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7 Conclusions and Recommendations In our society, no single ideology or theology governs people's mode of thinking. Different perspectives constitute the pillralistic base of our thought. This society Is one that considers the ethics of public policythat is, the identification of the set of values that places priorities on achieving what Is considered best for the common good. When decisions that affect the welfare of society are made, these ethical considerations are vital. Lacking a single world view tied to a specific religious or philosophical perspective, but believing in a need for a framework within which to make decisions, our society seeks to make policy decisions In science and all areas within an ethical framework. Try the Uniter] States, social decisions are Unposed not by au- thorities but by the will of the people acting through elected repro sentatives, whose responsibility it is to he" and consider differing voices. We live in a society based on a spirit of liberty. We must make public policy decisions within that spirit. III his address The Spirit of I,iberty,~ Judge I,earned H=d acknowledged the difficulty of defining the precise meaning of that term (Hand, 19603. Yet he underscored an attitude of humility with which a free people must make decisions when he said The spirit of liberty is the spirit which is not too sure that it in right; 68

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CONCLUSIONS AND }iECOMM=DATIONS the spirit of liberty is the spirit which seeks to understand the minds of other men and women; the spirit of liberty is the spirit which weighs their interests alongside its own without bias.... 69 III that context, persons with varying perspectives present their convictions on the issue of the use of animal in research. A few individual are opposed to any use of animate ~ research, while the vast majority favor their appropriate and humane use. We fee] that the majority is in fact correct. Our view is not based only on an abstract desire for the advancement of science. It also armes out of a concern for those who suffer from conditions such as Alzhenner's dmease, schizophrenia, m~ic-depressive psychoses, drug abuse, AIDS, cancer, spinal injuries, diabetes, and many other diseases that ~ a result of research might be prevented, alleviated, or cured. Animal experimentation has enormously benefited humans, as weD as animals, in the past and wiD continue to be necessary for cImica] ant] basic research in the future. Indeed, there is no reason to believe that animal experimentation will be less productive ~ the future. We are convinced that humans are morally obliged to each other to better the human condition. ~ cases in which research with animals ~ the best available method to reach that goal, animals should be used. We also believe that scientists are ethically obliged to ensure the welI-be~g of anunab in research and to m~nirruze their pain en c! suffering. RECOMMENDATIONS The committee affirms the principle of humane care of ~ ani- mals, including those used in research. The committee recornmend~ that all those responsible for the use and care of animals adhere to the principle that these animals be treated humanely. A large body of laws and regulations exists for the care and use of animals In research in the United States and internationally. In some countries, strict legislation has made it difficult to perform some research and has reduced potential contributions to human welfare through science. The committee believe it ~ necessary that laws and regulations be balanced to ensure the availability of animals so that research continues effectively. The present regulatory framework

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70 USE OF LABORATORY ANIMALS in the United States, if implemented properly, should meet current societal and ethical expectations and permit knowledge to continue to evolve with the appropriate balance between scientific and humane goals. ~ The committee recommends that no acIditional laws or regu- latory measures (excepting the regulations required by the Improved Standards for Laboratory Animals Act of 1985) affecting the use of animals In research be promulgated until, bred on experience, a careful accounting of the effects of the application of the present body of laws, regulations, and guidelines has been made and any evidence of the need for more regulation is available. When a number of new or revmed measures are introduced in a short time, it Is possible that the measures will have an untoward] effect on the performance of research using anunal~. Yet rules, once in place, are difficult if not impossible to alter. The committee believes that there must be a mechanism for ongoing review of these measures to ensure that they not only protect anneals but permit valid research to proceed. The committee calls attention to one specific case. The Guide for the Care and Use of Laboratory Animal was drafted originally as a general guide for good practices in research, animal care, and use of animals and was not meant to establish munimum standards. Subsequently, the PHS adopted the Guide as required policy for all PHS grantees. This gave the provisions of the Guide authority that had not been intended when it was drafted. ~ The comrn~ttee recommends that there be a mechanism for ongoing review of the regulatory framework of federal agencies for animal experimentation. It is essential that research scientists who must abide by this framework be prorn~nently involved in its =- ses~ment. Specifically, the Guide for the Care and Use of Laboratory Animals should be reviewed as soon as possible to determine whether revisions are necessary due to changing conditions and new informa- tion. Institutions and individual investigators are unnecessarily bur- dened and confused by the differing regulations and criteria imposed by different federal agencies. The Interagency Research Animal Com- mittee is attempting to correct this problem. Any attempt to reduce the confusion caused by the multiple authorities responsible for set- ting and enforcing regulations is useful:

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CONCLUSIONS AND RECOMMENDATIONS 71 . The committee recom~nends that federal standards developed by different agencies for the care and use of laboratory animals be congruent with each other. Intentions can be effected only if the means exist to do so. Those "means usually translate into more money. An inspection system to enhance the protection of research animate must have available to it funds to support adequate manpower and implementing structure. Yet financial support for inspection purposes has been difficult to obtain. Regulations that increase the cost of doing research for example, the replacement of small cages with larger ones are ex- pensive for research institutions. Yet funds for the rehabilitation of existing facilities, for the creation of new ones, and for compliance with new rules and regulations have decreased while the need for them has increased. It has been estimated that about $10 million annually are ret quired for the Animal and Plant Health Inspection Service (APHIS) to operate the inspection system mandated by the Animal Welfare Act and that an estimated several hundred million dollars would be required to mamtam and upgrade animal care facilities to comply with the act. The committee recognizes the fact that there is fierce compe- tition for funds for the support of research at a tune when federal expenditures for aD purposes, including research, are undergoing close scrutiny. Still, as individuals, and as a group interested in both the continuation of gratis research and the humane treatment of ani- mate used In that research, the committee ~ concerned that neither Of these awns can be reached unie" Mequate financial support is provided. The committee is also concerned that fiends not be diverted from other support of research. Additional funds, not diverted funds, are required to maintain the pace of biomedical Recoveries. The committee recoTnmends that sufficient federal funds be appropriated for the inspections required for the enforcement of the Animal Welfare Act. . The committee recommends that sufficient federal funds be appropriated for maintenance and unprovement of animal facilities to allow individuals and institutions to conduct animal research in compliance with government policies, regulations, and laws. It is important that such funds be added to ongoing research support. The committee focused on animal use in research rather than in

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72 USE OF LABORATORY AN~ALS testing or other areas. Large numbers of animals, however, are used in testing for the toxicity of substances found in consumer products such as food, drugs, and cosmetics. Such tests are prescribed by law and are intended to protect consumers. Considerable effort is being made to develop alternative testing methods. The comrn~ttee recognizes the need to protect the public health through testing. At the same time: ~ The committee recommends that federal regulatory agencies move rapidly to accept tests as such tests become validated that reduce the number of vertebrates used, insofar as this does not compromise the regulatory mission of an agency and protection of the public. In many instances a specific animal or procedure is the best or only system for performing research on a particular biological process. In some instances, though, alternative methods may be available that allow scientists to reduce the number of animals used, replace mammalian models with nonmammalian models, and refine experimental procedures to lessen any pain that animals may feel. The committee has discussed these issues in Chapter 4 and refers the reader to the National Research Council (1985b) report Modem for Biomedical Research: A New Perspective and to the Office of Technology Assessment (1986) report Alternatives to Animal Use in Research, Testing, and Education for more information. Although recognizing that in many instances no alternatives may exist: . The committee recommends that research investigators con- sider possible alternative methods before using animals in experi- mental procedures. The National Library of Medicine, the National Agricultural Li- brary, and other agencies have developed a number of databases and bibliographic resources for searching the broader sources of biological information. . The committee recommends that databases and knowledge bases be further developed and made available for those seeking appropriate experimental models for use in the design of research protocols. Much of the controversy surrounding animal experimentation is related to the use of animals from pounds. Many states and local communities have restricted the use of such animals. The effect

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CONCLUSIONS AND RECOMMENDATIONS 73 of these restrictions has been to increase the cost of research for scientists who have relied on that source of animals. Persons who object to the use of pound animals for research re- gard these animals as special because they may have been household pets. Those who believe that pound anunals may be used pout to the fact that over 10 million animus already are kiDed at pounds each year, precluding their use in adding to scientific knowledge. . The committee unanunously recommends that pound animals be made available for research in which the experunental animus are used in acute experunent~ fin which the anneals remain anesthetized until killed). While a majority of the committee supports the appro- priate use of pound animals in all experiments, a minority opposes the use of pound animate for chronic, survival experiments.

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