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Part I:
The Use of Animals in Research

The use of animals in research, teaching and testing is a controversial ethical and political issue. Much of the discussion about this issue revolves around the relative value, often referred to as 'moral value', of humans and animals. When the needs of animals and humans come into conflict, which takes precedence? Today there exists a wide spectrum of views on this subject, ranging from those concerned with animal 'rights' to those who view animals only as a resource to be exploited. All of these viewpoints have contributed to the development of ethical principles of animal use. These in turn have shaped animal use regulations promulgated by the USDA and the Public Health Service, and reinforced by organizations such as AAALAC, AALAS and the AVMA.

Current legislation also recognizes that there are diverse viewpoints about the moral value of animals. Thus, all live animal use in research, teaching or testing must be reviewed by a committee (the IACUC) with diverse membership. There is also an emphasis on minimizing the overall use of animals. Proposals for animal use are reviewed based on the potential for learning new information, or for teaching skills or concepts that cannot be obtained using an alternative. There are provisions for ensuring that animal use is performed in as humane a manner as possible, minimizing pain, distress or discomfort. These provisions include a requirement for a veterinarian to be employed at each institution, so that the needs of the animals are looked after by someone trained in, and sympathetic toward animals' needs. In addition to the requirements for analgesics, anesthetics and sedatives to be used where needed, it is also required that all personnel with animal contact be trained in appropriate handling techniques and that they be skilled in any experimental procedures that will be performed. Finally, basic husbandry requirements are specified, ensuring that an animal's food, water and shelter will be provided for in an optimal manner. Deviations from the numerous requirements are rarely granted by the IACUC, and then only if adequate justification is given that the proposed experiment is scientifically and socially important, and that any methods to alleviate pain or distress would frustrate the experimental objectives.

Animals have been used throughout history for anatomical and physiological research as well as for testing new medications and toxic substances.  Many medical advances, including vaccines for polio and rabies, the development of certain antibiotics, cancer treating agents and transplant medicines, have been developed thanks to the use of animals in research. 

The use of animals in research is a privilege and not a right. A research institution that receives money and support from the public is responsible for conducting research humanely and responsibly according to the limits set by society and regulatory bodies.

 

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Laws and Regulations

Animal Welfare Act

The Animal Welfare Act (AWA) was passed in 1966.  This act licenses dealers, exhibitors and breeders of animals, regulates research facilities that use animals, sets standards for the humane care and treatment of animals and regulates the transportation of animals. The Act has been amended multiple times adding further protections for animals covered by the Act. The AWA specifically exempts birds, mice, rats, amphibians and reptiles used in research as well as agricultural animals that are used for agricultural production.

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 (PHS) Policy on the Humane Care and Use of Laboratory Animals is based on the United States Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. This policy covers all vertebrate 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 Animal Welfare 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 the PHS policy.

Cover of Guide for the Care and Use of Laboratory AnimalsGuide 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

University of Minnesota Mark

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 approves all activities involving animals at the University of Minnesota. The AWA and PHS policy have specific membership requirements for the committee. There must be at least:

  • one veterinarian (with laboratory animal background and programmatic responsibility at the institution),

  • one member of the community (nonaffiliated member 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 the committee has many members, including several student members and ex-officio representatives from Occupational Health & Safety and the Department of Environmental Health and Safety.

The committee reviews all animal care and use protocols (ACUPs) to ensure:

  • that the use of animals is necessary to achieve the stated objectives,

  • that a search for alternatives to any procedures which may cause pain or distress is conducted

  • that pain and distress is minimized, and

  • that all the laws and policies for the use of 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 program that provides the housing and husbandry as well as the veterinary care for the laboratory animals on the Twin Cities campus. 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.


Reporting Concerns

For serious questions or concerns about animal welfare, the process of review, or about committee decisions, contact:

Cynthia S. Gillett

Institutional Veterinarian

612-624-4625

gille002@umn.edu

R. Timothy Mulcahy

Institutional Official

612-624-5054

mulcahy@umn.edu

You may make an anonymous report via the University’s Confidential Reporting Service “EthicsPoint” at https://secure.ethicspoint.com/domain/en/report_custom.asp?clientid=9167

You may also make a report by calling EthicsPoint directly at 1-866-294-8680, toll-free.

Note that, by federal law, no facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards.


Other Guidelines

Agricultural

Cover of the Guide for the Care and Use of Agricultural AnimalsThe 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

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.

 

Signs of acute pain in animals

Signs of chronic pain

  • vocalization
  • attempts to escape the stimulus
  • aggressive responses
  • increased heart and respiratory rates
  • anorexia or shaking
  • weight loss
  • poor or unkempt hair coats
  • depression or lethargy
  • general debilitation

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 utilize 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, should consider the 3 "R"s in when conducting procedures which may be painful or distressful and 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 should 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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Continue to: Part II - Use of Animals in Research & Teaching at the U of M

 

 
 
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