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ANIMAL USE IN RESEARCH: Regulations, Policies, and Procedures

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Covers warm blooded animals such as dogs, cats, primates, hamsters, rabbits ... IACUC reviews and approves, requests modification, or withholds approval on ... – PowerPoint PPT presentation

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Title: ANIMAL USE IN RESEARCH: Regulations, Policies, and Procedures


1
ANIMAL USE IN RESEARCH Regulations, Policies,
and Procedures
  • Tracy M. Heenan, D.V.M.
  • Director
  • Office of Animal Care and Use

2
Institutional Animal Care and Use Committee
  • IACUC Web Address
  • http//research.unc.edu/iacuc/
  • IACUC Email Address
  • iacuc_at_med.unc.edu
  • IACUC Phone Number
  • 966-5569
  • Institutional Official
  • Tony Waldrop, 962-1319

3
IACUC MEMBERSHIP
  • Doctor of Veterinary Medicine with laboratory
    animal experience
  • Participating scientist member
  • Non-scientist member
  • Non-affiliated member who does not use laboratory
    animals

4
Application to Use Live Vertebrate Animals
  • Before conducting any animal procedures, first
    describes the proposed procedures in Animal Use
    Application
  • Must be reviewed and approved before animals work
    can begin
  • Variety of proposed use from simple to complex

5
Introduction
  • no issue, with the exception of abortion, has
    generated more heated controversy than the
    appropriate use of laboratory animals.
    Consequently, the care and use of laboratory
    animals is among the most strictly regulated
    industries in the country, ranking close behind
    air traffic safety and the manufacture of safe
    drugs, devices, biologics, and food products.

6
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7
Battle Wages on
  • News release coincided with Senate vote on 2002
    Helms Amendment to Animal Welfare Act
  • Helms amendment proposed the exclusion of rats,
    mice, birds from coverage by USDA
  • Scientists, lawmakers, and animal activists
    battled for several decades over the coverage of
    rats, mice, birds by USDA
  • Believe rats, mice adequately covered under
    existing federal, accrediting, institutional
    policies

8
Animal Welfare Act
  • United States Department of Agriculture (USDA)
    enforces the AWA
  • Covers warm blooded animals such as dogs, cats,
    primates, hamsters, rabbits
  • Requires establishment of IACUCs
  • IACUCs are charged with ensuring humane treatment
    of research animals
  • USDA officers conduct unannounced inspections

9
Rats, Mice, and Birds
  • Animal Welfare Act
  • The 1970 amendment to the Animal Welfare Act
    defined animal as any live dog, cator other
    warm-blooded animal used or intended for use in
    research
  • Definition of animal specifically excluded
    birds, and Rattus and Mus species bred for
    research.

10
Rats, Mice, and Birds
  • Helms 2002 Amendment to the Animal Welfare Act
  • The term animal excludes (1) birds, rats of
    the genus Rattus and mice of the genus Mus, bred
    for use in research, not used for research
    purposes.

11
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12
Farm Bill Amendment
  • U.S. senate passed the Farm Bill in May 2002
    with the Helms amendment to exclude rats, mice
    and birds from the Animal Welfare Act

13
What Federal Regulations apply to the use of
Animals in Research?
  • Animal Welfare Act
  • United States Department of Agriculture (USDA)
  • warm blooded animals except, rats, mice, birds
  • Public Health Service Policy on the Human Care
    and Use of Laboratory Animals
  • Office of Laboratory Animal Welfare (OLAW)
  • all institutions receiving NIH funding
  • all vertebrate animals

14
Animal Welfare Assurance of Compliance
  • Describes the institutional commitment to humane
    care and use of animals
  • Describes the institutional lines of authority
  • Program for Animal Care and Use
  • Lists approved animal facilities
  • Lists IACUC members

15
OLAWs Approval of the Assurance Statement
  • Commits the institution and its officials,
    investigators, and other agents to full
    compliance with the PHS Policy

16
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17
Association for the Accreditation and Assessment
for Laboratory Animal Care (AAALAC)
  • Voluntary, international accreditation
  • Rigorous evaluation of institutions animal care
    and use program and animal facilities
  • Provides non-regulatory evaluation
  • AAALAC requires uniform standards for ALL
    vertebrate species
  • Provides written evaluation with mandatory and
    suggested items for correction

18
Guide for the Care and Use of Laboratory Animals
  • Standard on animal care and use
  • Provides scientifically, technically, and
    humanely appropriate guides for animal care and
    use
  • OLAW uses the Guide as its Standard

19
Federally Mandated IACUC Functions
  • Semi-annual review of the Animal Program
  • Satisfactory program of veterinary care
  • Personnel qualified to work with animals
  • Adequate animal facilities and husbandry
  • Program of occupational health and safety

20
Federally Mandated IACUC Functions
  • Inspect every 6 months all animal facilities to
    ensure adherence to federal regulations and
    accepted standards
  • DLAM animal housing facilities
  • Investigator maintained housing facilities
  • Investigator laboratories where animal procedures
    are performed

21
Federally Mandated IACUC Functions
  • Semi-annually prepare report of IACUC evaluations
    and recommendations about animal facilities,
    animal program, personnel training
  • Identify deficiencies
  • Schedule for correction
  • Prompt reporting to OLAW of serious or continuing
    noncompliance with PHS Policy or the Guide

22
Federally Mandated IACUC Functions
  • Review of Animal Use Applications
  • Consumes most of the IACUC member time
  • Describe proposed activities using animals
  • IACUC reviews and approves, requests
    modifications, or denies approval of proposed new
    activities

23
Federally Mandated IACUC Functions
  • Review of Amendments to the Animal Use
    Application
  • IACUC receives about 50 a month
  • IACUC reviews and approves, requests
    modification, or withholds approval on proposed
    significant changes in ongoing activities

24
Amendments to an approved animal use application
  • P.I. must submit in writing to IACUC any proposed
    changes to the approved procedures involving
    animals
  • Any changes to procedures described in the
    originally approved application must be reviewed
    and approved by IACUC prior to implementation
  • Performance of procedures without IACUC approval
    is reportable to the federal regulators

25
Federally Mandated IACUC Functions
  • Investigate concerns involving the care and use
    of animals

26
How to Report Animal Mistreatment or Animal Use
Application Noncompliance
  • To report concerns, contact one of the following
  • Office of Animal Care and Use at 966-5569,
    iacuc_at_med.unc.edu or CB 7193. Ask for the
    IACUC Compliance Coordinators or Director. 
  • Campus-wide Research Compliance Coordinator,
    Adrian Shelton at 962-0338, Adrian_Shelton_at_unc.edu
    or CB 2105.
  • UNC-CH Compliance Line (866)294-8688.

27
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28
REPORTING TO OLAW
  • Non-compliance with approved applications
  • Initiating unapproved animal work
  • Deviations from approved SOPs
  • Animal activities conducted by unauthorized or
    unqualified individuals
  • Ongoing, unresolved problems
  • Shortcomings in the animal care program that
    jeopardize the health of animals

29
Federally Mandated IACUC Functions
  • Suspend activities involving animals
  • Take corrective action
  • Report to the funding agency and federal
    regulators
  • Most serious IACUC responsibility
  • Can adversely affect institution reputation and
    PI funding

30
Investigator Responsibilities
  • Responsible for all aspects of animal use
    application
  • Training of personnel in proper use of animals
  • Research personnel adhere to approved application
  • Establish a Laboratory Coordinator
  • Establish a 24-hour contact name and number

31
Laboratory Coordinator Certification Program
  • PIs with active animal applications must appoint
    a Laboratory Coordinator (LC)
  • LC coordinates animal activities and personnel
  • LC must attend formal training and be certified
    by IACUC to ensure that they are qualified and
    experienced for conducting procedures on living
    animals

32
Animal Care and Use Application
  • Application describes the experimental procedures
    and is a binding contract between the research
    laboratory and the University concerning every
    aspect of the in-life portion of an animal use
    study.

33
Animal Use Application
  • Rationale and purpose of proposed animal use
  • (lay summary)
  • Summarize scientific objectives and describe how
    important to improving human or animal health
  • Justification of animal species
  • Justification of animal number

34
Animal Use ApplicationAnimal Welfare Act 9CFR
2.31 (d)
  • Consider alternatives to procedures that cause
    more than momentary or slight pain or distress
  • Provide methods and sources used to determine
    that alternatives are not available
  • Research activities do not unnecessarily
    duplicate previous experiments
  • Painful/distressful procedures performed with
    analgesics or anesthetics unless withholding is
    justified for scientific reason, in writing, by
    PI and will continue for only necessary period

35
Animal Use Application
  • Appropriate post procedural care and monitoring
  • Criteria used to ensure removal of animals from a
    study
  • Death (other than by euthanasia) is not an
    acceptable experimental endpoint
  • Appropriate method of euthanasia

36
Euthanasia
  • 2000 Report of the AVMA Panel on Euthanasia
  • http//www.avma.org/resources/euthanasia.pdf

37
Researchers should assume that others besides
their peers may read their grants. These other
individuals may hold a different philosophy about
the use of animals.
  • Andrew Monjan, Ph.D., National Institute of Aging

38
Public Information
  • North Carolina Open Meetings Law
  • Freedom of Information Act (FOIA)
  • PETA FOIA request January April 2002
  • 7000 pages
  • Halted work in IACUC office for a week

39
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40
Improved Animal Program
  • lowered threshold for non- compliance with policy
  • increased IACUC oversight of the animal care
    program
  • revised policies and standard operating
    procedures
  • animal users are more aware of investigator
    responsibilities and animal care and use policy
  • UNC demonstrated strong desire to comply fully
    with commitments in Animal Welfare Assurance
    Statement

41
  • Virtually every medical achievement of the
    last century has depended directly or indirectly
    on research in animals
  • US Public Health Service
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