Information Resources for Institutional Animal Care and Use Committees 1985-1999 *************************

Guide for the Care and Use of Laboratory Animals

Institute of Laboratory Animal Resources
National Academy Press 1996

Facilities receiving funds from the Public Health Service, National Institutes of Health are obligated to follow the Guide for the Care and Use of Laboratory Animals. For the purposes of this publication, references and other notations have been removed. A full-text version of the Guide is available at
http://www.nap.edu/openbook.php?record_id=5140


Chapter 1

INSTITUTIONAL POLICIES AND RESPONSIBILITIES

Proper care, use, and humane treatment of animals used in research, testing, and education (referred to in this Guide as animal care and use) 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. The guidelines in this section are intended to aid in developing institutional policies governing the care and use of animals.

Each institution should establish and provide resources for an animal care and use program that is managed in accord with this Guide and in compliance with applicable federal, state, and local laws and regulations, such as the federal Animal Welfare Regulations, or AWRs (CFR 1985), and Public Health Service Policy on Humane Care and Use of Laboratory Animals, or PHS Policy (PHS 1996). To implement the recommendations in this Guide effectively, an institutional animal care and use committee (IACUC) must be established to oversee and evaluate the program.

Responsibility for directing the program is generally given either to a veterinarian with training or experience in laboratory animal science and medicine or to another qualified professional. At least one veterinarian qualified through experience or training in laboratory animal science and medicine or in the species being used must be associated with the program. The institution is responsible for maintaining records of the activities of the IACUC and for conducting an occupational health and safety program.

MONITORING THE CARE AND USE OF ANIMALS

Institutional Animal Care and Use Committee

The responsible administrative official at each institution must appoint an IACUC, also referred to as "the committee," to oversee and evaluate the institution's animal program, procedures, and facilities to ensure that they are consistent with the recommendations in this Guide, the AWRs, and the PHS Policy. It is the institution's responsibility to provide suitable orientation, background materials, access to appropriate resources, and, if necessary, specific training to assist IACUC members in understanding and evaluating issues brought before the committee.

Committee membership should include the following:


The size of the institution and the nature and extent of the research, testing, and educational programs will determine the number of members of the committee and their terms of appointment. Additional information about committee composition can be found in the PHS Policy and the AWRs.

The committee is responsible for oversight and evaluation of the animal care and use program and its components described in this Guide. Its functions include inspection of facilities; evaluation of programs and animal-activity areas; submission of reports to responsible institutional officials; review of proposed uses of animals in research, testing, or education (i.e., protocols); and establishment of a mechanism for receipt and review of concerns involving the care and use of animals at the institution.

The IACUC must meet as often as necessary to fulfill its responsibilities, but it should meet at least once every 6 months. Records of committee meetings and of results of deliberations should be maintained. The committee should review the animal-care program and inspect the animal facilities and activity areas at least once every 6 months. After review and inspection, a written report, signed by a majority of the IACUC, should be made to the responsible administrative officials of the institution on the status of the animal care and use program and other activities as stated herein and as required by federal, state, or local regulations and policies. Protocols should be reviewed in accord with the AWRs, the PHS Policy, U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and this Guide.

Animal Care and Use Protocols

The following topics should be considered in the preparation and review of animal care and use
protocols:


Occasionally, protocols include procedures that have not been previously encountered or that have the potential to cause pain or distress that cannot be reliably controlled. Such procedures might include physical restraint, multiple major survival surgery, food or fluid restriction, use of adjuvants, use of death as an end point, use of noxious stimuli, skin or corneal irritancy testing, allowance of excessive tumor burden, intracardiac or orbital-sinus blood sampling, or the use of abnormal environmental conditions. Relevant objective information regarding the procedures and the purpose of the study should be sought from the literature, veterinarians, investigators, and others knowledgeable about the effects on animals. If little is known regarding a specific procedure, limited pilot studies designed to assess the effects of the procedure on the animals, conducted under IACUC oversight, might be appropriate. General guidelines for evaluation of some of those methods are provided in this section, but they might not apply in all instances.

Physical Restraint

Physical restraint is the use of manual or mechanical means to limit some or all of an animal's normal movement for the purpose of examination, collection of samples, drug administration, therapy, or experimental manipulation. Animals are restrained for brief periods, usually minutes, in most research applications.

Animals can be physically restrained briefly either manually or with restraint devices. Restraint devices should be suitable in size, design, and operation to minimize discomfort or injury to the animal. Many dogs, nonhuman primates (e.g., Reinhardt 1991, 1995), and other animals can be trained, through use of positive reinforcement, to present limbs or remain immobile for brief procedures.

Prolonged restraint, including chairing of nonhuman primates, should be avoided unless it is essential for achieving research objectives and is approved by the IACUC. Less-restrictive systems that do not limit an animal's ability to make normal postural adjustments, such as the tether system for nonhuman primates and stanchions for farm animals, should be used when compatible with protocol objectives. When restraint devices are used, they should be
specifically designed to accomplish research goals that are impossible or impractical to accomplish by other means or to prevent injury to animals or personnel.

The following are important guidelines for restraint:


Multiple Major Surgical Procedures

Major surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic function. Multiple major survival surgical procedures on a single animal are discouraged but may be permitted if scientifically justified by the user and approved by the IACUC. For example, multiple major survival surgical procedures can be justified if they are related components of a research project, if they will conserve scarce animal resources or if they are needed for clinical reasons. If multiple major survival surgery is approved, the IACUC should pay particular attention to animal well-being through continuing evaluation of outcomes. Cost savings alone is not an adequate reason for performing multiple major survival surgical procedures (AWRs).

Food or Fluid Restriction

When experimental situations require food or fluid restriction, at least minimal quantities of food and fluid should be available to provide for development of young animals and to maintain long-term well-being of all animals. Restriction for research purposes should be scientifically justified, and a program should be established to monitor physiologic or behavioral indexes, including criteria (such as weight loss or state of hydration) for temporary or permanent removal of an animal from the experimental protocol. Restriction is typically measured as a percentage of the ad libitum or normal daily intake or as percentage change in an animal's body weight.

Precautions that should be used in cases of fluid restriction to avoid acute or chronic dehydration include daily recording of fluid intake and recording of body weight at least once a week or more often, as might be needed for small animals, such as rodents. Special attention should be given to ensuring that animals consume a suitably balanced diet because food consumption might decrease with fluid restriction. The least restriction that will achieve the scientific objective should be used. In the case of conditioned-response research protocols, use of a highly preferred food or fluid as positive reinforcement, instead of restriction, is recommended. Dietary control for husbandry or clinical purposes is addressed in Chapter 2. (Ed. Note: This is not included in this excerpted version.)

VETERINARY CARE

Adequate veterinary care must be provided, including access to all animals for evaluation of their health and well-being. Institutional mission, programmatic goals, and size of the animal program will determine the need for full-time, part-time, or consultative veterinary services. Visits by a consulting or part-time veterinarian should be at intervals appropriate to programmatic needs. For specific responsibilities of the veterinarian, see Chapter 3.

Ethical, humane, and scientific considerations sometimes require the use of sedatives, analgesics, or anesthetics in animals. An attending veterinarian (i.e., a veterinarian who has direct or delegated authority) should give research personnel advice that ensures that humane needs are met and are compatible with scientific requirements. The AWRs and PHS Policy require that the attending veterinarian have the authority to. oversee the adequacy of other aspects of animal care and use. These can include animal husbandry and nutrition, sanitation practices, zoonosis control, and hazard containment.

PERSONNEL QUALIFICATIONS AND TRAINING

AWRs and PHS Policy require institutions to ensure that people caring for or using animals are qualified to do so. The number and qualifications of personnel required to conduct and support an animal care and use program depend on several factors, including the type and size of institution, the administrative structure for providing adequate animal care, the characteristics of the physical plant, the number and species of animals maintained, and the nature of the research, testing, and educational activities.

Personnel caring for animals should be appropriately trained and the institution should provide for formal or on-the-job training to facilitate effective implementation of the program and humane care and use of animals. According to the programmatic scope, personnel will be required with expertise in other disciplines, such as animal husbandry, administration, laboratory animal medicine and pathology, occupational health and safety, behavioral management, genetic management, and various other aspects of research support.

There are a number of options for the training of technicians. Many states have colleges with accredited programs in veterinary technology (AVMA 1995); most are 2-year programs that result in associate of science degrees, and some are 4-year programs that result in bachelor of science degrees. Nondegree training, with certification programs for laboratory animal technicians and technologists, can be obtained from the American Association for Laboratory Animal Science (AALAS). There are commercially available training materials that are appropriate for self-study. Personnel using or caring for animals should also participate regularly in continuing-education activities relevant to their responsibilities. They are encouraged to be involved in local and national meetings of AALAS and other relevant professional organizations. On-the-job training should be part of every technician's job and should be supplemented with institution-sponsored discussion and training programs and with reference materials applicable to their jobs and the species with which they work. Coordinators of institutional training programs can seek assistance from the Animal Welfare Information Center (AWIC) and ILAR. The Guide to the Care and Use of Experimental Animals by the Canadian Council on Animal Care and guidelines of some other countries are valuable additions to the libraries of laboratory animal scientists.

Investigators, technical personnel, trainees, and visiting investigators who perform animal anesthesia, surgery, or other experimental manipulations must be qualified through training or experience to accomplish these tasks in a humane and scientifically acceptable manner.

OCCUPATIONAL HEALTH AND SAFETY OF PERSONNEL

An occupational health and safety program must be part of the overall animal care and use program. The program must be consistent with federal, state, and local regulations and should focus on maintaining a safe and healthy workplace. The program will depend on the facility, research activities, hazards, and animal species involved. The National Research Council publication Occupational Health and Safety in the Care and Use of Research Animals contains guidelines and references for establishing and maintaining an effective, comprehensive program. An effective program relies on strong administrative support and interactions among several institutional functions or activities, including the research program (as represented by the investigator), the animal care and use program (as represented by the veterinarian and the IACUC), the environmental health and safety program, occupational-health services, and administration (e.g., human resources, finance, and facility-maintenance personnel). Operational and day-to-day responsibility for safety in the workplace, however, resides with the laboratory or facility supervisor (e.g., principal investigator, facility director, or veterinarian) and depends on performance of safe work practices by all employees.

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Last updated February 16, 2001