Developing guidelines on the care and use of animals.

Oversight of laboratory animal care and use in the research environment is multilayered. Federal and state regulations apply to many laboratory animal species; funding agencies frequently require adherence to additional guidelines; institutions may develop in-house policies; and an institution may choose to voluntarily participate in an accreditation program, indicating a commitment by the institution to apply the most rigorous standards to the animal care and use program. In general, regulations follow a prescriptive "engineering" approach, while guidelines applied to the care and use of research animals follow a "performance" approach, which defines the desired outcome in detail, but acknowledges that multiple methods may achieve that outcome. The performance approach relies on sound professional judgment, thereby allowing flexibility based on an institution's unique circumstances. Further, this approach should facilitate the international harmonization of animal care and use standards. The performance, or outcome, approach to developing guidelines is described, using the Guide for the Care and Use of Laboratory Animals (NRC, 1996) as the model.