Transcript INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL …

INTRODUCTION TO
THE USE OF ANIMALS
IN BIOMEDICAL RESEARCH
Research Animal Facility
Veterinary and IACUC Staff
DBL/EBR 02/11/04
OUTLINE
Why learn about animals in research?
Regulatory requirements
The IACUC
The 3 Rs and alternatives
Biohazards and zoonoses: Maintaining human health
Security and RAF access
Animal health and animal procedures
REGULATORY
REQUIREMENTS
Animal Welfare Act (AWA)
Public Health Service Research Extension Act
(PHSREA)
AAALAC International
Animal Welfare Act (AWA)
First enacted by Congress in 1966
Was the first law in United States pertaining to
use of animals in research
Animal Welfare Act (AWA)
Enforced by the USDA
Unannounced Site Visits by a USDA
Veterinarian (VMO)
Amended in 1970, 1976 and 1985
PHS and AAALAC cover all
vertebrate animals including
cold blooded vertebrates.
The Public Health Service Health
Research Extension Act, 1985
Covers all vertebrate animals
 Establishes Institutional Animal Care & Use Committee (IACUC)
Enforced by the Office for Laboratory Animal
Welfare (OLAW)
Must be observed by all institutions receiving
NIH funds
Basic guidelines for Humane Animal Care and
Use are mandated
AAALAC International
Association for the Assessment and Accreditation of Laboratory Animal Care
Voluntary membership
Peer reviews and site visits
Professional evaluations with stringent
standards
Uses the Guide for the Care and Use of
Laboratory Animals, “The Guide”
UMDNJ, Newark has maintained full AAALAC
accreditation since 1981
Institutional Animal Care & Use Committee
Became mandatory in 1985
• Mandated by the Animal Welfare Act
• Public Health Service and
• AAALAC International
Institutional Animal Care & Use Committee
Regulations and guidelines
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Members of IACUC
Scientist
Veterinarian
Chair
Nonaffiliated member
Nonscientist
(PHS requirement)
Institutional Animal Care & Use Committee
Membership
IACUC committee: currently 15 members
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Chair (Dr. Fitzgerald-Bocarsly)
Attending Veterinarian (Dr. Ryden)
Staff Veterinarian
Non-affiliated member
Nonscientist member
Scientists – Many departments represented
Institutional Animal Care & Use Committee
Responsibilities
• Review and approve proposed activities
• Inspect areas where animals are housed and used
• Review the RAF program for the humane care
and use of animals
• Review and investigate concerns regarding the
care and use of animals
Institutional Animal Care & Use Committee
Protocols
• Before any proposed research or teaching activity can
be undertaken at any institution, an IACUC application
must be approved by Committee.
• This application is called the IACUC Protocol.
• At the VA is called ACORP (Animal Component of
Research Protocol)
Institutional Animal Care & Use Committee
Protocol annual reviews
• Protocols are approved for 3 years with annual
reviews.
• Annual review notices are sent 2 months before the
expiration date--required for continued protocol
approval during the three-year period.
• An expired protocol inhibits an investigator from
ordering animals or performing any experiments
Institutional Animal Care & Use Committee
AMENDMENTS
An amendment must be submitted if significant
changes are planned after a protocol has been
approved by the Committee.
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Change in Procedures
Change in Species
Change in Anesthesia
Addition of Animals
Change in Endpoint
Personnel Add/Delete Form
An Add/Delete Form must be submitted if
New personnel are added or if
Personnel are deleted
Requirement for Training
New personnel are required to
1) Attend RAF Orientation and
2) To documents their experience and training
using the species and performing the
procedures to be used or
3) To state who will train them
Institutional Animal Care & Use Committee
Protocol questions
• Experimental Endpoint
• Humane Endpoint
• Animal must be humanely euthanized if in
distress which cannot be treated
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Euthanasia
USDA category
Literature search for alternatives
Biohazard Approval if relevant
Humane Endpoint vs
Experimental Endpoint
• Experimental Endpoint
• Planned endpoint when animal will be euthanized
and tissues harvested for in vitro analysis
• Humane Endpoint
• Unplanned endpoint (earlier than Experimental
endpoint) if something goes wrong
• Animal must be humanely euthanized if in
distress which cannot be treated
Institutional Animal Care & Use Committee
Alternatives
• Search for alternatives
• The 3 R’s
o Replacement
o Refinement
o Reduction
Russell and Burch (1959)
Institutional Animal Care & Use Committee
Replacement
• Replacing animals with in vitro models
o cell cultures
o tissue cultures
o computer models
• Replacing a higher more sentient animal with a
lower less sentient animal
o Instead of a monkey use a rat
Institutional Animal Care & Use Committee
Refinement
• Use of less invasive procedures
• Ex: Laparoscopy instead of laparotomy
• Blood collection from vein instead of cardiac
puncture
Institutional Animal Care & Use Committee
Reduction
• Reduction in number of animals used
• Reduction in number of procedures performed
on one animal
Institutional Animal Care & Use Committee
Considerations
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Anesthesia & Postoperative Care
Physical discomfort
Number of animals requested
Justification for using animals
RAF orientation and training
Institutional Animal Care & Use Committee
Literature search
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Search to document previous studies
Search for alternatives
Mandated by the AWA
Documented in the IACUC protocol
Institutional Animal Care & Use Committee
USDA category
• B Breeding colonies or animals not yet used in
research
• C No or minimal pain and distress
• D Pain or distress alleviated by analgesics,
anesthetics or tranquilizers
• E Pain or distress NOT alleviated by drugs
Institutional Animal Care & Use Committee
Protocol review process
• IACUC meets the 1st Tuesday of each month.
• Veterinary and administrative Prereview
• Committee Review: Two reviewers
Institutional Animal Care & Use Committee
Review process
Three possible outcomes at the meeting:
• Approval
• Conditional Approval
• Tabled
Institutional Animal Care & Use Committee
Biohazard review
Protocols using the following hazardous chemicals or
biologicals are submitted to the Biohazard
Committee for review:
• Chemical Hazards
• Carcinogens
• Radiation Hazards
• Infectious Hazards
• Bloodborne pathogens
• Recombinant DNA
Institutional Animal Care & Use Committee
Animal Biosafety Committee
(ABC)
The ABC meets monthly.
It consists of the following members:
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A representative from EOHSS
Pharmacologist & Toxicologist
Microbiologist/Virologist
Attending Veterinarian
Facility Manager ICPH
Institutional Animal Care & Use Committee
Institutional Biosafety Committee (IBC)
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A subsection of the IBC meets monthly
IBC is administered by EOHSS
Available on the UMDNJ web
Reviews Recombinant and infectious studies
Institutional Animal Care & Use Committee
Other Agencies
• OSHA
• PEOSH
• EOHSS
Occupational Safety and Health Administration
Public Employees Occupational Safety and Health
Environmental and Occupational Health and Safety Services
NJ and UMDNJ state regulations
Institutional Animal Care & Use Committee
How to report concerns about care
and use of laboratory animals
• Speak to any member of the IACUC or
any of the Veterinarians (who are members of
the IACUC)
• IACUC membership and contact information is
posted in the Animal Research Facility
Your concern will be kept confidential
Occupational Health
Pre-employment and Annual Physical Exams if
personnel has significant contact with and
exposure to animals
Tetanus immunization
TB test if working with nonhuman primates
Other vaccinations as recommended and
indicated
Occupational Health
Health concerns
What do you think is the most pervasive health
concern are from working with research
animals?
Allergies to animals
1) Allergies
30 – 40 % of staff working full-time with
animals may develop allergies over time
(primarily to mice, rats, cats, rabbits)
2) Bites and scratches may occur
Best prevention is to be trained in handling
each species and to wear appropriate clothing
How to protect yourself
Wear designated clothing over or instead of
your street clothes when working with your
animals: Long-sleeved lab coat or scrubs
Wear gloves when working with rodents
Wash your hands when you are finished
handling your animals
Clothing requirements for the RAF
Please note that lab coat or scrubs are
mandatory before entering RAF animal rooms
All RAF rodent rooms require some level of
Personnel Protective Equipment (PPE)
READ DOOR SIGNS BEFORE ENTERING ANY
ANIMAL OR ANIMAL PROCEDURE ROOM
HAZARDS
SPECIES-SPECIFIC CONCERNS
Most rodents, rabbits: Minor concerns
Cats:
Nonhuman Primates:
Toxoplasmosis
Herpes-B
Shigella
Tuberculosis
Other zoonotic
diseases
Bite and Scratch Prevention
Each animal room has a bite/scratch kit
If bitten or scratched, do the following:
Put animal down in cage
Scrub wound for 2 minutes by the clock
Report incident to RAF
Report incidence to your Supervisor
If indicated see doctor
Women of child-bearing age
Limit or avoid exposure to:
X-rays
Gas anesthesia
Cat feces and litter box (Toxoplasmosis)
Lifting
BrDU (Bromodeoxyuridine)
Other: as indicated by your doctor
Notify your supervisor
Injuries: How to proceed
1. First aid
Animal bite or scratch: Use Bite and Scratch kit
Other: Fall, Cut
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Incident report (Witness documented)
Risk & Claims (UMDNJ employees)
Own/Assigned doctor (students, residents)
Medical attention as needed
Insurance as arranged by department
RAF Card key access
SA17= Front door by personnel elevators
• PERSONNEL ENTRY
SA18= Back door by freight elevators
• ANIMAL AND EQUIPMENT ENTRY
SA19= Barrier access. Restricted.
• BARRIER MICE AND QUARANTINE AND BIOHAZARD STUDIES
Checking and using access
Wait 3 days after RAF Orientation
Then swipe your card key and see if it works
If not working within a week report back to RAF
Visitors policy
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No children allowed
Research and student personnel must be 17
years or older
Please make appointment if you want a tour
PLEASE DO NOT TAKE VISITORS TO SEE
YOUR ANIMALS WITHOUT CLEARING THIS
WITH RAF ADMINISTRATION (Mr. Rodriguez or Dr.
Ryden)
Do not take pictures without clearing this with RAF
Veterinary Staff
Let’s take a break
Sign up for RAF card key
access
Room key if applicable
Animal Procedures and
Veterinary Care
Three (3) Veterinarians
Four (4) Sr. Veterinary Technicians support
animal care and research
Training Coordinator
ANIMAL ORDERS
ORDER FORMS
• DEADLINE: Tuesdays @ 10:00
• COMMERCIAL vendors only
• Specify preferred housing room
• IACUC protocol must be active
ANIMAL ORDERS
DELIVERIES
• Pigs and rabbits: Mondays
• Canines: Tuesdays
• Rodents: Tues and Wed.
ANIMAL ORDERS
TRANSPORT IS STRESSFUL
ACCLIMATION
• Rodents (3 days)
• Large animals (7 days)
QUARANTINE
• Rodents (0 or 8 weeks)
• Most large animals (1
week)
ANIMAL ORDERS
TRANSPORT ON-CAMPUS
• Return animals to the same animal room on the same
day; overnight housing in the lab requires special IACUC
approval
• Submit completed Animal Transfer Form if a room
change is proposed
• Cover animals with dark plastic bag—use new bag each
time
• Transfer to clean rodent cages for post-operative
recovery for return transport
ANIMAL ORDERS
TRANSPORT OFF-CAMPUS
• All animal shipments from UMDNJ must be approved by Research
Animal Facility
Complete Animal Shipment Form.
• All Animal shipments from UMDNJ must be approved by Office of
Patents and Licensing
Complete Material Transfer Agreement
• All shipments to UMDNJ must be approved and coordinated by
Research Animal Facility in advance of shipment.
Complete Animal Shipment Form.
ANIMAL ORDERS
CAGE & CARCASS TRANSPORT
• CARCASS DISPOSAL
in necropsy freezer in A-664 or in box outside of A-664
• SOILED CAGE RETURN
• Return to dirty cage wash inside of plastic bag
• Please return all cages
ANIMAL ORDERS
vendor classes
Class A vendors
• Purpose-bred animals for
research
• Very stringent health
monitoring
• Very stringent genetic
monitoring
• USDA Class B vendors
• Use of random source (pound)
animals
• Not legal in NJ
Are pets used for research?
Class A versus Class B vendors
Animal
Welfare
Act
Public Law
89-544
August 24, 1966
VETERINARY SERVICES
Technical services
Small and large animal procedures (fee-for service)
• Operating rooms: email to Dr. Condobery at [email protected]
• Procedure room: sign-up board across from MSB-A610
• Rodent barrier hoods: sign-up sheets at entrance
• Euthanasia/necropsy room: contact veterinary staff
• Euthanasia, blood collection, treatments
Request for Technical Services
• Drug and supply orders:
Request for Technical Services, allow 48-hour notice.
General stock is for analgesia, anesthesia, anti-microbial,
diagnostic or therapeutic use only: no experimental drugs.
AVMA
2000 Panel of Euthanasia
Specifics acceptable methods of euthanasia
Addresses the following concerns:
Humane concerns (good death)
Ease of administration
Safety for animal and operator
Suitability for research goals
VETERINARY SERVICES
Emergency services
• Office and pager numbers are furnished
• A veterinarian is on-call 24/7/365
• Report concerns before they are problems
VETERINARY SERVICES
Consultations & Training
Contact Tracy Davis:email to [email protected]
• Barrier training: required for access to rodent barrier
• Rodent surgery:
• Euthanasia Training:
• Necropsy room: contact veterinary staff
• Euthanasia, blood collection, treatments
Request for Technical Services
• Drug and supply orders:
hour notice; otherwise $15 expedite fee
Request for Technical Services, allow 48-
VETERINARY SERVICES
Drug and supply orders
• Complete Request for Technical Services
• Return to MSB A-610
• Allow 48 hours notice
Calculate drug dose
Body weight (kg) X Dose (mg/kg)
Concentration (mg/ml)
DRUG CALCULATIONS
To calculate an individual
animal dose, multiply its
weight (kg) by the drug
dosage and divide by the
concentration.
Ex: 25 g x 100 mg/kg
10mg/ml
Don’t forget to convert the
weight to like units!!!
VETERINARY SERVICES
Drug and supply concerns
Lock all controlled substances.
Controlled drugs purchased under the Research
Animal Facility license remain the responsibility of
the licensee.
Designate Lab Staff to check drugs every month
Check expiration dates regularly.
Return expired controlled drugs to RAF.
Discard expired non-controlled drugs.
VETERINARY TECHNICAL SERVICES
Veterinary Technical Staff
4 Senior Veterinary Technicians
(nurses) are:
College trained
AALAS certified
Have several years of experience
Attend local and national meetings for CEC
VETERINARY SERVICES
Chronic care
LARGE ANIMAL
• Dental prophylactic dental care
• Pedicures
• Grooming
• Vaccinations
• Bloodwork
VETERINARY SERVICES
Chronic care
RODENTS: SENTINEL SURVEILLANCE
• Soiled bedding transfer performed once weekly
• Leave purple dots on cages
• Testing is performed every two months for viruses and
parasites. Most rodent concerns are sub-clinical!
• Rodent Room Order is adjusted as needed
e.g. barrier > conventional > necropsy
VETERINARY SERVICES
Adequate care
• Knowledge of and adherence to IACUC protocol
• Protocol deviations must be formally amended e.g. new drugs,
new surgeries, change of goals, animal use, animal numbers
• Knowledge of and adherence to Research Animal Facility
procedures to provide “adequate veterinary care”
ROLE OF INVESTIGATIVE STAFF
Adequate care
• Knowledge of and adherence to IACUC protocol
• Protocol deviations must be formally amended e.g. new drugs,
new surgeries, change of goals, animal use, animal numbers
• Knowledge of and adherence to Research Animal Facility
procedures to provide “adequate veterinary care”
ROLE OF INVESTIGATIVE STAFF
Animal illness or pain
Know the condition of the animal before the procedure
• Dehydration: report extended skin tenting
• Report blood, discharge, soiled discolored
bandages
• Report rough hair coats, poor grooming
• Report untouched food, water or absence of urine
and feces
• Report incision dehiscence (rupture)
Report findings in medical notes (date & initial)
Humane Endpoint vs
Experimental Endpoint
• Experimental Endpoint
• Planned endpoint when animal will be euthanized
and tissues harvested for in vitro analysis
• Humane Endpoint
• Unplanned endpoint (earlier than Experimental
endpoint) if something goes wrong
• Animal must be humanely euthanized if in
distress which cannot be treated
ROLE OF INVESTIGATIVE STAFF
Medical record notes (Large animal)
• Shared document
• Research lab
• Veterinary staff
• USDA inspectors
• IACUC inspectors
• Record observations, injections, treatments,
procedures (date and initial)
ROLE OF INVESTIGATIVE STAFF
Rodent surgical concerns
Pre-operative
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Dedicated surgical area
Sterile instruments
Sterile preparation of surgical site
Clean lab coat, sterile gloves, mask required
Post-operative
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Warmth
Ambulation
Access to food and water (e.g. sipper tube)
Analgesia
ROLE OF INVESTIGATIVE STAFF
Other rodent concerns
Breeding rodents
Wean at 3 weeks of age
Housing density
Four mice per one shoebox cage
Rats according to weight
Note Rodent Breeding SOP
FACILITY MANAGER
Plans and orders equipment
Physical Plant: climate-control, plumbing,
drains
Together with Supervisor manages staff
Research support: special cages, food, study
support
Security: keycards and keys
Animal Facility support staff
Administrative staff
Animal orders, Billing, Office support
Facility Manager
Supervises husbandry/animal care staff
Supervisor and animal care staff
Veterinary staff
Husbandry Staff
RAF has 10 Animal Caretakers
Several are Senior Animal Caretakers
Sr. ACT requires a minimum of 2 years of
experience and AALAS certification
RAF has 2 Cagewashers
RAF has staff working 24/7/365 caring for our
laboratory animals
HUSBANDRY SERVICES
Role of the Animal Caretaker
Daily ROOM evaluation and documentation
Daily ANIMAL evaluation and documentation
FEED & WATER
SANITATION
TREATMENTS
MORBIDITY & MORTALITY REPORTING
INTRODUCE YOURSELF!
GOOD ANIMAL CARE
PROMOTES GOOD RESEARCH