Humane Care and Use of Laboratory Animals
The American Association for Laboratory Animal Science (AALAS) endorses the United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and requires that all papers published in Comparative Medicine and the Journal of the Association for Laboratory Animal Science report research conducted in conformance with these principles. Research for papers submitted from outside the United States must be in conformance with the guidelines of that country's government. The editor reserves the right to reject papers reporting results of research not adhering to these principles.
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
[(Promulgated by the U.S. Interagency Research Animal Committee (1)]
For guidance throughout these principles please refer to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Research Council.
1. Published in the Federal Register, May 20, 1985, vo. 50, no. 97, by the Office of Science and Technology Policy.
Alleviating Pain and Distress in Laboratory Animals
The American Association for Laboratory Animal Science (AALAS) endorses the United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, which call for the avoidance or minimization of discomfort, distress and pain during these procedures. AALAS recognizes that the use of animals in research and teaching often creates a highly emotional debate with contradictory opinions within the public at large. Given that the advancement of scientific knowledge, particularly in the biomedical field, has been made possible by animal-based research(1), AALAS supports live animal research when it is performed in an ethical and humane manner. That is, anyone working with laboratory animals has the moral obligation to explore, consider, and implement any means for avoidance and minimization of pain and distress in laboratory animals, whenever possible.
Ensuring that the care and use of animals for research is conducted in a humane and ethical manner is a fundamental function of the Institutional Animal Care and Use Committees (IACUC). The Animal Welfare Act mandates that IACUCs oversee the care and use of animals covered by the Act(2). The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals(3) adopts a similar position. IACUCs are composed of scientists, veterinarians, a non-scientist, and at least one member not affiliated with the particular institution, often called a “community member.” The IACUC must review and approve any research protocol that proposes to use live, vertebrate animals in research, teaching, and testing. During the review, the committee must determine if (1) the proposed animal use is essential for achieving relevant scientific goals, (2) an appropriate species has been selected, (3) the number of animals requested is properly justified, (4) the care of the animals is appropriate, (5) the provisions for alleviating pain and distress are appropriate, and (6) alternatives to procedures that might cause pain or distress have been considered.
Institutions may use additional measures to ensure the responsible use of animals for research in their facilities by voluntarily participating in the assessment process for accreditation by the Association for Accreditation and Assessment of Laboratory Animal Care (AAALAC). AAALAC provides effective and comprehensive guidance, assessment, and monitoring to assure the highest standards of humane animal care and use.
Defining Pain and Distress
Pain is an unpleasant sensation that is highly subjective. The most widely accepted definition of pain is from The International Association for the Study of Pain, as follows: “An unpleasant sensory and emotional experience arising from actual or potential tissue damage or described in terms of such damage.”
Distress is more difficult to define, so its meaning is often described in the context of stress. In medicine, stress is a physical or psychological stimulus that can produce mental or physiological reactions. If these stimuli are strong enough and/or sustained over a period of time, stress leads to distress, the interruption of normal physiological functions, and, eventually, to illness. Distress has the potential to threaten an animal’s welfare(4).
AALAS Positions on Pain and Distress
The Scientific Basis for Regulation of Animal Care and Use
The care and use of laboratory animals in biomedical research and testing is highly regulated. Regulation, together with effective voluntary programs such as AAALAC accreditation, improves the health and welfare of laboratory animals and reassures the public of their humane care and use. Animal-directed standards have evolved from four primary sources.
Regulations based on empirical judgments lacking scientific confirmation can lead to variable interpretation or misinterpretation and detrimental conflict between regulators and scientists. Furthermore, empirically-based regulation can impede biomedical research and make it more costly. Because advancing and promoting information on the optimal conditions for maintaining species-specific laboratory animal health and welfare is integral to the AALAS mission, AALAS encourages the development of mandates that are based on scientific and ethical principles and are conducive to the species-specific health and well-being of laboratory animals.
Performance-Based Criteria as the Basis for Determining Laboratory Animal Housing Standards
The American Association for Laboratory Animal Science (AALAS) endorses the use of performance based criteria as the main determinant in establishing the standards of housing for animals housed within the research environment.
AALAS is an organization, formed in the early 1950’s, whose members provide the care of laboratory animals in the research environment, oversee the use of those animals in research, and perform a myriad of other duties associated with the animal care and use program of any institution, whether it be academic, pharmaceutical, contract, or government. Indeed, the members of AALAS have been intimately involved in the formulation of the initial and each succeeding edition of the Guide for the Care and Use of Laboratory Animals (The Guide).
Designing animal facilities that provide the basic needs of shelter, food, water, and a degree of environmental stability has long been appreciated. It is recognized that science has an ethical responsibility to house animals according to their species-specific needs. (1)
In the Introduction of the current Guide, it charges users of research animals with the responsibility for achieving specified outcomes but leaves it up to the individual institution as to the method of achieving that outcome. “This ‘performance’ approach is desirable because many variables (such as the species and previous history of the animals, facilities, expertise of the people, and research goals) often make prescriptive (‘engineering’) approaches impractical and unwarranted. Engineering standards are sometimes useful to establish a baseline, but they do not specify the goal or outcome (such as well-being, sanitation, or personnel safety) in terms of measurable criteria as do performance standards”.(2)
The Guide states “Proper housing and management of animal facilities are essential to animal well-being, to the quality of research data and teaching or testing programs in which animals are used, and to the health and safety of personnel. A good management program provides the environment, housing, and care that permit animals to grow, mature, reproduce, and maintain good health; provides for their well-being; and minimizes variations that can affect research results. Specific operating practices depend on many factors that are peculiar to individual institutions and situations”. (3)
Performance criteria use the professional input and judgment of the laboratory animal veterinarians and the animal care staff – those individuals with the most intimate knowledge of the needs of the animals within their care. The performance approach defines an outcome in detail and provides the criteria for assessing that outcome. This approach does not limit the methods by which the outcome is achieved.
All of these statements are even more applicable in today’s constantly changing research environment.
AALAS applauds the belief that the recommendations of The Guide should be based on published data, scientific principles, expert opinion, and experience with the methods and practices that have proved to be consistent with high-quality, humane animal care and use. When published scientific data are not available, recommendations in The Guide that are based on expert opinion and experience should be those opinions and experience that are widely accepted by the laboratory animal use community as beneficial to the humane care and use of those animals.
The performance approach defines an outcome in detail and provides the criteria for assessing that outcome. This approach does not limit the methods by which the outcome is achieved.
Species-adequate housing conditions are not only a safeguard for the wellbeing of the animals, but they also are a prerequisite for sound scientific methodology. Inadequacy of animal care (housing) can skew scientific findings and render the particular research useless. “Good husbandry minimizes variations that can modify an animal’s response to experimentation”. (4)
Cage size itself is so variable in studies of environmental effects on animal well-being that comparisons involving other factors can be clouded. For example, the standard cage sizes most commonly used for rodent housing in the United States do not match the standard rodent cage sizes in Europe.(5). The additional space is intended to allow for the addition of structural elements to enable animals to express their typical behaviors, which may help to minimize stress. In contrast to these European regulations, recent publications from groups in the United States suggest that less space might be beneficial for mice.
While engineering criteria may also use the professional input and judgment of laboratory animal veterinarians and the animal husbandry staff, the reference point provided by engineering criteria should only provide guidance especially if there is minimal evidence to support a single reference value or when there is not sufficient data to support it application across all strains and across all situations in individual research facilities. A strict engineering approach does not provide for interpretation or modification in the event that acceptable alternatives are available or unusual circumstances arise. Flexibility around the reference point is essential to allow for these potential alternative approaches and should be based on the professional judgment of those charged with providing optimal housing for the animals, the facility veterinarians, the husbandry staff, and the institutional animal care and use committee.
The creation of engineering criteria for each species of animals used or that could be potentially used in a research environment would be a daunting if not an impossible task. Coupled with this seemingly limitless list of potential species that would merit consideration is the unique environment of each institution conducting research and the unique requirements of each individual research project. Dealing with the uniqueness of institutions and of individual research projects is the responsibility of the institutional animal care and use program as described in Chapter 1 of The Guide: “Proper care, use, and humane treatment of animals used in research, testing, and education require scientific and professional judgment based on knowledge of the needs of the animals and the special requirements of the research, testing, and educational programs”.(6)
Standards for Assessing the Quality of Laboratory Rodents
Laboratory animals are essential for conducting biomedical research world-wide. As most animals used for biomedical research are mice and rats, the quality of laboratory rodents has a major influence on research results and ultimately on human health. Standards for the health care and genetic backgrounds of laboratory rodents have improved greatly, but new challenges will arise due to the accelerating development of diverse populations of genetically engineered animals. The use of genetically engineered rodents has increased significantly among major research centers in many countries, and this trend is likely to continue since the complete decoding of the human and rodent genomes. Further, laboratory exchanges of rodents and rodent products are expanding with the increase in inter-institutional collaborations related to animal experimentation. The rigorous assessment and reporting of the genetic and health status of genetically engineered rodents are critical for producing accurate research results.
AALAS encourages and supports the establishment of international standards for monitoring and maintaining the quality of rodents and rodent products, so as to strengthen and protect this crucial investment in animal-based research.
Health Care for Genetically Altered Rodents
The health quality of laboratory mice and other rodents has improved significantly due, in large part, to improved surveillance programs and housing. Further, as the use of laboratory rodents in biomedical research has increased, largely for transgenic and gene targeting studies, genetically-modified rodent substrains have assumed great value. These animals often are less robust, typically with a reduced reproductive efficiency and/or lowered disease resistance, and they may pose a challenge for both disease recognition and a correct phenotypic assessment in the presence of an infection. Maintaining these animals in optimal health is critical to meet the growing demands of cutting edge biomedical research.
Principles for Maintaining the Health Care of Genetically Altered Rodents
Infrastructural Support for Animal-Based Research
The infrastructural needs of animal-based research are likely to differ significantly as the future unfolds. Laboratory animal science and medicine have benefited from the great improvements in the microbiological quality and health of laboratory animals. The use of high quality laboratory animals demands state-of the-art infrastructural support in accordance with advancements in techniques involving animal production and maintenance.
Animal-based infrastructure is costly in terms of physical, personnel, and financial resources. Changing scientific needs, increasing populations of novel animals, new systems for housing and husbandry, and occupational health concerns necessitate an expanding knowledge of new developments in the operational and physical infrastructure technologies required to protect the quality and well-being of laboratory animals.
AALAS believes that the evolving and sophisticated use of laboratory animals must be complemented by new strategies and support in the design, development, and delivery of infrastructure to meet the needs of animal-based biomedical research.
Use of Animals in Precollege Education
This position statement presents guidelines and resources for the humane care and responsible use of animals in precollege education. This document also offers recommendations on classroom dissection and on the use of animals in science fair projects.
The American Association for Laboratory Animal Science (AALAS) recognizes that the appropriate and humane use of animals in the elementary and secondary classrooms can provide significant educational benefits to the students, and that a positive interaction between students and animals in the classroom enhances not only scientific learning but also provides an additional avenue promoting the development and growth of the students’ sense of responsibility and respect for all living things.
As part of its broader educational mission to ensure that all animal use is performed responsibly and humanely, AALAS has developed a series of species-specific informational pamphlets about species commonly found in classrooms settings such as mice, rats, hamsters, guinea pigs, rabbits, reptiles, and amphibians. These pamphlets can be found on the AALAS web site. Additionally, AALAS recognizes that other organizations have developed similar guidelines and recommends that teachers and educators familiarize themselves with these documents. These guidelines are:
Although developed by different organizations, the five documents above have a lot in common and are in harmony with each other. The ILAR principles are listed below with additional comments that suggest practical approaches to educators who want to ensure the ethical and humane treatment of animals in their classrooms.
Principles and Guidelines for the Use of Animals in Precollege Education
AALAS recommends three reference documents that provide information about the composition and function of an animal care and use committee and that can be used as a basis for review and approval of animals in the classroom. These are:
Recommendation on Classroom Dissection
Classroom dissection of nonhuman vertebrate animals is a useful adjunct to the biology curriculum if done with well-defined educational objectives and an appropriateness for the grade level and maturity of the students.
The animal used should represent the lowest phylogenic species that will satisfy educational objectives.
The dissection activity must be well supervised to ensure that:
Alternatives to animal dissection should be used whenever they would adequately serve as substitutes. Students’ views on dissection should be openly discussed and respected with non-dissection alternatives made available when feasible and the student allowed to opt out of the dissection if no alternative is possible.
Recommendation on the Use of Animals in Science Fair Projects
The use of nonhuman vertebrate animals in science fairs is a privilege and should adhere to the same high standards that are used in the scientific community to ensure the welfare of both the animals and the student.
All animals used must be treated humanely and cared for properly at all times:
Teachers and students who will handle or care for the animals should be trained in proper methods and techniques so as not to cause harm or stress to the animals, themselves, or others.
Except for observational studies, all research involving vertebrate animals should be directly supervised by the teacher or other professional.
In addition, AALAS recommends that individuals involved in science fairs familiarize themselves with the International Rules for Precollege Science Research: Guidelines for Science and Engineering Fairs published by Science Service, Washington, DC (http://www.societyforscience.org/document.doc?id=398). These rules govern all science fair projects at the Intel International Science and Engineering Fair (ISEF) and all affiliated fairs and are a detailed extension of the ILAR Guidelines. Strict adherence to the rules and guidelines governing the use of non-human vertebrate animals in this document is recommended.
Animal Rights Terrorism
The American Association for Laboratory Animal Science (AALAS) is dedicated to advancing responsible laboratory animal care and use for the scientific and medical benefit of both people and animals. AALAS and its members willingly join with other groups and individuals concerned about animal welfare to publicly condemn any violence, threats, and harassment to, and intimidation of individuals and businesses involved in the research process. AALAS believes that ethical and humane conduct of animal-based research has contributed, and will continue to contribute, to the advancement of science and medicine.
Acts of terrorism do not result in improvements in animal welfare. Progress comes only from thoughtful discussion and scientific assessment of alternative methods that refine the animal research process–efforts that AALAS itself fosters through educational and scientific programs. Terrorism in the name of “animal rights” jeopardizes the lives of people and animals–in the present by the violence itself, and in the future by hindering the progress of ethical animal-based research designed to find cures and treatments for diseases that affect humans and animals. The AALAS membership extends heartfelt support to our scientific colleagues and their families who have been affected by threats and acts of violence.