How Animal Research is Regulated in the U.S.

Humane treatment of animals is the foundation for good science as well as a legal and ethical imperative. The U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training provide an ethical framework that underlies all U.S. laws governing the treatment of animals. In addition, many institutions participate in a private program for accreditation of animal care programs.

Animal Welfare Act

 

The Animal Welfare Act (AWA) regulates the use of most warm-blooded vertebrates in research, teaching and testing. This includes guinea pigs, rabbits, hamsters, cats, dogs, non-human primates and farm animals when used in medical research. Rats, mice and birds that were bred for research are excluded from the AWA. However, most are covered either under the PHS Policy or through AAALAC, International accreditation. (See below.) The U.S. Department of Agriculture enforces the AWA.

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

Institutions that seek funds from federal agencies for research with any vertebrate animals must follow the PHS Policy on Humane Care and Use of Laboratory Animals. This applies to all the animals covered under the AWA as well as purpose-bred rats, mice and birds and cold-blooded vertebrates such as fish and reptiles. To qualify for federal funding, institutions must follow the Guide for the Care and Use of Laboratory Animals and provide an Assurance document describing their program for the care and oversight of research animals. NIH’s Office of Laboratory Animal Welfare (OLAW) enforces the PHS Policy.

Institutional Animal Care and Use Committees

The AWA and the PHS Policy both require that proposals for research involving animals must be reviewed and approved in advance by an Institutional Animal Care and Use Committee (IACUC). This is composed scientists, at least one veterinarian and someone who is unaffiliated with the institution. It determines whether or not the use of animals is necessary and makes certain that researchers have made appropriate plans to minimize the animals’ pain and distress. IACUCs must approve of a study before it can begin and they have the authority to halt ongoing research if they find it no longer in compliance.

AAALAC, International

AAALAC, International, is a private organization that provides independent, voluntary accreditation for animal care programs in industry, academia, and government. To earn AAALAC accreditation, institutions must demonstrate that they have a rigorous care and use program for all vertebrate animals that meets the standards set forth in the ILAR Guide. AAALAC accreditation is broadly accepted in industry and academia as an indicator of excellence in animal care.

Government and Other Oversight Resources