What does

1
What does IACUC stand for?

• Institutional Animal Care and Use Committee

2
IACUCs are required by..

• Federal Law (Animal Welfare Act)
• Regulations - United States Department of
  Agriculture (USDA)
• Policies - Public Health Service (PHS)

3
What are the IACUCs responsibilities?

• To assist investigators and instructors in
  maintaining the institutions 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)

4
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)

5
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)

6
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

7
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.

8
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

9
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

10
However..

• Institutions can establish policies requiring all
  vertebrate animal use subject to IACUC review
  and approval.
• This is the case at NCSU.

11
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.

12
Oversight of Animal Use - From the Top

• AWA administered by USDA-APHIS
• Regulations
• Policies
• Conducts annual inspections
• PHS (OLAW)
• Animal Welfare Assurance Statements
• AAALAC for accredited institutions (Optional)

13
down to NCSU

• 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

14
What members are required for the IACUC?

• 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

15
Whos on the IACUC at NCSU?

• 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

16
How do we do it?

• Interpretation and utilization of the regulations
  and guidelines
• Defining Pain and Distress
• Implementation of Institutional policies
• Linkages within the Institution
• Accepted Animal Care Guidelines

17
IACUC Considerations for Animal Use

• 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

18
Accepted Reference Guides for Animal Care and Use

• 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)

19
Linkages within the Institution

• Environmental Health and Safety
• Hazardous Materials
• Radiation Safety
• Biosafety
• Biological Resources Facility
• University Animal Resources
• Research and Teaching Units

20
A big question

• How long does it take to get IACUC approval?
• The answer is, It depends

21
IACUC Processing Statistics for 2002

• 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

22
IACUC Processing Statistics for 2002

• 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)

23
Where can I find information about animal use at
NCSU?

• NCSU IACUC Office
• Campus Box 8401
• Raleigh, NC 27695-8401
• www.ncsu.edu/iacuc
• Email iacuc_at_ncsu.edu