ABSTRACT

This chapter presents four areas of an animal use program for which specific documentation is necessary: the Institutional Animal Care and Use Committee/Oversite Body (IACUC/OB), the animal resources and facility operations, good laboratory practice (GLP), and select agents. In the United States, the Animal Welfare Act (AWA) and Animal Welfare Act and Regulations (AWAR) provide standards for ensuring the humane care and use of certain animal species in research facilities. Animal use protocol review is an important aspect of every animal care and use program in research and represents the initial step toward obtaining approval for conducting animal-based research. Not uncommonly, special considerations will arise during protocol review, and these should be considered carefully by the IACUC/OB because of their potential for causing unrelieved pain or distress, or other animal welfare concerns. The availability of electronic protocol review systems has greatly reduced the need to use paper protocols at many institutions.