REGULATIONS, POLICIES, AND PRINCIPLES

The use of laboratory animals is governed by an interrelated, dynamic system of regulations, policies, guidelines, and procedures. The Guide takes into consideration regulatory requirements relevant to many US-based activities, including the Animal Welfare Regulations (USDA 1985; US Code, 42 USC § 289d) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS 2002). The use of the Guide by non-US entities also presumes adherence to all regulations relevant to the humane care and use of laboratory animals applicable in those locations. The Guide also takes into account the U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (IRAC 1985; see Appendix B) and endorses the following principles:

  • consideration of alternatives (in vitro systems, computer simulations, and/or mathematical models) to reduce or replace the use of animals

  • design and performance of procedures on the basis of relevance to human or animal health, advancement of knowledge, or the good of society

  • use of appropriate species, quality, and number of animals

  • avoidance or minimization of discomfort, distress, and pain

  • use of appropriate sedation, analgesia, and anesthesia

  • establishment of humane endpoints

  • provision of adequate veterinary care

  • provision of appropriate animal transportation and husbandry directed and performed by qualified persons

  • conduct of experimentation on living animals exclusively by and/or under the close supervision of qualified and experienced personnel.

Interpretation and application of these principles and the Guide require knowledge, expertise, experience, and professional judgment. Programs should be operated in accord with the Guide and relevant regulations, policies, and principles. Also, institutions are encouraged to establish and periodically review written procedures to ensure consistent application of Guide standards. Supplemental information on various aspects of animal care and use is available in other publications prepared by the Institute for Laboratory Animal Research (ILAR) and other organizations (Appendix A). References in the Guide provide the reader with additional information that supports statements made in the Guide. In the absence of published literature, some information in the Guide is derived from currently accepted practice standards in laboratory animal science (see Chapter 1). The body



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