why are animals used in research?
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Why Are Animals Used in Research?. Organs and body systems are similar to humans Genetic makeup and immune system are similar to humans Susceptible to same diseases. Why Are Animals Used in Research?. - PowerPoint PPT PresentationTRANSCRIPT
Why Are Animals Used in Research?
Organs and body systems are similar to humans
Genetic makeup and immune system are similar to humans
Susceptible to same diseases
Why Are Animals Used in Research?
Physiological responses to environmental change and to disease are similar to humans
We can control their environment and thus minimize variables
Creation of models of disease
Translational Research
Past two decades focused on cellular and molecular biology
Now there is a need to bring that research into body systems
US Senate has mandated additional funding for such research
Health Benefits from Biomedical Research
Increased average US life-span and decreased infant mortality rate
Disease protection through immunization: polio, diptheria, mumps, rubella, hepatitis
Diabetes treatment and insulin safety
Health Benefits from Biomedical Research
Surgical and minimally invasive procedures: coronary bypass, cardiac catheterization, organ transplantation, joint replacement, cataract surgery
Chronic disease treatment: epilepsy, asthma, renal dialysis
Diseases Currently Depending on Biomedical Research
Congenital cardiac defectsSpinal injuryMultiple sclerosisSchizophreniaCancerSickle cell anemiaAIDSParkinson’s disease
Advances in Animal Health
Vaccines for rabies, distemper, parvo-virus infection, hepatitis, anthrax, tetanus, feline leukemia
Treatment of cardiac disease, cancers, traumatic injury,
Neonatal intensive care in foals
Recent Trends in Animal UseRecent Trends in Animal Use
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1997 1998 1999 2000 2001 2002
DogsCatsNHPsFarm
How Mice and Rats are Used in Research
These are 90% of all animals used in research
Transgenic animals--a foreign gene added Study of Parkinson’s disease, cancer, cystic
fibrosis, heart disease, muscular dystrophyGenetic knockout animals--specific
gene turned off
How Mice and Rats are Used in Research
Specific immunodeficiency annimalsAlzheimer’s disease--transgeneic
causing over-expression of amyloid protein and vaccination with protein
Cancer--sensitivity to environmental carcinogens and development of resistant genetic strains
Heart attack--regeneration of heart muscle cells
How Nonhuman Primates are Used in Research
Development of AIDS vaccine using Simian Immunodeficiency Virus
Vaccine development for hepatitis B and C
Malaria vaccine development--NHP’s are susceptible to the same parasite strain
Periodontal disease--NHP’s naturally develop the same disease
How Dogs are Used in Research
Development of surgical procedures for heart valve and artery replacement
Development of organ transplant procedures and management
Cause and treatment of diabetesCause and treatment of NarcolepsyCause and treatment of retinal
degeneration and blindness
How Cats are Used in Research
Study of nerve transmission in the brain
Understanding organization of neurons in the brain
Understanding normal and abnormal function of the visual system
Oversight of Animal Use in Research
Animal Welfare ActPublic Health Service: NIH Guidelines
for federally funded researchFDA: medical devices & drug
development and approvalEPA: health effects and
environmental effects testing
The Animal Welfare Act
Passed in 1966 and amended in 1970, 1976, 1985, 1990, 2002
“Top-down”--passed by Congress in response to publicity over dog theft
Includes input from animal protection and anti-vivisection groups
The Animal Welfare Act
1985 amendment authorizes institutions to form an IACUC, provide and exercise program for dogs, and provide for psychological wellbeing of primates
Covers all warm-blooded animals, but birds, mice and rats are excluded by act of the USDA
Enforcement of the Animal Welfare Act
Enforcement through the USDA, specifically APHIS through veterinary inspections
Unannounced site visits by USDA veterinarians and reporting of any non-compliance
AWA Summary
Federal law in response to allegations of pet theft--what the public demands
Input from animal protection groupsEnforced by the USDA through inspection
of research facilities, animal exhibitionsProtects all warm-blooded animals
EXCEPT rats, mice and birdsMandates the formation of the IACUC
Public Health Service: The NIH Guidelines
“Bottom-up” self-regulatory professional standards for lab animal care developed by veterinarians an animal care personnel
No input from animal protectionist groups
The Animal Care Panel wrote the Guide for the Care and Use of Laboratory Animals in 1963
The NIH Guidelines
NIH Policy guidelines encoded as law as the Health Research Extension Act in 1985
With this act, Congress made compliance with the Public Health Service Policy on Humane Care of Laboratory Animals mandatory for any institution receiving federal funds
Enforcement of the NIH Guidelines
Through voluntary accreditation by Assoc. for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) founded in 1963
Inspection every 3 years by lab animal veterinarians
NIH recognizes voluntary AAALAC accreditation as evidence of compliance
Enforcement of the NIH Guidelines
All vertebrate animals covered, but only institutions receiving PHS funding are required to comply
An institution may voluntarily make a commitment to comply with PHS policy on care and use of animals in research even if it does not receive federal funds
The IACUC--Convergence of the AWA and NIH Guidelines
Committee existence and makeup are mandated by the AWA and the PHS/NIH Office of Laboratory Animal Welfare
IACUC activities are evaluated during both the USDA inspection and the AAALAC inspection
IACUC members include peer scientists, a veterinarian, and a community member
Responsibilities of the IACUC
Evaluate the institutional program and facilities every 6 months Assure compliance with the Guide Formal report noting deficiencies and
time for correctionEvaluate all facilities: housing and
procedure space
Responsibilities of the IACUC
Approval of all new applications for animal research activity
Re-review of all research protocols every 3 years
Investigate all allegations of mistreatment or non-compliance investigation, reporting, and correction;
suspension of activity if warranted
Animal Welfare Considerations
Institutional Animal Care & Use Committee required by USDA, NIH, AAALAC Committee composition specified Semi-annual review of entire program and
correction of deficiencies required Protocol and grant pre-approval required Dissenting votes recorded
The Animal Experimentation Protocol
Section B: narrative description of proposed research--must be understandable by community member
USDA pain category applicable to research and number of animals in each
Description of surgical procedures, anesthesia and post-operative analgesia
The Animal Experimentation Protocol
Justification of species and numbers of animals proposed
Federal assurances regarding non-duplication and search for alternatives to painful procedures
USDA Pain Categories
Category C: No pain or distress greater than minor or momentary injections, blood sampling
Category D: Potentially painful or distressing expts. for which analgesic, anesthetic or tranquilizing drugs are used
Category E: As above, but for which use of such drugs would adversely affect results or interpretation
Guidelines for Animal Research--The 3 R’s
ReplacementReductionRefinement
These principles guide IACUC review of research proposals
Replacement
Adopting the: Use of less (or non) sentient
organisms Use of in vitro techniques The use of non-biological alternatives Human Studies
Reduction
Reducing the number of vertebrate animals in experiments
Not repeating unnecessary experiments
Using appropriate statistical tools
Refinement
Modification of procedures which must involve sentient animals to minimize animal suffering
Use of anesthetics and analgesics to minimize animal suffering
Improved animal husbandry and handling, reducing stress
Development of alternative methods of drug and product development where the severity of the endpoints is reduced