ABSTRACT

This chapter briefly describes some of the ethical issues involved in animal research and to summarize the current regulatory standards under which biomedical research using animals, including orthopaedic research, is conducted. The Public Health Service Policy on Humane Care and Use of Laboratory Animals of 1986 was published by the Public Health Service to implement The Health Research Extension Act of 1985. The United States Department of Agriculture regulations require veterinary consultation during protocol planning for any procedures that may cause more than momentary or slight pain or distress. Animal facility design must assure separation of species or test systems, separate individual projects, provide for quarantine of animals, and accommodate routine or specialized housing. Standard operating procedures must be in place to assure the quality and integrity of the data collected during the course of a study, and any deviation from the written protocol must be documented as part of the raw data.