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Institutional Animal Care and
Use Committee (IACUC)
From Research to Publishing Journal …
“Review of individual
Proposals/Projects by IACUC was
encouraged but not required” – IACUC
Guidebook
A Quality of Animal Care and Use
Program …


The Research Team







Institutional Official
Researchers
IACUC
Animal Care Staff (AV and technical staff)

Policies, Procedures, Resources and
Facilities
Institutional Official (IO)




Be informed about the program
Be engaged in the program
Sustained and visible support



In a position to influence institutional priorities
Can assure sufficient monetary and personnel
resources are allocated
IACUC








Clearly articulate policies and procedures so
that everyone understands expectations
Implement regulations using scientifically
sound, performance-based standards
Establish effective training programs that are
realistic
Assure the public of quality animal care
Researchers



Plan research in the context of quality animal care
Accept the responsibility




Engage in the process







Work to strengthen your animal care and use program
IACUC participation
Know the regulations

Be willing to communicate with administrators,
regulators, and Congress
Be proactive
Animal Care Staff






Ensure adequate and proper animal care and
use
Work in concert with the IACUC and
Investigators
Exercise professional judgment to facilitate
the science in the context of animal welfare
Animal Care and Use Program
Animal Care Staff

Each component must
make its contribution so
that the whole is greater
than the sum of the parts

Animal
Care and
Use
Program
Researchers

IACUC
Animal Care and Use Program (cont)









Properly constituted and functioning IACUC
Adequate veterinary care program
Occupational health and safety program
(OHSP)
Personnel training program
Environment, housing and management
program for animals
Appropriately maintained facilities
Components of Animal Care and Use Program
What IACUC do?







Oversees and evaluates entire animal care
and use program
Ensures compliance with “Guide”, PHS
Policy, AWRs
Represents institution and community
Serves as local oversight arm for APHIS/AC,
NIH/OLAW, AAALAC
IACUC Member






Chairperson
Veterinarian
Scientist / Non-scientist
Non-affiliated members
Alternate members
Chairperson




Knowledgeable and effective leader to an
effective IACUC
Need the full support of the IO
Veterinarian


According to PHS Policy and AWRs,
veterinarian must have;




Training / experience in lab animal science and
medical OR
In the care of species (animal) being used
Scientist / Non-scientist




A practicing scientist experienced in research
involving animals
A member whose primary concerns are in a
non-scientific area
Non-affiliated Members


Intended to represent general community
interests




Bring a non-institutional perspective to the
research

Equal status to every other committee
member



Should be provided the opportunity to
participate in all aspects of IACUC functions
Alternative Members






Should receives training similar or identical to
the training provided to regular IACUC
members
May not count toward a quorum at the same
time OR
Act in an official member capacity at the
same time
Conflict of Interest








Member of IACUC shall not review / approve
activity that has conflict of interest
Member shall notify IACUC Chair and not
participate in review / approval
Member potentially competing research
program
Member’s personal biases may interfere with
his / her impartial judgment
Responsibilities of IO


Maintain animal care and use program based
on recommendation / advise from;




IACUC
Veterinarian
IACUC professionals and administrative staff



Personnel training



Occupational health and safety



Maintenance of facilities
Responsibilities of Veterinarian







Selection and utilization of suitable anesthetic
and analgesic agents and methods of
euthanasia
Appropriate selection of species for research
projects
Proper performance of surgical procedures
Adequate pre-operative, surgical and postoperative care
Facility Review


All animal housing facilities must be
inspected in semiannual review, including






Satellite facilities
Areas in which surgical manipulation are
performed
Animal study areas
Holding facilities
Categories to be Inspected …












Sanitation
Food & water provisions
Animal identification
Waste disposal
Animal health records
Controlled and/or expired drugs
Environment control
OHS concerns
Staff training
Knowledge of applicable rules & regulations
Security
Documentation


Written report of semiannual program review
and facility inspection





The report to be signed by a majority of IACUC
Describe the adherence to AWRs, PHS Policy
and “Guide”
Identify deviations
Animal Enviroment






Housing
Temperature
Ventilation
Illumination
Noise
Husbandry





Animal Identification
Feeding
Watering
Bedding
Facility Maintenance




Cleaning and sanitation
Water disposal
Pest control
Occupational Health and Safety






Conduct a health and safety review of
research activities
Implement procedures to identify and
address non-experimental hazards
Ensure personnel comply with health and
safety requirements
Elements of OHSP







Administrative procedures
Facility design and operation
Risk assessment
Exposure control
Education and training
Equipment performance
Personnel Training and Education
Fundamental Issues



Protocol Review Criteria (Table A – C.1)
Proposal review procedures






Full committee review
Designated member review

Categories of IACUC actions
Reviewed of changes to approved protocols
The 3Rs Concept


Replacement / utilizing non-animal models







Living systems
Non-living systems
Computer simulations

Reduction of number of animal used
Refinement / elimination of unnecessary
pain and distress in animal
IACUC Deficiencies in Rank Order







Protocol Review
Semiannual Evaluations
Committee Composition & Member
Participation
Policies & Documentation
Training
Protocol Review


Justification for the numbers of animals used



Expedited review



Review of amendments



Alternatives to painful procedures



Management/evaluation of pain and distress
Semiannual Evaluations


Evaluation of animal activity areas



Classification of deficiencies as “minor” or
“significant”



Schedule and plan for correction



Follow-up to ensure schedule and plan met
Committee Composition and Member
Participation


Nonaffiliated member not appointed



Nonaffiliated member not attending meetings



Nonaffiliated member not participating in
semiannual evaluations
Policies and Documentation


Lack of policies/guidelines for common
experimental procedures (e.g., use of
adjuvants, tail snips)



Failure to review policies/guidelines regularly



Failure to record committee deliberations
Training


Failure to train (or to document the training
of) IACUC members



Failure to train (or to document the training
of) researchers
The IO, IACUC,
and Vet must
function as a
team!
Animal Care and Use Program


Institutional Official (IO)



Attending Veterinarian (Vet)



Institutional Animal Care and Use Committee
(IACUC)

Well-Balanced Program!
Implications on the published journals?
Still remain unclear !!! 
Animal Research – Guidelines and
Regulations









PHS
OLAW
NIH
IACUC
AAALAC
ARENA
AALAS
ARENA/OLAW IACUC Guidebook
Thank you !

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Institutional Animal Care and Use Committee (IACUC)

  • 1. Institutional Animal Care and Use Committee (IACUC) From Research to Publishing Journal …
  • 2. “Review of individual Proposals/Projects by IACUC was encouraged but not required” – IACUC Guidebook
  • 3. A Quality of Animal Care and Use Program …  The Research Team      Institutional Official Researchers IACUC Animal Care Staff (AV and technical staff) Policies, Procedures, Resources and Facilities
  • 4. Institutional Official (IO)    Be informed about the program Be engaged in the program Sustained and visible support   In a position to influence institutional priorities Can assure sufficient monetary and personnel resources are allocated
  • 5. IACUC     Clearly articulate policies and procedures so that everyone understands expectations Implement regulations using scientifically sound, performance-based standards Establish effective training programs that are realistic Assure the public of quality animal care
  • 6. Researchers   Plan research in the context of quality animal care Accept the responsibility   Engage in the process     Work to strengthen your animal care and use program IACUC participation Know the regulations Be willing to communicate with administrators, regulators, and Congress Be proactive
  • 7. Animal Care Staff    Ensure adequate and proper animal care and use Work in concert with the IACUC and Investigators Exercise professional judgment to facilitate the science in the context of animal welfare
  • 8. Animal Care and Use Program Animal Care Staff Each component must make its contribution so that the whole is greater than the sum of the parts Animal Care and Use Program Researchers IACUC
  • 9. Animal Care and Use Program (cont)       Properly constituted and functioning IACUC Adequate veterinary care program Occupational health and safety program (OHSP) Personnel training program Environment, housing and management program for animals Appropriately maintained facilities
  • 10. Components of Animal Care and Use Program
  • 11. What IACUC do?     Oversees and evaluates entire animal care and use program Ensures compliance with “Guide”, PHS Policy, AWRs Represents institution and community Serves as local oversight arm for APHIS/AC, NIH/OLAW, AAALAC
  • 12. IACUC Member      Chairperson Veterinarian Scientist / Non-scientist Non-affiliated members Alternate members
  • 13. Chairperson   Knowledgeable and effective leader to an effective IACUC Need the full support of the IO
  • 14. Veterinarian  According to PHS Policy and AWRs, veterinarian must have;   Training / experience in lab animal science and medical OR In the care of species (animal) being used
  • 15. Scientist / Non-scientist   A practicing scientist experienced in research involving animals A member whose primary concerns are in a non-scientific area
  • 16. Non-affiliated Members  Intended to represent general community interests   Bring a non-institutional perspective to the research Equal status to every other committee member  Should be provided the opportunity to participate in all aspects of IACUC functions
  • 17. Alternative Members    Should receives training similar or identical to the training provided to regular IACUC members May not count toward a quorum at the same time OR Act in an official member capacity at the same time
  • 18. Conflict of Interest     Member of IACUC shall not review / approve activity that has conflict of interest Member shall notify IACUC Chair and not participate in review / approval Member potentially competing research program Member’s personal biases may interfere with his / her impartial judgment
  • 19. Responsibilities of IO  Maintain animal care and use program based on recommendation / advise from;    IACUC Veterinarian IACUC professionals and administrative staff  Personnel training  Occupational health and safety  Maintenance of facilities
  • 20. Responsibilities of Veterinarian     Selection and utilization of suitable anesthetic and analgesic agents and methods of euthanasia Appropriate selection of species for research projects Proper performance of surgical procedures Adequate pre-operative, surgical and postoperative care
  • 21. Facility Review  All animal housing facilities must be inspected in semiannual review, including     Satellite facilities Areas in which surgical manipulation are performed Animal study areas Holding facilities
  • 22. Categories to be Inspected …            Sanitation Food & water provisions Animal identification Waste disposal Animal health records Controlled and/or expired drugs Environment control OHS concerns Staff training Knowledge of applicable rules & regulations Security
  • 23. Documentation  Written report of semiannual program review and facility inspection    The report to be signed by a majority of IACUC Describe the adherence to AWRs, PHS Policy and “Guide” Identify deviations
  • 26. Facility Maintenance    Cleaning and sanitation Water disposal Pest control
  • 27. Occupational Health and Safety    Conduct a health and safety review of research activities Implement procedures to identify and address non-experimental hazards Ensure personnel comply with health and safety requirements
  • 28. Elements of OHSP       Administrative procedures Facility design and operation Risk assessment Exposure control Education and training Equipment performance
  • 30. Fundamental Issues   Protocol Review Criteria (Table A – C.1) Proposal review procedures     Full committee review Designated member review Categories of IACUC actions Reviewed of changes to approved protocols
  • 31. The 3Rs Concept  Replacement / utilizing non-animal models      Living systems Non-living systems Computer simulations Reduction of number of animal used Refinement / elimination of unnecessary pain and distress in animal
  • 32. IACUC Deficiencies in Rank Order      Protocol Review Semiannual Evaluations Committee Composition & Member Participation Policies & Documentation Training
  • 33. Protocol Review  Justification for the numbers of animals used  Expedited review  Review of amendments  Alternatives to painful procedures  Management/evaluation of pain and distress
  • 34. Semiannual Evaluations  Evaluation of animal activity areas  Classification of deficiencies as “minor” or “significant”  Schedule and plan for correction  Follow-up to ensure schedule and plan met
  • 35. Committee Composition and Member Participation  Nonaffiliated member not appointed  Nonaffiliated member not attending meetings  Nonaffiliated member not participating in semiannual evaluations
  • 36. Policies and Documentation  Lack of policies/guidelines for common experimental procedures (e.g., use of adjuvants, tail snips)  Failure to review policies/guidelines regularly  Failure to record committee deliberations
  • 37. Training  Failure to train (or to document the training of) IACUC members  Failure to train (or to document the training of) researchers
  • 38. The IO, IACUC, and Vet must function as a team!
  • 39. Animal Care and Use Program  Institutional Official (IO)  Attending Veterinarian (Vet)  Institutional Animal Care and Use Committee (IACUC) Well-Balanced Program!
  • 40. Implications on the published journals? Still remain unclear !!! 
  • 41. Animal Research – Guidelines and Regulations         PHS OLAW NIH IACUC AAALAC ARENA AALAS ARENA/OLAW IACUC Guidebook