Introduction to the use of animals in biomedical research
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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 requirements The IACUC The 3 Rs and alternatives Biohazards and zoonoses: Maintaining human health

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Introduction to the use of animals in biomedical research

INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL RESEARCH

Research Animal Facility

Veterinary and IACUC Staff

DBL/EBR 02/11/04


Outline

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

REGULATORY REQUIREMENTS

  • Animal Welfare Act (AWA)

  • Public Health Service Research Extension Act (PHSREA)

  • AAALAC International


Animal welfare act awa

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 awa1

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

PHS and AAALAC cover all vertebrate animals including cold blooded vertebrates.


The public health service health research extension act 1985

The Public Health Service Health Research Extension Act, 1985

  • Covers all vertebrate animals

  • EstablishesInstitutional 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

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

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

Institutional Animal Care & Use CommitteeRegulations and guidelines

  • Members of IACUC (PHS requirement)

  • Scientist

  • Veterinarian

  • Chair

  • Nonaffiliated member

  • Nonscientist


Institutional animal care use committee membership

Institutional Animal Care & Use CommitteeMembership

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

Institutional Animal Care & Use CommitteeResponsibilities

  • 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

Institutional Animal Care & Use CommitteeProtocols

  • 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

Institutional Animal Care & Use CommitteeProtocol 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

Institutional Animal Care & Use CommitteeAMENDMENTS

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

Personnel Add/Delete Form

An Add/Delete Form must be submitted if

New personnel are added or if

Personnel are deleted


Requirement for training

Requirement for Training

New personnel are required to

  • Attend RAF Orientation and

  • To documents their experience and training using the species and performing the procedures to be used or

  • To state who will train them


Institutional animal care use committee protocol questions

Institutional Animal Care & Use CommitteeProtocol 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

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

Institutional Animal Care & Use CommitteeAlternatives

  • Search for alternatives

  • The 3 R’s

    • Replacement

    • Refinement

    • Reduction

      Russell and Burch (1959)


Institutional animal care use committee replacement

Institutional Animal Care & Use CommitteeReplacement

  • Replacing animals with in vitro models

    • cell cultures

    • tissue cultures

    • computer models

  • Replacing a higher more sentient animal with a lower less sentient animal

    • Instead of a monkey use a rat


Institutional animal care use committee refinement

Institutional Animal Care & Use CommitteeRefinement

  • Use of less invasive procedures

  • Ex: Laparoscopy instead of laparotomy

  • Blood collection from vein instead of cardiac puncture


Institutional animal care use committee reduction

Institutional Animal Care & Use CommitteeReduction

  • Reduction in number of animals used

  • Reduction in number of procedures performed on one animal


Institutional animal care use committee considerations

Institutional Animal Care & Use CommitteeConsiderations

  • Anesthesia & Postoperative Care

  • Physical discomfort

  • Number of animals requested

  • Justification for using animals

  • RAF orientation and training


Institutional animal care use committee literature search

Institutional Animal Care & Use CommitteeLiterature 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

Institutional Animal Care & Use CommitteeUSDA category

  • BBreeding colonies or animals not yet used in research

  • CNo or minimal pain and distress

  • DPain or distress alleviated by analgesics, anesthetics or tranquilizers

  • EPain or distress NOT alleviated by drugs


Institutional animal care use committee protocol review process

Institutional Animal Care & Use CommitteeProtocol 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

Institutional Animal Care & Use CommitteeReview process

Three possible outcomes at the meeting:

  • Approval

  • Conditional Approval

  • Tabled


Institutional animal care use committee biohazard review

Institutional Animal Care & Use CommitteeBiohazard 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

Institutional Animal Care & Use CommitteeAnimal 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

Institutional Animal Care & Use CommitteeInstitutional 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 CommitteeOther Agencies


Introduction to the use of animals in biomedical research

Institutional Animal Care & Use CommitteeHow 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

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

Occupational HealthHealth concerns

  • What do you think is the most pervasive health concern are from working with research animals?


Allergies to animals

Allergies to animals

  • 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

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

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

HAZARDS

SPECIES-SPECIFIC CONCERNS

Most rodents, rabbits: Minor concerns

Cats: Toxoplasmosis

Nonhuman Primates:Herpes-B

Shigella

Tuberculosis

Other zoonotic diseases


Bite and scratch prevention

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

Women of child-bearing ageLimit 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

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

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

    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

    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

    Let’s take a break

    • Sign up for RAF card key access

    • Room key if applicable


    Animal procedures and veterinary care

    Animal Procedures and Veterinary Care

    • Three (3) Veterinarians

    • Four (4) Sr. Veterinary Technicians support animal care and research

    • Training Coordinator


    Animal orders order forms

    ANIMAL ORDERSORDER FORMS

    • DEADLINE: Tuesdays @ 10:00

    • COMMERCIAL vendors only

    • Specify preferred housing room

    • IACUC protocol must be active


    Animal orders deliveries

    ANIMAL ORDERSDELIVERIES

    • Pigs and rabbits: Mondays

    • Canines: Tuesdays

    • Rodents: Tues and Wed.


    Animal orders transport is stressful

    ANIMAL ORDERSTRANSPORT 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

    ANIMAL ORDERSTRANSPORT 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

    ANIMAL ORDERSTRANSPORT 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

    ANIMAL ORDERSCAGE & 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

    ANIMAL ORDERSvendor 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

    Are pets used for research?Class A versus Class B vendors

    Animal Welfare ActPublic Law 89-544

    August 24, 1966


    Veterinary services technical services

    VETERINARY SERVICESTechnical 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

    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

    VETERINARY SERVICESEmergency 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

    VETERINARY SERVICESConsultations & 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: Request for Technical Services, allow 48-hour notice; otherwise $15 expedite fee


    Veterinary services drug and supply orders

    VETERINARY SERVICESDrug and supply orders

    • Complete Request for Technical Services

    • Return to MSB A-610

    • Allow 48 hours notice


    Calculate drug dose

    Calculate drug dose

    • Body weight (kg) X Dose (mg/kg)

    • Concentration (mg/ml)


    Drug calculations

    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

    VETERINARY SERVICESDrug 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

    VETERINARY TECHNICAL SERVICESVeterinary 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

    VETERINARY SERVICESChronic care

    LARGE ANIMAL

    • Dental prophylactic dental care

    • Pedicures

    • Grooming

    • Vaccinations

    • Bloodwork


    Veterinary services chronic care1

    VETERINARY SERVICESChronic 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

    VETERINARY SERVICESAdequate 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

    ROLE OF INVESTIGATIVE STAFFAdequate 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

    ROLE OF INVESTIGATIVE STAFFAnimal 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 endpoint1

    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

    ROLE OF INVESTIGATIVE STAFFMedical 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

    ROLE OF INVESTIGATIVE STAFFRodent 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

    ROLE OF INVESTIGATIVE STAFFOther 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

    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

    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

    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

    HUSBANDRY SERVICESRole 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

    GOOD ANIMAL CARE PROMOTES GOOD RESEARCH


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