The Guide for the Care and Use of Laboratory Animals — almost always shortened to just “the Guide” in research-administration and IACUC circles — is a specific published document, not a generic phrase for animal-welfare best practice. It is prepared by the National Research Council’s Institute for Laboratory Animal Research (ILAR), under the National Academies’ Division on Earth and Life Studies, and published by the National Academies Press (NAP). The current edition is the 8th edition, published in 2011. It sets out the scientific and professional consensus on the humane care and use of vertebrate animals in research, teaching, and testing, and it functions as the primary reference standard that US institutions, IACUCs, and accrediting bodies actually build their animal-care programs around.
This guide covers what the Guide contains, how it becomes a binding requirement even though it is not itself a federal regulation, how it relates to the Animal Welfare Act (AWA) and IACUC review, and where research administrators typically encounter it in practice.
What the Guide is and who publishes it
The Guide traces back to 1963, when NIH first published a short set of animal-care recommendations; it has been revised and expanded through the National Research Council roughly once a decade since, with the 8th edition (2011) the current version in force. It is written by a committee of veterinary, animal-science, and research-administration experts convened by the National Academies, drawing on peer-reviewed science and professional veterinary practice rather than issued directly by a federal regulator. That distinction matters: the Guide is a consensus scientific and professional standard, and its regulatory force comes from being incorporated by reference into other frameworks (below), not from being a statute or a set of federal regulations in its own right.
The five core sections
The 8th edition is organized around five major components of an animal care and use program:
- Key concepts — the ethical and scientific principles underlying humane use, including the 3Rs (replacement, reduction, refinement), literature searches for alternatives, and humane endpoints.
- Animal care and use program — institutional roles and responsibilities, IACUC function and protocol review, occupational health and safety for personnel who work with animals, and personnel training and qualification.
- Animal environment, housing, and management — species-specific housing, environmental enrichment, husbandry, and behavioral management standards.
- Veterinary care — the attending veterinarian’s role, preventive medicine, surgery, anesthesia and analgesia, and euthanasia.
- Physical plant — facility design, construction, and environmental-control standards for animal housing and support spaces.
Because it covers program structure, veterinary care, housing, and facilities together, the Guide functions less like a single rulebook and more like the reference an IACUC, attending veterinarian, and facilities office all consult for their respective piece of an institution’s animal-care program.
How the Guide becomes a requirement, not just a recommendation
The Guide itself carries no independent legal force — it becomes binding through two separate mechanisms:
PHS Policy and OLAW. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, administered by NIH’s Office of Laboratory Animal Welfare (OLAW) under authority of the Health Research Extension Act of 1985, requires every institution that receives PHS funding (including from NIH) to file an Animal Welfare Assurance describing its animal-care program — and PHS Policy explicitly directs institutions to use the Guide as the basis for that program. In practice, this is the main channel through which the Guide reaches enforceable status: an institution’s Assurance is evaluated against Guide standards, and OLAW can act on an institution’s Assurance if the program falls short.
AAALAC accreditation. The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) is a voluntary, non-governmental accrediting body, and the Guide is its primary accreditation standard. AAALAC accreditation is not legally required, but it is widely sought by research institutions — both because many funders and journals treat it as a credibility signal and because it demonstrates a program meets Guide standards independent of the PHS Assurance process. AAALAC accredits institutions outside the US as well, which is the main route by which the Guide’s standards extend beyond US federal funding relationships.
How the Guide differs from the Animal Welfare Act
Research administrators new to this area often conflate the Guide with the Animal Welfare Act (AWA), but they are distinct instruments with different scope and different enforcement mechanisms:
- Legal status — the AWA is a federal statute (7 U.S.C. §§ 2131–2159) with implementing regulations at 9 CFR, enforced by USDA’s Animal and Plant Health Inspection Service (APHIS) through registration, licensing, and periodic inspection. The Guide is a professional/scientific reference document with no independent statutory basis.
- Species scope — the AWA statutorily excludes purpose-bred laboratory rats, mice, and birds (the large majority of animals actually used in biomedical research). The Guide’s standards apply to essentially all vertebrate species used in research, filling that coverage gap for PHS-funded work through the PHS Policy/OLAW channel above.
- Mechanism — the AWA is enforced through direct USDA inspection and can result in citations, fines, or license action. The Guide is enforced indirectly, through an institution’s PHS Assurance (OLAW) and/or its AAALAC accreditation status.
Many institutions, particularly AAALAC-accredited ones, simply adopt Guide standards as institutional policy for all vertebrate animal work and route it through IACUC review, regardless of which specific legal or accreditation mechanism technically requires it for a given species — which is why, in day-to-day practice, researchers and administrators tend to encounter Guide standards as the default rather than sorting out AWA-vs-PHS-Policy coverage protocol by protocol.
What IACUCs actually use the Guide for
An Institutional Animal Care and Use Committee (IACUC) is the committee an institution’s Animal Welfare Assurance requires it to convene, and the Guide is the standard that committee applies day to day: reviewing and approving animal-use protocols before work begins, conducting the semiannual program review and facility inspection that both PHS Policy and AWA regulations separately require, and evaluating housing, veterinary care, and personnel training against Guide benchmarks. When an AAALAC site visit occurs, it is also assessed against the Guide, so an institution’s IACUC program and its accreditation status are typically judged against the same underlying reference document even though the two processes are administratively separate.
Frequently asked questions
Is the Guide for the Care and Use of Laboratory Animals legally binding?
Not on its own. It becomes effectively binding for PHS-funded institutions because PHS Policy, administered by NIH’s OLAW, requires institutions to base their animal-care program on it as a condition of their Animal Welfare Assurance. Separately, AAALAC International uses it as its accreditation standard, which is voluntary but widely pursued.
Who publishes the Guide, and what edition is current?
The National Academies Press publishes it on behalf of the National Research Council’s Institute for Laboratory Animal Research. The current version is the 8th edition, published in 2011.
How is the Guide different from the Animal Welfare Act?
The AWA is a federal statute enforced by USDA/APHIS inspection and excludes purpose-bred rats, mice, and birds from its coverage. The Guide is a scientific/professional reference covering essentially all vertebrate research species, made binding for PHS-funded institutions through PHS Policy/OLAW rather than through USDA enforcement.
Does AAALAC accreditation use the Guide even outside the United States?
Yes. AAALAC International accredits institutions in many countries, and the Guide is its primary reference standard regardless of whether the institution receives US federal funding, which is the main way Guide standards extend beyond the US PHS-funding relationship.
What are the five main sections of the 8th edition?
Key concepts; the animal care and use program (including IACUC function and occupational health); animal environment, housing, and management; veterinary care; and physical plant.
See also: Animal Welfare Act (AWA), IACUC, and CITI Program for the training track institutions typically use to satisfy Animal Care and Use personnel-qualification requirements the Guide sets out.
