ANIMALS IN RESEARCH
Katherine A. Goans
Associate Director
Department of Laboratory Animal Resources
Decision to use animals in research requires critical thought, judgment, and analysis
Using animals in research is a privilege granted by society with the expectation that such use will provide either significant new knowledge or lead to improvement in human and/or animal well-being
Ethics and Animal Use
Animal Welfare Act – administered and enforced by the US Dept of Agriculture (USDA), this act licenses dealers, exhibitors and breeders of animals, regulates research facilities that use animals and regulates the transport of animals. The original passage of this act was in 1966.
Animal Welfare Act Regulations – Title 9 of the Federal regulations includes information on registering research facilities, appointing an Institutional Animal Care and Use Committee, hiring an attending veterinarian, record-keeping requirements, submission of an annual report, and requirements for training personnel.
Animal Care Resource Guide Policies – Supplemental to the regulations; provides additional clarification regarding the Veterinary Care Program, Necropsy Requirements, Consideration to Alternatives to Painful/Distressful Procedures, and Major Survival Surgery
US Dept of Agriculture, APHIS – the Animal and Plant Health Inspection Service is a multi-faceted Agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities.
REGULATORY BODIES
Public Health Service Policy on Humane Care and Use of Laboratory Animals – administered and enforced by the Office of Laboratory Animal Welfare (OLAW) at the National Institute of Health (NIH), this policy covers all species of animals including birds, mice and rats. It also covers all research funded by the NIH.
Health Research Extension Act of 1985, Public Law 99-158, November 20, 1985, “Animals in Research”
US government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
Public Health Service Policy on Humane Care and Use of Laboratory Animals – ASSURANCE
Regulatory Bodies
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The Guide for the Care and Use of Laboratory Animals – Published by the National Research Council, this document is designed to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate. Its standards are mandatory for institutions filing an Animal Welfare Assurance to receive Public Health Service funding and also for institutions accredited by the AAALAC.
Association for Assessment and Accreditation for Laboratory Animal Care International (AAALAC) – an independent and voluntary accreditation organization. AAALAC accredits laboratory animal facilities through a process of intensive inspections every 3 years and yearly reports. It follows the high standards set forth in The Guide. While voluntary, accreditation represents a commitment to excellence in animal care by an institution. UT-HSC is currently accredited; UT-MC will be included in the inspection at the end of this year.
Regulatory Bodies
Institutional Official – individual with the authority to make a commitment on behalf of the institution that the requirements of the Assurance will be met. Dr. William Messer in the Vice President of Research.
IACUC – appointed by the IO and composed of scientists, non-scientists, the attending veterinarian and a non-affiliated community member. The committee is responsible for:
1. Semi-annual inspection of the animal facilities
2. Semi-annual review of the program
3. Review of protocols and amendments
4. Submission of reports to the IO
5. Mechanism for receipt and review of concerns involving the
care and use of animals at an institution
Institutional Animal Care and Use Committee
Originally published in 1959, the concept of the “3 Rs” is an internationally accepted approach.
Replacement – methods that avoid the use of animals; includes absolute replacements as well as relative replacements (animals lower on the phylogenic scale)
Refinement – modification of husbandry or experimental procedures to enhance animal well-being and minimize or eliminate pain and distress
Reduction – strategies for obtaining comparable levels of information from the use of fewer animals or maximizing the information obtained from the animals used
Protocol Design
Regulatory Body Interaction
Regulatory Body Interaction
Veterinary Care Program
Primary focus is to oversee the well-being and clinical
care of animals
Personal Qualifications and Training
All personnel must be adequate education, trained and/or qualified
Occupational Health & Safety
Must be consistent with federal, state, and local regulations and should focus on maintaining a safe and health workplace.
Animal Environment, Housing, and Management
The facility should be well-planned, well-designed, well-
constructed, properly maintained and managed
Programs
“No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulations or standard under the Act.” (9CFR (AWAR) § 2.32 © (4)).
Reporting Concerns
Conclusion
The topic of animal research is a highly debated one. Without these animals, we would not have accomplished the advances in medicine that we have. It is our responsibility to provide the best care possible and to conduct the research with the highest integrity.
CONGRESS
UDA / APHIS
NAS / ILAR
ALL RESEARCH FUNDED BY
PHS / NIH
PHS / NIH / OLAW
ANIMAL WELFARE ACT
REGULATIONS
PHS POLICY
ASSURANCE
APHIS
INSPECTIONS
THE GUIDE
ALL RESEARCH INVOLVING
USDA –REGULATED
ANIMALS
HEALTH RESEARCH
EXTENSION ACT
ANIMAL WELFARE ACT
FEDERAL LAWS
RSP / IACUC OFFICEANIMAL CARE PROGRAM
VETRINARIAN
IACUC
INSTITUTIONAL OFFICIAL
RESEARCH AND SPONSORED PROGRAMS
INVESTIGATOR
RESEARCH
STAFF
CHAIRMAN
