Oversight and Review of Clinical Gene Transfer Protocols

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Publisher : National Academies Press
ISBN 13 : 030929665X
Total Pages : 78 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Oversight and Review of Clinical Gene Transfer Protocols by : Institute of Medicine

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.

Human Genome Editing

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Publisher : National Academies Press
ISBN 13 : 0309452880
Total Pages : 329 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Human Genome Editing by : National Academies of Sciences, Engineering, and Medicine

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.

Genetic Engineering of Plants

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Publisher : National Academies Press
ISBN 13 : 0309034345
Total Pages : 97 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Genetic Engineering of Plants by : National Research Council

Download or read book Genetic Engineering of Plants written by National Research Council and published by National Academies Press. This book was released on 1984-02-01 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The book...is, in fact, a short text on the many practical problems...associated with translating the explosion in basic biotechnological research into the next Green Revolution," explains Economic Botany. The book is "a concise and accurate narrative, that also manages to be interesting and personal...a splendid little book." Biotechnology states, "Because of the clarity with which it is written, this thin volume makes a major contribution to improving public understanding of genetic engineering's potential for enlarging the world's food supply...and can be profitably read by practically anyone interested in application of molecular biology to improvement of productivity in agriculture."

The Recombinant DNA Controversy

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Publisher :
ISBN 13 :
Total Pages : 420 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Recombinant DNA Controversy by : Donald S. Fredrickson

Download or read book The Recombinant DNA Controversy written by Donald S. Fredrickson and published by . This book was released on 2001 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Relying on vast archives of hearings records, correspondence, and extensive personal records and diaries, Dr. Fredrickson recalls the numerous personalities from microbiology, molecular biology, and other scientific disciplines, as well as the leaders among Congress, the administration, and government agencies, environmentalists, and many others, who had a role during this challenging period."--BOOK JACKET.

Sources of Medical Technology

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Publisher : National Academies Press
ISBN 13 : 0309587611
Total Pages : 255 pages
Book Rating : 4.3/5 (95 download)

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Book Synopsis Sources of Medical Technology by : Committee on Technological Innovation in Medicine

Download or read book Sources of Medical Technology written by Committee on Technological Innovation in Medicine and published by National Academies Press. This book was released on 1995-01-15 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.

Biotechnology Research in an Age of Terrorism

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Publisher : National Academies Press
ISBN 13 : 0309089778
Total Pages : 164 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Biotechnology Research in an Age of Terrorism by : National Research Council

Download or read book Biotechnology Research in an Age of Terrorism written by National Research Council and published by National Academies Press. This book was released on 2004-03-02 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.

Preparing for Future Products of Biotechnology

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Publisher : National Academies Press
ISBN 13 : 0309452058
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

The Regulation of Recombinant DNA Research

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Author :
Publisher :
ISBN 13 :
Total Pages : 18 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis The Regulation of Recombinant DNA Research by : Wisconsin. Legislature. Legislative Reference Bureau

Download or read book The Regulation of Recombinant DNA Research written by Wisconsin. Legislature. Legislative Reference Bureau and published by . This book was released on 1978 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Safety of Genetically Engineered Foods

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Publisher : National Academies Press
ISBN 13 : 0309166152
Total Pages : 254 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Safety of Genetically Engineered Foods by : National Research Council

Download or read book Safety of Genetically Engineered Foods written by National Research Council and published by National Academies Press. This book was released on 2004-07-08 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them. The book offers a framework to guide federal agencies in selecting the route of safety assessment. It identifies and recommends several pre- and post-market approaches to guide the assessment of unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps.

Genetic Alchemy

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Publisher : Mit Press
ISBN 13 : 9780262610384
Total Pages : 445 pages
Book Rating : 4.6/5 (13 download)

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Book Synopsis Genetic Alchemy by : Sheldon Krimsky

Download or read book Genetic Alchemy written by Sheldon Krimsky and published by Mit Press. This book was released on 1984-11-01 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic Alchemy summarizes and clarifies the background of policy and ethical issues, the debates engendered by uncertain risks to researchers and the population at large, and the roles played by scientists involved in one of the most prominent and controversial new technologies, gene splicing. The author, Assistant Professor of Urban and Environmental Policy at Tufts University, brings to the topic his experience on the Cambridge Review Board as it considered the siting of a recombinant DNA research facility, and on the NIH's Recombinant DNA Advisory Committee.

Laboratory Safety Monograph

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Publisher :
ISBN 13 :
Total Pages : 260 pages
Book Rating : 4.M/5 ( download)

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Book Synopsis Laboratory Safety Monograph by : National Cancer Institute (U.S.). Office of Research Safety

Download or read book Laboratory Safety Monograph written by National Cancer Institute (U.S.). Office of Research Safety and published by . This book was released on 1979 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Recombinant DNA

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Publisher : Macmillan
ISBN 13 : 9780716722823
Total Pages : 644 pages
Book Rating : 4.7/5 (228 download)

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Book Synopsis Recombinant DNA by : James D. Watson

Download or read book Recombinant DNA written by James D. Watson and published by Macmillan. This book was released on 1992-02-15 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: An overview of recombitant DNA techniques and surveys advances in recombinant molecular genetics, experimental methods and their results.

Splicing Life

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Publisher :
ISBN 13 :
Total Pages : 128 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Splicing Life by : United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

Download or read book Splicing Life written by United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and published by . This book was released on 1982 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regulation of Recombinant DNA Research

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Publisher :
ISBN 13 :
Total Pages : 464 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Regulation of Recombinant DNA Research by : United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Science, Technology, and Space

Download or read book Regulation of Recombinant DNA Research written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Science, Technology, and Space and published by . This book was released on 1978 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Responsible Research with Biological Select Agents and Toxins

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Publisher : National Academies Press
ISBN 13 : 030914535X
Total Pages : 188 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Responsible Research with Biological Select Agents and Toxins by : National Research Council

Download or read book Responsible Research with Biological Select Agents and Toxins written by National Research Council and published by National Academies Press. This book was released on 2010-02-12 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.

Introduction to Basics of Pharmacology and Toxicology

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Publisher : Springer Nature
ISBN 13 : 9813297794
Total Pages : 410 pages
Book Rating : 4.8/5 (132 download)

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Book Synopsis Introduction to Basics of Pharmacology and Toxicology by : Gerard Marshall Raj

Download or read book Introduction to Basics of Pharmacology and Toxicology written by Gerard Marshall Raj and published by Springer Nature. This book was released on 2019-11-16 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most crucial principles involved in pharmacology and allied sciences. The title begins by discussing the historical aspects of drug discovery, with up to date knowledge on Nobel Laureates in pharmacology and their significant discoveries. It then examines the general pharmacological principles - pharmacokinetics and pharmacodynamics, with in-depth information on drug transporters and interactions. In the remaining chapters, the book covers a definitive collection of topics containing essential information on the basic principles of pharmacology and how they are employed for the treatment of diseases. Readers will learn about special topics in pharmacology that are hard to find elsewhere, including issues related to environmental toxicology and the latest information on drug poisoning and treatment, analytical toxicology, toxicovigilance, and the use of molecular biology techniques in pharmacology. The book offers a valuable resource for researchers in the fields of pharmacology and toxicology, as well as students pursuing a degree in or with an interest in pharmacology.

Molecular Politics

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Publisher : University of Chicago Press
ISBN 13 : 0226910660
Total Pages : 615 pages
Book Rating : 4.2/5 (269 download)

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Book Synopsis Molecular Politics by : Susan Wright

Download or read book Molecular Politics written by Susan Wright and published by University of Chicago Press. This book was released on 1994-10-17 with total page 615 pages. Available in PDF, EPUB and Kindle. Book excerpt: The promise of genetic engineering in the early 1970s to profoundly reshape the living world activated a variety of social interests in its future promotion and control. With public safety, gene patents, and the future of genetic research at stake, a wide range of interest groups competed for control over this powerful new technology. In this comparative study of the development of regulatory policy for genetic engineering in the United States and the United Kingdom, Susan Wright analyzes government responses to the struggles among corporations, scientists, universities, trade unions, and public interest groups over regulating this new field. Drawing on archival materials, government records, and interviews with industry executives, politicians, scientists, trade unionists, and others on both sides of the Atlantic, Molecular Politics provides a comprehensive account of a crucial set of policy decisions and explores their implications for the political economy of science. By combining methods from political science and the history of science, Wright advances a provocative interpretation of the evolution of genetic engineering policy and makes a major contribution to science and public policy studies.