Author(s): Stephanie J. Bird, Ph.D.
Background and Module Content
The scientific rationale underlying the use of animals in biomedical research is that a living organism provides an interactive, dynamic system that can be observed and manipulated experimentally in order to investigate mechanisms of normal function and of disease. As a result, a greater understanding of living systems can be attained and this knowledge can be generalized to other species including humans, facilitating the development of effective therapies. One particular use of animals in research is in the development and use of animal models of particular human physiological functions (e.g., immune response, cardiovascular function, vision) and diseases. These are commonly used in all areas of biomedical research and have contributed significantly to medical progress. Yet while the use of nonhuman animal models is a common component of biomedical research, the role of animal models in research, and its scientific and ethical justification, are frequently not addressed in the education and training of junior researchers.
Students need experience in identifying and thinking through the development of an animal model and the extent to which it can be generalized. In addition, the Institutional Animal Care and Use Committee (IACUC) approval is required for research and teaching that involves animals. Thus, researchers and instructors need to understand the purpose and function of IACUC.
At the same time, scientific research is funded and conducted under the auspices of society as a whole. Both those who use animals in research or teaching and those who do not are members of society and need to understand the scientific and ethical justification for, criteria for, and limits of the use of nonhuman animals in research and teaching, as well as the range of societal views and concerns regarding the use of animals.
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Method and Scenarios
- Presentation and discussion of scientific and ethical issues in the use of animals in research.
- Participants read federal and institutional regulations and other guidelines regarding the care and use of animals in research, their primary goals, and the structure and functions of IACUCs.
- Distribution of scenarios developed as protocols for IACUC review to the students and faculty.
- Panel discussion based on those scenarios and questions and any others that students or faculty wish to add.
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Readings (recommended for discussion of scenarios)
- Explanation of Federal Regulations covering research with animals.
- Links to these regulations are listed in the resources section below.
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This Module will Provide:
- a framework for understanding the ethical pros and cons for the use of nonhuman animals in research and teaching.
- information about resources and regulations regarding the care and use of nonhuman animals.
- theoretical underpinnings and practical experience with regard to the purpose and function of IACUC.
- experience in thinking through the issues they relate to cases drawn from biomedical engineering.
Participants who do or will use animals in research or teaching will:
- understand and explain the validity of the animal model.
- be familiar with the regulations, conventions, and accepted practices regarding the use of animals in research.
- understand the range of societal views and ethical concerns regarding the use of animals in research.
- be able to identify and articulate his or her own scientific and ethical views regarding the use of animals in research.
- understand the elements of the research protocol that serve as the basis for committee members' decisions regarding acceptability and be able to complete an IACUC protocol form so as to adequately convey the rationale and methodology of the research for IACUC review.
- learn the rudiments of serving on a committee that requires critical thinking and moral reasoning (e.g., IACUC, Institutional Review Board for human subjects research, Project Review Committee).
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Bibliography (for further reading)
"Animal Experiments: Where do you Draw the Line?", New Scientist, May 22, 1999. A recent sampling of the opinions of British adults on the use of animals in research.
Donnelley, Strachan and Nolan, Kathleen. "Animals, Science, and Ethics." Hastings Center Report, special supplement. May/June: 1-32; 1990.
Dresser, Rebecca. "Standards for Animal Research: Looking at the Middle." Journal of Medicine and Philosophy. L3: 123-143; 1988.
NIH Animal Advisory Committee. Using Animals in Intramural Research: Guidelines for Investigators and Guidelines for Animal Users. (NIH Office of Animal Care and Use, 2000). A written course and handbook for principal investigators and animal users containing current practices, policies, and laws that affect the use of research animals.
For further reading please see the additional Annotated Bibliography
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Relevant Web Sources
- Animal Welfare Act.
- This law authorizes the Secretary of Agriculture to regulate the transport, sale, and handling of various non-human animals intended for research or "other purposes". This law has implications for institutions involved with biomedical research. On this site there is a link to common questions and answers about this act and its regulations for biomedical research institutions. The most recent addition to this act, the "Improved Standards for Laboratory Animals," clarifies what is meant by humane care. It also specifies that pain and distress of animals be minimized and that animals be provided with an adequate physical environment to enhance their psychological well being.
- Animal Welfare Regulations.
- Title 9 of the federal regulations includes information on registering research facilities, appointing an Institutional Animal Care and Use Committee (see section 2.31), hiring an attending veterinarian (section 2.33), record-keeping requirements, the requirement to prepare and submit an annual report, and requirements for training personnel of the research facility (section 2.32).
- 1993 Report of the AVMA (American Veterinary Medical Association) Panel on Euthanasia.
- This report gives information on the euthanasia of animals in research. Its purpose is to give professional guidance for relieving pain and suffering of animals to be euthanized. Researchers should consult this document when designing research protocols.
- Institutional Animal Care and Use Committee Guidebook.
- Prepared by ARENA (Applied Research Ethics National Association) and NIH (National Institutes of Health), this is a guidebook meant to help institutions comply with the federal requirement that all research facilities doing animal research institute an Animal Care and Use Committee.
- The seventh edition of the Guide for the Care and Use of Laboratory Animals.
- This document discusses appropriate handling and care of traditional and nontraditional animals and contains discussion of some federal regulations.
- A Web Tutorial
- The Public Health Service policy on Humane Care and Use of Laboratory Animals.
- The American Physiological Society
- Provides its own answers to frequently asked questions about animal research, such as "Why are cosmetics tested on animals?", "How are research animals protected?" and "Are there alternatives to doing research with animals?" The site also includes a case study regarding polio.
- Public Health Service
- The PHS statement on "The Importance of Animals in Biomedical and Behavioral Research."
- Federation of American Societies for Experimental Biology
- This site has public policy statements on the use of animals in research and education.
- Care and Use of Animals in Research
- As presented in the American Psychological Association Ethics Code.
- Information Resources for Adjuvants and Antibody Production: Comparisons and Alternative Technologies: 1990-1997.
- Prepared by the U. S. Department of Agriculture, Agricultural Research Service, National Agricultural Library, and Animal Welfare Information Center, this website contains a bibliography of published articles and guidelines about the use of animals in research.
- American Association for Laboratory Animal
- Professional Society website with extensive links for education.
- Science Association for Assessment and Accreditation of Laboratory Animal Care International
- Includes links on how to develop alternative research methods rather than using animals, in addition to other important information.