Institute for Laboratory Animal Research – författare

Scientific advances in our understanding of animal physiology and behavior often require theories to be revised and standards of practice to be updated to improve laboratory animal welfare. This new book from the Institute for Laboratory Animal Research (ILAR) at the National Research Council, Recognition and Alleviation of Distress in Laboratory Animals, focuses on the stress and distress which is experienced by animals when used in laboratory research. This book aims to educate laboratory animal veterinarians; students, researchers, and investigators; animal care staff, as well as animal welfare officers on the current scientific and ethical issues associated with stress and distress in laboratory animals. It evaluates pertinent scientific literature to generate practical and pragmatic guidelines. Recognition and Alleviation of Distress in Laboratory Animals focuses specifically on the scientific understanding of the causes and the functions of stress and distress, the transformation of stress to distress, and the identification of principles for the recognition and alleviation of distress. This book discusses the role of humane endpoints in situations of distress and principles for the minimization of distress in laboratory animals. It also identifies areas in which further scientific investigation is needed to improve laboratory animal welfare in order to adhere to scientific and ethical principles that promote humane care and practice.

Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.

The use of animals in research adheres to scientific and ethical principles that promote humane care and practice. Scientific advances in our understanding of animal physiology and behavior often require theories to be revised and standards of practice to be updated to improve laboratory animal welfare. Recognition and Alleviation of Pain in Laboratory Animals, the second of two reports revising the 1992 publication Recognition and Alleviation of Pain and Distress in Laboratory Animals from the Institute for Laboratory Animal Research (ILAR), focuses on pain experienced by animals used in research. This book aims to educate laboratory animal veterinarians; students, researchers and investigators; Institutional Animal Care and Use Committee members; and animal care staff and animal welfare officers on the current scientific and ethical issues associated with pain in laboratory animals. It evaluates pertinent scientific literature to generate practical and pragmatic guidelines for recognizing and alleviating pain in laboratory animals, focusing specifically on the following areas: physiology of pain in commonly used laboratory species; pharmacologic and non-pharmacologic principles to control pain; identification of humane endpoints; and principles for minimizing pain associated with experimental procedures. Finally, the report identifies areas in which further scientific investigation is needed to improve laboratory animal welfare.

Much has been written about the care of research animals. Yet little guidance has appeared on protecting the health and safety of the people who care for or use these animals.

This book, an implementation handbook and companion to Guide For the Care and Use of Laboratory Animals, identifies principles for building a program and discusses the accountability of institutional leaders, managers, and employees for a program''s success. It provides a detailed description of risks—physical and chemical hazards, allergens and zoonoses, and hazards from experiments—which will serve as a continuing reference for the laboratory.

The book offers specific recommendations for controlling risk through administrative procedures, facility design, engineering controls, and periodic evaluations. The volume focuses on the worker, with detailed discussions of work practices, the use of personal protective gear, and the development of an emergency response plan.

This handbook will be invaluable to administrators, researchers, and employees in any animal research facility. It will also be of interest to personnel in zoos, animal shelters, and veterinary facilities.

Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.

Scientific and Humane Issues in the Use of Random-Source Dogs and Cats in Research examines the value of random-source animals in biomedical research and the role of Class B dealers who acquire and resell live dogs and cats to research institutions. Findings include that, while some random-source dogs and cats may be necessary and desirable for National Institutes of Health (NIH)-funded research, there is no clear need to obtain those animals from Class B dealers. Several options for random-source animal acquisition already exist and additional options are recommended, which would further ensure the welfare of these animals and foster a positive public image for NIH.While the scientific community has recognized and responded to concerns for humane treatment of animals in research, government oversight has thus far been unable to fully enforce the Animal Welfare Act in regard to Class B dealers of live animals. Although the animals acquired by Class B dealers are destined for research—and NIH research in particular—the standard of care while in the possession of some Class B dealers requires an inordinate amount of government enforcement and is not commensurate with the policies of most NIH-funded research laboratories. This dichotomy of standards reflects poorly on public perceptions of NIH and jeopardizes animal welfare. This book will be crucial for NIH and other groups using random-source animals in research, including veterinary schools and research facilities. Animal welfare advocates, policy makers, and concerned pet owners will also find this a vital and informative work for reconciling the needs of research with the welfare of animals.

Scientific and Humane Issues in the Use of Random-Source Dogs and Cats in Research examines the value of random-source animals in biomedical research and the role of Class B dealers who acquire and resell live dogs and cats to research institutions. Findings include that, while some random-source dogs and cats may be necessary and desirable for National Institutes of Health (NIH)-funded research, there is no clear need to obtain those animals from Class B dealers. Several options for random-source animal acquisition already exist and additional options are recommended, which would further ensure the welfare of these animals and foster a positive public image for NIH.While the scientific community has recognized and responded to concerns for humane treatment of animals in research, government oversight has thus far been unable to fully enforce the Animal Welfare Act in regard to Class B dealers of live animals. Although the animals acquired by Class B dealers are destined for research—and NIH research in particular—the standard of care while in the possession of some Class B dealers requires an inordinate amount of government enforcement and is not commensurate with the policies of most NIH-funded research laboratories. This dichotomy of standards reflects poorly on public perceptions of NIH and jeopardizes animal welfare. This book will be crucial for NIH and other groups using random-source animals in research, including veterinary schools and research facilities. Animal welfare advocates, policy makers, and concerned pet owners will also find this a vital and informative work for reconciling the needs of research with the welfare of animals.

The use of animals in research adheres to scientific and ethical principles that promote humane care and practice. Scientific advances in our understanding of animal physiology and behavior often require theories to be revised and standards of practice to be updated to improve laboratory animal welfare. Recognition and Alleviation of Pain in Laboratory Animals, the second of two reports revising the 1992 publication Recognition and Alleviation of Pain and Distress in Laboratory Animals from the Institute for Laboratory Animal Research (ILAR), focuses on pain experienced by animals used in research. This book aims to educate laboratory animal veterinarians; students, researchers and investigators; Institutional Animal Care and Use Committee members; and animal care staff and animal welfare officers on the current scientific and ethical issues associated with pain in laboratory animals. It evaluates pertinent scientific literature to generate practical and pragmatic guidelines for recognizing and alleviating pain in laboratory animals, focusing specifically on the following areas: physiology of pain in commonly used laboratory species; pharmacologic and non-pharmacologic principles to control pain; identification of humane endpoints; and principles for minimizing pain associated with experimental procedures. Finally, the report identifies areas in which further scientific investigation is needed to improve laboratory animal welfare.

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:

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.

Toxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.

The Development of Science-based Guidelines for Laboratory Animal Care is the summary of an international workshop held in Washington, DC, in November 2003 to bring together experts from around the world to discuss the available knowledge that can positively influence current and pending guidelines for laboratory animal care, identify gaps in that knowledge in order to encourage future research endeavors, and discuss the scientific evidence that can be used to assess the benefits and costs of various regulatory approaches affecting facilities, research, and animal welfare.

The report identified various factors which contributed to creating an unfulfilled need for veterinarians in the biomedical research workforce, including an increase in the number of NIH grants utilizing animals and the burgeoning use of transgenic rodents, without a comparable change in the supply of appropriately-trained veterinarians. The committee developed strategies for recruiting more veterinarians into careers in biomedical research.

Science, Medicine, and Animals and the Teacher''s Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher''s Guide was reviewed by members of the National Academies'' Teacher Associates Network.

Science, Medicine, and Animals is recommended by the National Science Teacher''s Association.

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 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.

Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs.

In this first in a proposed series of workshops on regulatory issues in animal care and use, the Institute for Laboratory Animal Research (ILAR) has addressed the existing and proposed requirements for reporting pain and distress in laboratory animals. The Animal Welfare Act, administered by the Animal and Plant Health Inspection Service of the United States Department of Agriculture (USDA), mandates that pain and distress in laboratory animals be minimized. USDA is considering two policy changes with regard to this specific mandate. Firstly, since there has been no functional definition of "distress," USDA has prepared such a definition and requested feedback from the scientific community on its usefulness for regulatory and reporting requirements.

The second issue concerns the pain and distress categorization scheme for reporting to USDA. Various groups and individuals have questioned the efficacy of the current categories, and specific changes have been proposed by the Humane Society of the United States. USDA is considering these and other potential changes to the existing scheme. Thus, given these potential changes to animal welfare policy, the aim of the ILAR/NIH joint workshop was to provide feedback to the USDA. The speakers were asked to address these two issues as well as to comment upon whether the information contained in the 1992 ILAR report Recognition and Alleviation of Pain and Distress in Laboratory Animals is still useful to investigators in assisting them to comply with regulations. The speakers provided perspectives based on their individual expertise in the areas of science of pain and distress, animal welfare policy, protocol review, and/or as representatives of relevant organizations or institutions. The following proceedings are an edited transcript of their presentations.

Care and use of animals in research are expensive, prompting efforts to contain or reduce costs. Components of those costs are personnel, regulatory compliance, veterinary medical care, and laboratory animal management, equipment, and procedures. Many efforts have been made to control and reduce personnel costs, the largest contributing factor to cost, through better facility and equipment design, more efficient use of personnel, and automation of many routine operations. However, there has been no comprehensive, recent analysis of the various cost components or examination of the strategies that have been proven or are purported to decrease the cost of animal facility operation.

Strategies that Influence Cost Containment in Animal Research Facilities examines the current interpretation of governmental policy (Office of Management and Budget Circular A-21) concerning institutional reimbursement for overhead costs of an animal research facility and describes methods for economically operating an animal research facility. This report develops recommendations by which federal auditors and research institutions can establish what cost components of research animal facilities should be charged to institutions'' indirect cost pool and what animal research facility cost components should be included in the per diem charges to investigators, and assesses the financial and scientific ramifications that these criteria would have among federally funded institutions. Further, the report determines the cost components of laboratory animal care and use in biomedical research and assesses and recommends methods of cost containment for institutions maintaining animals for biomedical research.

US/Japan meetings on laboratory animal science have been held virtually every year since 1980 under the US/Japan Cooperative Program on Science and Technology. Over the years these meetings have resulted in a number of important documents including the Manual of Microbiologic Monitoring of Laboratory Animals published in 1994 and the article Establishment and Preservation of Reference Inbred Strains of Rats for General Purposes. In addition to these publications, the meetings have been instrumental in increasing awareness of the need for microbiologic monitoring of laboratory rodents and the need for genetic definition and monitoring of mice and rats.

In cooperation with the Comparative Medicine section of NCRR/NIH, the ILAR Council and staff are pleased to become the host for this important annual meeting and look forward to participating in future meetings. The support and sponsorship of NCRR (P40 RR 11611) in the United States and the Central Institute for Experimental Animals in Japan are gratefully acknowledged. Bringing together the leading scientists in the field of laboratory animal care has resulted in increased understanding of American and Japanese approaches to laboratory animal science and should continue to strengthen efforts to harmonize approaches aimed at resolving common challenges in the use of animal models for biomedical research and testing. This effort to improve understanding and cooperation between Japan and the United States should also be useful in developing similar interaction with other regions of the world including Europe, Australia, and Southeast Asia.

US-Japan meetings on laboratory animal science have been held virtually every year since 1980 under the US-Japan Cooperative Program on Science and Technology. Over the years these meetings have resulted in a number of important documents including the Manual of Microbiologic of Monitoring of Laboratory Animals published in 1994 and the article Establishment and Preservation of Reference Inbred Strains of Rats for General Purposes published in 1991. In addition to these publications, these meetings have been instrumental in increasing awareness of the need for microbiologic monitoring of laboratory rodents and the need for genetic definition and monitoring of mice and rats.

The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb.

In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method.

The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.

A 1985 amendment to the Animal Welfare Act requires those who keep nonhuman primates to develop and follow appropriate plans for promoting the animals'' psychological well-being. The amendment, however, provides few specifics.

The Psychological Well-Being of Nonhuman Primates recommends practical approaches to meeting those requirements. It focuses on what is known about the psychological needs of primates and makes suggestions for assessing and promoting their well-being.

This volume examines the elements of an effective care program—social companionship, opportunities for species-typical activity, housing and sanitation, and daily care routines—and provides a helpful checklist for designing a plan for promoting psychological well-being.

The book provides a wealth of specific and useful information about the psychological attributes and needs of the most widely used and exhibited nonhuman primates. Readable and well-organized, it will be welcomed by animal care and use committees, facilities administrators, enforcement inspectors, animal advocates, researchers, veterinarians, and caretakers.

In the 15 years since the last Institute of Laboratory Animal Resources report on the general management of rodents was published, important advances in biomedical research and increased public awareness have created a new environment for animal research. Modern technology-such as insertion of functional genes from other species into mice or rats, elimination of a single selected gene or function in mice, and the re-creation of elements of the human immune system in mice-has greatly expanded the usefulness of rodents in drug development and as models of human diseases. The technologic requirements of such advanced systems have led to improved understanding and implementation of environmental requirements for the care and use of rodents in research. The intent of this report is to provide current information to laboratory animal scientists (including both animal-care technicians and veterinarians), investigators, research technicians, and administrators on general elements of rodent care and use that should be considered both for optimal design and conduct of research and to meet current standards of care and use.