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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 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 firstname.lastname@example.org • 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@example.com • 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
"INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL RESEARCH"