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What does “IACUC” stand for?. Institutional Animal Care and Use Committee. IACUCs are required by…. Federal Law (Animal Welfare Act) Regulations - United States Department of Agriculture (USDA) Policies - Public Health Service (PHS). What are the IACUC’s responsibilities?.

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What does “IACUC” stand for?

Institutional Animal Care and Use Committee


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IACUCs are required by…..

  • Federal Law (Animal Welfare Act)

  • Regulations - United States Department of Agriculture (USDA)

  • Policies - Public Health Service (PHS)


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What are the IACUC’s responsibilities?

  • To assist investigators and instructors in maintaining the institution’s compliance with the Animal Welfare Act and federal animal welfare regulations

  • Review of research and teaching activities involving the use of vertebrate animals

  • Review/monitor welfare of vertebrate animals maintained by the institution (housing and care)


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Who is concerned with animal welfare?

  • Governmental Agencies

    - USDA- Animal and Plant Health Inspection Service (APHIS)

    - Health and Human Services (HHS) Public Health Service (PHS)

    National Institutes of Health (NIH)

    Office of Laboratory Animal Welfare (OLAW)

    Food and Drug Administration (FDA)


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And also

  • Scientists

    - Scientists Center for Animal Welfare (SCAW)

    - American Association for Laboratory Animal Science (AALAS)

    - Association for the Accreditation and Assessment of Laboratory Animal Care (AAALAC, International)

    - Institute for Laboratory Animal Research (ILAR)

    - Federation of Animal Science Societies (FASS)


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Who else is interested?

  • Public Animal-Centric Organizations American Humane Association (AHA) Humane Society of the United States (HSUS)

    Society for the Prevention of Cruelty to Animals (SPCA)

  • Health Care Consumers(medical treatments, vaccines, cures for disease)

  • Agricultural Operations(Meat and Dairy Producers)

  • Consumers


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Animal Welfare versus Animal Rights

USDA, PHS, OLAW and IACUCs are concerned with the safe, appropriate and humane use of animals for agricultural and biomedical research and teaching. Our charge is animal welfare.

Many animal rights groups are based upon the philosophical views of individuals who are opposed to the production or consumption of animals for food, and the use of animals for research, education, transportation, recreation, or exhibition. Some of these groups are even opposed to pet ownership.


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Public Records - FOIA

Freedom Of Information Act (FOIA)

USDA Inspection Reports

Approved Protocols

Minutes of IACUC meetings

Assurance Statement

Animal Care Program reviews

Facility inspection reports


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Why do Universities need IACUCs?

  • Laws, Regulations, and Policies

    • These committees were established in accordance with the Animal Welfare Act (1966, 1970) and the 1976, 1985, and 1990 AWA Amendments

    • Mice, Rats, and Birds were originally excluded from the act

      • 1999 a petition was filed with the USDA Secretary of Agriculture to remove this exclusion

      • The Helms amendment to the 2002 Agriculture Bill specifically exempts Mice, Rats and Birds


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However……..

  • Institutions can establish policies requiring all vertebrate animal use subject to IACUC review and approval.

  • This is the case at NCSU.


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What can happen if an institution is found to be out of compliance with federal regulations?

Federal funding (USDA, NIH, PHS, etc.) could be withdrawn from an institution found to be noncompliant with the AWA and federal regulations. The Animal Welfare Assurance Statement that NCSU has on file with OLAW assures the federal government that NCSU will comply with the AWA and all federal regulations.


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Oversight of Animal Use - From the Top compliance with federal regulations?

  • AWA administered by USDA-APHIS

    • Regulations

    • Policies

    • Conducts annual inspections

  • PHS (OLAW)

    • Animal Welfare Assurance Statements

  • AAALAC for accredited institutions (Optional)


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…down to NCSU compliance with federal regulations?

  • Chancellor (our Institutional Official)

    • Relies on the IACUC reports

  • Vice Chancellor for Research

    • Provides feedback to the chancellor

  • IACUC

    - Reviews and approves, or disapproves proposed animal use; monitors conditions of animal housing and use areas through facility inspections; conducts semiannual program reviews; reports to the Institutional Official


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What members are required for the IACUC? compliance with federal regulations?

  • PHS policy states that IACUCs must consist of no less than 5 members, including:

    • A veterinarian

    • A practicing scientist experienced in animal research

    • A member whose primary concerns are in a nonscientific area

    • A member who is not affiliated with the institution outside of IACUC membership and is not a member of the family of an IACUC member

    • One individual may fulfill more than one requirement


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Who’s on the IACUC at NCSU? compliance with federal regulations?

  • Associate Vice Chancellor, Research Administration (non-voting)

  • Associate Vice Chancellor, Environmental Health and Public Safety (non-voting)

  • IACUC Administrative Officer/Coordinator

  • The University Director of Animal Resources

  • The Assistant Director of Animal Resources

  • Director, Biological Resources Facility

  • 13 faculty members from CVM and CALS (animal users and non-animal users)

  • 1 unaffiliated, nonscientist member from our local community


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How do we do it? compliance with federal regulations?

  • Interpretation and utilization of the regulations and guidelines

  • Defining Pain and Distress

  • Implementation of Institutional policies

  • Linkages within the Institution

  • Accepted Animal Care Guidelines


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IACUC Considerations for Animal Use compliance with federal regulations?

  • What is the Rationale for using Animals

  • Appropriateness of the Species

  • For Category of use D and E

    • Required Search for Alternatives

    • Consideration of the “Three Rs”

      • Replacement

      • Reduction

      • Refinement

  • Literature Search

    • Other information services

    • Search methods used

    • Summarize and justify findings


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Accepted Reference Guides for Animal Care and Use compliance with federal regulations?

  • Guide for the Care and Use of Laboratory Animals (National Academy Press, 1996)

  • Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (FASS, 1999)

  • AVMA Panel Report on Euthanasia (American Veterinary Medical Association, 2000)


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Linkages within the Institution compliance with federal regulations?

  • Environmental Health and Safety

    Hazardous Materials

    Radiation Safety

    Biosafety

  • Biological Resources Facility

  • University Animal Resources

  • Research and Teaching Units


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A big question… compliance with federal regulations?

How long does it take to get IACUC approval?

The answer is, “It depends……”


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IACUC Processing Statistics for 2002 compliance with federal regulations?

  • Number of applications reviewed: 120

  • Number of applications approved: 108

  • Number of applications not approved: 12 (includes 11 withdrawn from review by the investigators, usually because grant applications were not funded for reasons outside of IACUC approval)

  • Average review time (from date of receipt in IACUC office to date of approval by IACUC Chair): 6.5 weeks


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IACUC Processing Statistics for 2002 compliance with federal regulations?

  • Longest review time: 30 weeks (investigator could not be reached while out of the country for several weeks during review)

  • Shortest review time: 1 week (expedited review of a maintenance protocol)


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Where can I find information about animal use at NCSU? compliance with federal regulations?

NCSU IACUC Office

Campus Box 8401

Raleigh, NC 27695-8401

www.ncsu.edu/iacuc

Email: [email protected]


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