IACUC Member Training by eot15664

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									IACUC Member Training

       June 15, 2006
Training Objectives
   A Quick Overview of the Rules

   Basics of Protocol Review

   IACUC Member Standards
    Current Animal Welfare
    Regulations, Policies & Guidelines
   Animal Welfare Act - 9 CFR Chapter 1

   USDA Regulations and Animal Care
    Policies

   PHS Policy (1986)

   The Guide (NRC--5th Ed.)
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
    USDA Regulations
   Cover all warm-blooded animals
       exclude rats, mice and birds
   Provide performance standards for:
       veterinary care
       animal husbandry
       animal transportation
   Animal Care policies cover more than just
    research
   Set requirements for committee (IACUC)
    composition and function
        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
   Office of Laboratory Animal Welfare is responsible
    for assuring compliance with PHS policy.
PHS Policy

   Covers the use of all live vertebrate
    animals
   Applies to all institutions that accept
    money from the Public Health Service
    for research, testing and teaching.
   Requires negotiation of an animal
    welfare assurance with OLAW
       Key Elements of PHS Policy:

   Requirements for the submission of funding
    applications (e.g., description of the use of
    animals, grant-protocol match)
   Record keeping requirements
   Reporting requirements to enable funding
    agencies and OLAW to exercise oversight
   Composition of the IACUC (somewhat different
    than USDA requirements)
Composition of the IACUC
   USDA requires:
       At least 3 members
       Veterinarian, Non-affiliated member
   PHS Policy requires:
       At least 5 members
       Veterinarian, Nonscientist, Non-affiliated,
        at least 1 practicing scientist
The “Guide”
              Performance Standards:
               Institutional policies and
                responsibilities
               Animal environment,

                housing, and
                management
               Veterinary medical care

               Physical plant (facilities)
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.
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
Ethical Principles of Animal Use


    The three Rs
        Principles of Humane Experimental
         Technique by Wllm. Russell and Rex
         Burch, 1959
        Written a long time ago, resurfaced in the
         90’s
                    The Three Rs
   Replacement
       Use something other than a live animal if possible
   Refinement
       Make the procedures as non-invasive and painless
        as possible
   Reduction
       Use as few animals as possible to achieve scientific
        significance without increasing pain and distress
      Protocol Review
   Project Overview             Training & experience
   Experimental Design          Procedural Description
   Justification of Animal      Pain, Distress and
    Numbers                       Discomfort
   Use of Live Animals          Analgesia
   Literature Searches          Euthanasia
    for Alternatives
USDA pain category –
              What’s 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
    (that’s why there’s no pain category A).
   Number of animals used in the preceeding
    year are listed in columns B – E
USDA Pain/Distress Categories
   B = animals used only for breeding
    purposes (breeder moms, stud males,
    culled pups, etc.)
   C = momentary pain or distress
       Needle Stick for blood draw or
        administration of euthanasia
       No anesthesia needed for a similar
        procedure in a human
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
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
    Special Review Issues
   Multiple Survival Surgery
   Prolonged Restraint
   Food and Water Restriction
   Use of paralytic agents
   Category E procedures
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)
  It’s 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.
 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
    The USDA on Scientific Merit
   “Rationale for…species”
   “Appropriate species…to obtain valid
    results”
   “Activities do not unnecessarily duplicate…”
   “Procedures… for the conduct of
    scientifically valuable research”
                               - 9 CFR 2.31
    Protocol Review Process
   Pre Review - before the meeting :
       Read the protocol carefully, as far in advance of
        the meeting as possible
       Consult with veterinarians and the administrator
        with general questions.
       Discuss protocol with primary or secondary
        reviewer
       Reach out to Lead Researchers with questions as
        appropriate
Protocol Review Process

Before the final vote :
 Participate in the review and discussion


   Understand why the researcher should be
    allowed to use live vertebrate animals in
    research, teaching or testing.
   Ask yourself whether your decision is
    consistent with the humane care of animals
Committee Decisions

   Approved

   Tabled Administratively (M)

   Tabled for Subcommittee Review (T)

   Resubmission Required (R)
Approved!
 All IACUC concerns and administrative
 issues have been addressed adequately
 in the submission. No changes are
 required.
    Tabled Administratively (M)
   Minor administrative details or modifications
    are required to address concerns that do not
    alter the content of the protocol itself.
   No subcommittee review – approval is
    processed on receipt of clarifications.
   Examples:
       Minor miscalculation of animal numbers
       Missing contact information
       Procedure boxes incorrectly marked
        Tabled for Subcommittee Review
   Animal welfare issues have been adequately
    addressed, but additional information, details or
    clarifications are necessary before approval can be
    granted.
   Examples:
       Clarification of experimental design or justification of
        animal numbers
       Additional descriptive information regarding procedures.
       Alternatives search is missing or inadequately
        documented
       Significance of the research is not in lay language
    Resubmission Required (R)
   A reasonable judgement cannot be made regarding
    the experimental design or scientific merit of the
    proposed work, based on the information supplied.

   Serious animal welfare concerns have not been
    adequately addressed.

   Modification request is are beyond the scope of work
    described in the original protocol (must be
    resubmitted as a stand-alone protocol).
IACUC Member Standards
   Attendance

   Confidentiality

   Participation

   Conflict of Interest Disclosure
       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.
    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.
Participation
 Keep up-to-date with regulations, policies,
  etc.
 Attend the meetings, including the semi-
  annual Program Evaluation
 Participate in Semi-Annual Facility
  Inspections
 Volunteer to serve on subcommittees
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.
        AAALAC Accreditation –
           Why bother?
   AAALAC International is a private, nonprofit
    organization that promotes the humane treatment of
    animals in science through its voluntary accreditation
    and assessment programs.
   AAALAC works with institutions and researchers and
    serves as a bridge between progress and animal well-
    being. Through AAALAC's voluntary accreditation
    process, research programs demonstrate that they
    meet the minimum standards required by law, and
    are going the extra step to achieve excellence in
    animal care and use.
Who ARE those guys?
AAALAC site visit teams typically consist of a
member of the Council on Accreditation and an
ad-hoc member:
   AAALAC Council Member –
       Brian Ermeling, DVM
       Dartmouth University
   Ad hoc Member –
       Barton Weick, DVM
       NIH/NIDA Intramural Research
    …and what do they want
           from me?
AAALAC site visitors may ask you:
   What policies does the IACUC have, and how
    are they implemented?
   How you were trained as a committee
    member?
   Where do you go to find help in reviewing
    protocols?
    Questions?
   “Especially for IACUC Committee Members”
        New web page under construction

   Member Binder
        You got one when you
         joined the committee

   When in doubt, ASK!

								
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