ANIMAL USE IN RESEARCH: Regulations, Policies, and Procedures

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ANIMAL USE IN RESEARCH Regulations, Policies,
and Procedures

• Tracy M. Heenan, D.V.M.
• Director
• Office of Animal Care and Use

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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

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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

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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

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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.

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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

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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

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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.

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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.

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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

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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

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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

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OLAWs Approval of the Assurance Statement

• Commits the institution and its officials,
  investigators, and other agents to full
  compliance with the PHS Policy

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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

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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

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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

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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

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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

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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

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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

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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

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Federally Mandated IACUC Functions

• Investigate concerns involving the care and use
  of animals

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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 [phone].

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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

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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

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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

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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

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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.

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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

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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

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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

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Euthanasia

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

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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

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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

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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

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