Regulation of Animal Research in the U.S.

The Animal WelfareAct (AWA) regulates the use of animals in research, teaching, and testing, with the notable exception of rats and mice specially bred for research. The US Department of Agriculture oversees AWA enforcement through its Animal and Plant Health Inspection Service (APHIS). The major species regulated by the USDA include guinea pigs, rabbits, hamsters, cats, dogs, non-human primates, and farm animals used in medical research. The AWA regulations apply to regulated animals regardless of who provides financial support for the research.

However, that is not the end of the oversight story. In order to be eligible for federal funds, a research institution must agree to abide by animal welfare rules that apply to all vertebrate species, including rats and mice. The research must be conducted within the framework of the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training and must comply with the requirements of the well-respected Guidefor the Care and Use of Laboratory Animals. The National Academy of Sciences’ Institute for Laboratory Animal Research (ILAR) publishes the Guide and periodically brings in animal care experts to review and update its recommendations.

Both the AWA and the ILAR Guide require that research proposals pass through an ethical review committee known as an Institutional Animal Care and Use Committee or “IACUC.” The IACUC determines whether the use of animals is necessary to the research and makes certain that the researcher will do everything possible to minimize the animals’ pain and distress.

Universities, medical schools, and independent institutions conduct much of the medical and biological research in this country, and a significant amount of that research is funded by the National Institutes of Health (NIH). In order to receive NIH funds, institutions must agree to follow the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. This includes providing an Assurance to The NIH Office of Laboratory Animal Welfare (OLAW) that the institution has an animal care and use program that can provide for the welfare of all its research animals. This Assurance is a legal requirement for the institution to receive federal funds, and if it is withdrawn, the funding will be halted.

There is also a third major oversight body, namely the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC), International. AAALAC is a nongovernmental organization that provides independent, voluntary accreditation of animal care programs in industry, academia, and government. To earn AAALAC accreditation, a research institution must demonstrate that its animal care and use program for all vertebrate animals (including rats and mice) meets the standards set forth in the ILAR Guide. AAALAC accreditation is broadly accepted in both the pharmaceutical industry and academic research institutions as a mark of excellence in animal care.