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INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL RESEARCH

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INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL RESEARCH Powered By Docstoc
					    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

•   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 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
•   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


•   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 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:                Toxoplasmosis

Nonhuman Primates:        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
2.   Incident report (Witness documented)
3.   Risk & Claims (UMDNJ employees)
4.   Own/Assigned doctor (students, residents)
4.   Medical attention as needed
5.   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

    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 condobpk@umdnj.edu
• 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 davista@umdnj.edu
• 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:                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/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
  •   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 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

				
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