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Oversight and Review of Clinical Gene Transfer Protocols

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2014-03-27

Total Pages: 78

ISBN-13: 030929665X

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

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-08-13

Total Pages: 329

ISBN-13: 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.

Genetic Engineering of Plants

Author: National Research Council

Publisher: National Academies Press

Published: 1984-02-01

Total Pages: 97

ISBN-13: 0309034345

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"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."

Sources of Medical Technology

Author: Committee on Technological Innovation in Medicine

Publisher: National Academies Press

Published: 1995-01-15

Total Pages: 255

ISBN-13: 0309587611

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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

Author: National Research Council

Publisher: National Academies Press

Published: 2004-03-02

Total Pages: 164

ISBN-13: 0309089778

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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.

Genetic Alchemy

Author: Sheldon Krimsky

Publisher: Mit Press

Published: 1984-11-01

Total Pages: 445

ISBN-13: 9780262610384

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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.

The Regulation of Recombinant DNA Research

Author: Wisconsin. Legislature. Legislative Reference Bureau

Publisher:

Published: 1978

Total Pages: 18

ISBN-13:

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Safety of Genetically Engineered Foods

Author: National Research Council

Publisher: National Academies Press

Published: 2004-07-08

Total Pages: 254

ISBN-13: 0309166152

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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.