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  Home > Ethics > Curriculum > Animal Subjects
Teaching Ethics for Research, Scholarship, & Practice

Animal Subjects

Eric Klinger (with verbatim contributions by Dale Cooper) May, 1999

Learning Objectives

University Policies and Procedures

Curriculum Overview

Information Resources

 

Learning Objectives

  1. List the principles that must be adhered to in conducting research on animals.
  2. Briefly describe the jurisdiction, mission, structure and functions of an IACUC, including mechanisms for accountability and enforcement.

Greater depth:

  1. Given a list of species, identify those that are covered by the Animal Welfare Act.
  2. Given descriptions of protocols that require oversight of the use of animals in research, the learner will indicate a) when and b) how institutional oversight is applied.
  3. Prepare an application for use of animal subjects in research that meets criteria for IACUC approval.

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University Policies and Procedures

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Curriculum Overview

History of Regulation of Animals Used in Research

History of abuse of animals and the issue of their humane use, the development of the Humane Society, the role of NIH since 1896 in advocating humane use of animals in research, and enactment of the Animal Welfare Act and subsequent legislation and regulation.

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Principles of Protection of Animal Subjects During Research Procedures

Standards dictated by the Animal Welfare Act. Balancing societal benefits with imposition on animals, both with respect to suffering and numbers of animals.

  • Minimization of pain, suffering, and distress in all procedures
  • Species-appropriate housing, feeding, and care
  • Involvement of veterinary personnel
  • Qualifications of investigators and their personnel.

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Legal and Regulatory Framework:

  • Animal Welfare Act
  • National Academy of Sciences Guide for the Care and Use of Laboratory Animals
  • 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.

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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.

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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.

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What and Who is 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

  • IACUCs 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. University of Minnesota policy requires a committee of at least five individuals. In practice, the committee is larger than this.

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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 Institutional Official. 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.

  • Decision process:
    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.

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Accountability and Enforcement

Who reports to whom?

  • Principal investigators employing animals report to the IACUC. The IACUC reports to the Institutional Official (IO) designated by the University President every six months. The IO reports to the USDA Animal and Plant Health Inspection Service every six months and also on suspension of activities. In addition, the Academic Health Center, College of Liberal Arts, Hormel Institute and Duluth Medical School animal care programs are covered by an accreditation body, AAALAC, International. They perform a site visit every 3 years.

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.

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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.

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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.

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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.

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Levels of Review

Summary of the roles of principal investigators, IACUC's, AAALAC, and federal regulatory agencies.

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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 Institutional Official, 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.

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Record-Keeping

The IACUC maintains records of all reports and inspections as well as of the individual histories of individual members of certain species.

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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.

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Responsibilities of Principal Investigators

This section, recapitulating and summarizing much of the other material, describes the PI's role in designing appropriate facilities, care, and research procedures, training personnel, monitoring them, applying for IACUC approval of research protocols, maintaining records, submitting to semiannual inspections, and reporting irregularities. Principal investigators are responsible for monitoring the welfare of the animals entrusted to them.

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Management Structure for Maintaining Animal Resources at the University of Minnesota

Within the University’s major facilities (i.e. those in the AAALAC accredited units) the facilities and care are normally managed by someone other than the PI. For the Twin-Cities campus it is Research Animal Resources or the College of Veterinary Medicine animal facilities management (they will merge in July). Hormel, the Duluth Campus, and many of the agricultural facilities also have centralized management. However, some laboratories maintain their own animal facilities. Investigators who maintain their own animal facilities need to be aware of Facilities & Operating Standards, Animal Health and Husbandry Standards, and Transportation Standards for vertebrate animals.

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Information Resources

Web Sites

Research Animal Resources, Academic Health Center, University of Minnesota
http://www.ahc.umn.edu/rar/

Institutional Animal Care and Use Committee
http://www.research.umn.edu/iacuc/

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References

Board of Regents of the University of Minnesota (1999). "Animal Care and Usage."

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 (19??). 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.

University of Minnesota Animal Care and Use Manual

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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