• Written by congress
•  broad overview 
•  designates agency to implement 

• written by agency 
• designed to implement the spirit of the law

• Animal welfare =  health and wellbeing, 5 freedoms
• Animal rights = animals having same rights that people have

• plants, computer models, tissue cultures 
• Technology cannot replicate what goes on in a whole, living system. Alternatives cannot be used in clinical research.

• often computer models/plants
• advance knowledge of life processes/diseases

• computer models, tissue cultures, or live animals
• uses existing knowledge to solve SPECIFIC problems

• builds on knowledge from basic and applied research
• always conducted on animals and humans

1. Identify problem
2. Detailed search of literature 
3. Hypothesis 
4. Develop design 
5. Submit to IACUC

• Reduce - fewest number of animals 
• Replace - lower life forms or artificial means
• Refine - least amount of pain/distress

NIH

PHS and AAALAC

evaluation of animal use and inspection of facilities

NO

• American Association for Laboratory Animal Science
• forum for the exchange of information for the care and use of lab animals
• Provides certification for Lab Animal Techs

• Good Laboratory Practice 
• Regulation with standards provided by the FDA
• Responsible for assuring a study's validity.
• Non-clinical studies for products regulated by the FDA

What are the key requirements for GLP? 

(3)

• Define responsibilities of personnel
• standard operating procedures 
• raw data acquired and recorded

• put teeth of the law in the PHS policy 
• requires adherence to the guide
• requires IACUC to submit the assurance 

• documentation assuring compliance with PHS policy
• must be submitted to OLAW in order to recieve funding

• Mandates adherence to AWA 
• Mandates adherence to the Guide
• Submission of the assurance by the IACUC
• Proposoals for grants must include certain information 

• institution pays a fee
• submits program description
• inspection every 3 yrs 

• USDA license(if USDA species are used)
• NIH Assurance (if PHS funding is used)
• IACUC
• Appropriate animal care
• appropriate facilities
• veterinary care
• training program

• Review the Animal Care and use program
• maintain records and report (for USDA and OLAW)
• Personnel qualifications
• review AUF

• application to request use of vertebrate animals 
• documents all aspects of the project and justifies it
• primary investigator completes
• IACUC approves before beginning research

• Document the project on the AUF and submit to the IACUC 

• improves animal care
• ability to recognize problems and take appropriate action
• reduce
• refine
• Prevent spread of disease

• Require resolution within specified time
• suspend researcher temporarily or permanently
• suspend institution temporarily or permanently
• fine the institution
• withdraw researcher's or institution's funding

• Ethical responsibility
• good data 
• legally required

• scientific merit of the study
•  lay summary
•  justify the use of animals and the species used
• justify number of animals used
• specify the humane use category
•  proof that a vet was consulted for the proper use of medications
• literature search for alternatives
• project description
•  personnel training 
• animal housing
• assessment of pain and distress, and care provided to alleviate
• pre and post procedural care
• surgical procedures and asepsis
• endpoints
• method of euthanasia or other final dispostion of animals
• hazardous materials 

• What you are looking for in the study
• what is the endpoint 
• criteria and method of euthanasia
• all procedures performed
•  adverse consequences

• provide a healthy diet that is appropriate for the species
•  expiration date either provided by manufacturer or 6 mos after manufacture
•  clean - no mold or pesticides
• storage - proper temp, sealed containers if not refrigerated 

• Ensure minimum standards
• Animal welfare
• Data integrity
• Protect workers
• Protect environment

• B: breeders/offspring not used in experiment, animals not used in experiment, but euthanized
• C: No pain/distress, does not require anesthesia/analgesia, pain assoc. with needle stick
• D: Pain and distress - anesthesia/analgesia required
• E: Pain and distress - nothing to alleviate 

• safety
• minimize stress
• comfort
• health
• good research 

• no recirculation of air - 100% fresh outside air
• 10-15 room air changes per hour 

examples of enrichment - what other things do you have to consider?

Heat (180 = disinfection, 250 = sterilization)

Chemical