IACUC Member Training

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IACUC Member Training

• September 27, 2007

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Training Objectives

• A Quick Overview of the Rules
• IACUC Member Standards
• Protocol Review Procedures

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Animal Welfare Regulations, Policies Guidelines

• Animal Welfare Act - 9 CFR Chapter 1
• Originally the Pet Protection Act, 1966
• USDA Regulations and Animal Care Policies
• PHS Policy (1986)
• The Guide (National Research Council - 5th Ed.)

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U.S. Dept. of Agriculture

• Enforces and Administers the Animal Welfare Act
• Enforces the Act through the Animal Welfare
  Regulations
• 9 CFR Chap. 1, Parts 1-3
• Provides clarification of the Regulations through
  the Animal Care Policies

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USDA Regulations

• Cover all warm-blooded animals
• exclude rats, mice and birds
• Animal Care policies cover more than just
  research
• Routine inspections of facilities
• Specific performance standards for
• veterinary care and animal husbandry
• animal transportation and other issues
• Set requirements for committee (IACUC)
  composition and function

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PHS Policy NIH Office of Laboratory Animal
Welfare (OLAW)

• Health Research Extension Act of 1985 is the
  legislative mandate for PHS Policy.
• Covers all vertebrate animals
• NIH-funded institutions must adhere to the PHS
  Policy
• Oversight - Office of Laboratory Animal Welfare
  at NIH

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PHS Policy

• Covers all vertebrate species
• Reptiles, aquatics, birds, mice and rats, etc.
• Applies to all institutions that accept money
  from the Public Health Service for research,
  testing and teaching.
• UCI received 132,789,355 in last fiscal year
• All animal related costs are unallowable during
  lapses in approval
• Requires negotiation of an animal welfare
  assurance with OLAW
• Detailed description of our animal care and use
  program

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Key Elements of PHS Policy

• Requirements for the submission of funding
  applications (e.g., description of the use of
  animals, grant-protocol match)
• More specific record keeping requirements
• Different reporting requirements than USDA (no
  regular inspections)
• Composition of the IACUC (somewhat different than
  USDA requirements)

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Composition of the IACUC

• USDA requires
• At least 3 members
• Veterinarian, Non-affiliated member
• PHS Policy requires
• At least 5 members
• Veterinarian, Nonscientist, Community/Non-affiliat
  ed member, at least 1 practicing scientist

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The Guide

• Performance Standards
• Institutional policies and responsibilities
• Animal environment, housing, and management
• Veterinary medical care
• Physical plant (facilities)

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The Guide

• First edition issued in 1963 by the Animal Care
  Panel (renamed ILAR)
• The 5th and most recent edition was published in
  1985.
• Used by AAALAC to evaluate animal care use
  programs
• Covers all aspects of the animal care and use
  program, including facilities.

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Other References

• 2000 Report from the AVMA Panel on Euthanasia
• Humane euthanasia techniques
• Endorsed by USDA and OLAW
• NASA Principles
• Respect for life
• Societal Benefit
• Non-maleficence

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Ethical Principles of Animal Use

• Principles of Humane Experimental Technique by
  Russell and Burch, 1959
• Written a long time ago, resurfaced in the 90s
• The Three Rs
• Replacement
• Reduction
• Refinement

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The Three Rs

• Replacement
• Use something other than a live animal if
  possible
• Reduction
• Use as few animals as possible to achieve
  scientific significance without increasing pain
  and distress
• Refinement
• Make the procedures as non-invasive and painless
  as possible

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Protocol Review
Replacement/Reduction
Refinement

• Project Overview
• Use of Live Animals
• Literature Searches for Alternatives
• Experimental Design
• Justification of Animal Numbers

• Procedural Description
• Pain, Distress and Discomfort
• Analgesia
• Euthanasia
• Training Experience

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USDA pain category Whats up with that?

• Letters refer to the columns on the USDA Animal
  Usage report we file once per year
• Column A animal species is listed here (thats
  why theres no pain category A).
• Number of animals used in the preceding year are
  listed in columns B E

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USDA Pain/Distress Categories

• B animals used only for breeding purposes
  (breeder moms, stud males, culled pups, etc.)
• C momentary (or less) pain or distress
• Needle stick for blood draw or administration of
  euthanasia
• No anesthesia needed for a similar procedure in a
  human

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USDA Pain/Distress Categories

• D Some pain/distress, treated with anesthetic,
  analgesic or tranquilizing drugs
• Similar procedure in a human would require
  topical or systemic anesthesia
• Post-surgical pain treated with analgesia
• Anesthesia used for restraint
• Cardiac Perfusion? Maybe not..

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USDA Pain/Distress Categories

• E Pain/distress for which the use of
  appropriate anesthetic, analgesic or
  tranquilizing drugs would adversely affect the
  research.
• Analgesic studies
• Death as an endpoint
• REQUIRES SCIENTIFIC JUSTIFICATION

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Special Review Issues

• Multiple Survival Surgery
• Prolonged Restraint
• Food and Water Restriction
• Use of paralytic agents
• Category E procedures

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Review of Scientific Merit

• Protocols involving animals should have a sound
  research design, the animals selected should
  yield valid results, and the project should have
  relevance and scientific value (i.e. merit) .
• (based on PHS Policy and USDA Regulations)

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Its your responsibility

• IACUC review of merit is not just for unfunded
  projects both USDA and PHS delegate much of the
  responsibility for protocol review, including the
  assessment of merit, to the institution.

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PHS Policy on Scientific Merit

• Procedures with animals will avoid or minimize
  discomfort, distress, and pain to the animals,
  consistent with sound research design.
• - PHS Policy (IVC1a)
• The animals selected for a procedure should be
  of an appropriate species and quality and the
  minimum number required to obtain valid results.
  - U.S. Government Principles III

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The USDA on Scientific Merit

• Rationale forspecies
• Appropriate speciesto obtain valid results
• Activities do not unnecessarily duplicate
• Procedures for the conduct of scientifically
  valuable research
• - 9 CFR 2.31

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Training Objectives

• A Quick Overview of the Rules
• IACUC Member Standards
• Protocol Review Procedures

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IACUC Member Standards

• Attendance
• Confidentiality
• Participation
• Conflict of Interest Disclosure

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Attendance

• Members are responsible for attending all
  convened meetings and staying until business has
  been completed.
• If you cannot attend a meeting, notify the IACUC
  Administrative Office as soon as possible so an
  alternate member can be contacted if necessary to
  maintain quorum.
• Official committee business, including protocol
  review, cannot be conducted without a quorum of
  voting members.

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Confidentiality

• IACUC protocols may contain personal,
  confidential and proprietary information.
• Members of the IACUC are responsible for
  maintaining all committee proceedings and
  documents in strict confidence.
• Information discussed at IACUC meetings may not
  be disclosed without the prior written permission
  of the Vice Chancellor for Research.

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Participation

• Attend the meetings, including the semi-annual
  Program Evaluation and monthly Business Meetings
• Participate in Semi-Annual Facility Inspections
• Keep track of email/subcommittee reviews and
  respond promptly
• Volunteer to serve on subcommittees
• Keep up-to-date with regulations, policies, etc.

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Conflicts of Interest

• Members of the IACUC must disclose all potential
  conflicts to the IACUC Chair or Administrator
• Examples of a conflict of interest
• IACUC member is the Lead Researcher, faculty
  sponsor or collaborator on the project
• IACUC member has a significant financial or
  management interest in the sponsor of a project
  under review.
• IACUC member believes existing circumstances may
  effect his/her objectivity.

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Training Objectives

• A Quick Overview of the Rules
• IACUC Member Standards
• Protocol Review Procedures

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The New Review Procedure

• Prior to the Meeting
• Administrative and Veterinary Pre-review
• IACUC Pre-review
• LR revision period
• At the Convened Meeting
• Final Discussion and Approval

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Pre-review Timeline

• Deadline 3 weeks prior to meeting
• Week 1 Admin/vet pre-review and distribution to
  committee via CD
• Week 2 IACUC pre-review
• Protocols will be assigned to a primary and
  secondary reviewer, but all members are
  encouraged to review and comment all protocols
• Members pre-review comments must be returned to
  Administrator as soon as possible
• Week 3 LR revisions
• LRs revised protocol will be emailed to primary
  and secondary reviewers prior to the IACUC
  meeting.

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At the Meeting

• Primary/Secondary Reviewers will
• Present a BRIEF synopsis of the project
• Summarize the issues raised in pre-review and
  confirm that required changes were made
• Recommend Approval, Resubmission or Table for
  further revisions

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Prior to Approval

• Before the final vote, it should be clear to all
  members
• That the need for live vertebrate animals in
  research, teaching or testing has been clearly
  articulated by the researcher.
• That the committees decision is consistent with
  the humane care of animals

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Committee Decisions

• Approved
• Tabled Administratively (M)
• Very minor non-scientific issues
• Tabled for Subcommittee Review (T)
• Review by Primary/Secondary Reviewers
• Resubmission Required (R)
• Complete rewrite serious scientific or welfare
  issues

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Tabled to Subcommittee The Process

• LR submits a response to the IACUCs review
• Revised application, appendices
• Cover letter addressing each point of the IACUCs
  memo
• Response materials are emailed to IACUC
  Subcommittee
• Primary and Secondary Reviewers, plus others as
  appropriate

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Tabled to Subcommittee The Process (cont)

• Subcommittee responds to Administrator
• OK to approve
• Additional information needed
• Email response is filed as documentation in the
  official protocol record.

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Designated Review of Modifications

• Described in our OLAW assurance
• Appropriate for modification requests of a
  less-significant nature
• Increase in animal numbers (lt 10 of approved
  allocation)
• Refinements in technique
• Minor changes in procedure
• Requires polling of entire committee
• It only takes one member to call for full
  committee review
• Volunteers required for the standing subcommittee!

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Training Objectives

• A Quick Overview of the Rules
• IACUC Member Standards
• Protocol Review Procedures

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Questions?

• IACUC Webpage
• http//www.rgs.uci.edu/ora/rp/acup/index.htm
• Especially for IACUC Committee Members
• Member Binder
• You got one when you
• joined the committee
• When in doubt, ASK!