| Animal
Subjects
Eric Klinger (with verbatim contributions by Dale Cooper) May,
1999
Learning Objectives
University Policies and Procedures
Curriculum Overview
Information Resources
Learning
Objectives
- List the principles that must be adhered to in conducting research
on animals.
- Briefly describe the jurisdiction, mission, structure and functions
of an IACUC, including mechanisms for accountability and enforcement.
Greater depth:
- 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, the learner will indicate 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.
top
University
Policies and Procedures
top
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.
top
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.
top
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.
top
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.
top
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.
top
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.
top
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.
top
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.
top
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.
top
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.
top
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.
top
Levels of Review
Summary of the roles of principal investigators, IACUC's, AAALAC,
and federal regulatory agencies.
top
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.
top
Record-Keeping
The IACUC maintains records of all reports and inspections as well
as of the individual histories of individual members of certain
species.
top
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.
top
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.
top
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.
top
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/
top
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.
top
|
