Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee's Books

Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee

By: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

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Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee

By: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

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.

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National Academies Press

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ISBN 10

030929665X

ISBN 13

9780309296656

Human Genome Editing

Science, Ethics, and Governance

By: National Academies of Sciences, Engineering, and Medicine,National Academy of Medicine,National Academy of Sciences,Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations

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Human Genome Editing

Science, Ethics, and Governance

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.

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329

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National Academies Press

Published Date

ISBN 10

0309452880

ISBN 13

9780309452885

Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee

By: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

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Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee

By: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

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National Academies Press

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ISBN 10

030929665X

ISBN 13

9780309296656

A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology

Interim Report

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Life Sciences,Board on Chemical Sciences and Technology,Committee on Strategies for Identifying and Addressing Biodefense Vulnerabilities Posed by Synthetic Biology

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A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology

Interim Report

Building on an increasingly sophisticated understanding of naturally occurring biological processes, researchers have developed technologies to predictably modify or create organisms or biological components. This research, known collectively as synthetic biology, is being pursued for a variety of purposes, from reducing the burden of disease to improving agricultural yields to remediating pollution. While synthetic biology is being pursued primarily for beneficial and legitimate purposes, it is possible to imagine malicious uses that could threaten human health or military readiness and performance. Making informed decisions about how to address such concerns requires a comprehensive, realistic assessment. To this end, the U.S. Department of Defense, working with other agencies involved in biodefense, asked the National Academies of Sciences, Engineering, and Medicine to develop a framework to guide an assessment of the security concerns related to advances in synthetic biology, to assess the level of concern warranted for various advances and identify areas of vulnerability, and to prioritize options to address these vulnerabilities. This interim report proposes a framework for identifying and prioritizing potential areas of concern associated with synthetic biologyâ€"a tool to aid the consideration of concerns related to synthetic biology. The framework describes categories of synthetic biology technologies and applicationsâ€"such as genome editing, directed evolution, and automated biological designâ€"and provides a set of initial questions to guide the assessment of concern related to these technologies and applications.

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National Academies Press

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ISBN 10

030946286X

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9780309462860

Food and Drug Administration Advisory Committees

By: Institute of Medicine,Committee to Study the Use of Advisory Committees

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Food and Drug Administration Advisory Committees

By: Institute of Medicine,Committee to Study the Use of Advisory Committees

Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

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239

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National Academies Press

Published Date

ISBN 10

0309048370

ISBN 13

9780309048378

NIH Extramural Center Programs

Criteria for Initiation and Evaluation

By: Institute of Medicine,Board on Health Sciences Policy,Committee for Assessment of NIH Centers of Excellence Programs

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NIH Extramural Center Programs

Criteria for Initiation and Evaluation

By: Institute of Medicine,Board on Health Sciences Policy,Committee for Assessment of NIH Centers of Excellence Programs

Grants for research centers located in universities, medical centers, and other nonprofit research institutions account for about 9 percent of the National Institutes of Health budget. Centers are popular because they can bring visibility, focus, and increased resources to bear on specific diseases. However, congressional debate in 2001 over proposed legislation directing NIH to set up centers for muscular dystrophy research highlighted several areas of uncertainty about how to decide when centers are an appropriate research mechanism in specific cases. The debate also highlighted a growing trend among patient advocacy groups to regard centers as a key element of every disease research program, regardless of how much is known about the disease in question, the availability of experienced researchers, and other factors. This book examines the criteria and procedures used in deciding whether to establish new specialized research centers. It discusses the future role of centers in light of the growing trend of large-scale research in biomedicine, and it offers recommendations for improving the classification and tracking of center programs, clarifying and improving the decision process and criteria for initiating center programs, resolving the occasional disagreements over the appropriateness of centers, and evaluating the performance of center programs more regularly and systematically.

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233

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National Academies Press

Published Date

ISBN 10

0309091527

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9780309091527

Book's by Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

Oversight and Review of Clinical Gene Transfer Protocols

Oversight and Review of Clinical Gene Transfer Protocols

Human Genome Editing

Human Genome Editing

Oversight and Review of Clinical Gene Transfer Protocols

Oversight and Review of Clinical Gene Transfer Protocols

A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology

A Proposed Framework for Identifying Potential Biodefense Vulnerabilities Posed by Synthetic Biology

Food and Drug Administration Advisory Committees

Food and Drug Administration Advisory Committees

NIH Extramural Center Programs

NIH Extramural Center Programs

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