PRINCIPLES FOR THE UTILIZATION AND CARE OF VERTEBRATE ANIMALS USED IN TESTING, RESEARCH, AND EDUCATION

U.S. Interagency Research Animal Committee

1985

Developed in 1984 by the U.S. Interagency Research Animal Committee, which serves as a focal point for the discussion by federal agencies of issues involving the use of animals in research and testing, these principles are based on the CIOMS Guiding Principles. The U.S. principles are endorsed, implemented, and supplemented by the National Institutes of Health's Public Health Service Policy on Humane Care and Use of Laboratory Animals, which was revised in 1986, and the Guide for the Care and Use of Laboratory Animals, prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences, in 1985. The Public Health Service (PHS) policy applies to all PHS researchers, grantees, and contractors who use warm-blooded vertebrates in research and testing. The policy requires compliance with the Animal Welfare Act (AWA) (7 U.S.C. 2131 et seq.) and the USDA regulations that implement it (9 CFR, Subchapter A—Animal Welfare).

The AWA was originally enacted in 1966 to impose civil and criminal penalties on persons who stole household pets and sold them to biomedical research facilities. It has been amended many times to provide additional protections for warm-blooded animals used in agriculture, the food and fiber industry, circuses, pet shops, and research. In 1985, the AWA was amended by P.L. 99–198 to require, among other provisions, the establishment of Animal Care and Use Committees to oversee animal housing and care and to review proposed research. Both the USDA regulations implementing the act and the PHS policy reference the Guide for the Care and Use of Laboratory Animals as the standard according to which programs for the care and use of laboratory animals will be judged.

The AWA and its accompanying regulations and the correlative Public Health Service Act and its accompanying PHS policy together with the guide constitute the fundamental documents that govern the care and use of animals used for research, testing, and teaching in the United States. Additionally, the Food and Drug Administration's Good Laboratory Practices regulations include similar provisions for the care and use of animals in testing sites used by the industry.

The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered to:

1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7U.S.C. 2131 et seq.) and other applicable Federal laws, guidelines and policies.
2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
9. Where exceptions are required in relation to the provision of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal research committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.