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Section Five:
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O N L I N E   R E S E A R C H   E T H I C S   C O U R S E

Section Five: Animals in Research
Introduction | Major Issues for Discussion | Case Study |
Footnotes | Additional Resources | Section Assessment and Certificate

The use of animals in research has a long and successful history. Life-saving drugs and techniques for humans and for other animals have been perfected because of the use of animal models in research. The history is also troubled by allegations of misuse of animal subjects -- some perceived and some all too real.

There is also conceptual debate as to whether the use of animals is a topic of ethics, at all. Traditionally, moral philosophy has been the study only of what people do and how they should act in regards to one another. While some historical figures in moral philosophy have briefly addressed the treatment of animals, it was not until the 20th century that the treatment of animals came to be generally regarded by moral philosophers as a matter of moral consideration. The 18th Century notion of British philosopher David Hume that the reasoning difference between humans and non-human animals is a difference of degree, rather than kind, stands out as a kind of historical oddity in philosophical perspectives regarding animals.

Throughout the 20th Century, philosophers, researchers, and the general public reached vague agreement that animals used in research should be treated in a humane fashion. Arguments for humane treatment differ in their starting assumptions.

The first argument is from the perspective of animal rights, based on the notion that animals have some intrinsic interest or claim that they not be caused pain or distress. Based on the animals' sentience, some contemporary philosophers have argued that animals used in research are due moral consideration in their own right. The fact that some entity can perceive and react to noxious stimuli ethically implies that it ought not be subjected to noxious stimuli without good reason.

Other philosophers argue that researchers have duties to their animal subjects regardless of any animal "rights" argument. This argument is based on the belief that since specific animals are bred or chosen for research use creates a moral responsibility toward those particular animals that may not extend to other sentient creatures in other contexts. Without denying that all animals have interest in not being caused pain or distress, this argument focuses on the stewardship responsibility of researchers to individual animals in their care. This second approach is helpful in determining how it is that the same species of animal may have different moral standing in different contexts -- for example, mice used as research subjects are treated differently from pest mice that may also be found in the halls of the facility, which are treated differently from mice that are used to feed other research subjects. For a provocative discussion of these role distinctions, read the article by Harold Herzog, "The Moral Status of Mice," by clicking this link.

Traditionalists need go no further than the standard idea of humans as the only beings worthy of moral consideration to make an argument for ethical treatment of research animals. Some people are caused great emotional pain by the knowledge that animals are used in research. Regardless of what one thinks about moral considerations for research animals, it is not ethically justified to cause human beings pain without good reason. If animals are used needlessly in research or are unnecessarily caused distress or suffering, there is not sufficient justification for causing those humans the painful knowledge that animals are being used. If animals are used judiciously and are caused as little distress or suffering as possible, there is justification for causing some people the painful knowledge that animals are being used. Justifications for ethically questionable acts (causing pain to other humans is ethically questionable) are based upon the rational interests of an impartial audience. With appropriate rules and regulations, it has been decided by public policy to be in the rational interest of people to have animals used in research when there is no other alternative and when pain and distress are minimized or eliminated for the animal.

Federal agencies, including the Public Health Service and The United States Department of Agriculture, have set forth policies regarding the treatment of animals used in research. The Animal Welfare Act (AWA) is a federal law that sets a minimum standard for the treatment of animals. The Animal Welfare Act first went into effect in 1966 and has been amended four times since then, with the latest amendment in 1990. The Act sets out requirements for how animals are obtained, the housing and care of various species, veterinary care, and responsibilities of minimizing pain and distress. In addition, the AWA requires all research institutions that use animals in research to have an oversight committee to ensure proper use and care of animal subjects.

The definition of what counts as an animal for research purposes is a little complicated as the Animal Welfare Act has historically excluded mice, rats and birds. Settlement action is currently pending that would bring these species under the protective umbrella of the Act./1 However, as of early 2002, the U.S. Congress is considering legislation attached to the Farm Bill that would legislatively exclude birds, mice and rats. Some laboratory officials argue that keeping individual records on each bird, mouse or rat (required if included in the AWA) would be too costly./2

PHS policy defines an animal as "any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes."/3 The broader definition is supposed here.

All research institutions are required to conform to Federal rules and regulations regarding the use of animals in research. In addition, The University of Montana is one of 640 research institutions in 18 countries to have earned accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). This is a voluntary accreditation program that sets higher standards than those required by federal laws and regulations for the treatment of animals used in research. AAALAC endorses the use of animals in research only "when there are no non-animal alternatives, and when it is done in an ethical and humane way."/4

By completing this section, successful readers will be able to

1). Describe concepts relating to animal pain and distress;
2). Explain how alternative methodologies are used in animal research;
3). List ethical expectations for UM researchers using animals; and
4). Describe the role and responsibilities of the IACUC.

Some of the material contained in this section was developed or adapted from Elliott, D. and Brown, M. (1997) "Animal Experimentation," in Elliott, D. and Stern, J. (eds). Research Ethics, A Reader. Hanover, NH: University Press of New England, pp. 246-285.

2/Southwick, R. (2002). "Senate Votes to Block Expansion of Lab Animal Regulations. Chronicle of Higher Education. March 1, p. A25.

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Major Issues for Discussion

1). Animal Pain and Distress
Regulations for humane treatment of animal research subjects rests on the assumption that animals are capable of experiencing pain and distress. If animals do not experience pain or distress, there is no need to be concerned about the effect that research might have on them.

Seventeenth Century French philosopher Rene Descartes argued that non-human animals were organic machines that did not feel pain and that were not capable of rational thought. His respected views were used to justify horrendous experimentation with animals. But, even contemporary philosophers have argued that "animal pain" is an oxymoron. According to philosopher P. Harrison, "Pain is the body's representative in the mind's decision-making process. Without pain, the mind would imperil the body...But without the rational decision-making mind, pain is superfluous. Animals have no rational or moral considerations which might overrule the needs of the body."/1 Thus, Harrison concludes, animals do not experience what humans would call pain.

Given that one can never really know the mind or experience of a non-human animal, the sentience of non-human animals used in research -- the ability to perceive noxious and pleasant stimuli -- is assumed by most people. Indeed, the fact that animal models are used in clinical pain studies rests on the belief that animal pain is analogous to human pain. As philosopher and physiologist Bernard Rollin points out, "[A]s soon as one has admitted that animals can be hurt in ways which matter to them...or that unnecessary animal suffering is wrong, one has implicitly but inescapably presupposed that animals are in the moral arena, that one can be morally wrong in how one uses or treats animals...."/2

A recent poll conducted on behalf of The Humane Society of the United States found that 75 percent of those in the general public who were polled disapproved of experiments that subject animals to pain or distress. According to Martin Stephens, Vice President for Animal Research Issues at HSUS, "Not only is animal suffering unnecessary, it also interferes with the research itself and makes the results less meaningful. There are real, relatively simple, and immediate steps that can be taken to improve the quality of life for the suffering laboratory animals and also improve the quality of biomedical science. This is what both the public and scientific community want."/3

Federal regulations reflect an assumption of animal pain. According to the U.S. Government Principles for the Utilization of and Care of Vertebrate Animals Used in Testing, Research and Training, "Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain and distress in other animals."/4

Humane treatment is most usually defined as eliminating pain and distress whenever possible, or using procedures to minimize pain and distress when full elimination is not possible. Pain is classified as awareness of discomfort. Acute pain is abrupt, short, and should usually be relieved by analgesics. Chronic pain exists over a long duration and can not be entirely relieved by analgesics. Distress may accompany pain, but is defined as a state of physical or mental stress that results from pain, anxiety, or fear. According to a 1992 NCR/ILAR report, "Distress is an aversive state in which an animal is unable to adapt completely to stressors and shows maladaptive behaviors. It can be evident in the presence of various experimental or environmental phenomena, such as abnormal feeding, absence or diminution of postprandial grooming, inappropriate social interaction with handlers, and inefficient reproduction. Distress can also result in pathologic conditions that are not evident in behavior, such as gastric and intestinal lesions, hypertension, and immunosuppression." It is important for researchers to understand that they may be causing animals distress, even if they are not in pain. Tranquilizers can be used to relieve distress, but do not relieve pain./5

Pain and distress should be avoided or minimized. The AWA requires an annual report from institutions indicating a breakdown of research within the four following classifications:

1). Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes;
2). Animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs;
3). Animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, of tranquilizing drugs were used;
4). Animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretations of the teaching, research, experimentation, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reason such drugs were not used shall be attached to the annual report./6

The best way to decrease animal pain and distress is to decrease animal use. Application of the 3 R's (replacement, reduction, and refinement) requires researchers to justify their use of the particular animal model, the number of animals used and the experimentation to be performed.

2). Alternative Methodologies
Replacement requires investigators to use in vitro or computer models, less sentient animals, micro-organisms, or plants whenever possible. Researchers are required to demonstrate that they have searched for alternatives to their proposed animal model.

Reduction includes using sharing animals or data gained from an individual animal in more than one way; animals that are anesthetized and that will be euthanized without gaining consciousness may be used for a second experiment. Their organs or tissues may be used in yet a third experiment at the time of necropsy. The number of animals used in research may also be reduced by better research design. "Experimental protocols which utilize serial sacrifice, group sequential testing and crossover designs can significantly reduce the numbers of animals required."/7 These are all procedures that maximize the use of data gained from individual animals. Other methods for reducing the number of animals used include appropriate choice of statistical method and the avoidance of unnecessary duplication of prior research. In addition, "better health status of animals so that research subjects are not lost due to disease and better husbandry to limit the confounding effects of non-experimental variables," helps reduce the number of animals used./8

Refinement includes constructing experiments so that animals are subjected to as little pain and distress as possible. The refinement of research also includes using appropriate euthanasia techniques. Death that occurs because the animal has succumbed to the intervention or side effects to the experimental intervention is rarely an appropriate endpoint for experimental use of an animal. Once data is obtained from individual animals, they should be humanely euthanized. Appropriate euthanasia techniques for different species can be found here. Note: This is a PDF (Adobe Acrobat) file.

3). Ethical Expectations for UM researchers using animals
These expectations provide a model for humane use of animals:

1). It is the moral and ethical obligation of each authorized faculty and staff member, and all persons working under their direction, to insure that:

a). All animals, regardless of species, are treated humanely.
b). When methods are used that may cause pain, discomfort, or distress, all measures possible, including the use of anesthetic and analgesic drugs must be provided to alleviate or minimize pain, discomfort or distress. Experiments involving methods that may cause pain, discomfort or distress must be of the shortest possible duration for valid results. Any animal which exhibits severe pain or distress that cannot be alleviated must be euthanized immediately.
c). Methods which cause suffering or distress which cannot be justified by the expected quality of data are not used.
d). Experiments involving pain or distress without the use of anesthetics or analgesics will be proposed only if the objective of the research is to investigate the mechanisms of pain and if the use of pain-relieving drugs would interfere with the objective of the research.
e). If the induction of hunger or thirst through food and water deprivation is a necessary part of an experiment, it will be conducted in a manner that does not interfere with the normal growth and development or health of the animal.
f). Physical restraint will not be used as a substitute for anesthesia. Any physical restraint must be designed to eliminate pain, minimize distress or discomfort, and eliminate any possible abnormal changes in physiology or anatomy, unless such changes are demonstrably relevant to the research goals. Restraint must conform to NIH guidelines.
g). The research is designed to utilize the best methods on the smallest number of animals of the appropriate species yielding valid results.
2). It is the obligation of the PI to ensure that sufficient funds are available for proper animal care and use.
3). Methods designed primarily for the convenience of the researcher are not justified if such methods would cause more pain, distress or discomfort than alternative procedures that might be less convenient to the researcher.
4). Breeding programs for mammals must be designed to prevent production of animals in excess of the number the laboratory is prepared to care for.
5). It is the obligation of the principal investigator and other responsible members of the research team to explore all possible alternatives to the use of animals before proposing to conduct animal research.
6). All aspects of animal care must be directed toward the achievement and preservation of the animals' well-being. Species specific behavioral and environmental needs shall be addressed.
7). Video tapes, films and preserved specimens must always be used in place of live animals when they are a reasonable substitute. The use of live animals in teaching will only be authorized if all other reasonable alternatives have been explored and found inadequate.
8). Courses must be designed to utilize a minimum number of animals and to provide maximum instructional supervision for each group of students working with animals. Departments sponsoring the course must ensure an adequate teaching-assistant to student ratio, and ensure that the students are trained in humane methods of handling and use.
9). Instruction in surgical procedures will be limited to students whose curricula or involvement in research demonstrates that their professional aspirations require such knowledge. Following an invasive procedure, animals should not be allowed to regain consciousness, but, if this is necessary, the animal must be provided with analgesia during recovery, then humanely killed immediately after the critical results are obtained.
10). The use of painful experiments solely for the instruction of students or for the demonstration of established scientific knowledge will not be authorized./9

4). The Role of the IACUC
The Animal Welfare Act requires that each research institution that uses animals have an Institutional Animal Care and Use Committee (IACUC). The IACUC must have at least five members, including a veterinarian with program responsibilities, a scientist experienced in laboratory animal research, a non-scientist and an individual who has no other affiliation with the Institution besides membership in the IACUC. Unlike most University committees, which serve advisory roles to administrative officers, the IACUC has the authority to suspend research activities. The IACUC evaluates the entire animal use program and facilities every six months; prepares a report on the evaluation and the inspection of the facilities for the Institutional Official; and make recommendations to this Official concerning deficiencies, with a proposed timetable for corrections.

The IACUC has an obligation to review all research projects that include animals, prior to their receiving funding and prior to the beginning of any work using animals. The project must be conducted in accordance with the Animal Welfare Act, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) guidelines, University guidelines and any other regulations set forth by the potential funder. The IACUC has authority to approve, require modifications before approval, or withhold approval of proposals submitted to it for review.

By federal mandate, the IACUC must perform the following functions:

1). Review, at least once every 6 months, the research facility's program, using USDA Regulation/Guide as basis.
2). Inspect, at least once every 6 months, all of the animal facilities, including animal study areas/satellite facilities, using USDA Regulations/Guide, as basis.
3). Prepare reports of IACUC evaluations and submit the reports to the Institutional Official.
4). Review and investigate legitimate concerns involving the care and use of animals at the research facility resulting from public complaints and from reports of non-compliance received from facility personnel or employees.
5). Make recommendations to the Institutional Official regarding any aspect of the research facility's animal program, facilities or personnel training.
6). Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals.
7). Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities.
8). Suspend an activity involving animals when necessary; take corrective action and report to funding agency and USDA./10
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Case Study

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Case Study: Recovery and Multiple Use.

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1/P. Harrison, "Do animals feel pain," Philosophy 66 (1991):38.

2/B. Rollin, The Experimental Animal in Biomedical Research, Vol. 1, A Survey of Scientific and Ethical Issues for Investigators, Boca Raton, Fla: CRC Press, 1990), p. 27.






8/Marilyn J. Brown, D.V.M. personal communication.



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Additional Resources

Below are links that may help you understand animal subject issues a little better:

  • Research Involving Animals: "A tutorial for new animal care and use committee members, institutional administrators, investigators, animal care personnel, veterinarians, or others who are interested in learning about the PHS Policy on Humane Care and Use of Laboratory Animals."

  • Scientists Center for Animal Welfare: "The Scientists Center for Animal Welfare (SCAW) is a non-profit educational association of individuals and institutions whose mission is to promote the best practices of humane care, use, and management of animals involved in research, testing or education in laboratory, agricultural, wildlife or other settings."

  • Association for Assessment and Accreditation of Laboratory Animal Care: "The AAALAC is a private non-profit organization that promotes the humane treatment of animals in science through a voluntary accreditation program. More than 640 companies, universities, hospitals, government agencies and other research institutions have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC's program, in addition to complying with the local, state and federal laws that regulate animal research."

  • Institute for Laboratory Animal Research: "Founded in 1952, the Institute for Laboratory Animal Research (ILAR):
        * prepares authoritative reports on subjects of importance to the animal care and use community
        * serves as a clearinghouse for information about animal resources
        * develops and makes available scientific and technical information on laboratory animals and other biological research resources to:
            -- the scientific community
            -- institutional animal care and use committees (IACUCs)
            -- the federal government
            -- science educators and students
            -- the public."

  • 2000 Report of the American Veterinary Medical Association Panel on Euthanasia: NOTE--This is a PDF (Adobe Acrobat) Document. This 28-page report is a "new version of a 1993 report that updates information on euthanasia of animals in research and animal care and control facilities."

  • Animal Welfare Information Center: "Providing information for improved animal care and use in research, teaching, and testing."

  • Information Resources for Institutional Animal Care and Use: "Veteran Administration (VA) medical centers, acting through the SAS, are responsible for ensuring the humane care and treatment of vertebrate animals used or intended for use in laboratory research. This responsibility extends not only to animals owned by VA and housed in VA facilities, but also to those: (1) owned by VA, but housed in non-VA research facilities, and those (2) housed in VA research facilities, but owned by non-VA entities."

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    Section Assessment and Certificate

    Make sure you have reviewed all of the materials within this section, before you attempt the assessment.

    When you have successfully completed the assessment, you will be offered an opportunity to print out a certification document for your records. You can then close the window and return to the course.

    To begin the assessment, click this link.

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  • Ethical Issues in Research | Interpersonal Responsibility | Institutional Responsibility |
    Professional Responsibility | Animals in Research | Human Participation in Research |
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