europe * Provides details on how to communicate risks in gene therapy
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452880
Category : Medical
Languages : en
Pages : 329
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Book Description
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: Institute of Medicine
Publisher: National Academies Press
ISBN: 030929665X
Category : Medical
Languages : en
Pages : 78
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Book Description
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: Ross M. Mullner
Publisher: SAGE
ISBN: 1412951798
Category : Medical
Languages : en
Pages : 1457
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Book Description
Within two volumes, more than 400 signed entries and their associated bibliographies and recommended readings authoritatively cover issues in both the historical and contemporary context of health services research.
Author: The Royal Society
Publisher: National Academies Press
ISBN: 0309671132
Category : Medical
Languages : en
Pages : 239
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Book Description
Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.
Author: Benjamin D. Trump
Publisher: Springer Nature
ISBN: 3030272648
Category : Technology & Engineering
Languages : en
Pages : 434
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Book Description
Synthetic biology offers powerful remedies for some of the world’s most intractable problems, but these solutions are clouded by uncertainty and risk that few strategies are available to address. The incentives for continued development of this emerging technology are prodigious and obvious, and the public deserves assurances that all potential downsides are duly considered and minimized accordingly. Incorporating social science analysis within the innovation process may impose constraints, but its simultaneous support in making the end products more acceptable to society at large should be considered a worthy trade-off. Contributing authors in this volume represent diverse perspectives related to synthetic biology’s social sciences, and reflect on different areas of risk analysis and governance that have developed for the field. Such perspectives include leading scholarly discussion pertaining to risk assessment, governance, ethics, and communication. The chapters of this volume note that while the first twenty years of synthetic biology development have focused strongly on technological innovation and product development, the next twenty should emphasize the synergy between developers, policymakers, and publics to generate the most beneficial, well governed, and transparent technologies and products possible. Many chapters in this volume provide new data and approaches that demonstrate the feasibility for multi-stakeholder efforts involving policymakers, regulators, industrial developers, workers, experts, and societal representatives to share responsibilities in the production of effective and acceptable governance in the face of uncertain risk probabilities. A full consideration of such perspectives may prevent a world of draconian regulations based on an insufficient or incomplete understanding of the science that underpins synthetic biology, as well as any hesitancy or fear by the public to adopt its eventual products.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309047986
Category : Medical
Languages : en
Pages : 353
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Book Description
Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
Author: Marcello Barbieri
Publisher: Springer Science & Business Media
ISBN: 1402048149
Category : Science
Languages : en
Pages : 530
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Book Description
Combining research approaches from biology, philosophy and linguistics, the field of Biosemiotics proposes that animals, plants and single cells all engage in semiosis – the conversion of objective signals into conventional signs. This has important implications and applications for issues ranging from natural selection to animal behavior and human psychology, leaving biosemiotics at the cutting edge of the research on the fundamentals of life. Drawing on an international expertise, the book details the history and study of biosemiotics, and provides a state-of-the-art summary of the current work in this new field. And, with relevance to a wide range of disciplines – from linguistics and semiotics to evolutionary phenomena and the philosophy of biology – the book provides an important text for both students and established researchers, while marking a vital step in the evolution of a new biological paradigm.
Author: Maria Cristina Galli
Publisher: Springer
ISBN: 3319186183
Category : Medical
Languages : en
Pages : 235
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Book Description
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
