The Guiding Principles for the Care and Use of Vertebrate Animals in Research and Training are a code of ethics for members of the American Physiological Society (APS) who work with animals. They provide a framework intended to promote the humane treatment of animals and are based upon principles of humane care articulated in 1909 by Harvard physiologist Walter B. Cannon.
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Ethical Grounds for Animal Research
- The updated APS Guiding Principles incorporate language from the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training stating that ethically valid rationales for animal studies include “relevance to human or animal health, the advancement or knowledge, or the good of society.” The APS Guiding Principles state further that the use of animals “is also justified to provide scientific, veterinary and medical training that is not possible through other mechanisms.”
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Study Design
- Specific factors to be considered in designing studies involving vertebrate animals include “the appropriateness of the experimental procedures, the species of animals used, and the number of animals required.” Investigators should also consider whether animal studies can be adequately replaced by alternatives such as in vitro and/or in silico studies.
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Prospective Approval
- Advance approval of the research protocol by an institutional animal care and use committee (IACUC) or similar oversight body is required when the species in question is subject to regulatory oversight. This ethical review should consider the use of animals could be replaced by other experimental approaches such as in vitro or in silico studies.
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Other Oversight Bodies
- The term “similar oversight body” acknowledges the fact that the animal welfare oversight system in other countries may differ from the U.S. system. In the U.S., Institutional Animal Care and Use Committees (IACUCs) are required to conduct prospective reviews of research protocols involving vertebrate animals. However other countries employ other oversight systems. In the United Kingdom, a project license must be obtained from the national Home Office. The APS Guiding Principles state approval should be obtained under the oversight system of the country where the research is to be performed.
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Animals Covered
- The extent of regulation varies from country to country. In the U.S., proposals to utilize live vertebrate animals in teaching or research usually require prospective approval by an oversight committee such as an IACUC, whereas proposals involving invertebrate animals do not. However, if local law or institutional policy also regulates invertebrate species, researchers are expected to comply with those requirements.
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Legal and Regulatory Requirements
- Animals utilized in research and teaching must be acquired legally. In addition, the transport, care, and conduct of research with animals must comply with federal, state, and local laws and regulations. In the U.S., most research is subject to the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (which includes the requirement that research is conducted in accordance with the Guide for the Care and Use of Laboratory Animals,[1] the Animal Welfare Act (AWA), and/or the Good Laboratory Practice Act (GLP)).
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Pain and Distress
- Pain and distress should be minimized through analgesics and other non-pharmaceutical measures unless doing so would compromise the scientific objectives of the work. Laws and regulations in the United States and most other countries permit studies that entail pain or distress because this is necessary to study diseases that result in painful conditions or to assess the effectiveness of pain-relieving drugs. A research oversight body must prospectively review and approve any studies that are expected to produce significant pain or distress in animals.
- Animals must be properly anesthetized during surgery. Some surgical procedures require muscle relaxants or paralytics, but these drugs can only be employed in combination with appropriate anesthesia or with procedures such as decerebration that render the animal unable to experience pain.
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Euthanasia
- If the design of the study requires that an animal be euthanized, a humane method of doing so must be employed. The American Veterinary Medical Association (AVMA)’s Panel on Euthanasia produces guidance that is widely accepted as setting the standard for methods of humane euthanasia.
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Humane Endpoints
- Some scientific studies involve creating an animal model of a particular disease so that possible treatments can be tested. The health of these animals may deteriorate over time, which can cause pain or distress. Designating humane endpoints means making an advance decision about when an animal in pain or distress should be euthanized. Studies with the potential to cause significant pain or distress should include appropriate monitoring of the animals so that these conditions can be alleviated as much as possible without compromising the integrity of the study. If animals experience pain or distress that cannot be alleviated, they should be euthanized promptly unless this would compromise the integrity of the study. An oversight body such as an IACUC must grant specific approval for studies that include unalleviated pain or death as an experimental endpoint.
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Death as an Endpoint
- Death as an endpoint refers to the death of an animal as a planned part of the study design, whether due to the progression of a disease or through an experimental manipulation. This does not refer to studies where the death of the animal occurs through euthanasia. Death as an experimental endpoint can be an acceptable part of the study design if an oversight body such as an IACUC reviews the rationale and approves it. For the vast majority of studies, the experimental objectives can and should be realized without using death as the endpoint.
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Standard of Care
- Animals must be provided with husbandry that is appropriate for their species and their condition and should also be given appropriate veterinary care. Research in the U.S. may be subject to the Animal Welfare Act, the ILAR Guide for the Care and Use of Laboratory Animals, or other guidelines established by funding agencies. In addition, “[t]he procurement, transport, maintenance, and use of animals must in all cases comply with federal, state and local laws and regulations.” This means that research must also conform to the requirements of the locality and country in which it is conducted.
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Training
- Personnel should receive training for the tasks they are expected to perform. In addition, when animals are used by students or trainees, their work should be supervised directly by an experienced teacher, investigator, or veterinarian.
1. Institute for Laboratory Animal Research (ILAR). Guide for the Care and Use of Laboratory Animals. Washington, D.C.: National Academy Press, 1996. A prepublication version of the 8th edition of the Guide was released June 2, 2010, but NIH’s Office of Laboratory Animal Welfare has announced that the 1996 edition will remain in effect for the PHS Policy on Humane Care and Use of Laboratory Animals until the new edition of the Guide is published in its final form.