1. IACUC Institutional Animal Care and Use Committee

2. IACUC STAFF IACUC Chair, Ron Butler IACUC Coordinator, Toni Andres IACUC Administrative Asst., Sue Babcock Others –Brenda Payne –Patti Wojcik

3. ORIA Office Office for Research Integrity and Assurance (ORIA) – Compliance –Dr. E. Ray Stinson, Asst. Vice President for Research Compliance and Director, Research Integrity & Assurance –IACUC – Animal Care and Use –IRB – Human Participants –IBC – Biosafety Issues –Responsible Conduct in Research –Conflict of Interest and Commitment (2007) Currently located at 35 Thornwood Drive (near the airport) Suite 500

4. IACUC Why is an IACUC necessary –Animal Welfare Act – law –Ability to receive federal funds –Two regulatory agencies require USDA - any institution using animals in research PHS – any institution conducting PHS-supported activities

5. Charges of IACUC 1.Review protocols 2.Review continuation – Annual Review 3.Review Amendments to Protocols

6. Charges of the IACUC Review, at least once every 6 months, the institution’s program for animal care and use (IACUC Semiannual Report) Inspect, at least once every 6 months, animal facilities, animal study areas, satellite facilities, using Animal Welfare Act (USDA) and Guide (PHS)

7. Animal Facilities & Procedure Areas Number of Sites: 32 Number of Buildings: 115 Number of Procedure Areas: 44 Number of Satellite Facilities: 4 –Duck Lab – Long Island –Little Moose –Shoals Marine Lab –Shackelton Point

8. IACUC Charges Submit report to IO of evaluation of program and facilities Review and investigate concerns Make recommendations to IO regarding animal program, facilities, personnel training Review and approve, require modifications or withhold approval of components of proposed activities related to care and use of animals Suspend activity involving animals if doesn’t comply with AWAR, Guide, PHS Policy or Animal Welfare Assurance of Institution

9. IACUC Committee Requirements: –Veterinarian (PHS, USDA) –Chair –Nonaffiliated Member – represent community concerns (PHS, USDA) –Scientist (PHS) –Nonscientist (PHS)

10. Cornell’s IACUC Chair (scientist) Veterinarian ( + 5 alternates) 2 Unaffiliated Members ( + 1 alternate) 7 Scientists (2 alternates) – not counting Chair and Veterinarian 1 Nonscientist ( +1 alternate) Nonvoting Members –IACUC Coordinator ( + alternate) –Institutional Official –Asst. Vice President for Research Compliance

11. IACUC Monthly meetings – third Thursday of each month –Annual Reviews of Protocols –New Protocols –Updated Protocols –Amendments –Exemptions to Standards

12. Protocol Committee Votes: –Approved (very few approved at meeting) –Require modifications to secure approval, IACUC Chair can approve –Referred to subcommittee (usually 2 IACUC members, Chair and Veterinarian) to review modifications to secure approval – all subcommittee members must approve –Approval withheld

13. eSirius System Protocol Management Database Web based http://esirius.research.cornell.edu/esirius/ PI can complete protocol form and submit electronically to IACUC Protocol numbers –Before 86-18-04 –Now 1986-0018 (remains the same)

14. Protocols and Grant Applications

15. Comparison: Protocol to Grant An institution must be able to produce documentation that the IACUC approved the information contained in the grant application If an institution is using a protocol numbering system, it must be able to link those protocol numbers to grant numbers. It does not have to be a 1:1 ratio

16. Procedural Matters Just- in- time allows IACUC approval date to be submitted to NIH anytime prior to grant award If IACUC review occurs after application is submitted and the IACUC requires modifications related to animal usage, the modifications should be reported to NIH along with the IACUC approval date

17. How Can We Accomplish this? Some institutions have Grants Officers compare protocols and grant proposals Others -- the IACUC Office staff Others -- the IACUC review both grant requests and protocols together

18. Compliance Office –Will compare animal care and use protocols with grant proposals

19. Protocol to Grant Comparison –Single protocol might cover multiple grants –Multiple approved animal protocols might apply to a single grant

20. FORM 10 When we receive a Form 10 by e mail attachment or by campus mail –Add title to PI’s listing of projects in e-Sirius under Protocol Number given by PI –Letter if required with new title for Grants Officer

21. How can IACUC Office Help You? Funding reports (MUMPS generated) will no longer be available Form 10 – letters attached and sent back to GO? E mails – feel free to e mail either me (MA36) or Sue (SAL9)if you have questions

22. Contact the IACUC Office We will work with you to get you the information you need in a timely manner and in the most useful way possible. Toni Andres (ma36) – 5-3749 Sue Babcock (sal9) – 5-6439 Brenda Payne (bp75) – 5-3943

23. Thank You