VA Animal Research Topics for Research Administrators Dr. Mike Fallon Chief VMO, ORD, VHA Additional information provided by Drs. Joan Richerson and Alice Huang

Note: To see the answers to the survey questions, you must view this as a PowerPoint slide show.

Topics Communications and field support FOIA Requests Possible feed/bedding contract AAALAC Contract HVAC issues MOUs The new Guide for the Care and Use of Laboratory Animals (Guide), 8th edition New VA semi-annual IACUC forms Case studies

Communication- Our Job is to Support You Mike Fallon, DVM, PhD, DACLAM, CPIA (michael.fallon@va.gov) MOUs, animal facility plan reviews, FOIA issues, AAALAC contract, NIA agreement, animal policy questions, IACUC questions Alice Huang, PhD, CPIA (alice.huang@va.gov) Admin setups for JIT and CITI, additions to VA animal research listserv, help for JIT and CITI applications, IACUC questions Joan Richerson, MS, DVM, DACLAM, CPIA (joan.richerson@va.gov) Animal research JIT /document clearance, quarterly IACUC training scenarios, revisions to CITI animal research coursework, IACUC questions

FOIA Requests Please notify Mike Fallon immediately if you become aware of a FOIA request related to animal research. Previously, a VA animal researcher was targeted with a fire bomb at their residence; researcher privacy and animal facility security must be maintained. Involve VHA FOIA Officer, who wrote Aug 18 2008 memo:

August 19 2008 Memo from VHA FOIA Officer

Possible Animal Feed/Bedding Contract Mike Walsh, AO/R&D at Nashville, is working with a SAO East Contracting Officer to develop an agency-wide lab animal food/bedding contract. This would not be a mandatory vendor, but could result in significant cost savings. More details will follow.

Which animal must have Vitamin C in its feed to prevent scurvy? 1. Mouse 2. Guinea Pig 3. Rabbit 4. Dog 5. Pig

AAALAC Contract New contract with AAALAC signed on January 25, 2012 for a base year and 4 option years. CVMO is the COTR on the contract- any problem with AAALAC accreditation issues, please notify. PHS Policy on Care and Use of Animals references AAALAC as the recognized accrediting body for animal research. AAALAC will provide CVMO and ORO copies of AAALAC Annual Report and correspondence from AAALAC to station and from station to AAALAC, relieving stations of this burden.

AAALAC Contract Issue for Some Stations If your program is covered by an affiliate's AAALAC accreditation vs. your own accreditation, AAALAC has to get permission from the affiliate to send correspondence to VA. If the affiliate does not agree, you will have to continue to send AAALAC correspondence to the CVMO per VHA Handbook 1200.07, item 8.l.(2), "Reports."

Animal facilities that house animals purchased with VA funds, or used for VA or VA research and education corporation projects must be accredited by AAALAC. True False Maybe

Heating, Ventilation, Air Conditioning (HVAC) Issues 1200.07, item 7.a.(2) "(a) All HVAC reheat boxes serving one or more rooms housing animals must be designed so that they fail in the “off” or “safe” position, to prevent the loss of animals due to excessive temperature. Laboratory animals can not be housed at any VA facility in rooms that are not so equipped." Guide for the Care and Use of Laboratory Animals, 8th edition "Valves controlling reheat coils should fail in the closed position; steam coils should be avoided or equipped with a high-temperature cut-off system to prevent space overheating and animal loss with valve failure."

VA Facilities Challenges ORO site visits and IACUC self-reviews of VA animal facilities suggest that improper reheat configurations may still be a problem. Shortly...nationwide data call to identify all stations possibly out of compliance with VA policy and the Guide. Expectation- identify problems and come up with a corrective action plan. Engage CVMO if there are questions or problems.

MOU- Using the Affiliate's IACUC "In lieu of establishing a subcommittee, the R&D Committee may obtain these services from ...other sources as allowed by VA policies...These subcommittees must...be established through a Memorandum of Understanding (MOU) or other written agreement which defines definitions for all roles and responsibilities of each party." New Guide, 8th edition, page 15, "Collaborations" "Interinstitutional collaboration has the potential to create ambiguities..., the participating institutions should have a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) that addresses the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight..."

Elements of the Animal Research MOU, 1200.07 8.b. The affiliate commits to complying with the USDA AWA, PHS Policy, and VA Policy, as described in this Handbook, and with VHA Handbook 1058.01, with regard to VA animal research and to complying with all requirements in this handbook. Affiliate agrees to provide local and national VA representatives regulatory documents relevant to the animal research program at the VA facility. Affiliate agrees to allow local VA facility personnel, the ORD CVMO, ORO staff, and designees, to review internal affiliate records and interview key affiliate personnel

Affiliate agrees to notify VA personnel in a timely fashion and provide all information needed when concerns about potentially reportable deficiencies related to VA animal research are raised.. The VMO or VMC, and at least one other VA compensated scientist with animal research experience must sit on the affiliate’s IACUC as voting members with full committee privileges. Affiliate’s IACUC must agree to review the VA ACORP for those VA investigators submitting VA applications... the VA medical facility Director must officially appoint all members in writing.

Help with MOUs Both CVMO and ORO (Dr. Susan Harper) have templates for use. Plan far ahead- university and VA legal reviews are lengthy and...sometimes challenging.

Station A's animal research program files several self-reports of deficiencies annually whereas Station B's program files none over a 3 year period. Regarding Station B: 1. It should be commended. 2. It should be site visited for probable failure to self-report. 3. We can't determine anything about the quality of its animal research program from this information.

New Guide, 8th edition, released 2011 Single most important revision to an animal research regulatory document in a decade Already in use by AAALAC during their site visits; AAALAC has released FAQs defining their expectations on key Guide components Public Health Service has adopted it using a stepped process; they have released their own FAQs VA programs must be AAALAC accredited and must be covered by PHS Policy.

At 220 pages, the new Guide is almost twice as long as the old version At 220 pages, the new Guide is almost twice as long as the old version. About how many MUST, SHOULD, and MAY "statements" are contained within the new Guide? 1. 10, 120, 150 2. 25, 200, 150 3. 30, 250, 200 4. 45, 600+, 200+

Some Key Changes in the New Guide MOUs. Written agreements required for collaborative animal research (page 15). HVAC. Reheat boxes must fail safe; steam coils should be avoided or have a high temp cut-off system (page 140). Authority of Veterinarian. If the PI cannot be reached or disagrees with the veterinarian about an urgent animal health concern, the veterinarian must have the authority to render appropriate medical care, including euthanasia if necessary (page 114).

Rabbit caging height. The USDA AWA Regs specify a 14" height for rabbit cages. The Guide now specifies 16" (page 59). If rabbits housed in 14” cages are able to assume natural postures and make postural adjustments including holding their ears erect without touching the walls or ceiling, then the 14” cage height is acceptable. "IACUCs may consider the use of a rabbit cage that is 14 inches in height, if appropriate. The IACUC should establish, through performance indices related to animal well-being, that the cage provides sufficient space to meet the physical, physiologic and behavioral needs of the animal."

Breeder mouse space requirements (page 57). The previous Guide allowed trio breeding (1 male and 2 females with litters) in standard small mouse cages. The new space recommendations in the Guide do not (51 in2 per mother with litter; US small cages are <852 so 2 litters would not be allowed). Frustrating fact- the new space recommendations are based upon the European ETS 123 standard which states that 51 in2 is acceptable for a monogamous pair (outbred/inbred) or a trio (inbred). OLAW Guidance: "Adjustments to recommendations for primary enclosures may be made at the institutional level by the IACUC. The IACUC should critically evaluate objective measures of outcome-based performance..."

Surgical Training (page 116) All personnel (including physician surgeons) performing surgical procedures must have appropriate training. The IACUC and veterinarian share responsibility for determining if personnel are appropriately qualified and trained to perform surgery. Allergies- Laboratory animal allergy has become a significant issue for individuals in contact with laboratory animals. The medical surveillance program should promote the early diagnosis of allergies (page 22).

IACUC Review for Procedures Involving Pain or Distress Harm to Benefit Consideration. Certain animal use protocols include procedures or approaches that require special consideration during the IACUC review process due to their potential for unrelieved pain or distress or other animal welfare concerns. The topics below are some of the most common requiring special IACUC consideration. For these and other areas the IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns (page 27). CVMO's Office will release an updated version of the ACORP by November 2012 with this and other new Guide elements (eg use of non-pharmaceutical drugs) incorporated.

Field Support- New Semi-Annual IACUC Review Forms Released in May 2012 for field use Incorporates new Guide "Must" statements and most new "Should" requirements. OLAW requires that the IACUC must perform a semi-annual review using he new Guide contents before the end of the year. Available on animal research page on ORD website. Forms will continue to change based upon feedback and additional OLAW guidance.

Field Support- Quarterly IACUC Training Scenarios Contact Joan Richerson for past training scenarios Voluntary Help meet IACUC training requirements in Guide, expected to be received well by AAALAC Focus on common challenges and new Guide provisions

Scenario/ Series # Title Release Date 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 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.

Scenario/ Series # Title Release Date Description #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 8th edition of the Guide 12/1/11 Outlines the major topics in each new Guide chapter and notes new and/or expanded topics. New “must” statements are summarized in a table by chapter and page number.

Scenario/ Series # Title Release Date Description #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 Guide implementation for other species. #2-2012 New Semiannual Evaluation Forms 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.

Case Studies/Concepts- Test Your Knowledge STOP Choose the best practical standard for detail in IACUC minutes: 1. Enough detail for competent outside observer to understand business conducted. 2. As little detail as possible- prevent FOIA vulnerabilities. 3. Transcript- verbatim comments of Chair and members. 4. Language tempered so that the non-affiliated and non-scientific members can understand the minutes.

Choose the best practical standard for IACUC minutes: 1. Suitable for outside observer 2. As little info as possible 3. Verbatim transcript 4. Suitable for NAM and NSM

The Medical Center Director disagrees with the IACUC's findings following an IACUC semi-annual review. How should the MCD communicate his/her opinion to the CVMO's office? 1. File a minority opinion and attach it to the signed semi-annual report (sent to CVMO's office). 2. Instruct the IACUC to reconvene and reconsider its findings, with edits to the semi-annual as needed. 3. Provide his/her comments in a cover letter attached to the signed semi-annual report. 4. Refuse to sign or officially submit the report to the CVMO until the report is changed.

The Medical Center Director should: 1. File minority report. 2. Send the IACUC back to reconsider. 3. Attach a memo to the report. 4. Refuse to sign or send until the report is changed.

The community (non-affiliated) voting member of the IACUC tragically dies in an accident. Can the IACUC conduct official business until a new NAM is appointed by the MCD? Yes No

In two previous IACUC meetings the Attending Veterinarian was absent in one meeting and the non-affiliated voting member (NAM) was absent in the other. Could the IACUC conduct official business in both meetings? Yes No

The certification available for IACUC administrators through PRIM&R is: 1. CPIA. 2. LATG. 3. CMAR. 4. CIP.

If each required voting role on the IACUC is filled by a separate person, the minimum required number of voting members is: 1. Five. 2. Six. 3. Seven. 4. Not specified.

The annual cost to VA for the agency-wide AAALAC contract is about: 1. $250,000. 2. $500,000. 3. $750,000. 4. $1,000,000.

Of the following, the LEAST important goal of an effective IACUC is to: 1. Assure very high levels of compliance among researchers. 2. Balance the needs of animals with need for research. 3. Be willing to correct problems when identified. 4. Seek consensus when possible but encourage all views.

Questions