Laboratory Animal Program Use of Animals in Research History and Regulations Valerie Bergdall, DVM, DACLAM Director, University Laboratory Animal Resources Professor, Veterinary Preventive Medicine
Laboratory animal science: information and techniques applicable to lab animal husbandry, nutrition, behavior, management of animal care programs Laboratory animal medicine: diagnosis, treatment, and prevention of laboratory animal diseases
Greeks and Romans were the first known to use animals for scientific observations. In the 19 th and 20 th centuries animal In the 19 and 20 centuries, animal research advanced exponentially leading to the discovery of vaccines, anesthetics, the concept of infections, and need for sanitation to name a few.
Dr. Simon Brimhall of the Mayo Clinic became the first laboratory animal veterinarian in 1915 In 1950, the Animal Care Panel (ACP) was established, and in 1967 became known as AALAS (American Association for Laboratory Animal Science).
The AALAS organization serves to communicate information related to the production, care, and study of lab animals, certifies technicians, and promotes education via publications, meetings, and other venues. http://www.aalas.org/index.aspx
AAALAC International (Association for the Assessment and Accreditation of Laboratory Animal Care, International) Voluntary accreditation organization which evaluates an animal care program s conformation to high standards of animal care NABR (National Association for Biomedical Research) Promotes education on benefits of research to the public and lobbies on behalf of research iifar (Incurably Ill For Animal Research) Patient-led organization to promote the use of animals in research to help find cures for chronic or terminal diseases AVMA (American Veterinary Medical Association) Organization for all veterinarians in the US and producer of the AVMA Guidelines on Euthanasia ACLAM (American College of Laboratory Animal Medicine) Recognized by AVMA in 1957 as a veterinary specialty organization whose members have demonstrated comprehensive knowledge of laboratory animal medicine via successful completion of an examination PETA (People for the Ethical Treatment of Animals) Organization devoted to stop the use of animals in research as well as other venues. Primarily a lobbying and public relations group.
Role of the animal care staff: Support the research effort through standardized animal care, and identification of potential problems (illness, environmental conditions, etc) Critical member of the research team since changes in the environment or handling of animals can introduce variable to research projects leading to incorrect research hinterpretations. t ti
Ethics of Animal Use principles of honor and morality; accepted rules of conduct; moral principles of an individual Biomedical scientists t use animals because of the similarities we share and knowledge that would otherwise not be gained Animal research has ethical opponents who do not believe that the knowledge gained justifies animal use in research
Rules of conduct related to animal research: Russell and Burch 3 R s Replacement by non-animal models Refinement by minimizing stress or pain Reduction using minimal numbers of animals
Who benefits from animal research? Anyone who gets a vaccination Anyone who receives an antibiotic Recipients of organ transplants, heart surgery, joint replacements Newborns with congenital diseases such as heart defects Basically everyone (including animals) that has received medical care!!!!
How does research happen?
Research proposal Grant sent to funding agency Grant awarded pending IACUC approval of animal work if applicable Research project can start
Research Team: Principal investigator (PI) is the scientist who plans and coordinates all phases of the research Co-Investigators and Research Techs perform the tasks including collecting, organizing, and analyzing the data Lab Animal Techs perform animal care functions critical to the maintenance of healthy animals and control/identify variables in the animals environment that could negatively impact the research Lab Animal Veterinarian responsible for colony health and regulatory compliance; consult on animal model selection and IACUC protocol development
Variables with the potential to impact research: Differences in cleaning schedules and procedures Changes in feed and bedding Changes in temperature, humidity, light, or noise Changes in smells such as perfumes or cleaning agents
Funding sources i.e. grants Highly competitive Federal funding includes National Institute of Health (NIH; primarily biomed research) National Science Foundation (NSF; general science disciplines) Other private sources include American Heart Association, American Cancer Society, etc Drug companies and other biomedical companies also fund animal research
Some studies are required by the US Food and Drug Administration (FDA), the agency responsible for determining if new drugs and medical devices are safe and effective, and monitoring their performance once approved. Established by Congress in 1938 (Food, Drug and Cosmetic Act), amended in 1962. In 1978, FDA required all studies supporting their mission to be done using Good Laboratory Practices (GLP) standards similar to EPA study requirements.
Animal Use Proposal or Protocol: Description of the procedures involving animal use that is submitted to the IACUC (Institutional Animal Care and Use Committee) Animal use must be approved by the IACUC before the animal work can start!!!
Animal Use Proposal or Protocol includes the following: Rationale for the project Scientific question to be answered by the work Species and number of animals to be used Description of what will be done to the animals Qualifications of the research team Method of euthanasia if applicable
PI writes protocol in consultation with the lab animal vet IACUC reviews protocol Approves study, requires clarifications, pp y, q, disapproves study
IACUC Responsibilities: Review animal use protocols Conduct semiannual facility inspections Review entire animal use program semiannually Reports to the Institutional Official and regulatory agencies as required
So. Where does the IACUC get the authority/ responsibility for the animal care program?????
Laws: 28 hour law enacted in 1873 The Federal Humane Slaughter Act of 1958 requires compliance with humane slaughter conditions The Animal Welfare Act enacted ed by congress in 1966, amended several times since Standards (written expectations) developed and enforced by APHIS (Animal Plant Health Inspection Service branch of the USDA)
AWA was originally enacted in 1966 by Congress in order to address concerns by the public regarding stolen pets being used for research in response to Life magazine article Initially covered dogs and cats only
amended in 1970 to include other species when used in research, exhibition, or the wholesale pet trade amended in 1976 to cover transportation of animals amended in 1985 to address well-being of dogs and primates, establishment of animal use protocols and committees to oversee animal use amended d in 1990 to establish a holding period for dogs and cats at shelters
Species covered by the AWA live or dead dogs cats primates guinea pig hamster rabbit any other warm-blooded animal for research, teaching, or exhibition purposes
AWA currently EXCLUDES: birds rats of the genus Rattus mice of the genus Mus farm animals used for food/ fiber research or production coldblooded animals
AWA regulations address: Housing Handling Feed and watering Sanitation Ventilation Separation of species Veterinary care
Requirements for lab animal research facilities by AWA: Register with the USDA Maintain records on source and disposition Annual report to USDA by Dec 1: species and number of animals used in projects categorized for pain status; details on projects which cause pain or distress Provide appropriate housing and environmental conditions for each animal. Sanitize cages and facility per regulations Provide adequate veterinary care Provide proper transportation conditions when shipping/receiving animals
Additional AWA requirements added by the 1985 amendment: Training for research team Dog exercise Primate psychological py well-being gplan Requirement for relief of pain unless scientifically justified to with-hold Limiting i i of one major survival surgery per animal Establishment of the IACUC Inspection of facilities by IACUC Consideration of alternatives to animal use
AWA enforcement: Annual inspection, unannounced Violations can result in fines, removal of animals, and even jail time Public can request copies of records of inspections via the Freedom of Information Act (FOIA)
Public Health Service (NIH and CDC) funded institutions must follow additional regulations called the Public Health Service Policy on Humane Care and Use of Laboratory Animals Covers all vertebrates including those which are excluded by the AWA Enforced by the Office of Laboratory Animal Welfare (OLAW) at NIH
The institution is required to send an Animal Welfare Assurance Statement to OLAW which is valid for no more than 5 years, and includes: Institution s s organization chart including lines of authority and compliance Qualifications, authority, and responsibilities of the veterinary staff IACUC membership list IACUC protocol review process description Occupational health program for animal personnel Animal training program Description of the facilities and average daily census by species
The Guide for the Care and Use of Laboratory Animals originally published in 1963, most recently updated in 1996. Currently in the process of being updated again Must be followed according to PHS policy for those institutions receiving their funds
The Guide sections: Institutional policies Lab animal management Veterinary care Physical plant Appendix
covers all live, vertebrate animals used for research Prepared by The Institute of Laboratory Animal Resources (ILAR) Developed by panel of researchers, public members, veterinarians, and approved by NIH
The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching used for Ag research biomedical animals housed in a farm setting (housing facility section only) published by the Federation of American Societies of Food Animal Sciences.
AAALAC uses the AWA regulations, the Guide and other applicable laws and policies as the basis for their evaluation Inspections occur every three years Complete descriptions of the animal care program must be submitted every three years Annual reports to AAALAC
Career Opportunities: ALAT LAT LATG Supervisor Progressively increased responsibility AALAS Certification is recognized throughout the lab animal community