introduction to the use of animals in biomedical research research animal facility veterinary and...
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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 requirementsThe IACUCThe 3 Rs and alternativesBiohazards and zoonoses: Maintaining human
healthSecurity and RAF accessAnimal 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 1966Was the first law in United States
pertaining to use of animals in research
Animal Welfare Act (AWA)
Enforced by the USDAUnannounced 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 membershipPeer reviews and site visitsProfessional evaluations with stringent
standardsUses 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
• Members of IACUC (PHS
requirement)
• Scientist• Veterinarian• Chair• Nonaffiliated member• Nonscientist
Institutional Animal Care & Use Committee Membership
IACUC committee: currently 15 members• 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.• 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 and2) 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• 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 Replacemento Refinemento Reduction
Russell and Burch (1959)
Institutional Animal Care & Use Committee Replacement
• Replacing animals with in vitro modelso cell cultureso tissue cultureso computer models
• Replacing a higher more sentient animal with a lower less sentient animalo 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
• Anesthesia & Postoperative Care• Physical discomfort• Number of animals requested• Justification for using animals• RAF orientation and training
Institutional Animal Care & Use Committee Literature search
• 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:
• A representative from EOHSS• Pharmacologist & Toxicologist• Microbiologist/Virologist• Attending Veterinarian• Facility Manager ICPH
Institutional Animal Care & Use Committee Institutional Biosafety Committee (IBC)
• 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 Occupational Safety and Health Administration
• PEOSH Public Employees Occupational Safety and Health • EOHSS 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 immunizationTB test if working with nonhuman
primatesOther 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) Allergies30 – 40 % of staff working full-time with animals may develop allergies over time(primarily to mice, rats, cats, rabbits)
2) Bites and scratches may occurBest 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 rodentsWash 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: Toxoplasmosis
Nonhuman Primates: Herpes-BShigellaTuberculosisOther zoonotic diseases
Bite and Scratch Prevention
Each animal room has a bite/scratch kitIf bitten or scratched, do the following:
Put animal down in cageScrub wound for 2 minutes by the clockReport incident to RAFReport incidence to your SupervisorIf indicated see doctor
Women of child-bearing ageLimit or avoid exposure to:
X-raysGas anesthesiaCat feces and litter box (Toxoplasmosis)LiftingBrDU (Bromodeoxyuridine)Other: as indicated by your doctorNotify your supervisor
Injuries: How to proceed
1. First aid Animal bite or scratch: Use Bite and Scratch kit Other: Fall, Cut
2. Incident report (Witness documented)3. Risk & Claims (UMDNJ employees)4. Own/Assigned doctor (students,
residents)4. Medical attention as needed5. 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 OrientationThen swipe your card key and see if it
worksIf not working within a week report back
to RAF
Visitors policy
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 researchTraining 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 FacilityComplete Animal Shipment Form.
• All Animal shipments from UMDNJ must be approved by Office of Patents and LicensingComplete 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
ActPublic 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, treatmentsRequest 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, treatmentsRequest for Technical Services
• Drug and supply orders: Request for Technical Services, allow 48-hour notice; otherwise $15 expedite fee
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/kg10mg/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• Dedicated surgical area• Sterile instruments• Sterile preparation of surgical site• Clean lab coat, sterile gloves, mask required
Post-operative• 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 densityFour mice per one shoebox cage
Rats according to weight
Note Rodent Breeding SOP
FACILITY MANAGER
Plans and orders equipmentPhysical Plant: climate-control, plumbing,
drainsTogether with Supervisor manages staffResearch 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 staffVeterinary staff
Husbandry Staff
RAF has 10 Animal CaretakersSeveral are Senior Animal CaretakersSr. ACT requires a minimum of 2 years of
experience and AALAS certificationRAF 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 documentationDaily ANIMAL evaluation and documentationFEED & WATERSANITATIONTREATMENTSMORBIDITY & MORTALITY REPORTING
INTRODUCE YOURSELF!
GOOD ANIMAL CARE PROMOTES GOOD RESEARCH