Public Health Service (PHS) Policy (also known as NIH Policy) applies to all live vertebrate animals, including mammals, amphibians, reptiles, fish, and birds used or intended for use in PHS supported research. Each institution receiving PHS funding is required to file an Animal Welfare Assurance Statement to the Office of Laboratory Animal Welfare (OLAW) and the National Institute of Health (NIH) for approval. The Assurance Statement indicates that the institution is committed to compliance with standards detailed in the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, and all other applicable laws and regulations. The Assurance Statement must describe the institution’s program for care and use of all animals used in research, research training, and biological testing. It must also explain in detail the training available to scientists, technicians, and other personnel involved in animal care, treatment, or use.
Each awardee institution is subject to review (including unannounced site visits) at any time by PHS staff to assess the accuracy of the institution’s compliance statement. Failure to comply with PHS Policy can lead to various actions, including the termination of PHS service for all projects involving animals.
As an example, an unannounced NIH site visit to a major university research center in 1986 resulted in suspension of funding for all animal research except that involving rodents and blocked future funding for all research involving animals. Problems identified included ineffective administrative organization and management of the animal use program, inadequate review of animal use procedures, substandard housing and sanitation in animal facilities, poor record keeping and occupational health programs, insufficient personnel training, inadequate provision of veterinary care, and deficiencies in supervision of anesthesia, analgesia, surgery, and postoperative care.
Although this institution was able to correct their program deficiencies and submit Assurance Statements that allowed research to resume, such examples emphasize that insufficient attention to animal care programs can have severe consequences, and that grantee institutions must abide by existing guidelines.