PHS policy requires that each awardee institution provide a written assurance setting forth how that institution will comply with regulations. This assurance then forms the basis for the care and use of animals in research, education, and testing at that institution and is the basis for judging the adequacy of the institution's compliance with the policy. PHS policy calls for the establishment of a program for animal care and use, using the NRC guide as a basis for developing the program. Also required is the creation of an institutional animal care and use committee (IACUC), appointed by the chief executive officer of the institution. This committee must have at least five members, including at least one veterinarian experienced in laboratory animal science, one scientist, one layperson, and one person unaffiliated with the institution. PHS policy then charges this committee with oversight responsibility for: semiannual review of the program of animal care and use; semiannual inspection of facilities; review of research protocols, or proposals for the use of animals; investigation of all concerns raised by anyone regarding the humane use of animals at the institution; recommendations for personnel training; and suspension of activities deemed improper.
An institution's program for the care and use of laboratory animals encompasses institutional policies, laboratory-animal husbandry procedures, and veterinary care practices. Institutional policies address such personnel provisions as veterinary qualifications, procedures for safely handling hazardous agents, occupational health and personal hygiene including appropriate clothing and practices, and the prohibition of smoking and eating in animal rooms; special considerations are also addressed through policies, such as those concerning prolonged physical restraint of animals and multiple surgeries on a single animal. Laboratory-animal husbandry procedures include housing systems (size of cages and provision for social interaction among animals where appropriate); temperature, humidity, ventilation, lighting control, and cage and room sanitation schedules; and methods of animal identification and of clinical record keeping. Veterinary care practices include preventive-medicine strategies; methods for detecting and treating diseases; giving investigators advice about appropriate anesthesia, analgesia, and surgical and postoperative care; and methods of euthanasia.
Facility inspection covers not only visiting the physical plant but also assessing the health of the animals and reviewing portions of the institutional program for animal care. The physical plant should be properly constructed to house the species being used and to permit sterile surgery to be performed, if necessary.
PHS policy sets forth several criteria to be followed by the IACUC in reviewing protocols. These criteria go beyond mere care and housing guidelines. The care and use of animals in proposed research must be consistent with the NRC guide, unless acceptable scientific justification is provided for any deviation. The investigator must explain the rationale for using animals at all in the proposed research as well as the appropriateness of the species to be used, the number of animals, and their proposed use. PHS policy stipulates requirements for the use of sedatives, analgesics, and anesthetics if the proposed procedure might cause more than slight pain or distress; it also requires prompt euthanasia at the end of (or, when appropriate, during) a procedure for "animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved" and imposes methods of euthanasia consistent with American Veterinary Medical Association (AVMA) guidelines. All personnel involved in the use of animals in research must be appropriately trained and qualified in the procedures to be employed in the experiment.
Each IACUC must have procedures for investigating concerns raised about the care and use of animals at the institution. In addition, the IACUC must ensure that the institution has a training program for both animal-care staff (people actually caring for the animals) and research staff; videotapes and training handbooks may be used to satisfy this requirement. The final charge—the power to suspend an improperly conducted activity—must come from an official of the institution such as the chief executive officer or the vice president. Without this official support, the IACUC cannot fulfill its duty to ensure compliance with PHS policy.
Several features of PHS policy are of special importance. While its legal force is restricted to awardee institutions, its scope includes all live vertebrates. It was the first U.S. law to call for a consideration of animal welfare during a procedure and to call for the establishment of a committee to review protocols for the appropriateness of design, the importance of knowledge sought (as set forth in the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training," published in both the PHS policy and the NRC guide), and the competency of personnel. Thus, through PHS policy, committees have been created to review the use of animals in research, much like the committees that review the participation of humans in research.
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