The outline and general format for this module were taken from the University of Minnesota site for animal care and use, and this material is used with permission from the University of Minnesota (http://www.research.umn.edu/ethics/modAnimals.html)
Learning Objectives
For General Background
List the principles that must be adhered to in conducting research on animals.
Describe the jurisdiction, mission, structure, and functions of an Institutional Animal Care and Use Committee (IACUC), including mechanisms for accountability and enforcement.
For Researchers who Use Animals in their Research
Given a list of species, identify those that are covered by the Animal Welfare Act.
Given descriptions of protocols that require oversight of the use of animals in research, you should be able to say: a) when and b) how institutional oversight is applied.
Prepare an application for use of animal subjects in research that meets criteria for IACUC approval.
Relevant University Policies and Procedures
University of Memphis IRB (http://irb.memphis.edu)
University of Memphis Guidelines for Use of Human Subjects (http://irb.memphis.edu/process.html)
Code of Conduct (http://www.memphis.edu/facultyhandbook/2007FHB_Chapter5.htm#Academic%20Misconduct)
Academic Misconduct (http://www.memphis.edu/facultyhandbook/2007FHB_Chapter5.htm#Academic%20Misconduct)
University of Memphis IACUC forms (http://researchsupport.memphis.edu/comp.html)
Relevant Federal Guidelines and Procedures
Guide for the Care and Use of Laboratory Animals (http://oacu.od.nih.gov/regs/guide/guidex.htm)
History of Regulation of Animals in Research
The following material is taken from the National Association of Biomedical Research site (http://www.nabr.org/issues.htm) and used with permission.
Virtually every major medical advance of the last century has depended upon research with animals. Data from experiments on humans are obviously the most scientifically reliable; how-ever, in many cases human research is ethically unacceptable. Researchers first must use animals, the living systems most closely related to humans, before humans are asked to participate in experimentation. Animals serve as surrogates in the investigation of human diseases and new ways to treat, cure or prevent them. The health of animals also has improved due to animal research. Approximately 70% of the American public supports the necessary use of animals in biomedical research. Yet, people also are justifiably concerned about the care and treatment of laboratory animals. They want assurance that animals are treated humanely, do not suffer, and are kept under conditions that allow them to be as healthy and comfortable as possible. The scientific community recognizes its professional obligation to safeguard and improve the welfare of laboratory animals. In fact, individual researchers concerned about the care and treatment of laboratory animals were the first to set voluntary care standards at the turn of the century, long before federal laws and regulations were instituted. In 1909, the first voluntary procedures regarding lab animals were adopted and enforced in medical school laboratories. To care more effectively for research animals, veterinarians created a board-certified specialty in laboratory animal medicine in 1957. The scientific community founded a host of organizations to improve laboratory animal care, such as the American Association for Laboratory Animal Science (AALAS) and the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Many medical specialty societies and voluntary health organizations, such as the Society for Neuroscience and the American Heart Association, have written standards for the care and treatment of laboratory animals. Researchers advocate high-quality animal care and treatment not only for reasons of conscience, but also for reasons of science. Good animal care is good science.
During the 1940s, a group of professionals involved in animal research were concerned about the varying standards of lab animal care. In 1950, this group founded AALAS, which today has more than 8,000 individual and institutional members ranging from veterinarians to lab technicians to university administrators. AALAS is dedicated to developing and maintaining the highest standards of animal care. The Association serves as a forum for presenting and exchanging scientific information on all phases of laboratory animal welfare through its educational activities and certification programs. Leading veterinarians and researchers organized AAALAC in 1965 “to promote high standards of animal care, use and well-being and enhance life sciences research and education through the accreditation process.” AAALAC conducts voluntary peer review evaluation of laboratory animal care facilities and programs which involves site visits, evaluation of site visit reports and recommendations concerning proposed accreditation status. Professional societies, such as the American Physiological Society, the American Psychological Association, and the Association for Research in Vision and Ophthalmology, have codes and policies governing animal research, which their members must follow. Voluntary health organizations, such as the American Heart Association, the American Cancer Society, and the Juvenile Diabetes Foundation, have adopted official policies outlining acceptable standards for the care and use of lab animals. Research funded by these organizations must meet these criteria.
Principles of protection of animal subjects during research procedures: A preview.
Good animal care is essential to good science. If a laboratory animal is unhealthy due to stress or disease, the researcher will be unable to collect reliable data. Animals that are treated well ,on the other hand, provide the normal biological or behavioral responses that researchers need to examine. In protecting their lab animals, researchers are protecting the source of their scientific data. Researchers are guided by the following four basic principles:
Ensure all research animals receive good care and humane treatment;
Use animal models only when non-animal methods are inadequate or inappropriate;
Use as few animals as possible; and
Design experiments so that all animal studies yield scientifically reliable results.
Numerous professional organizations comprising researchers and scientists have their own standards for lab animal care. The Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and the American Association for Laboratory Animal Science (AALAS) are two of the most prominent organizations.
Legal and Regulatory Framework:
Animal Welfare Act, National Academy of Sciences Guide for the Care and Use of Laboratory Animals, and Public Health Service Policy on Humane Care and Use of Laboratory Animals; NIH Office for Protection from Research Risks
The Animal Welfare Act of 1985 is the governing federal legislation for the “humane handling, care, treatment, and transportation” of animals. Its provisions have been incorporated into the regulatory frameworks of the Public Health Service's Policy on Humane Care and Use of Laboratory Animals and other agencies. Its administration and coordination in the PHS has been delegated to the NIH Office for Protection from Research Risks. The Animal Welfare Act, however, charges the USDA's Animal and Plant Health Inspection Service to license and inspect businesses and other organizations who use animals for trade, show, or research. Conventions for uses of animals in research, teaching, and testing have been assembled and integrated in the Guide for the Care and Use of Laboratory Animals by the Institute of Laboratory Resources, Commission on Life Sciences, of the National Research Council of the National Academy of Sciences.
Species and uses covered by law and regulation
The Animal Welfare Act addresses “warm-blooded animals.” However, the Guide for the Care and Use of Laboratory Animals, which has become the standard for federal research agencies, explicitly covers “any vertebrate animal” and suggests that many of its general principles apply to invertebrate species as well.
Laboratory versus farm settings
The Guide for the Care and Use of Laboratory Animals recognizes the blurred boundary between laboratory and farm research, teaching, and testing and acknowledges that specific standards for the use of animals in these two settings differ even as basic ethical principles for treatment of animals remain the same.
The Institutional Animal Care and Use Committee (IACUC)
All federal agencies that fund research require that organizations licensed for the use of animals in research establish an IACUC to oversee that use.
Jurisdiction
The IACUC has the responsibility to evaluate, report on, and inspect the facilities of all units employing animals for research, teaching, or testing.
Mission
The mission of the IACUC is to assure the humane handling, care, treatment, and transportation of covered animal species.
Structure
IACUC's must have a minimum of three members, at least one of whom must be a doctor of veterinary medicine. At least one must be a practicing scientist with relevant animal experience, and at least one must be a "public member" not otherwise associated with the institution or an immediate family member of someone affiliated with it and who is not a user of laboratory animals.
Procedures of the IACUC
The IACUC receives and approves, defers, or rejects applications from investigators proposing to use animals in research. No research with animals may proceed without IACUC approval. IACUC subsequently inspects animal facilities and laboratory settings in which animals are used on a semiannual schedule. It has the power to suspend research operations with animals to correct violations of policy. It reports semiannually to the Vice Provost for Research. IACUC has specific guidelines established for common experimental techniques that may cause pain or distress to animals. This would include need for analgesics, use of anesthesia, sterile surgery requirements, blood collection, immunization, euthanasia, tumor induction, animal handling and restraint.
This section describes the process whereby the IACUC reaches its conclusions about the approvability of research proposals and about stipulations for carrying them out.
Continuing review
Approval of research proposals by the IACUC is but the first step in a continuing oversight process. PI's submit annual reports on their activities and submit to semiannual inspections.
Inspection schedule for animal facilities
A subcommittee of the IACUC inspects every animal facility every six months. Representatives of AAALAC inspect the facilities they accredit every three years.
Accountability and enforcement
Who reports to whom?
Principal investigators employing animals report to the IACUC. The IACUC reports to the Vice Provost for Research every six months. The Vice Provost reports to the USDA Animal and Plant Health Inspection Service every six months and also on suspension of activities.
USDA Animal and Plant Health Inspection Service inspection
The USDA's APHIS carries out periodic inspections of institutional facilities and procedures to assess compliance with federal law and regulations.
Licensing and Sanctions
Repeated violations of licensing requirements could lead to suspension or revocation of the University's license to carry on activities that make use of animals.
Risk/benefit Analysis
Subjecting animals to risk or certainty of discomfort, pain, and distress requires that the scientific benefits be at least commensurate. Investigators are responsible for designing research in which benefits outweigh risks or harm to animals and for persuading the IACUC that this is so. Additionally, investigators must show that there are no acceptable alternatives to animal use. Alternatives may include non-animal alternatives, but also include concepts such as using the “lowest” species possible, minimizing the numbers used (statistical planning of the experiment, minimizing variability within the model, etc.) and minimizing the pain/distress associated with a particular model.
Species-specific standards for housing and care of animals, including identification of individuals
Housing standards address structural soundness, cleanliness, climatization, ventilation, lighting, and other variables. These must be appropriate to the species, condition, and history of the individual animal. Animals must be treated with consideration for species-specific behavioral needs, including with regard to feeding, watering, exposure to the elements, housing density, and proximity of other species. Similar considerations apply to transportation of animals.
Role of veterinary supervision
Investigators, dealers, and exhibitors must provide veterinary supervision of animal facilities. IACUC's and their site inspection teams must include at least one veterinarian.
Levels of review
Summary of the Roles of Principal Investigators, IACUC's, AAALAC, and Federal Agencies
Reporting requirements
The IACUC conducts semiannual reviews of animal research projects and semiannual inspections of each animal facility. It submits a semiannual report of its findings to the Vice Provost for Research, who submits an annual report to the APHIS, REAC sector for the institution's state and to the Office for Protection from Research Risks, National Institutes of Health.
Record-keeping
The IACUC maintains records of all reports and inspections as well as of the individual histories of individual members of certain species.
Supervision and training of personnel
All personnel in contact with animals must be suitably trained or supervised by suitably trained individuals. All must be certified for animal contact by IACUC. All animal facilities must operate additionally under the supervision of a veterinarian. In both the fall and spring semesters, the University of Memphis IACUC offers a course in animal care and use, taught by the University of Memphis veterinarian. This course is required of all graduate students and new faculty and staff who conduct animal research.
Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council (1996). Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press.
Institutional Animal Care and Use Committee Guidebook (1985).Rockville, MD: Office for Protection from Research Risks, National Institutes of Health.
Public Health Service Policy on Humane Care and Use of Laboratory Animals (1986). Rockville, MD: Office for Protection from Research Risks, National Institutes of Health.
Beauchamp, T. L. (1997). Opposing views on animal experimentation: Do animals have rights? Ethical issues of animal research. Ethics & Behavior, 7, 113-121.
Cohen, C. (1997). Do animals have rights? Ethical issues of animal research. Ethics & Behavior, 7, 91-102.
DeGrazia, D. (1991). The moral status of animals and their use in research. Kennedy Institute of Ethics Journal, 1,48-70.
Frey, R. G. (1997). Moral community and animal research in medicine. Ethical issues in animal research. Ethics & Behavior, 7, 123-136.
Orlans, F. B. (1997). Ethical decision making about animal experiments. Ethical issues of animal research. Ethics & Behavior, 7, 163-171.
Regan, T. (1997). The rights of humans and other animals. Ethical issues of animal research. Ethics & Behavior, 7, 103-111.
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