Safety of Genetically Engineered Foods


Book Description

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.




Oversight and Review of Clinical Gene Transfer Protocols


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.




Biosafety in the Laboratory


Book Description

Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safetyâ€"and more.




Animal Cell Culture


Book Description

​Animal cells are the preferred “cell factories” for the production of complex molecules and antibodies for use as prophylactics, therapeutics or diagnostics. Animal cells are required for the correct post-translational processing (including glycosylation) of biopharmaceutical protein products. They are used for the production of viral vectors for gene therapy. Major targets for this therapy include cancer, HIV, arthritis, cardiovascular and CNS diseases and cystic fibrosis. Animal cells are used as in vitro substrates in pharmacological and toxicological studies. This book is designed to serve as a comprehensive review of animal cell culture, covering the current status of both research and applications. For the student or R&D scientist or new researcher the protocols are central to the performance of cell culture work, yet a broad understanding is essential for translation of laboratory findings into the industrial production. Within the broad scope of the book, each topic is reviewed authoritatively by experts in the field to produce state-of-the-art collection of current research. A major reference volume on cell culture research and how it impacts on production of biopharmaceutical proteins worldwide, the book is essential reading for everyone working in cell culture and is a recommended volume for all biotechnology libraries.







Resource Sharing in Biomedical Research


Book Description

The United States is entering an era when, more than ever, the sharing of resources and information might be critical to scientific progress. Every dollar saved by avoiding duplication of efforts and by producing economies of scale will become increasingly important as federal funding enters an era of fiscal restraint. This book focuses on six diverse case studies that share materials or equipment with the scientific community at large: the American Type Culture Collection, the multinational coordinated Arabidopsis thaliana Genome Research Project, the Jackson Laboratory, the Washington Regional Primate Research Center, the Macromolecular Crystallography Resource at the Cornell High-Energy Synchrotron Source, and the Human Genome Center at Lawrence Livermore National Laboratory. The book also identifies common strengths and problems faced in the six cases, and presents a series of recommendations aimed at facilitating resource sharing in biomedical research.




Building Vulnerability Assessments


Book Description

All too often the assessment of structural vulnerability is thought of only in terms of security upgrades, guards, and entrance barriers. However, in order to fully ensure that a building is secure, the process of design and construction must also be considered. Building Vulnerability Assessments: Industrial Hygiene and Engineering Concepts focuses




Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research


Book Description

Expanding on the National Research Council's Guide for the Care and Use of Laboratory Animals, this book deals specifically with mammals in neuroscience and behavioral research laboratories. It offers flexible guidelines for the care of these animals, and guidance on adapting these guidelines to various situations without hindering the research process. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research offers a more in-depth treatment of concerns specific to these disciplines than any previous guide on animal care and use. It treats on such important subjects as: The important role that the researcher and veterinarian play in developing animal protocols. Methods for assessing and ensuring an animal's well-being. General animal-care elements as they apply to neuroscience and behavioral research, and common animal welfare challenges this research can pose. The use of professional judgment and careful interpretation of regulations and guidelines to develop performance standards ensuring animal well-being and high-quality research. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research treats the development and evaluation of animal-use protocols as a decision-making process, not just a decision. To this end, it presents the most current, in-depth information about the best practices for animal care and use, as they pertain to the intricacies of neuroscience and behavioral research.




Guide for the Care and Use of Laboratory Animals


Book Description

A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.