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Laws and Regulations

The US Animal Welfare Act (AWA) and Regulations, the Health Research Extension Act of 1985, and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals mandate high-quality care, housing and veterinary care for research animals. They require that all research proposals using animals are reviewed and approved by an institutional animal care and use committee (IACUC); that all animals are provided with adequate food, water, living conditions, environmental enrichment, and veterinary attention; that all personnel working with animals are trained; that pain and distress are minimized; and appropriate analgesics and anesthesia are used when necessary.

Researchers are deeply concerned about the condition of the animals they study. Poor care results in unreliable research data. Pain and distress are thought to have a negative effect on the immune system; therefore, researchers are careful to protect the animals from undue pain and stress. It is well recognized that animals have been indispensable to medical and scientific research. We have a moral duty to provide them the best care and treatment possible.

 

The Animal Welfare Act (AWA) and Regulations:

The Animal Welfare Act (AWA) was passed by the US Congress in 1966 and has been updated many times since. Most research institutions that use laboratory animals must abide by these laws and regulations. It requires all research facilities using protected species to register with the USDA and have an Institutional Animal Care and Use Committee (IACUC) to review research protocols (see below for IACUC information). The law also established an information center where researchers can review a database of alternatives to animal experiments.

Inspectors from the US Department of Agriculture (USDA) are responsible for inspecting the research facilities and enforcing the Animal Welfare Act. They visit research institutions at least once a year. The inspectors show up unannounced and inspect the buildings, the animal housing facilities, and the protocols and records kept on each animal and experiment. Violations can be punished with fines, cease-and-desist orders, and/or license suspension or revocation.

 

Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals:

The Health Research Extension Act of 1985 requires all research facilities that receive federal funding, which includes most universities and colleges that use animals in research, adhere to another federal standard called the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. The PHS Policy is based on the Health Research Extension Act, and it covers the use of all vertebrate animals used in research. The policy requires institutions to maintain an IACUC, and to report whether or not they have received AAALAC accreditation (see below for AAALAC information). The PHS Policy requires institutions to comply with the Guide for the Care and Use of Laboratory Animals.

 

Guide for the Care and Use of Laboratory Animals:

The Guide for the Care and Use of Laboratory Animals gives expert advice on how to care for various species of animals. The Guide sets the framework for the humane care and use of laboratory animals. It gives advice on the animal's environment, husbandry, and management as well as appropriate veterinary care. The Guide provides guidelines for designing and operating an animal care program that meets, and sometimes exceeds, the requirements of the Animal Welfare Act (AWA) and the Public Health Service (PHS) Policy.

Violations of the Guide result in the loss of AAALAC accreditation and can seriously jeopardize an institution's federal funding from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Disease Control (CDC).

 

Institutional Animal Care and Use Committee (IACUC):

All research institutions are required to have an Institutional Animal Care and Use Committee (IACUC) that is responsible for monitoring and evaluating the entire animal care program.  They also approve and review research protocols for all experiments involving animals. They ensure that proper anesthesia and medications are used when appropriate and that alternatives to animals are used whenever possible. They must inspect the research facilities twice a year to make sure federal policies are being followed. The Office of Laboratory Animal Welfare at the National Institutes of Health provides guidelines to help facilities maintain an effective IACUC.

The IACUC must include a veterinarian and a member that is not affiliated with the research institution. All research involving animals must be proposed to the IACUC in writing and it must include the number of animals to be used, a justification as to why that species is necessary, and what steps will be taken to prevent unnecessary pain to the animals. The IACUC can reject any proposal, recommend changes, or stop any current research if the IACUC believes the animal welfare standards are not being met.

Note: The Animal Welfare Act (AWA) requires a minimum of 3 members. The Public Health Service (PHS) Policy requires a minimum of 5 members on the IACUC and includes the requirement of including a scientist and a nonscientist. Typically, the actual number of IACUC members corresponds with the size of the institution. A large academic or pharmaceutical company may have over 20 IACUC members, while a small biotech company or a small college may only have 5.

 

Research Protocols (reviewed by the IACUC) must include a justification for using animals, the chosen species, and the number of animals to be used; an explanation of methods/sources used to search for alternatives to animals; the procedures/drugs to be used to eliminate pain and distress; and an explanation of the search process used to make sure the experiment is not unnecessarily duplicating previous research.

 

Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC):

Most institutions also voluntarily have their programs assessed and accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). AAALAC is a nonprofit organization that was founded in 1965 to advance uniform standards for animal care in US labs. Institutions that meet or exceed state and federal standards are given accreditation by AAALAC. Institutions with AAALAC accreditation are known for their exceptional commitment to humane animal care and full compliance with the Guide for the Care and Use of Laboratory Animals.

 

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training:

US Government agencies that develop requirements for testing, research, or training procedures involving the use of vertebrate animals must adhere to these principles. When government agencies sponsor (give out grants) or perform these testing, research, or training procedures they must also adhere to these principles. These principles were incorporated into the Public Health Service (PHS) Policy which is required for all research institutions that receive federal funding.

 

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PSBR Statement on the Transportation of Animals for Research

The Pennsylvania Society for Biomedical Research (PSBR) is a 501 (c)(3) non-profit science education organization formed by universities, medical schools, pharmaceutical firms and professional societies in Pennsylvania.  Our members and supporters include leading biomedical research and educational institutions, professional societies, and hospitals within the Pennsylvania, Delaware, West Virginia, Maryland and Northern Virginia area.

PSBR’s mission is to promote a better public understanding of the value of animal-based biomedical research and the vital role of the responsible use of animals in improving the quality of human and animal health.  PSBR’s programs support education as a means of establishing and maintaining a knowledgeable public that supports medical research including the responsible use of animals in this research. 

Animal research yields medical discoveries which saves countless lives for both humans and animals. Effective research depends on a reliable source of healthy laboratory animals.  The ability to transport laboratory animals from licensed commercial breeders and between research facilities, prevents each research site from breeding their own animals, thus preventing increased cost and an unnecessary increase in the number of animals for research.

The safe and reliable transportation of live research animals is of absolute importance to the biomedical research arena. The Pennsylvania Society for Biomedical Research fully supports the professional organizations working to provide this vital service as partners in the future of biomedical advancement.

 

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