VA Animal Research Selected Topics for AOAA's for R

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VA Animal ResearchSelected Topics for AO/AA's
for RD

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Presentation Outline

• Acronyms and terms
• Components of an animal research program
• Role of the AO/AA in the program
• How do I know if I have a quality program?
• Balancing the VMU budget

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Basic Lingo

• VMU (Veterinary Medical Unit). The animal
  housing area and husbandry personnel.
• VMO (Veterinary Medical Officer). Veterinarian
  with a VA appointment who is a specialist in lab
  animal medicine.
• VMC (Veterinary Medical Consultant).
  Veterinarian with WOC appointment hired on
  contract basis who is a specialist in lab animal
  medicine.
• CVMO (Chief Veterinary Medical Officer)

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• AWA (Animal Welfare Act) Regulations. The
  primary source of regulations for animal
  research.
• PHS (Public Health Service) Policy. Another
  important source of regulations. (OLAW)
• 1200.7 (VA Handbook 1200.7, "Use of Animals in
  Research"). The VA guide to animal research and
  how to maintain compliance with the AWA and PHS
  Policy.

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• AAALAC (Association for Assessment and
  Accreditation of Laboratory Animal Care). The
  one and only accrediting body for animal
  research.
• ACLAM (American College of Laboratory Animal
  Medicine). Specialty board for lab animal vets.
  Members are designated "diplomates."
• IACUC (Institutional Animal Care and Use
  Committee). In the VA system, a subcommittee of
  the RD Committee.

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The Components of an Animal Research Program

• Investigators. Need to be properly trained and
  aware of responsibilities.
• Supervisor and Animal Care Staff. Need qualified
  individuals, preferably with AALAS certification.
  
• Veterinarian. Need a qualified individual to
  provide clinical expertise and expert advice to
  researchers and the IACUC.
• IACUC. Single most important component
• AO/AA, other Administrators. Support of IACUC and
  VMU.

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Investigators

• Both AWA Regulations and PHS Policy mandate that
  researchers be qualified to perform procedures
  involving animals. Hot compliance topic
• How to provide and document training?
• VA-specific and generic training available for
  investigators and IACUC members on the web at
  www.wwla.org.
• Serving on the IACUC is excellent training

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Supervisor and Animal Care Staff

• Need qualified individuals, preferably with AALAS
  certification- see 1200.7, section 5.c.(2)
• Continuing education of Supervisor and husbandry
  staff very important. CE addressed in 1200.7,
  section 5.c.(5).
• Supervisor should be able to take care of day-
  to-day operations of facility. Duty guidelines in
  1200.7, section 5.c.(4).
• Often useful to have the Supervisor serve on
  IACUC as non-voting member

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Veterinarian

• Need a qualified individual to provide clinical
  expertise and expert advice to researchers and
  the IACUC. Duties listed in 1200.7, section
  5.b.(5)
• Continuing education very important. CE addressed
  in 1200.7, section 5.b.(8).
• 1200.7 section 5.b.(2) gives minimum credentials

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Appointing and Promoting Veterinarians

• All VMO/VMC appointments as well as recruitment
  at the GS-14 or GS-15 level, and promotions to
  GS-14 or GS-15 level must be approved by the
  CRADO. 1200.7, Section 5.b.(3)(a) and (b)
• Check qualifications against criteria in 1200.7,
  Section 5.b.(2).
• Submit letter with CV through CVMO to initiate
  approval process. See 1200.7, Section 5.b.(3).

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VMO Recruiting- Possible Solutions

• VAHQ does not want to encourage grade disparities
  Suggestions to make VMO salary competitive
• Use one-time bonus and recurring retention pay to
  make career conditional GS-14 positions comp.
  See www.vmuinfo.org for reference documents and
  help.
• Hire on contract
• Hire as VA foundation employee
• Hire through affiliate
• Hire as part-time VA employee, supplement
  remaining portion using other sources

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IACUC

• Recognized as the self-regulatory body for animal
  research by all regulatory agencies.
• Source of largest percentage of cited animal
  program deficiencies by regulatory agencies and
  AAALAC.
• Cornerstone of a good animal care and use program.

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AO/AA for RD, Other Administrators

• Administrators. Two positions recognized by AWA
  and PHS Policy
• Chief Executive Officer (CEO). Highest ranking
  administrator at the institution.
• Institutional Official (IO). Official authorized
  to commit institutional resources necessary
  correct deficiencies. Multiple required duties.
  1200.7- Hospital Director must be IO.

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Why Can't the ACOS be the IO?

• The ACOS is often not able to control
  institutional resources outside of Research
  Service to correct facility and program
  deficiencies (e.g. Engineering, Safety, Employee
  Health). 1200.7, Section 5.a.
• OLAW has expressed concern a number of times that
  having the ACOS as IO can result in a conflict of
  interest because the ACOS is a first-line
  supervisor of most of the IACUC members.

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Duties of the IO(Medical Center Director)

• Communicate with the IACUC to receive
  recommendations and reports of suspensions.
• Sign the PHS Assurance, if the VA has its own.
• Meet with IACUC for discussion of semi-annual
  IACUC report findings. The IO must sign the
  report 1200.7, Section 6.n.(10)(a)6
• Sign correspondence to regulatory agencies,
  AAALAC, and VAHQ regarding the animal care and
  use program.

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The AO/AA for RDMany Roles

• Make sure the IACUC has good support.
• Monitor IACUC, vet, and husbandry staff
  training.
• Monitor IACUC and VMU compliance.
• Monitor USDA, PHS, AAALAC, and VA reports for
  timeliness and routing (1200.7 Sect. 6.n., 7.).
• Monitor effectiveness of the veterinarian.
• Monitor the VMU budget.

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The Role of the AO/AA for RD Proper IACUC
Support

• How much IACUC support is needed? Rough
  estimate 1 full-time support person per every
  150-250 active protocols.
• IACUC SUPPORT IS CHALLENGING! Recruit a person(s)
  with good grasp of English, good word processing
  and filing skills, and good e-mail skills.
• Ask the IACUC about their impression of how the
  committee is running.

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IACUC- How to Evaluate?

• HQ uses the Secondary Veterinary Medical review
  Program, and reviews of minutes and other
  documents.
• Locally, the same tools can be used.
• Minutes (1200.7, Section 6.n.(11))
• Do they reflect deliberations?
• Are members present and absent noted?
• Is a quorum present?
• Is there project continuity?
• Are they prepared in a timely fashion?

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The Role of the AO/AA for RD-Monitoring
Adequate Training

• The law requires training for all staff who
  utilize animals in research
• Resources for providing training must be
  identified
• Supervisor and husbandry staff.
• Veterinarians.
• Investigators.
• IACUC Members.
• Web courses at www.wwla.org, listing of IACUC
  didactic courses at OLAW web site at
  http//www.grants.nih.gov/grants/olaw/olaw.htm.

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The Role of the AO/AA for RD-Monitoring
Compliance

• How can IACUC and VMU compliance be evaluated?
• Pay attention to IACUC minutes and semi-annual
  self-review reports.
• Ask IACUC members confidentially for their
  impressions.
• Meet with the IACUC Chair and ask for responses
  to "Ten Questions" (see handout)
• Station scoring in the Secondary Veterinary
  Medical Review Program

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The Secondary Veterinary Medical Reviewer
Program- Scoring
No concerns. No IACUC action needed
0
Minor concerns. IACUC discussion required
(minutes)
1
Significant concerns. Hold placed (formal release
process)
2
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The Secondary Veterinary Medical Review Program-
Station Reports

• Twice yearly, ACOS and vet receive
• Average score of all rated projects for last
  cycle and for last 3 cycles
• Relative rank vs. other VA IACUCs for both
  averages
• VAHQ does not use these reports as a "score
  card", but historically IACUCs with consistently
  low scores often reflect weak programs

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The AO/AA RD and Animal Research-Monitoring
Reports

• Required annual reports given in 1200.7, Sec. 7.
• Other mandatory reports
• Semi-annual IACUC self-reviews (Sec.
  6.n.(10)(a)5)
• Suspension of a project (Sec. 6.n.(16))
• Allegations of improper animal care or use (Sec.
  6.n.(17))
• IACUC Minutes (Sec. 6.n.(13)) No longer
  routinely submitted. Now reviewed on a three
  year cycle- please don't send unless asked!!

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The AO/AA RD and Animal Research-Monitoring the
Veterinarian

• HQ expectations- that your trained lab animal
  station veterinarian will meet the needs of your
  animals, research staff, and IACUC.
• Duties listed in 1200.7, Sec. 5.b.(5)(a)- (n).
• Performance evaluation multifaceted
• Using local companion animal practitioners as a
  VMC is no longer appropriate!!!

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Evaluating the Veterinarian-Possible Signs of
Problems

• ACORPs
• Particular sections of ACORPs consistently
  deficient (post-op care, lack of analgesics for
  rodents, outdated anesthetics or procedures)
• Signature on low-quality ACORPs
• Consistently poor station SVMRP scores
• Minutes and other documents
• Sloppy, incomplete preparation reflects poorly on
  IACUC, but also suggests vet is not providing
  expert guidance

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Evaluating the Veterinarian-Possible Signs of
Problems

• Veterinary expert guidance to IACUC and staff
• Passive role on IACUC, does not know regulations
• Research staff express frustration with lack of
  support
• Veterinary consults done half-heartedly
• Veterinary expert guidance to VMU
• Supervisor feels unsupported, and unable to get
  professional advice on important issues
• Attendance spotty, and does not match contract
  terms

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Evaluating the Veterinarian

• If you need a second opinion, call the CVMO

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The AO/AA RD and Animal Research-Monitoring the
VMU Budget

• To run the animal facility as a revenue-neutral
  or revenue-surplus enterprise year after year
  usually requires a source of non-VA revenue

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Funding the VMU

• MRS provides partial funding for VMUs as core
  facilities
• Called the "cost center 105" or "cc105" funding,
  similar to cc101
• Must have 3 funded VA projects with an ACORP to
  receive any CC105 funding

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cc105

• Formula includes a veterinarian salary component
  as well as a component based upon a aggregate VA
  funding for projects involving animal research
• The CC105 budget is set, then the station
  portions are determined based upon formula
  tweaks- not open-ended.

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Representative cc105 Formula

• A3Y Average of aggregate VA funding for projects
  with submitted ACORPS for last three years
• Station Allocation
• 9 of A3Y up to 1 million
• 4 of A3Y between 1 and 2 million
• 2 of A3Y above 2 million
• Veterinarians Salary

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Collect Your Fair Share of CC105

• Make sure all investigators performing animal
  research in their VA projects submit an ACORP
  with their VA application.
• Encourage them to choose VA money instead of
  non-VA money

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Other Revenue Sources for VMU

• Per diem collections from non-VA project sources
• Non-VA federal sponsored by VA Foundation (PHS,
  DoD)
• Non-profit Charitable (AHS, ACS, ADF)
• PHS projects sponsored by affiliate
• VA Foundation projects
• One or two-tiered rate system? Consider
  affiliate's rates and admin burdens

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Finé