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VA Animal Research IACUC

VA Animal Research IACUC. IACUC (Institutional Animal Care and Use Committee) Charged with ensuring compliance ACORP (Animal Component of Research Protocol) Official VA animal protocol form

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VA Animal Research IACUC

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  1. VA Animal ResearchIACUC

  2. IACUC(Institutional Animal Care and Use Committee) Charged with ensuring compliance • ACORP(Animal Component of Research Protocol) Official VA animal protocol form • AAALAC(Assoc. for Assessment & Accreditation of Lab Animal Care)Accrediting body for animal research recognized by VA • OLAW(Office of Laboratory Animal Welfare) PHS office that administers policy on animal use and care. • ORO(Office of Research Oversight) VA advising office on compliance and assurance

  3. The Components of our Animal Research Program Marci Mylan, Ph.D., DIRECTOR Omaha Veterans Affairs Medical Center The lines of authority and responsibility for administering the animal research program and ensuring compliance. Research and Development Committee Subcommittee of Animal Studies IACUC Subcommittee of Animal Studies IACUC Debra Romberger, M.D. Associate Chief of Staff/Research Service ACOS/R&D • IACUC Coordinator: • Wendy Inselman, 995-3940 • Wendy.Inselman@va.gov Ellis G. Jensen, D.V.M. Veterinary Consultant John Hudson II, Ph.D. Administrative Officer Ellis G. Jensen, D.V.M. P.D. Westenburg, D.V.M. Veterinary Consultants Robert Wiegert ARF Supervisor Robert Wiegert ARF Supervisor T. Norman Thomas Animal Caretaker

  4. IACUC Self-regulatory body for animal research • Responsibilities: • Perform review and oversight functions PHS Policy- The Guide VHA Handbook 1200.7 • Perform semi-annual program and facility reviews AAALAC Review this fall NEW ACORP VERSION 4

  5. Announcements concerning AAALAC review: • Please check expiration dates on all substances (food, drugs, chemicals and other materials). • Bob W. will be inspecting for this before Sept. 1 • Please make sure that all secondary containers are properly labeled.

  6. NEW ACORP VERSION 4 From Central Office: • Version 4 is major update over Version 3 – begin use as soon as possible- New forms must be used for review at the September IACUC meeting (August 25th deadline). • Separate files for forms and instructions (instruction files include more detailed explanations, references, and examples) • Substantive updates to address new regulatory emphases • Harm-benefit analysis • Use of non-pharmaceutical agents • Managing deviations/departures

  7. Application to perform animal research http://www.nebraska.va.gov/services/Research/iacuc/iacuc_forms.asp http://www.research.va.gov/programs/animal_research/.

  8. Animal specific forms: OLD

  9. Use of NEW forms: Required submissions: • Initial – entire ACORP • Annual Continuing review • Triennial – entire ACORP • Optional submissions: • Amendment –entire ACORP with highlighted changes AND all appropriate appendixes • Amendment to add new personnel: • expedited- DMR

  10. Initial / Triennial / Amendments– NEW ACORP

  11. Substantive updates to address new regulatory emphases • Harm-benefit analysis • Use of non-pharmaceutical agents • Managing deviations/departures Harm-Benefit Analysis is now explicitly addressed in Item B of Main Body

  12. Harm-Benefit Analysis • ACORP Main Body • Description of Relevance and Harm/Benefit Analysis. … describe how this research project is intended to improve the health of people and/or other animals, or otherwise to serve the good of society, and explain how these benefits outweigh the pain or distress that may be caused in the animals … • ► ACORP Instructions Description of Relevance and Harm/Benefit Analysis. (US Government Principles, Principle II) … The IACUC is obligated to weigh the benefits to be gained from the work against potential concerns about animal welfare (AAALAC FAQs, C.3, Guide, p. 27), so it is important for the protocol to provide the information that the IACUC needs to assess this.

  13. Substantive updates to address new regulatory emphases • Harm-benefit analysis • Use of non-pharmaceutical agents • Managing deviations/departures Non-pharmaceutical-grade agents are now addressed explicitly in Appendix 3

  14. Non-Pharmaceutical Agents • Note: Every material that appears anywhere in the ACORP should be listed in item 1, regardless of whether there are any biosafety concerns

  15. Expanded instructions for the table in Item 2 of Appendix 3 are given in the Instructions file • Summary of How Materials will be Administered. Provide the details … • OLAW requires that only pharmaceutical grade compounds be administered to animals unless the use of non-pharmaceutical grade compounds is justified by scientific necessity and the lack of availability of an acceptable veterinary or human pharmaceutical grade compound (OLAW FAQs, F.4). … Mark with a * each material, diluent, or vehicle to be administered to the animals on this protocol that is not pharmaceutical grade. For each of these, provide the justification for using a non-pharmaceutical grade compound, and describe how it will be ensured that the grade, purity, sterility, pH, pyrogenicity, osmolality, stability, formulation, and pharmacokinetics of the material will be suitable for use in the animals (Guide, p. 31).

  16. Substantive updates to address new regulatory emphases • Harm-benefit analysis • Use of non-pharmaceutical agents • Managing deviations/departures Appendix 9 is a new feature in Version 4 of the ACORP and is used to record Departures from “Must” and “Should” Standards in the Guide (2011). ** The Instructions for Appendix 9 include test questions and a flow chart for determining deviations /departures.

  17. Appendix 9 is a new feature in Version 4 of the ACORP and is used to record Departures from “Must” and “Should” Standards in the Guide (2011). ***Appendix 9 is used to document DEPARTURES that have been approved by the IACUC for your protocol ***DEPARTURES are determined from “deviations” from the “Guide”— most commonly appear in the following questions: Main ACORP: C.2.c : description of animal use M: husbandry T: endpoint criteria U: termination or removal from protocol V: special procedure Appendices: 2,4,5,6,7

  18. When a deviations is a DEPARTURE and requires Appendix 9 submission

  19. When a deviation does not require Appendix 9 submission Example 1

  20. When a deviation does not require Appendix 9 submission Example 2

  21. When a deviation does not require Appendix 9 submission Example 3

  22. When a deviation is a DEPARTURE and requires Appendix 9 submission

  23. Summary • READ instructions • Answer all questions: Fill in all tables that apply • Answer when prompted ► • Enter N/A for any item that does not apply • 3. Start using new forms for protocols to be reviewed in Sept (August 25th deadline) • 4. Use resources: GUIDE etc. • 5. Ask questions

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