INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL RESEARCH

1. INTRODUCTION TO THE USE OF ANIMALS IN BIOMEDICAL RESEARCH Research Animal Facility Veterinary and IACUC Staff DBL/EBR 02/11/04

2. 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

3. REGULATORY REQUIREMENTS • Animal Welfare Act (AWA) • Public Health Service Research Extension Act (PHSREA) • AAALAC International

4. Animal Welfare Act (AWA) • First enacted by Congress in 1966 • Was the first law in United States pertaining to use of animals in research

5. Animal Welfare Act (AWA) Enforced by the USDA Unannounced Site Visits by a USDA Veterinarian (VMO) Amended in 1970, 1976 and 1985

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

7. 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

8. 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

9. Institutional Animal Care & Use Committee Became mandatory in 1985 Mandated by the Animal Welfare Act Public Health Service and AAALAC International

10. Institutional Animal Care & Use CommitteeRegulations and guidelines • Members of IACUC (PHS requirement) • Scientist • Veterinarian • Chair • Nonaffiliated member • Nonscientist

11. 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

12. 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

13. 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)

14. 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

15. 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

16. Personnel Add/Delete Form An Add/Delete Form must be submitted if New personnel are added or if Personnel are deleted

17. 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

18. 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

19. 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

20. Institutional Animal Care & Use CommitteeAlternatives • Search for alternatives • The 3 R’s • Replacement • Refinement • Reduction Russell and Burch (1959)

21. 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

22. Institutional Animal Care & Use CommitteeRefinement • Use of less invasive procedures • Ex: Laparoscopy instead of laparotomy • Blood collection from vein instead of cardiac puncture

23. Institutional Animal Care & Use CommitteeReduction • Reduction in number of animals used • Reduction in number of procedures performed on one animal

24. Institutional Animal Care & Use CommitteeConsiderations • Anesthesia & Postoperative Care • Physical discomfort • Number of animals requested • Justification for using animals • RAF orientation and training

25. Institutional Animal Care & Use CommitteeLiterature search • Search to document previous studies • Search for alternatives • Mandated by the AWA • Documented in the IACUC protocol

26. Institutional Animal Care & Use CommitteeUSDA 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

27. Institutional Animal Care & Use CommitteeProtocol review process • IACUC meets the 1st Tuesday of each month. • Veterinary and administrative Prereview • Committee Review: Two reviewers

28. Institutional Animal Care & Use CommitteeReview process Three possible outcomes at the meeting: • Approval • Conditional Approval • Tabled

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. Occupational HealthHealth concerns • What do you think is the most pervasive health concern are from working with research animals?

36. 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

37. 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

38. 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

39. HAZARDS SPECIES-SPECIFIC CONCERNS Most rodents, rabbits: Minor concerns Cats: Toxoplasmosis Nonhuman Primates: Herpes-B Shigella Tuberculosis Other zoonotic diseases

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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

46. Let’s take a break • Sign up for RAF card key access • Room key if applicable

47. Animal Procedures and Veterinary Care • Three (3) Veterinarians • Four (4) Sr. Veterinary Technicians support animal care and research • Training Coordinator

48. ANIMAL ORDERSORDER FORMS • DEADLINE: Tuesdays @ 10:00 • COMMERCIAL vendors only • Specify preferred housing room • IACUC protocol must be active

49. ANIMAL ORDERSDELIVERIES • Pigs and rabbits: Mondays • Canines: Tuesdays • Rodents: Tues and Wed.

50. ANIMAL ORDERSTRANSPORT IS STRESSFUL ACCLIMATION • Rodents (3 days) • Large animals (7 days) QUARANTINE • Rodents (0 or 8 weeks) • Most large animals (1 week)