Use of Animals in Research

United States Department of Veterans Affairs

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Overview
Mission and Activities
Contacts
Important Documents
Required training for staff involved in the use of animals in research
Guidance on Animal Research FOIA Requests
Animal Facility (Veterinary Medical Unit) renovation and construction design manuals

Overview

The use of animals in VA research is a privilege granted to those investigators and programs that commit to meeting the highest ethical and regulatory standards. VA animal care and use programs must follow VA policy on the use of animals found in Handbook 1200.7, "Use of Animals in Research", which incorporates compliance with USDA Animal Welfare Act Regulations and PHS Policy. All VA animal care and use programs are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC, International). VA places great emphasis on the importance of the Institutional Animal Care and Use Committee (IACUC) in self-regulation and accountability of local programs. ORD support for field animal care and use programs is coordinated by the office of the Chief Veterinary Medical Officer (CVMO).

Mission and Activities

The primary mission of the CVMO's office is to provide professional and administrative guidance and support to VA field animal care and use programs. This is accomplished by phone and email consultations, periodic training sessions, and development of web-based support systems. IACUC support and training site visits to local programs can be arranged. A variety of representative documents are available, including memoranda of understanding with affiliates, VMO and animal facility supervisor position descriptions, and animal facility standard operating procedures. The CVMO provides a yearly summary of VA animal research issues at the annual meeting of the American Association of Laboratory Animal Science (AALAS), typically on the Tuesday of the meeting at noontime. The office also provides support for research staff experiencing difficulties using the CITI website for research compliance training.

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Contacts
CVMO:	Michael T. Fallon, DVM, PhD, DACLAM, CPIA Atlanta VA Medical Center Research Service- 508/151V, Room 4A106 1670 Clairmont Road Decatur, GA 30033	michael.fallon@va.gov 404-327-4964 (FAX) 404-728-7644 (Ofc)
Staff Scientist and Deputy, IACUC Guidance:	Alice Huang, PhD, CPIA Atlanta VA Medical Center Research Service- 508/151V, Room 4A107 1670 Clairmont Road Decatur, GA 30033	alice.huang@va.gov 404-327-4964 (FAX) 404-417-1823 (Ofc)
Assistant CVMO:	Joan Richerson, MS, DVM, MS, DACLAM, CPIA Tennessee Valley Healthcare System Research Service- 151, F-201 ACRE Bldg. 1310 24th Ave South Nashville, TN 37212	joan.richerson@va.gov 615-752-5018 (FAX) 615-574-8198 (Ofc)

At the VA-VMO luncheon on October 4, 2011, the following PowerPoint slides were presented regarding the 8th edition of the Guide for the Care and Use of Laboratory Animals (Guide). The second document is a table of the "must,""should," and "may" statements found in the 8th edition of the Guide.

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Important Documents

VHA Handbook 1200.7, Use of Animals in Research (418 KB, PDF)
These are the most recent forms for use by VA IACUCs performing the Semiannual Evaluations of the Institutional Care and Use Program and Facilities. Each report should include all four of the following documents:
- Part 1, Section A. Review of the Program: 2012 05 10 VA Semiannual Program Review Form 1A.docx
- Part 1, Section B. Inspection of the Facilities: 2012 05 10 VA Semiannual Facility Inspect Form 1B.docx
- Part 2. Table of Deficiencies and Departures: 2012 05 10 VA Semiannual Eval Part 2 (Def Dep).docx
- Part 3. Post-Review Documentation: 2012 05 10 VA Semiannual Report Part 3 Post Eval.docx
Animal Component of Research Protocol - following are the forms and instructions for the current version (Version 4, released 1/26/13) of the ACORP and its Appendices. Their use is encouraged as soon as possible, and they will be required for any work that will be reviewed by the IACUC after February 1, 2014, for submission in support of an application for VA funding:

* Files below are in Word format.
- Main body and ACORP Instructions
- Appendix 1 (Additional Local Information) and ACORP App. 1 Instructions
- Appendix 2 (Antibody Production) and ACORP App. 2 Instructions
- Appendix 3 (Biosafety) and ACORP App. 3 Instructions
- Appendix 4 (Ante-Mortem Specimen Collection) and ACORP App. 4 Instructions
- Appendix 5 (Surgery) and ACORP App. 5 Instructions
- Appendix 6 (Special Husbandry and Procedures) and ACORP App. 6 Instructions
- Appendix 7 (Use of Patient Care Equipment or Areas for Animal Studies) and ACORP App. 7 Instructions
- Appendix 8 (Use of Explosive Agent(s) within the VMU or in Animals) and ACORP App. 8 Instructions
- Appendix 9 (Departures from "Must" and "Should" Standards in the Guide) and ACORP App. 9 Instructions"

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Required training for staff involved in the use of animals in research

VA web-based training requirements for animal research are found in section 8.m of VHA Handbook 1200.07, "Use of Animals in Research." Training must be renewed at intervals of no more than two years to demonstrate compliance with Federal animal research training mandates. The web courses listed below are available free of charge to all VA programs at both the CITI website and the AALAS website through agreements. Contact the CVMO for more information about which site would best meet your needs.

Required training is as follows:

1. IACUC Members and IACUC support staff (IACUC administrators, coordinators, etc). Personnel that serve on or provide support to either a VA Institutional Animal Care and Use Committee (IACUC) or an affiliate IACUC that serves as the IACUC of record for a VA program must take the following web-based training at least biennially:

Essentials for IACUC Members

* Optional additional training for IACUC members. The table below provides access to a library of the optional training scenarios that have been developed by the Office of the CVMO and distributed periodically to the field. (Unless noted otherwise, the files below are in Word format.)

Scenario/ Series Number	Title	Release Date (original)	Description
1-2011	IACUC Minutes Content	5/17/11	IACUC minutes should accurately reflect attendance, committee activities, deliberations, and outcomes of discussions; the inclusion of extraneous information should be avoided.
2-2011	Pain & Distress Categories Scenario, Reference	7/19/11	The IACUC must consider the potential for pain and distress in research studies. Assignment to the appropriate category is particularly challenging when working with animal models of chronic diseases.
3-2011	IACUC Composition	9/5/11	Poses the question of which nominees to the IACUC are eligible to fill the vacant lay member and nonaffiliated member positions.
4-2011	Overview of the 8^th Edition of the Guide	12/1/11	Outlines the major topics in each new 8^th Edition of the Guide chapter and notes new and/or expanded topics. New "must" statements are summarized in a table by chapter and page number.
1-2012	Rabbit Housing	2/29/12	This scenario uses the new space standards for rabbits as an example of the thought process that can be applied to addressing implementation of the 8^th Edition of the Guide for other species.
2-2012	New Semiannual Evaluation Forms Part 1 - Checklist, Section A. Review of the Program Part 1 - Checklist, Section B. Inspection of the Facilities PART 2 - Table of Deficiencies and Departures PART 3 - Post-Review Documentation	5/10/12	The CVMO's Office has developed new semiannual evaluation forms to assist stations in complying with the 8^th Edition of the Guide. The new forms reflect the new Guide's recommendations and recent modifications to VHA Handbook 1200.07.
3-2012	Deviations and Departures (728, PPT)	12/26/12	Categorizing deviations and departures from the 8^th Edition of the Guide can be challenging; this scenario reviews example cases, reporting requirements and flowcharts to aid the IACUC in making appropriate determinations.
4-2012	Suspension, Termination, Stop (170 KB, PPT)	12/31/12	Reviews terminology, explains which entity has the authority to take these actions, and clarifies reporting requirements.
1-2013	OLAW Annual Report	1/11/13	Reviews highlights of the webinar presented by OLAW in December 2012 on how to correctly complete and submit the new annual report form.

2. Personnel who participate in or supervise research that involves laboratory animals. If personnel participate in or supervise animal procedures conducted at the VAMC, work with animals purchased with VA funds regardless of performance location, or work with animals during VA duty hours, regardless of location, they must complete the following web-based training at least biennially:

Working with VA IACUC (the non-VA version of the course may be acceptable in some situations; contact the CVMO as needed)

They must also complete at least biennially each species-specific course that is relevant to their work:

Working with Cats in Research Settings
Working with Dogs in Research Settings
Working with Rats in Research Settings
Working with Mice in Research Settings
Working with Guinea Pigs in Research Settings
Working with Rabbits in Research Settings
Working with Hamsters in Research Settings
Working with Gerbils in Research Settings
Working with Swine in Research Settings
Working With Non-Human Primates in Research Settings
Working with Amphibians in Research Settings
Working with Ferrets in Research Settings

If your station wants to utilize alternate training to satisfy VA training requirements, please contact the CVMO. The station will be asked to document of how each item addressed in the CITI courses above will be covered in the alternate training. Education goals for web-based training will be considered met when personnel are able to pass an exam that covers important topics in the training. The exam must be of sufficient difficulty to provide some assurance that important concepts have been learned. Alternate training will only be acceptable if approved by the CVMO. 3. Animal care staff. Animal care staff members should receive training appropriate for their responsibilities, and consistent with the training commitments in both the AAALAC Program Description and PHS Assurance. Some stations utilize the web coursework in item number 2 as part of the overall training program, but this is not a requirement in VA policy.

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Guidance on Animal Research FOIA Requests

On January 30, 2013, VHA issued updated guidance to FOIA Officers (1.6 MB, PDF) on FOIA requests related to animal research. Please notify the CVMO's office immediately if your station receives such a request.

Animal Facility (Veterinary Medical Unit) renovation and construction design manuals

The VA Office of Construction & Facilities Management provides mandatory construction and renovation standards for VA animal facilities. The following design manuals that impact VA animal facilities are available in PDF format at http://www.cfm.va.gov/til/dManual.asp:

Architectural Design Manual, August 2011, 76 pages, see section 4.33.2.
TIL Design and Construction Procedures (PG-18-3), see "Topic 6 - Floor Slab Depressions".
TIL Technical Summaries, see section on "Research", which contains the document "HVAC Requirements in Animal Facilities".
HVAC Design manual for New, Replacement, Addition, and Renovation of Existing VA Facilities, March 2011, see Animal Research and Holding Areas, pp. 6-19 through 6-26

Some of the design manuals above reference sections in the 1993 Veterinary Medical Unit (VMU) VA Design Guide, which remains an important source of VA animal facility design criteria. This 1993 design guide is also available on the TIL Design Guides (PG-18-12), see section on "Veterinary Medical Unit"."

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