va animal research iacuc
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
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VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
VA Animal ResearchIACUC
VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
• 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
VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
The Components of our Animal Research Program
The lines of authority and responsibility for administering the animal research program and ensuring compliance.
Marci Mylan, Ph.D., DIRECTOROmaha Veterans Affairs Medical Center
Research and Development Committee
Subcommittee of Animal StudiesIACUC
John Hudson II, Ph.D.Administrative Officer
Ellis G. Jensen, D.V.M.P.D. Westenburg, D.V.M.
Veterinary Consultants
Debra Romberger, M.D.Associate Chief of Staff/Research Service
ACOS/R&D
Robert WiegertARF Supervisor
T. Norman ThomasAnimal Caretaker
Subcommittee of Animal StudiesIACUC
Ellis G. Jensen, D.V.M.Veterinary Consultant
Robert WiegertARF Supervisor
IACUC Coordinator:Wendy Inselman, [email protected]
VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
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
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Announcements concerning AAALAC review:Announcements concerning AAALAC review:
1.Please check expiration dates on all substances (food, drugs, chemicals and other materials).
Bob W. will be inspecting for this before Sept. 1
2. Please make sure that all secondary containers are properly labeled.
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• 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
NEW ACORP VERSION 4NEW ACORP VERSION 4From Central Office:
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Application to perform animal researchApplication to perform animal research
http://www.nebraska.va.gov/services/Research/iacuc/iacuc_forms.asp
http://www.research.va.gov/programs/animal_research/.
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VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
Animal specific forms: OLD
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Version Number NEW FORMS (August 2013)
4 Animal Component of Research Protocol (ACORP) Main Body(ACORP Instructions)
Appendix 1– Additional Local Information(ACORP App. 1 Instructions)
Appendix 2– Antibody Production(ACORP App. 2 Instructions)
Appendix 3– Biosafety(ACORP App. 3 Instructions)
Appendix 4-- Ante-mortem Specimen Collection (ACORP App. 4 Instructions)
Appendix 5– Surgery (ACORP App. 5 Instructions)
Appendix 6– Special Husbandry and Procedures (ACORP App. 6 Instructions)
Appendix 7– Use of Patient Care Equipment or Areas for Animal Studies (ACORP App. 7 Instructions)
Appendix 8– Use of Explosive Agent(s) within the VMU or in Animals (ACORP App. 8 Instructions)
Appendix 9– Departures from "Must" and "Should" Standards in the Guide(ACORP App. 9 Instructions)
VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
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
VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
Initial / Triennial / Amendments– NEW ACORP
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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
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Harm-Benefit Analysis
ACORP Main BodyB.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 …
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ACORP InstructionsB.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.
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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
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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
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Expanded instructions for the table in Item 2 of Appendix 3 are given in the Instructions file
2. 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).
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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.
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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
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When a deviations is a DEPARTURE and requires Appendix 9 submission
When a deviation does not require Appendix 9 submission
Example 1
“Should”statement
Specifically described Guide exception
Implications for the IACUC
Food and Fluid Regulation:“The objective should be to use the least restriction necessary to achieve the scientific objective while maintaining animal well–being.” (pg. 30-31)
“Regulation of food or fluid intake may be required for some research protocols. Body weights should be recorded at least weekly and more often for animals requiring greater restrictions (NRC 2003b).” (pg. 30-31)
If the IACUC confirms that food restriction is scientifically justified and the animals are weighed weekly, and the IACUC approves the restriction, this would be a specifically described Guide 8th edition exception.
No appendix 9 required
Example 2
“Should” statement Specifically described Guide exception
Implications for the IACUC
Individual housing:“Social animals should be housed in stable pairs or groups of compatible individuals…” (pg. 51)
“…unless they must be housed alone for experimental reasons or because of social incompatibility
If the IACUC approves an appropriate justification then it is an example of a specifically described Guide 8th edition exception.
No Appendix 9 required
When a deviation does not require Appendix 9 submission
Example 3
“Should” statement Specifically described Guide exception
Implications for the IACUC
Non-pharmaceutical grade (NPG) chemicals and other substances:“The use of NPG substances ensures that toxic or unwanted side effects are not introduced…They should therefore be used “...
The use of NPG substances should be described and justified in the animal use protocol and be approved by the IACUC (Wolff et a,. 2003);
NPGs may be necessary to meet the scientific goals of a project or when a veterinary or human pharmaceutical-grade product is unavailable.” (pg. 31)
If the PI justifies the use of a NPG agent in their protocol and the IACUC approves the use, this would be a specifically described Guide 8th edition exception.
No appendix 9 required
When a deviation does not require Appendix 9 submission
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When a deviation is a DEPARTURE and requires Appendix 9 submission
VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM
Summary
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1. READ instructions
2. 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