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Part I:
Ethics of Animals Use in Research

The use of animals in scientific research is a controversial issue. Animals have been used throughout history for anatomical and physiological research as well as for testing toxic substances.

Many medical advances, including vaccines for polio and rabies, the development of certain antibiotics and cancer treating agents and transplant medicine, have been developed thanks to the use of animals in research. But the question arises as to whether it is right or wrong to use animals for these purposes.

As scientific advances demonstrated that animals have nervous systems similar to that of human beings, concern grew over the pain and suffering experienced by animals. Eighteenth century Utilitarian philosophers believed that pain and suffering should be minimized and that animals deserved moral protection. Jeremy Bentham, a Utilitarian philosopher in Great Britain is quoted as saying: “the question is not, can they reason? nor, can they talk? but can they suffer?” (1789)

Great Britain was a leader in the animal welfare movement and founded the Society for Prevention of Cruelty to Animals in 1824. The Cruelty to Animals Act was passed in Great Britain in 1876 and regulated animal experimentation.

There are however, other views of the moral value (or status) of animals, that influence the question of if and how animals are used in research. While the Judeo-Christian and other religious traditions draw a moral distinction between humans and other animals, other philosophical views question the basis of these differences. Factors such as the ability to experience emotion, the ability to reason, the development of language, self awareness or self interest, and the capacity for beliefs and desires are all qualities that have been examined when determining the moral status given to animals.

Animal rights theorists equate the lives of animals (or some animals more than others) with those of human beings and believe that humans do not have the right to use animals solely as a means to a human end. Extremists have taken political and social action to draw attention to their views.

Those who espouse an animal welfare point of view however, may believe that while humans and animals are not necessarily morally equivalent, animals do have a 'right' not to suffer needlessly. For a discussion about the differences between animal rights and animal welfare please see: http://www.sover.net/~lsudlow/ARvsAW.htm

Even those who do not believe that animals have any moral standing in relation to humans may believe that it is harmful to a human being to inflict needless pain and distress on a sentient being. And from a scientific point of view, pain and distress can add an uncontrollable variable into an experiment and so it is in the interest of good science to control pain and distress when ever possible.

A research institution that receives money and support from the public is responsible for conducting research according to the limits set by society. In this instance, the use of animals in research is a privilege and not a right.

The consensus at this time in the United States is that animals should be treated humanely and that pain and distress should be minimized when animals are used for research or teaching purposes. This is evident in the laws and regulations that have been developed by democratic processes.

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Laws and Regulations

Animal Welfare Act

In the 1960's, there was public concern over the conditions experienced by research animals and fears of pet animals being stolen and sold into research. A Life magazine article and picture spread demonstrated some of the living conditions experienced by animals being bred for research. These concerns led to the passage of the Animal Welfare Act (AWA) in 1966.

This act licenses dealers, exhibitors and breeders of animals, regulates research facilities that use animals, lists standards for the humane care and treatment of animals and regulates the transportation of animals. The Act was amended in 1970, 1976, 1985, and 1990. These amendments added further protections and improved conditions for animals covered by the Act.

The AWA specifically exempts birds, mice and rats used in research as well as agricultural animals that are used for agricultural production. The Act also exempts horses that are not used for research purposes. Amendments to add coverage of birds, mice and rats are proposed on a regular basis, but many people feel that the protection for these animals is covered by other regulations and inclusion under the AWA would be redundant.

The United States Department of Agriculture is the government agency that is responsible for the enforcement of this act. Facilities must submit an annual report to the USDA. The USDA conducts unannounced inspections of research facilities at least once a year. If violations of the Act are found, fines can be imposed or research activities can be stopped.

Public Health Service Policy

The Public Health Service Policy on the Humane Care and Use of Laboratory Animals is based on the nine United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. This policy covers all species of animals including birds, mice and rats and it covers all research that is funded by the National Institutes of Health (NIH).

Institutions covered by this policy, must annually submit a written document called an assurance to NIH, which documents how the institution is complying with all the regulations covering animals used in research. The Office of Laboratory Animal Welfare (OLAW) at NIH is the agency that is responsible for enforcement of this policy.

Guide for the Care and Use of Laboratory Animals

The Guide for the Care and Use of Laboratory Animals ("The Guide") was first developed in 1963 as a manual for research facilities receiving public funding for research using animals. The latest (1996) version of the Guide, sets specific standards for the care and use of laboratory animals.

It addresses institutional responsibilities, husbandry and housing standards, veterinary care and physical plant specifications. It is written by experts in laboratory animal care and is published by the National Research Council. It is also available in several languages.

AAALAC

AAALAC stands for the Association for the Assessment and Accreditation of Laboratory Animal Care. This is an independent (non-government) and voluntary accreditation organization. AAALAC accredits laboratory animal facilities through a process of intensive inspections (every 3 years) and reports (yearly). AAALAC follows the high standards put forth in the Guide. Accreditation, while voluntary, represents commitment to excellence in animal care and is an important factor to many funding agencies.

University of Minnesota Policy

The Regents Policy on Animal Care and Use addresses the use of all animals in research, teaching or display at the University of Minnesota. This policy follows from the federal and other laws and regulations. It addresses the roles and responsibilities of the Institutional Official, the Institutional Animal Care and Use Committee (IACUC), Research Animal Resources and the University Community.

The Institutional Official (IO) is appointed by the University President and reports directly to him (her) as well as to the federal authorities regarding compliance with all laws and regulations governing the use of laboratory animals in research and teaching. The President has formally delegated responsibility to appoint IACUC members to the Institutional Official.

The IACUC, which is a committee mandated by the AWA and the PHS policy, reviews and must approve all activities involving animals at the University of Minnesota. The AWA and PHS policy state membership requirements for the committee. There must be at least:

• one veterinarian (with laboratory animal background and responsibility at the institution),
• one member of the community (to represent the public interest),
• one scientist who uses animals in research, and
• one non-scientist member.

University policy states that the committee should have at least 5 members, but currently the committee has 17 members, including 2 student members.

The committee reviews all animal usage protocols. In addition, the committee ensures:

• that the use of animals is necessary to answer a scientific question,
• a search for alternatives to the pain and distress is conducted and that pain and distress experienced by the animals is minimized, and
• that all the laws and policies for the use of laboratory animals are followed.

The committee also ensures the humane care of animals through the inspection of animal housing and use facilities twice a year and by investigating any complaints made regarding animal use. The committee is also responsible for reporting any instances of non-compliance and recommending corrective action.

Research Animal Resources (RAR) is designated by University policy as the group that provides the housing and husbandry as well as the veterinary care for the laboratory animals. They are also designated to serve as a consultation resource for the care and use of animals in research and teaching.

University policy also lists the roles and responsibilities of the University community. The University researchers and staff are to be appropriately trained and qualified to conduct activities with animals and are to abide by the decisions of the University and the IACUC.

Other Guidelines

GLP

Some FDA or EPA research must be performed using Good Laboratory Practices (GLP). There are additional regulations that apply to laboratory animals, including the development of SOPs (Standard Operating Procedures), when doing GLP research.

Researchers conducting projects slated to be used as support for human clinical trials should consider following GLP guidelines.

Agricultural

The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching is a text published by the Federation of Animal Sciences Societies. This Guide addresses standards for agricultural animal husbandry, housing and veterinary care. It does not apply to agricultural animals used for biomedical type research or teaching.

The standards are slightly different than those listed in the Guide for the Care and Use of Laboratory Animals. For example, cage space requirements may differ slightly between the two texts. Although this text is not regulatory, the University uses its provisions and principles as the basis for its care and use programs involving animals used for production or agricultural research.

Wildlife

There are several references available for the use of fish, amphibians and mammals in wildlife research. Again, these documents are not regulatory documents but are excellent references for the care and handling of these animals.

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Pain and Distress

Pain

It is difficult to know how animals experience pain and distress. While many animals have nervous systems similar to that of human beings, how pain is perceived and experienced by animals is not fully understood. The AWA defines a painful procedure in an animal as: "any procedure that would reasonably be expected to cause more than slight or momentary pain or distress in a human being to which that procedure was applied, that is, pain in excess of that caused by injections or other minor procedures."

Pain can be acute, short lived - or chronic, lasting a long time. The signs manifesting acute or chronic pain may differ and may be different in different species. Prey species of animals can be adept at hiding signs of pain or illness and may be more difficult to assess discomfort.

Distress

Distress is harder to define. Distress differs from stress, which is a physiological reaction that can lead to an adaptive response. Distress is currently defined as "a state in which an animal cannot escape from or adapt to the external or internal stressors or conditions it experiences resulting in negative effects upon its well being…" Principle IV of the US Government Principles states that unless the contrary is established, the assumption must be made that a procedure that causes pain or distress in a human being will cause pain and distress in an animal.

Alternatives

Current regulations stress the need to search for and develop alternatives to procedures on animals that cause more than momentary pain or distress. The concept of the three "R"s has been used when thinking about alternatives to animal use. This concept was developed in 1959 by Russell and Burch in their book: The Principles of Humane Animal Experimental Techniques.

The three "R"s are Replacement, Reduction, and Refinement. Investigators at the University of Minnesota, who use animals that may undergo more than momentary pain or distress, must consider the 3 "R"s in the design of their experiments or teaching protocols and must demonstrate their search for alternatives.

Replacement of animals with other systems may be an option. Computer modeling or in vitro testing may be a substitute for animal models. "Lower" or non-vertebrate animals, such as the fruit fly may be used in some situations rather than a higher order animal.

Reduction of the number of animals used for research is also an important concept. This is done mostly through experimental design and the use of statistics. The use of too few animals could result in statistically invalid results, which could necessitate the use of even more animals in subsequent experiments. Pilot studies to help determine statistical parameters can sometimes assist in determination of group sizes. Reduction of pain and distress may also actually require the use of more animals so that repeated procedures are not conducted on the same animal.

Refinement refers to methods that decrease the amount of pain and distress experienced by the animals that are actually needed to perform an experiment. This is done through the use of pain relieving measures such as anesthetics and analgesics whenever possible.

The use of early endpoints can also be a form of refinement. For instance if an animal were to suffer from an early indicator of disease or a tumor reaches a certain measurable size, this could be used as the endpoint. The animals could be humanely euthanized at this point rather than waiting until the death of the animal.

For more examples of replacement/reduction/refinement and searches for alternatives, see IACUC's web page on alternatives or RAR's web page on alternatives.

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