Unit 1: General principles of laboratory animal science
What is necessary to include in an annual report to the USDA?
That the institution follows the AWA That Principle investigators considered alternative to procedures painful for animals The location of all the institution's animal facilities How many animals were used in each USDA pain category
T/F A training program on occupational health and safety should be comprehensive for the risks likely to occur in the institution
True
T/F An occupational health and saftey program should reflect the nature of the work and the health and safety needs of personnel
True
Class B dealer
dealers that purchase and re-sell animals, including random-source dogs and cats, import human primates, and resell animals from research facilities.
Class A Dealer
dealers that raise animals themselves; purpose bred
What is the AVMA's term for recommended methods of euthanasia?
acceptable
Institutional official (IO)
responsible for the entire animal care and use program at an institution. Should have the ability to allocate resources.
OLAW
office of laboratory animal welfare
T/F: Biomedical research grant proposals can only be submitted to the NIH for funding
False
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle III
Selection of Animals
Per the AWR for what period of time is a protocol using the USDA-covered species approved?
1 year
Indirect Costs
costs incurred by the animal facility that are not specifically identifiable with a particular animal species or project: facility operations and management, administrative salaries, security, and equipment depreciation.
Fixed costs
costs that are typically consistent throughout the budget period: rent, utility, preventative maintenance
Direct Costs
costs that can be directly attributed to a specific research project: cost of the animals, cost to maintain animals, cost of salaries for project staff, cost of food, bedding and other supplies.
How often must the institution update its registration with the AWA and AWR?
Every 3 years
List 5 areas that personnel should receive training for each species they work with.
1. Appropriate handling and procedures 2. Pre and post procedural care 3. ways to apply the 3 R's 4. proper used of anasthetics, analgesics and tranquilizers 5. methods for reporting deficiencies in animal care and treatment.
List 5 items that training documents should include
1. Date of training 2. Subject matter 3. names of individuals attending the training 4. length/duration of training 5. Names of individuals conducting the training
Describe the 5 steps in which an investigator performs data collection
1. Define the question to be investigated 2. Determine the strategy to answer the question 3. Collect data 4. Analyze data 5. Report data and conclusions
What are the 5 steps of job planning.
1. Establish/organize goals 2. Prioritize/ schedule tasks 3. Identify resources needed to complete tasks 4. Begin work on the task 5. Reassess to-do list for remaining tasks
Give 2 reasons why ethics is important when using animals
1. Everyone involved with animals needs to think about their wellbeing 2. Thinking about animal ethics in your research helps your options and personal reasons for supporting animal research.
List 6 pieces of information included in a typical animal use protocol.
1. Rationale and purpose for using animals 2. Justification of the species and number of animals included 3. Evidence of consideration for alternate procedures that may cause more than momentary pain or distress. 4. List of personal assigned to conduct procedures under the protocol 5. Complete description of the procedures to be performed including anesthetics and analgesia. 6. Planned safety precautions to protect personnel.
Per the animal welfare regulations, what are the 2 methods that can be used to identify dogs and cats?
1. Tattoo 2. collar and tag
Name the 3 things you must do when delegating tasks to others
1. Specify procedures to be followed 2. specify time frame for completion of tasks 3. specify outcome
What are the two main duties of the IACUC?
1. To review animal use protocols 2. To review the animal care and use program every 6 months
List the four core values for the ethical treatment of laboratory animals
1. Use of scientific research should be relevant 2. Animal use should be maintained in a way that provides them with as much physical and psychological wellbeing as possible 3. Animals should not be subjected to unnecessary pain or duress 4. If an animals pain cannot be relieved they should be humanely euthanized.
What are the 3 types of members required by the USDA to sit on IACUC
1. Veterinarian 2. Community/ non-affiliated member 3. Chairperson
What are the 5 types of members required by PHS to sit on IACUC?
1. Veterinarian 2. Community/ non-affiliated member 3. Chairperson 4. Practicing scientist with animal experience 5. Non-Scientist
What is the minimum required for the following records for the PHS: Protocol records Semi-annual inspection reports Minutes of IACUC meetings
3 years after the completion of a study 3 years 3 years
What is the minimum required for the following records for the USDA: Protocol records Semi-annual inspection reports Minutes of IACUC meetings
3 years for all
Define "humane care" from the guide
Actions taken to assure that laboratory animals are treated according to high ethical and scientific standards
What animals are covered under the PHS Policy?
All vertebrates
Test System
Animals or any other entity that is administered a substance
Appendix III of CITES covers what?
Animals protected by a member country that requests cooperation to prevent exploitation.
Name the key differences between the animal welfare act & regulations vs the PHS policy regulatory requirements
Animal welfare act requires 3 members on IACUC. PHS requires 5. Animal welfare act includes the species: warm-blooded, vertebrate animal (excluding birds, rats, and mice bred for research). PHS policy species includes: All vertebrate animals AWA Inspections are annual, and unannounced. PHS inspections are for cuase. AWA Registration is registration. PHS registration is Animal Welfare Assurance. AWA is enforced by the USDA, APHIS. PHS is enforced by OLAW
What document is signed by the IO and is filed to commit the institution to compliance with the PHS Policy?
Animal welfare assurance
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle VII
Animal's living conditions
Pain Category B
Animals being bred, conditioned or held for use in teaching, testing, experiments, research or surgery but not yet used for such purposes
Defines Ethics
Approach to judging and discussing the consequences and effects of humans using animals in research.
According to the AVMA Guidelines on Euthanasia, what step much be taken before an animal carcass dispossal
Assurance of death
Quality Assurance Unit
Audits studies to ensure compliance with GLPs
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle I
Compliance with the Animal Welfare Act
CITES
Convention on International trade in Endangered Species of Wild Fauna and Flora
Variable Costs
Costs that vary based upon demand: expendable supplies, labor costs for husbandry and technical staff.
"Must" in the Guide
Describes aspects of a program that are essential or imperative to humane care and use of laboratory animals
"Should" In the Guide
Describes aspects of a program that are strong recommendations to achieve a goal
Function of AWR
Describes what a facility must do to comply with the AWA
who regulated the use of controlled substance in laboratory animal facilities?
DEA
Two federal agencies that must comply with the GLPs
EPA and FDA
Standard operating procedure
Detailed description of a procedure to be performed. These help ensure standardization of procedures.
T/F All Instiutions are required to have the same occupational health and safety program
False
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle VI
Euthanasia
Pain Category D
Experiments, teaching, research, or tests causing pain or distress to the animals for which appropriate anesthetic, analgesic, or tranquilizing drugs were used
T/F Small institutions are exempt from the requirements for an occupational health and safety program
False
T/F The only way to obtain funding for research grants is through the federal government
False
T/F The USDA requires common laboratory rodents to be shipped with a health certificate
False; The USDA Requires one for dogs, cats or non-human primates only
T/F Specific state regulation on the sale of dogs exist because of distemper vaccine requirements
False; They exist because of rabies vaccine requirements
T/F: Animals may be used for research after an animal use protocol is submitted to the IACUC
False; it must be approved
How many bio-safety levels are described in BMBL?
Four
Which animals are covered under the Animal Welfare Act and Animal welfare regulations?
Guinea Pigs Non-human Primates Wild mice Cotton rats
Who has the authority to deny an investigator permission to begin a research project using animals or to stop a previously approved animal use protocol?
IACUC
What must the institution submit to the USDA each year
Institutions housing USDA covered animals must submit an annual report
Define Compliance
Knowing and following the rules
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle V
Managing pain or distress
What agency enforces PHS policy?
OLAW
What is the name of the reference document used for guidance on occupational health and safety programs?
Occupational health and safety in the care and use of animal research
OLAW
Office of laboratory animal welfare
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle IV
Proper use of animals
Study Director
Person responsible for all aspects of a study
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle VIII
Personnel qualifications and experience
Function of PHS
Provides peer evaluation of animal care and use programs
Attending Veterinarian (AV)
Responsible for the health and well being of all the laboratory animals used at the institution.
PHS
Public health service
Function of AAALAC
Published the policy on the Humane Care and Use of Laboratory Animals.
Define Refinement
Refining procedures to minimize or eliminate animal distress and pain. Ex. Providing analgesia
Institutional Animal care and use committee (IACUC)
Responsible for the oversight and assessment of the animal care and use program
Define Reduction
Reducing the number of animals used while still providing valid data
Function of the USDA
Registers institutions using species covered by the AWA
US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Principle II
Relevance to health and society
The 3 R's
Replacement, refinement, and reduction
Define Replacement
Replacing animals with non living alternatives like computer modeling.
Function of the FDA
Requires compliance with the Good Laboratory Practices (GLPs)
Appendix II of CITES covers what
Species very likely to be endangered
Pain Category E
Teaching, experiments, research surgery or tests causing pain or distress to animals for which appropriate anesthetic, analgesic, or tranquilizing drugs were not used because they would adversely affect the procedures, results or interpretation.
Centralized Management system:
The animal care program is a separate department that serves all of the institutions care needs and requests
Which document is used by the AAALAC and the USDA when inspecting agricultural animals used in biomedical reserach
The guide for the care and use of animals in research and teaching
Raw Data.
The observations, measurements, and specimens related to a study
Define Humane Endpoint
The point at which pain or distress in and experimental animal is prevented, terminated, or relieved.
What is the goal of a post-approval monitoring program?
To ensure that IACUC-approved procedures are being followed.
Why are records on animal census important?
They recover operating costs through per diem charged to the investigator
Who conducts inspections unannounced of registered Institutions?
USDA Veterinary Medical Officer (VMO)
What AVMA's term for methods of euthanasia that should not be used is?
Unacceptable
USDA
United states department of agriculture
Define Cost Center
an activity or entity that has expenses but no direct revenue
AWR
animal welfare regulations
Appendix I of CITES covers
animals that are most endangered
Decentralized management system
each department in the institution that keeps laboratory animals for either research or teaching maintains its own facilities and operating budgets; each department is responsible for it's own animal care staffing; procures its own animals and facility equipment; and provides daily care and maintenance of it's own animals
Define Per Diem
refers to the cost charged to maintain one unit, typically either one animal or cage of animals, for one day.
Pain Category C
teaching, research, experiments or tests conducted that cause no pain or distress and thus do not require the use of pain-relieving drugs