Public Health Service Policy on Humane Care and Use of Laboratory Animals

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals incorporates the changes in the Public Health Service Act (PHS Act) mandated by the Health Research Extension Act of 1985, Public Law 99-158, November 20, 1985. The PHS Policy, frequently referred to as the NIH Policy, requires each institution receiving PHS funds for research involving animals to submit detailed information regarding the institution’s program for the care and use of animals (including farm animals, mice, and rats) to the Office of Laboratory Animal Welfare (OLAW). This information is in the form of an Animal Welfare Assurance Statement that must be resubmitted at least every four years. Significant changes in existing assurance status or problems encountered in implementing this policy must be reported immediately to the OLAW.

Institutions are required to identify an institutional official who is ultimately responsible for the institution’s program for the care and use of animals and a veterinarian qualified in laboratory animal medicine who will participate in the program. At the University of Nebraska-Lincoln, the Associate Vice Chancellor for Research is the designated institutional official, and the attending veterinarian is director of the Institutional Animal Care Program (IACP). Each institution is also required to designate clear lines of authority and responsibility for those involved in animal care and use in university activities.

The policy clearly defines the role and responsibilities of the institutional animal care and use committees. The committee must be composed of at least five members and include an individual unaffiliated with the institution; a veterinarian who has program responsibilities along with training or experience in laboratory animal science and medicine; a practicing scientist experienced in research involving animals; and a member whose concerns are in a nonscientific area. (USDA requires at least a three-member committee: a veterinarian, a person unaffiliated with the institution other than by his/her committee membership, and one other member.)

The policy requires institutional animal care and use committees to review and approve those sections of PHS grant applications relating to the care and use of animals before merit reviews by the PHS will be conducted. The committee is also required to conduct semiannual assessments of the institutions program based on the Guide for the Care and Use of Laboratory Animals. Significant deficiencies in the institution’s program must be identified by the committee, and the institution must adhere to an approved plan and schedule for correction of those deficiencies.

An institution’s failure to comply with these policies may lead to various actions including termination of PHS support for all projects involving animals at the institution.