Animal Care and use Mandy Fair, IACUC Administrator
Orientation Agenda • Oversight and Regulation • Submissions • Investigator Responsibilities • IACUC Policies
Oversight and Regulation Agencies outside of TTUHSC
Office for Laboratory Animal Welfare (OLAW) http://grants.nih.gov/grants/olaw/olaw.htm • 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 Compliance http://www.ttuhsc.edu/sponsoredPrograms/acuc/ The PHS Assurance describes how we conduct business regarding the use of animals.
United States Department of Agriculture The USDA regulates the treatment of animals in research via the Animal Welfare Act http://www.aphis.usda.gov/animal_welfare/awa.shtml Animals NOT regulated by USDA: Mus genus mice used for research Ratus genus rats Birds • 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
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 protocols Types 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
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 frames Submit to email@example.com 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.
TTUHSC IACUC Policieshttp://www.ttuhsc.edu/sponsoredPrograms/ACUC/policyindex.aspx 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 Euthanasia 10 Experimental Neoplasia in Rodents 11 Complaints of Mistreatment of Animals and Policy Noncompliance at TTUHSC 12 Procurement, Housing and Accountability for Use of Live Vertebrate Animals 13 Protocol Approval, Implementation, Review and Amendment Processes 14 Review of Protocols and Housing of Animals Between TTU and TTUHSC 15 Survival Surgery 16 Tail Snipping and Tail Biopsy of Rodents 17 Rescinded 18 Frog Oocyte Harvest 19 Humane Endpoints Regarding Severe or Chronic Pain or Distress 20 Administrative Approval of Amendments 21 Use of Non-Pharmaceutical Grade Compounds 22 Review of Grant Content with IACUC Protocol
Questions? Contact: Mandy Fair, MPA, CPIA firstname.lastname@example.org or email@example.com 806-743-3603