Office of Research & Development

 

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 1200.07, "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 at lunchtime 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)

    Important Documents



    Use of Animals in Research - VHA Handbook 1200.07 (418 KB, PDF)

    Copies to the CVMO


    Forms for Semiannual Evaluations of the Institutional Care and Use Program and Facilities

    Each row in the table below shows a version of the set of forms used for reporting on the Semiannual Evaluations performed by VA IACUCs. Please be sure to use the current version of the forms for each Semiannual Evaluation; for each report, complete all four of the documents, which are available via the links in first row of the table.

    Version Date

    Form

    Comments

    Status




    2/28/2013

    2/28/2013

    2/28/2013

    2/28/2013

    VA Semiannual Evaluation of the Institutional Animal Care and Use Program and Facilities

    Part 1 – Checklist (Section A)

    Part 1 – Checklist (Section B)

    Part 2 – Table of Deficiencies and Departures

    Part 3 – Post-Review Documentation

    Minor update with clarifications and corrections

    Current version now required




    5/10/2012

    5/10/2012

    5/10/2012

    VA Semiannual Evaluation of the Institutional Animal Care and Use Program and Facilities

    Part 1 – Checklist (Sections A and B)

    Part 2 – Table of Deficiencies and Departures

    Part 3 – Post-Review Documentation

    Major update to incorporate the provisions of the 8th edition of the Guide and document "departures"

    May be used for evaluations completed before 9/30/2013



    April 2011

    April 2011


    April 2011

    VA IACUC Semi-Annual Self-Review Forms

    Form 1. Checklist (Parts A and B)

    Form 2. Table of Program and Facility Deficiencies

    Form 3. Post Review Documentation

    Includes new features in response to review of VA animal programs by OIG (e.g., table of work orders)

    No longer in use, as of 11/30/2012



    February 2011

    February 2011


    February 2011

    VA IACUC Semi-Annual Self-Review Forms

    Form 1. Checklist (Parts A and B)

    Form 2. Table of Program and Facilities Deficiencies

    Form 3. Post-Review Documentation

    Interim update

    No longer in use, as of 10/31/2011



    October 2005

    October 2005


    October 2004

    VA IACUC Semi-Annual Self-Review Forms

    Form 1. Checklist (Parts A and B)

    Form 2. Table of Program and Facilities Deficiencies

    Form 3. Post-Review Documentation

     

    No longer in use, as of 8/31/2011

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    Animal Component of Research Protocol

    Each row in the table below shows a version of the ACORP used for documenting protocols for review by the IACUC. Please be sure to use the current version for any work that will be reviewed by the IACUC for submission in support of an application for VA funding. For each protocol, complete the Main Body and all applicable Appendices; the forms and instructions are available via the links in the first row of the table.

    Version Number

    Form

    Comments

    Status

    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)

    Major update from Version 3

    Separate expanded instructions – with references and examples

    Current version now required for any protocol submitted to the IACUC for initial or triennial review.

    3

    Animal Component of Research Protocol (ACORP)

    Appendix 1 – Use of a Non-VA Facility to House Animals Purchased with VA or VA Research and Education Corporation Funds

    Appendix 2 – Antibody Production

    Appendix 3 – Test Substances

    Appendix 4 -- Antemortem Specimen Collection

    Appendix 5 – Surgery

    Appendix 6 – Special Husbandry and Procedures

    Appendix 7 – Request to Use Patient Care Procedural Areas for Animal Studies

    Appendix 8 – Request to Use of Explosive Agent in the Animal Facility or in Animals

    Appendix 9 – Additional Local Information

    Major update from version 2/2a

    May be used for protocols submitted to the IACUC before 2/1/14

    2a

     

     

    No longer in use, as of 1/1/2005

    2

     

     

    No longer in use, as of 1/1/2005

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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 any VA programs through an agreement for VA use of the CITI website, and at the AALAS website for those stations that choose to pay for institutional registration. 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

    Training Exercises (optional).

    The table below provides access to a library of the optional training exercises 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.)

    Exercise/Series Number

    Title

    Release Date

    (original)

    Description

    2-2014

    Calculating CO2 Flow as Percent of Chamber Volume

    7/7/14

    How to calculate the flow meter readings (in L/min) that correspond to 10%-30% displacement of chamber volume per minute.

    1-2014

    Semiannual Evaluation Report

    3/4/14

    Reviews the rules about whose signatures are needed on the report of each semiannual evaluation.

    4-2013

    Rabbit Housing Deviation

    12/30/13

    Another look at Guide deviations and departures. This exercise has been reviewed and approved by OLAW.

    3-2013

    More about Guide Deviations and Departures

    10/29/13

    Four scenarios illustrating specifically established Guide exceptions and approved departures

    2-2013

    Rodent CO2 Euthanasia

    5/21/13

    Reviews the "dos" and "don'ts" of carbon dioxide euthanasia in rats.

    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.

    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.

    3-2012

    Deviations and Departures (728, PPT)

    12/26/12

    Categorizing deviations and departures from the 8th Edition of the Guide can be challenging; this scenario reviews example cases, reporting requirements and flowcharts to aid the IACUC in making appropriate determinations.

    2-2012

    New Semiannual Evaluation Forms

    o Part 1 - Checklist, Section A. Review of the Program

    o Part 1 - Checklist, Section B. Inspection of the Facilities

    o PART 2 - Table of Deficiencies and Departures

    o 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 8th Edition of the Guide. The new forms reflect the new Guide's recommendations and recent modifications to VHA Handbook 1200.07.

    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 8th Edition of the Guide for other species.

    4-2011

    Overview of the 8th Edition of the Guide

    12/1/11

    Outlines the major topics in each new 8th 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.

    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.

    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.

    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.



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    The table below provides access to a library of the presentations that have been given by the Office of the CVMO at various meetings. (Unless noted otherwise, the files below are in PowerPoint format.)

    Meeting

    Title of Presentation

    Date Posted

    Description

    PRIMR IACUC Meeting (April 2014)

    PRIMR IACUC Meeting; Session C16, A Dialogue with the VA

    Common Problems Identified during Secondary Review of ACORPs

    Not Just the Usual...IACUC Functions

    4/3/14

    Current topics in VA animal research

    AALAS Meeting (October 2013)

    VA Animal Research Update and More Guide Departures and Deviations

    10/28/13

    A list of pressing topics for the coming year and four IACUC scenarios to practice proper characterization of Guide deviations/departures.

    PRIM&R IACUC Meeting (March 2013)

    The Continuing Saga of Deviations & Departures

    4/16/13

    A discussion of selected "should" statements, with examples of specifically described exemptions, and an approved departure. This presentation also includes guidance on using Appendix 9 of ACORP (version 4) to document an approved departure.

    PRIM&R IACUC Meeting (March 2013)

    What's New from the Office of the CVMO? Tools to Facilitate Compliance with the 8th Edition of the Guide

    4/16/13

    A summary of new features in Version 4 of the ACORP, and the most recent version of the forms for reporting Semiannual Evaluations of the Institutional Animal Care and Use Program and Facilitites.

    AALAS National Meeting

    (November 2012)

    Deviations and Departures

    12/26/12

    Categorizing deviations and departures from the 8th Edition of the Guide can be challenging; this presentation reviews example cases, reporting requirements and flowcharts to aid the IACUC in making appropriate determinations.

    AALAS National Meeting

    (November 2012)

    Suspension, Termination, Stop

    12/31/12

    Reviews terminology, explains which entity has the authority to take these actions, and clarifies reporting requirements.

    AALAS National Meeting

    (October 2011)

    Complying with the 8th Edition of the Guide

    12/2/11

    Highlights of the 8th Edition of the Guide

    AALAS National Meeting

    (October 2011)

    Must-Should-May in the 8th Edition of the Guide

    12/2/11

    A table of the "must", "should", and "may" statements found in the 8th edition of the Guide

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    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 either of the following two web-based courses at least biennially:

    • Working with the VA IACUC
    • Working with the IACUC

    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 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.

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    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:

    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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