Animal research is as carefully regulated as human research, but for different reasons. With humans, regulation stems from the need to assure that the benefits all humans gain from human research do not impose unacceptable burdens on some research participants. Animals may benefit from the information gained through animal experimentation and some research with animals is conducted specifically for the purpose of improving animal health (veterinary medicine and animal husbandry research). But most animal research is conducted primarily for the benefit of humans, not animals. Moreover, unlike humans, animals cannot consent to participate in experiments or comment on their treatment, creating special needs that should be taken into consideration in their care and use.
The current rules, policies, and professional guidelines for the responsible use of animals in research are the product of roughly 50 years of ongoing discussion between government, the public, animal care professionals, and researchers. The conclusions reached through these discussions are laid out in two key sources of information for researchers who use animals in their work: Federal regulations and professional guidelines.
Federal regulations. Over the last 50 years, Congress has addressed the responsible use of animals in research on a number of occasions and drafted two important statutes:
- the 1966 Animal Welfare Act (revised 1970, 1976, 1985, and 1990) and
- the 1985 Health Research Extension Act, Sec. 495.
The former broadly assigns authority for the responsible transportation, care, and use of animals to the United States Department of Agriculture (USDA), as implemented by Title 9 of the Code of Federal Regulations. It covers animals used “in research facilities or for exhibition purposes or for use as pets.” The latter law delegates authority for the responsible use of animals in “biomedical and behavioral research” to the Secretary of Health and Human Services (HHS), acting through the Director of the National Institutes of Health (NIH) and the Office of Laboratory Animal Welfare (OLAW), NIH.
Researchers who use animals in research, including observational research, or teaching, can come under the jurisdiction of the USDA animal welfare regulations and/or the PHS Policy on Humane Care and Use of Laboratory Animals (hereafter, PHS Policy), which carries out the provisions of the 1985 Health Research Extension Act. They therefore should be familiar with both.
Guidelines. In the late 1950’s, a group of animal-care professionals formed the “Animal Care Panel” (ACP) specifically for the purpose of establishing a professional standard for laboratory animal care and facilities. Their work led to the publication of a comprehensive and influential Guide for Laboratory Animal Facilities and Care (1963, revised 1965, 1968, 1972, 1978, 1985, and 1996). The current edition, now called the Guide for the Care and Use of Laboratory Animals, or Guide, as it is commonly referenced, was prepared by a committee appointed by the National Research Council of the National Academy of Sciences and provides guidance on:
- Institutional Policies and Responsibilities;
- Animal Environment, Housing, and Management;
- Veterinary Medical Care; and
- Physical Plant.
The Guide is widely accepted by both government and research institutions as the most authoritative source of information on most animal care and use questions. The PHS Policy requires that PHS-funded institutions use the Guide as a basis for developing and implementing an institutional program for animal care and use.
The term “animal” is defined differently in the statutes, codes, policies, and guidelines that govern animal research. Federally funded research is guided by two key definitions:
- The PHS Policy, which applies to all PHS-funded activities involving animals, defines “animals” as “any live, vertebrate animals used or intended for use in research, research training, experimentation, or biological testing or for related purposes.”
- The Federal Code that implements the Animal Welfare Act (Title 9) covers warm-blooded animals but excludes “[b]irds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals….”
Many institutions apply uniform and consistent standards to all activities involving animals regardless of the source of funding or legal requirements as a way of ensuring broad compliance with all regulations covering the care and use of animals in research.
Researchers are not authorized to make decisions about covered or excluded research themselves. Therefore, anyone who plans to use animals in research, teaching, testing and other covered activities is well advised to assume a broad definition and to consult with their institutional committee before ordering animals or beginning work.
The task of assuring that researchers adhere to the regulations and guidelines for the responsible care anduse of animals is generally recognized to be an institutional responsibility. Institutions vest authority for animal care and use in an “institutional official” (IO), who in turn appoints the Congressionally mandated Institutional Animal Care and Use Committee (IACUC), administers institutional care and use units at institutions that are large enough to have such, and handles other general matters relating to the care and use of animals at that institution.
IACUCs. Following the provisions of the 1985 Health Research Extension Act, PHS Policy, USDA regulations, the Guide, and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) require research institutions to establish an IACUC. IACUCs oversee and evaluate all aspects of the institution’s animal program, procedures, and facilities. Its members must include a doctor of veterinary medicine, one researcher who uses animals in research, and one person who is not affiliated with the institution. Many IACUCs also have a researcher who does not use animals or a member who has some grounding in ethics.
IACUC Members are appointed by their institution, but they have considerable independent authority. Their responsibilities include:
- reviewing and approving all animal use research proposals,
- reviewing the institution’s animal care program,
- inspecting (at least twice a year) the institution’s animal facilities,
- receiving and reviewing concerns raised about the care and use of animals, and
- submitting reports to the Institutional Official.
IACUCs also have independent authority to suspend projects if they determine that they are not being conducted in accordance with applicable requirements. This authority comes directly from Congress through the Health Research Extension Act and can be exercised independent of any other institutional administrative authority.
Animal care and use units. Research institutions with large animal research programs generally have centralized animal care and use units that provide veterinary support, training in procedures, and advice on analgesics, anesthesia, euthanasia, and occupational health and safety. While the staff employed in these units cannot approve research protocols for the institution or make decisions specifically assigned to the institutional IACUC, as animal care professionals they are an excellent local source of information about the responsible care and use of animals in research.
Principles for the Use of Animals in Research
There is a range of views about the morality of animal experimentation. Antivivisectionists hold that humans have no right to place their own welfare above the welfare of animals and therefore all animal experimentation is immoral. Many animal welfare organizations find that some scientifically necessary experimentation is acceptable, but that it should be kept to a minimum and conducted on animals low on the phylogenetic scale, in ways that minimize pain and suffering. Many scientists feel that extensive animal experimentation is necessary and moral, provided it is based on sound scientific practices and utilizes quality animal care, along with minimization of pain and distress.
To help researchers and IACUCs make decisions about the responsible and appropriate use of animals in research, the Federal government has adopted nine Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training (see box, next page). These principles specify requirements for planning and conducting research and are useful to investigators and IACUCs. When questions arise, PHS policy and USDA regulations provide further criteria for researchers and IACUCs to consider in assessing protocols.
Further practical advice on ways to assure appropriate respect for animals can be found in the “three Rs of alternatives” devised by Russell and Burch in 1959:
- Replacement—using non-animal models such as microorganisms or cell culture techniques, computer simulations, or species lower on the phylogenetic scale.
- Reduction—using methods aimed at reducing the numbers of animals such as minimization of variability, appropriate selection of animal model, minimization of animal loss, and careful experimental design.
- Refinement—the elimination or reduction of unnecessary pain and distress.
Although PHS Policy is not explicit in addressing refinements,the requirements to use appropriate animal models and numbers of animals and to avoid or minimize pain and distress are, for all practical purposes, synonymous with requirements to consider alternative methods that reduce, refine, or replace the use of animals. USDA animal welfare regulations require a written narrative of the methods used and sources consulted to determine the availability of alternatives.
Knowing the concerns society has about the use of animals in research, researchers should be prepared to explain why they are using a particular species in their research; why pain or discomfort cannot be avoided; why it may be necessary to sacrifice the animals; and why non-animal options cannot be used to gather the same information or to achieve the same ends.
Policies, Reports, and Policy Statements
United States. Congress. Animal Welfare Act, PL 89-544, 1966. (Link)
National Academy of Sciences. Institute of Laboratory Animal Resources Commission of Life Sciences. Guide for the Care and Use of Laboratory Animals, Washington, DC: National Academy Press, 1996. (Link)
Public Health Service. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Washington, DC: GPO, 2002. (Link)
U.S. Department of Agriculture. Animal Care Policy Manual, Washington, DC: GPO, 2002. (Link)
National Institutes of Health. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, Bethesda, MD: National Institutes of Health, nd. (Link)
General Information Web Sites
Association for the Assessment and Accreditation of Laboratory Animal Care. Home Page, nd. (Link)
National Institutes of Health. Office of Laboratory Animals Welfare. Home Page, (Link)
U.S. Department of Agriculture. Animal Care Program. Home Page, nd. (Link)
The Graduate School wishes to thank the Office of Research Integrity for the use of the mentoring material above. The source is the text book, ORI Introduction to the Responsible Conduct of Research, by Nicholas H. Steneck, Ph.D., HTML Version, September, 2006, updated from Revised Printed Edition, June, 2004.