M A N DY FA I R , I AC U C A D M I N I S T RAT O R

ANIMAL CARE AND USE

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ORIENTATION AGENDA

• Oversight and Regulation

• Submissions

• Investigator Responsibilities

• IACUC Policies

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OVERSIGHT AND REGULATION

Agencies outside of TTUHSC

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Office for Laboratory Animal Welfare (OLAW)

• OLAW is the organization within the NIH responsible for administering policy.

• We cannot receive NIH money without a PHS Assurance.

• An annual report.• IO receives reports of semiannual program review and inspections.• Advisement of deviations & noncompliance.

PHS Assurance of Compliancehttp://www.ttuhsc.edu/sponsoredPrograms/acuc/

The PHS Assurance describes how we conduct business regarding the use of

animals.

http://grants.nih.gov/grants/olaw/olaw.htm

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United States Department of AgricultureThe USDA regulates the treatment of animals in research via the Animal Welfare Act http://www.aphis.usda.gov/animal_welfare/awa.shtml

• The USDA is the organization within the Animal and Plant Health Inspection Service that is responsible for administering policy.

• USDA representatives conduct site visits at least annually.• They require we submit an annual report.• The Animal Welfare Act is considered the minimum acceptable standard.• They establish many of the operating rules for the IACUC.• Animal Welfare Policy Manual at

http://www.aphis.usda.gov/animal_welfare/policy.shtml

Animals NOT regulated by USDA:

Mus genus mice used for research

Ratus genus rats

Birds

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So where does AAALAC fit in?

Association for the Assessment and Accreditation of Laboratory Animal Care, International

• has no regulatory authority• provides an independent evaluation of our procedures and policies • accreditation carries a lot of weight with OLAW, USDA and other institutions• requires submission of an annual report• conducts site visits every three years to continue accreditation

Abilene, Amarillo, Lubbock and El Paso are accredited

(next site visit due 2016)

ANIMAL PROTOCOLSTypes of Applications

• Initial or 3 year Renewal (full descriptions and reviews)• Types: Experimental, Training, and Breeding• Typically reviewed by Full Committee (FCR)

• Amendments (only changes described)• Minor – Personnel, funding source, location changes (Administrative)• Major – Species, numbers above 10%, and Procedural (Full CR)

• Designated Member Review • Request to be reviewed in shorter time frame, must be

unanimous vote.• Annual Status Reports

• Last 12 months, goals for next 12 months, and #s used.• ASR & Amendment can be submitted together with Amendment• Reviewed by Designated Member Review

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PROTOCOL REVIEWTIMELINE

• Submission received and confirmed eligible.• Review Subcommittee assigned

• Primary Reviewer (IACUC Scientist member)• Secondary Reviewer (IVet)• Tertiary Reviewers (– Safety, non-scientist or Non-affiliated)

• Review Subcommittee agrees on necessary changes• PR inputs stipulations & notifies IACUC Staff to send• PI submits revision to IACUC Staff mailbox

• Staff enter info into iRIS and assign back to reviewer(s)• PR presents at IACUC monthly meeting

• Committee decision transmitted to PI by IACUC Staff (Approved, Pending revisions, or Tabled)

PROTOCOL REVIEW TIME FRAMESSubmit to iacuc.submissions@ttuhsc.edu or through

iRIS

• Meeting = 2nd Friday of the Month• Revisions Due = 1st Friday of the Month• Initial or 3 year Renewal (3 – 6 weeks)• Amendments

• Administrative (1 day – 3 months)• Major (3 – 6 weeks)

• ASRs (DMR) – Typically 2 – 3 weeks

INVESTIGATOR RESPONSIBILITIES

• Semi-Annual Inspections: April/October

(currently)

• Reduction – of numbers of animals used.

• Refinement

• of techniques to minimize numbers of animals and

need for pain and distress.

• Replacement – of using animals models.

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0 Introduction to IACUC Policies and Procedures 1 Animal Use Performed by/for TTUHSC Investigators at Non-TTUHSC Sites 2 Veterinary Care 3 Breeding Colonies 4 Pain Categories for Experimental Protocols 5 Cervical Dislocation or Decapitation of Animals 6 Use of Complete Freund's Adjuvant and Other Adjuvants in Laboratory Animals 7 Designated Reviews 8 Rodent Survival Surgery and Euthanasia 9 Inhalant Euthanasia10 Experimental Neoplasia in Rodents11 Complaints of Mistreatment of Animals and Policy Noncompliance at TTUHSC12 Procurement, Housing and Accountability for Use of Live Vertebrate Animals13 Protocol Approval, Implementation, Review and Amendment Processes14 Review of Protocols and Housing of Animals Between TTU and TTUHSC15 Survival Surgery16 Tail Snipping and Tail Biopsy of Rodents17 Rescinded18 Frog Oocyte Harvest19 Humane Endpoints Regarding Severe or Chronic Pain or Distress20 Administrative Approval of Amendments21 Use of Non-Pharmaceutical Grade Compounds22 Review of Grant Content with IACUC Protocol

TTUHSC IACUC POLICIESHTTP://WWW.TTUHSC.EDU/SPONSOREDPROGRAMS/ACUC/POLI

CYINDEX.ASPX

QUESTIONS?

Contact: Mandy Fair, MPA, CPIAmandy.fair@ttuhsc.edu

or iacuc.submissions@ttuhsc.edu

806-743-3603

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