1. The Animal Research Environment
ALAT Chapter 2
The Animal Research Environment

2. Biomedical Research NIH – largest government source
Goal: gain new knowledge with which to improve the future of people and animals
Funding sources:
NIH – largest government source
other government agencies
private organizations – cancer, heart
pharmaceutical and chemical companies

3. Benefits of Research Humans Animals vaccinations antibiotics
joint replacements,organ transplants
chemotherapy
etc, etc etc………
Animals
vaccines
disease treatments (see above)
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2006

4. Animal Research Regulations
All individuals working with lab animals should be aware of and comply with regulations and guidelines of the field
Guide for the Care and Use of Laboratory Animals
Animal Welfare Act and the Animal Welfare Regulations
Public Health Service Policy
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.
American Veterinary Medical Association Guidelines on Euthanasia
ALAT certification reference list

5. Development of regulations and guidelines
Earliest law to protect animals in America passed in 1641 in Mass.
1st federal anti-cruelty law in 1873
Meat packing industry
Limit amount of time animals were confined for transport
Mandated food, water, and rest
Anti-cruelty laws extended to lab animals in 20th century
ACP published 1st edition of Guide in 1963

6. Government Guidelines
1873 – the 28-hour law – first federal law mandating humane treatment of farm animals during shipment; no animal could go longer than 28 hr without food, water or rest

7. The Guide Prepared by Institute of Laboratory Animal Research (ILAR)
Last revised in 1996
Primary source of the standards and guidelines for lab animal care in the US.

8. The Guide Describes standards for the following components
Personnel qualifications
Occupational Health and Safety
Veterinary care
Animal environment and housing
Animal Procurement and transportation
Surgery and Post-Surgical care
Alleviation of pain and distress
Euthanasia Techniques
Physical plant design and construction

9. AAALAC Created by the ACP
The Association for the Assessment and Accreditation of Laboratory Animal Care
Private, non-profit organization that promotes humane treatment of lab animals and accredits animal research programs
Also uses the Guide for accreditation
This voluntary organization evaluates animal care and use programs

10. Later Regulations Legal standards for laboratory animal care.
Animal Welfare Act - USDA
Legal standards for laboratory animal care.
regulates all warm-blooded vertebrates except birds, laboratory rats and mice and farm animals (wild rodents are covered)
requires that the facility keep records and submit an annual report of animal use by December 1 of each year
covers sanitation, feeding, housing, transportation and veterinary care

11. Animal Welfare Regulations
Published yearly in the Code of Federal Regulations (CFR)
Defines roles of different individuals in the laboratory
Describes what a facility must do to comply with the AWA
Administered by Animal and Plant Inspection Service (APHIS) of the United States Department of Agriculture (USDA)

12. 1985 – Revised AWA establishment of IACUC
New regulations added:
establishment of IACUC
enrichment programs for NHP and exercise for dogs
training of personnel
guidelines for surgical procedures and the use of analgesics
USDA inspection of facilities and records

13. USDA inspections
A matter of public record due to the Freedom of Information Act
Unannounced
Looks at facility, animals, and records
Deficiencies are reported to the IO for correction
Failure to correct may result in suspension of research activities

14. IACUC - Institutional Animal Care and Use Committee
Required by the Animal Welfare Act and the Public Health Service (PHS)
At minimum, must have:
Chairman
laboratory animal veterinarian
scientist
non-scientist
a non-affiliated member
Members appointed by the institutional official (CEO of the company)

15. IACUC Duties Oversee animal research programs
Ensure regulatory compliance
Review submitted protocols
Semiannual facility inspection and evaluation of animal programs
Report deficiencies and plans for correction to the institutional official

16. Public Health Service Oversees many government agencies
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Substance Abuse and Mental Health Services Administration (SAMHSA)

17. PHS
Requires that institutions ensure the appropriate care and use of all animals involved in PHS-conducted or supported research.
Covers all vertebrates – even those not covered under AWA
Also covers cold-blooded vertebrates

18. PHS Requires Occupational Health and Safety program
Grant recipients must follow
AWA
The Guide
AVMA Guidelines on Euthanasia
Administered by Office of Laboratory Animal Welfare (OLAW)

19. Public Health Service
Facilities using funds provided by agencies of PHS (includes NIH) must provide a yearly Animal Welfare Assurance Statement and follow the Guide for the Care and Use of Laboratory Animals, prepared by Institute of Laboratory Animal Resources (ILAR)

20. Animal Welfare Assurance Statement
List lines of authority and qualifications of veterinarians
Members of IACUC protocol review procedures
Description of OHS program
Outline of training
Description of facilities

21. Research Program
Submit research proposal – aims, methods and expected results
Review of animal use protocol – procedures, housing and care
Apply for funding or grant
Do the study and evaluate the results

22. Protocol Scientific principles Governmental regulations
A detailed description of the procedures involving use of animals
Must be approved by IACUC
Approval based on:
Scientific principles
Governmental regulations
IACUC may also look at scientific merit

23. Food and Drug Administration
Regulates research of drugs, food additives, biomedical devices and biologicals
Established Good Laboratory Practices for all research funded or reviewed by the FDA
Also required by those funded or reviewed by the EPA

24. Good Laboratory Practices (GLP)
Purpose is to validate and document the processes by which safety tests are conducted so they can be replicated
Requires SOPs, training records and evaluations, training of personnel
Proper husbandry, sanitation, records of daily care and individual animal treatments
Supporting documentation must be kept for 2 yr after completion of the project
Separate housing for each species

25. Standard Operating Procedures (SOPs)
Written instructions, approved by management, used to perform a routine activity
Step by step
General housekeeping, husbandry chores, feed storage
Breeding, blood collections, dosing

26. AVMA Guidelines on Euthanasia
Lists acceptable, conditionally acceptable, and unacceptable methods of euthanasia
Must be followed - The Guide and PHS policy

27. Ethics of Animal Use in Research
Use should be scientifically relevant.
Physical and psychological well-being
Not submitted to unnecessary pain and distress
Euthanasia to end suffering
The Three “R’s”
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2006

29. The Three “R’s” Replacement Refinement Reduction
replace animals with cell or tissue cultures, or by computer models, etc
Refinement
minimize stress or pain where possible
Reduction
reduce number of animals to numbers that yield a statistically sound scientific benefit
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2006

30. Career Opportunities in Laboratory Science
Public health
Teaching
Research
Pharmaceutical, chemical and feed manufacturers
Commercial animal suppliers