Local Accountability: Critical Roles in the Animal Care and Use Program

1
Local AccountabilityCritical Roles in the
Animal Care and Use Program
Mike Fallon, DVM, PhD, DACLAM CVMO,
ORD michael.fallon_at_va.gov
"Always do right. This will gratify some people
and astonish the rest." Mark Twain (1835 - 1910)
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Animal Care and Use Program- Critical Roles

• CEO/Institutional Official
• IACUC and Attending Veterinarian
• IACUC Coordinator
• Research Administrators
• Animal Facility Supervisor
• Animal Care Staff

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CEO IO
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Two Important Officials

• To meet its regulatory mandates, the IACUC must
  interact effectively with two administrators
  given specific responsibilities by the Animal
  Welfare Act Regulations and PHS Policy
• The CEO (Chief Executive Officer)
• The IO (Institutional Official)

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What Do They Do?

• CEO as the highest operating official of the
  institution (such as the president of a
  university). The CEO is required to appoint
  members qualified to serve on the IACUC.
• IO the person in the organization having the
  administrative and operational authority to
  commit institutional resources to ensure that the
  animal care and use program complies with
  requirements of the Animal Welfare Act
  Regulations, PHS Policy, and VA Policy.

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The Director is the CEO and Must be the IO

• Many VA Research Chiefs held the position of IO
  in years past, but their lack of influence over
  other hospital services such as Facilities
  Management /Engineering proved to be problematic.
  Thus VA Policy requires the Director to retain
  both roles. (1200.7, items 3g and 3k)

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Duties of the IO

• The IACUC must notify the IO whenever significant
  deficiencies are found in the animal care and use
  program.
• When progress toward correcting significant
  deficiencies falls short of the plan and schedule
  for these corrections, the IACUC must inform the
  IO.
• When the IACUC suspends a protocol previously
  approved by the IACUC, the IO, in consultation
  with the IACUC, must review the reasons for the
  suspension and take appropriate corrective
  action, and report the incident to ORD/ORO, OLAW,
  USDA/APHIS, and other affected federal funding
  agencies.

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Duties of the IO

• The IO must receive recommendations from the
  IACUC about any aspect of the animal care and use
  program, facilities, or personnel training.
• The IO must sign the PHS Assurance document which
  must be submitted and approved by OLAW prior to
  use of PHS funds for animal research. (each VA
  must be covered by the affiliates or their own
  PHS Assurance item 4b(4)(a))
• The IO must sign the USDA/APHIS Annual Report,
  which must be submitted annually to the USDA
  (online submission using the USDA website is now
  required).

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OLAW Best Practices for the IO

• The institutional or attending veterinarian and
  the IACUC should report directly to the IO.
• IO should clearly define and assign
  responsibilities and reporting channels for other
  essential program elements such as training,
  occupational health, and facility maintenance.
• OLAW Staff. Frequently Asked Questions about the
  Public Health Service Policy on Humane Care and
  Use of Laboratory Animals. ILAR News
  35(3-4)47-49, Summer/Fall, 1993 (Institutional
  Responsibilities, Question 4)

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Approving Animal Procedures

• The USDA Animal Welfare Act Regulations and PHS
  Policy provide only the IACUC with authority to
  approve animal studies on behalf of the
  institution, and no official has the authority to
  approve an animal study in the absence of IACUC
  approval. However, the IO or any other
  administrator may suspend any animal study for
  any reason without IACUC concurrence. (Tab C,
  AWAR Section 2.31(d)(8))
• -Animal Welfare Act Regulations, 9 CFR Part 2
  (Regulations), Subpart C (Research Facilities),
  Section 2.31 (Institutional Animal Care and Use
  Committee, IACUC), paragraphs (c)(6), (c)(8), and
  (d)(2)(viii)
• -Public Health Service Policy on Humane Care And
  Use of Laboratory Animals, IV. Implementation by
  Institutions, paragraphs B.6., B.8, and C.8

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Director Specific VA Policies

• Approve tours of the animal research facility
  by internal/external groups. (1200.7, item
  7j(1))
• Assure adequate administrative support for the
  IACUC (to include timely preparation of minutes
  and timely preparation of investigator
  correspondence and other documents). (1200.7,
  item 8)

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Director Specific VA Policies

• Officially appoint members to the IACUC in
  writing, and include the term length. (1200.7,
  item 8a)
• Chair 1 year term, may be renewed (1200.7, item
  8a(6)(a))
• Other members term up to 3 years, may be renewed
  (1200.7 item 8a(6)(b))
• Arrange time to meet in person with IACUC to
  discuss semi-annual self-review within 60 days of
  the review. (1200.7 Appendix E, item 7e)
• Personally sign the semi-annual report form no
  other official may sign for the Director. (1200.7
  Appendix E, item 7e)

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Director Specific VA Policies

• Review and forward written IACUC reports of
  investigations of internal/external adverse
  allegations about the animal care and use program
  to ORD/ORO and other entities as needed. (1200.7,
  item 8i)
• Review and forward copies of any regulatory
  correspondence to and from other agencies and
  groups to ORD/ORO within 15 business days of
  receipt or submission. (1200.7, items
  8g(5)(a)-(g))

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An Effective Director

• Understands program obligations.
• Commits enough intellectual capital to understand
  problems in the animal care and use program.

• Brings adequate resources to bear on problems
  identified by the IACUC so that timely
  corrections are made.
• Holds all stakeholders and support personnel
  accountable- across hospital services.
• Is a strong advocate for the research program
  within the VISN- makes the best possible case for
  VISN support of compliance and committee support
  positions

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An Effective Director

• Communicates a strong interest in the research
  staff taking their committee responsibilities
  seriously, and expresses appreciation for time
  and effort committed.

• Has an open door policy and ensures that concerns
  are heard and addressed fairly. People respect a
  well reasoned no answer much better than no
  answer.
• Gets out of the office and walks around
  unannounced to see how research labs and the
  animal facility look without prior notice.

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The Mother Test of Appearances

• If I showed this animal (housing/surgery/laborator
  y) area to my mother and told her that procedures
  on animals are being performed, what would she
  think?

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The Director Holds Primary Responsibility for
Compliance with Animal Research Regulations and
Policies

• Section 9 of the Animal Welfare Act
• When construing or enforcing the provisions of
  this Act, the act, omission, or failure of any
  person acting for or employed by a research
  facilityshall be deemed the act, omission, or
  failure of such research facility as well of
  such person.

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IACUC
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IACUC- Guts of the Program

• Without a functioning and committed IACUC, a
  program is doomed to failure.
• Composed mostly of scientists who use animals in
  their work another form of a peer review group.
• In the Animal Welfare Act, Congress purposely
  gave the IACUC broad powers and responsibilities
  as a self-regulatory agent on behalf of the
  institution.
• This contrasts to European philosophies in which
  the government dictates the conduct of animal
  research to a much greater degree.

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Brief Summary of IACUC Functions

• 1. Review and approve proposed activities
  involving animals in research, testing, or
  teaching, and significant changes to previously
  approved activities.
• 2. Evaluate the animal care and use program and
  the animal facility itself at least every six
  months.
• 3. Review any concerns about the care and use of
  animals at the institution and institute
  appropriate action.
• 4. Suspend animal work if its conduct is not in
  compliance with regulations or consistent with
  conditions of approval.
• 5. Make recommendations to a designated
  Institutional Official to make sure the
  institution is aware of issues affecting the
  animal research program.

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An IACUC Must be Constituted

• To perform any official business, an IACUC must
  have the following members appointed in writing
  per PHS Policy (1200.7, item 8a(1))
• Chair
• Attending Veterinarian (ex officio)
• Scientist using animals in research, teaching, or
  testing
• Non-affiliated member (NAM)
• Non-scientist (NSM or lay member)
• by virtue of the office commonly
  misconstrued to denote a non-voting position, or
  to apply to non-voting members

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An IACUC Must be Constituted

• If an appointed member who fills a specified
  position leaves the committee such that the
  position is no longer filled, the IACUC is not
  properly constituted and may not conduct official
  business (1200.7, item 8a(1))
• Consequently, it is a best practice to have at
  least two NAM and two lay members because
  replacing one on short notice can be difficult.
  One person can fill both a NAM and a NSM (lay)
  position if they meet the criteria for both. (PHS
  Guidance, IACUC Composition, Functions and
  Authority, Q1)

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Chair

• Should not be concurrently filling another
  required position. (PHS Guidance, IACUC
  Composition, Functions and Authority, Q1)
• Can not simultaneously chair another committee
  such as RD or SRS. (1200.7, item 8a(2))

• Should be a more senior scientist with animal
  research experience and good committee management
  skills. (1200.7, item 8a(2))
• VA programs are encouraged to rotate chairs often
  to develop a cadre of experience IACUC members.
  (1200.7, item 8a(6)(a))

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Chair- Desirable Characteristics

• 1. Experience or familiarity with animal research
  and animal research regulations.
• 2. A working knowledge of parliamentary process
  to conduct IACUC business fairly and efficiently.
• 3. Enough maturity to keep deliberations focused,
  to make sure all IACUC members can participate,
  and to prevent attempts to silence dissenting
  opinions.
• 4. Adequate institutional seniority and authority
  in order to perform duties without concern that
  IACUC actions may jeopardize position or career.

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Attending (or Institutional) Veterinarian

• 1. They must have graduated from a veterinary
  school accredited by the AVMA Council on
  Education, or have an ECFG certificate. (Tab B
  AWAR Tab G item A.3.b.(1))
• 2. They must be certified by the American College
  of Laboratory Animal Medicine (ACLAM) or have
  received training and/or have experience in
  laboratory animal medicine and in the care and
  management of the species at the institution. (
  AWAR PHS Policy item A.3.b.(1) see also VA
  Handbook 5005, Staffing, Part II, Appendix F32.)
• 3. They must have direct or delegated authority
  (and accordingly, responsibility) for activities
  involving animals at the institution. ( AWAR PHS
  Policy item A.3.b.(1))

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Attending Veterinarian- Specific Authority

• 1. Must approve specific details of proposals
  involving surgery, including pre- through
  post-procedural care and relief of pain and
  distress, and to change postoperative care as
  necessary to ensure the comfort of animals. (USDA
  Policies, 3)
• 2. Must make recommendations regarding activity
  level or restrictions of animals in health
  records. (Tab E, USDA Policies, 3)
• 3. Must decide when necropsies (autopsies) of
  animals should be performed to investigate health
  problems in the institution. (USDA Policies, 22)
  
• 4. Must provide consultations during the planning
  stages of proposed animal activities, prior to
  IACUC review. (1200.7, item 8d(2)(b))
• 5. Must determine the frequency, method, and
  duration of dog exercise in consultation with and
  approval by the IACUC. (AWAR, Section 3.8 pars
  (a) and (b))
• 6. Must direct the required environmental
  enrichment plan for primates. (AWAR, Section
  3.81, preamble)

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Attending Veterinarian- No Regulatory Authority
Given to

• Suspend any animal procedure unilaterally
  unless that privilege is given to them by the
  institution
• Veto IACUC decisions regarding protocol reviews
  or other matters before the committee
• Set animal care policies without IACUC review
  and approval.
• Howeverwhomever makes the decision takes the
  responsibility

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Attending Veterinarian- Interaction with IACUC

• Each of the preceding responsibilities of the
  attending veterinarian is carried out as part of
  the overall veterinary care program with the
  support and approval of the IACUC. It is
  important, therefore, for the attending
  veterinarian and IACUC to work together closely
  and well.

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Veterinarians Oath

• Being admitted to the profession of veterinary
  medicine, I solemnly swear to use my scientific
  knowledge and skills for the benefit of society
  through the protection of animal health, the
  relief of animal suffering, the conservation of
  livestock resources, the promotion of public
  health and the advancement of medical knowledge.
• I will practice my profession conscientiously,
  with dignity and in keeping with the principles
  of veterinary medical ethics.
• I accept as a lifelong obligation the continual
  improvement of my professional knowledge and
  competence.

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Attending Veterinarian and IACUC- Ethical
Tensions

• The IACUC and veterinarian are responsible for
  advancing the interests of two entities- the
  animals, and the public health (researchers, and
  by extension, our VA patients). 
• These interests conflict, and the mark of a good
  IACUC-veterinarian partnership is the ability to
  find ways to compromise and maximize benefits to
  both entities.
• Typically an IACUC that does so will foster a
  program that is both compliant and
  service-oriented to investigators. 

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Attending Veterinarian and IACUC- Ethical
Tensions

• The animal care and use program exists because
  investigators are successful in convincing their
  peers and others that their work is worthy of
  funding.  Accordingly, a

critical role of the veterinarian in the program
is to assist the investigators in completing
their work so that they can receive the money
they need to do their work, and thus benefit
humanity. 
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Attending Veterinarian and IACUC- Ethical
Tensions

• For the veterinarian to be in an effective
  partnership, a trust relationship must be in
  place- the investigators can be trusted to do
  their best to treat animals humanely and
  according to what the IACUC has approved, and the
  veterinarian can be trusted to help the
  investigators do their work. 
• This trust relationship allows the veterinarian
  and IACUC to face the tension caused by the joint
  obligation to protect the interests of animals
  while accepting the credo that animal research is
  an ethical imperative because human life is more
  precious than animal life.

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Human vs. Animal Interests

• Principle 3 of the Nuremberg Code of 1947. The
  (human) experiment should be so designed and
  based on the results of animal experimentation
  and a knowledge of the natural history of the
  disease or other problem under study, that the
  anticipated results will justify the performance
  of the experiment.

• Title 45 CFR part 46, Subpart B (the Common
  Rule research protections for pregnancy/fetuses).
  No activity to which this subpart is applicable
  may be undertaken unless appropriate studies on
  animals and non-pregnant individuals have been
  completed except when the purpose of the
  activity is to meet the health needs of the
  mother or the particular fetus

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Human vs. Animal Interests

• Animal Welfare Act, Section 1
• The Congress further finds that--
• (1) the use of animals is instrumental in
  certain research and education for advancing
  knowledge of cures and treatment for diseases and
  injuries which afflict both humans and animals

• U.S. Government Principles for the Utilization
  and Care of Vertebrate Animals Used in Testing,
  Research, and Training
• The development of knowledge necessary for the
  improvement of the health and well-being of
  humans as well as other animals requires in vivo
  experimentation with a wide variety of animal
  species.

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Human vs. Animal Interests

• 1200.7, item 2. Most research and testing
  involving human patients continue to be based on
  the results of animal experimentation. To provide
  hope for veterans suffering from diseases that
  currently lack cures or effective treatments, VA
  actively supports the use of animals in research,
  teaching, and testing.

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Attending Veterinarian and IACUC- Hallmarks of a
Healthy Relationship

• Support for Investigators. If an
  investigator's request for support does not
  involve a practice that is illegal, immoral, or
  unethical, then the animal care staff should try
  very hard to say "yes." 
• Service-Oriented Philosophy. The animal care
  staff should understand that investigators are
  customers and that helping them is a priority. 

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Attending Veterinarian and IACUC- Hallmarks of a
Healthy Relationship

• Reciprocity of Respect and Accountability.
• Investigators commit to a good faith effort to
  follow regulations and interact with animal care
  staff to protect well-being of animals, and the
  vet and animal care staff know that if they have
  concerns about something they see, the IACUC will
  take their concerns seriously, and treat them as
  legitimate.  

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Attending Veterinarian- Typical Duties

• Manage animal care program professionally and
  with financial responsibility.
• Monitor supervisor and animal are staff.
• Work with supervisor to develop SOPs to
  standardize practices and maintain consistency of
  care.
• Interact with veterinary colleagues to find
  solutions and help investigators.
• Keep IACUC and IO informed of problems
• Serve as regulatory and veterinary medical
  consultant
• Full list of duties found in 1200.7 (item 6b(5))

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Scientist

• Must have experience in research involving
  animals. (PHS Policy, IV. Implementation by
  Institutions, paragraph A.3.b.(1)-(2))
• Further guidance is not given, but it is always
  helpful to have a scientist on the IACUC with
  expertise and knowledge that overlaps with the
  research being proposed to the IACUC.
• The majority of IACUC members are typically
  scientists with animal research experience.

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Non-Scientific (NSM or Lay) Member

• Must be an individual whose primary concerns are
  in a nonscientific area (for example, an
  ethicist, lawyer, or member of the clergy). (PHS
  Policy, IV. Implementation by Institutions, para
  A.3.b.(3)
• It is common sense for the Chair and other IACUC
  members to help this member gain an adequate
  understanding of issues before the IACUC. Jargon
  should be minimized, and questions raised by any
  member during the meeting should be addressed to
  the satisfaction of the NSM (as well as the NAM).

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Non-Affiliated (NAM) Member

• Must not be affiliated with the institution in
  any way other than as a member of the IACUC, and
  cannot be a member of the immediate family of a
  person who is affiliated with the institution."
  (PHS Policy, IV. Implementation by Institutions,
  para A.3.b.(5)
• Cannot be a laboratory animal user at any
  research facility. (USDA Policy Manual, 15
  Guide, Institutional Animal Care and Use
  Committee, page 9)
• A veterinarian can fulfill this role as long as
  the veterinarian is not the Attending
  Veterinarian (and meets other criteria). (USDA
  Policy Manual, 15)

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Non-Affiliated (NAM) Member

• Members of the clergy, lawyers, and teachers
  often sought to fill this position.
• Both PHS and USDA allow financial compensation to
  the non-affiliated member for expenses such as
  travel, parking, meals, and even participation,
  as long as such compensation
• Is not so substantial as to be considered an
  important source of income.
• Does not influence the member's voting on the
  IACUC, and
• Does not qualify the member as an employee of the
  institution. (PHS Guidance, IACUC Composition,
  Functions and Authority Q11 USDA Policy Manual,
  15)

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Veterans Serving on the IACUC- 1200.7

• 8a(3)(a) A veteran who volunteers at the medical
  center is considered to have an affiliation with
  the institution and is disqualified from serving
  as the non-affiliated IACUC member however,
  appointment of such veterans to the IACUC in
  another capacity, such as lay member is strongly
  encouraged.
• 8a(3)(b) Veterans who do not use a VA medical
  center for medical care may serve as the
  non-affiliated member on that medical centers
  IACUC, as long as they have no other affiliation
  with the medical center and are not in the
  immediate family of a medical center employee.

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IACUC Coordinator
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IACUC Coordinator- Requires Complex Skills

• IACUC appointment letters are current for all
  required positions.
• Minutes, packets, and agendas go out on schedule
  before meetings.
• Dates of semi-annual reviews are planned so that
  no more than 6 months elapse between them.
• Written correspondence to investigators is
  initiated promptly to allow timely responses and
  reduce delays in approvals.

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IACUC Coordinator

• Complete IACUC files maintained
• Final version of ACORP approved by IACUC
• Documentation of IACUC reviews and investigator
  responses
• Approval letters
• Amendments and proof of approvals
• Proof of training is maintained either in
  individual files, or in a master folder

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IACUC Coordinator

• Other documentation
• Records of previous semi-annual reports and other
  regulatory reports are maintained.
• A clear paper trail for self-reported
  deficiencies is available.
• AALAC Program Descriptions and correspondence
  are maintained.

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Keeping Records- How Long?

• All records and reports shall be maintained for
  at least three years. Records that relate
  directly to proposed activities and proposed
  significant changes in ongoing activities
  reviewed and approved by the IACUC shall be
  maintained for the duration of the activity and
  for an additional three years after completion of
  the activity. All records shall be available for
  inspection and copying by authorized APHIS or
  funding Federal agency representatives at
  reasonable times. (AWAR Section 2.35, item (f)
  PHS Policy, IV.E.2)

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IACUC Coordinator- Other Duties

• Interface with investigators to help them arrange
  veterinary consults and facilitate document
  submission.
• Make sure letters requesting annual and triennial
  documents go out in advance to prevent lapses in
  protocol approval.
• Maintain a list of animal procedure areas outside
  the animal facility so the IACUC can visit them
  as part of the semi-annual review.

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1200.7, items 8f(1) and 8d(1)(d)3a(6)

• Preparation of IACUC Minutes. IACUC minutes must
  be written and published within 3 weeks of the
  meeting date. VA medical centers with their own
  IACUCs must format their minutes to comply with
  following subparagraphs 8f(1)(a) through
  8f(1)(j). For VA projects under consideration,
  the minutes of joint or affiliate IACUCs need to
  contain the same information somewhere in the
  document.
• Inadequate IACUC administrative support is a
  serious, reportable deficiency.

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Research Administrators
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ACOS and AO for RD

• On behalf of the Director, ensure adequate
  administrative support for the IACUC.
• ACOS- as the direct supervisor of investigators,
  intervene as needed to ensure that IACUC
  sanctions are taken seriously and followed.
• Arrange meetings with other service chiefs as
  needed to develop plans and correct physical
  plant and security deficiencies identified by the
  IACUC.
• When needed, support IACUC investigations by
  arranging interviews and providing meeting rooms.
  

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ACOS and AO for RD

• 6c(4) Continuing Education. Training is mandated
  for all personnel who work with laboratory
  animals, including laboratory animal
  veterinarians, the supervisor, and husbandry care
  staff. NOTE See USDA AWAR (9 C.F.R. 2.32,
  Personnel qualifications), the U.S. Government
  Principles for Training (Principle VIII), PHS
  Policy (see Section IV.1.g.), and the Guide.
  Accordingly, it is critical that local funds be
  allocated for continuing education activities on
  an annual basis.
• Make it possible for animal care staff to attend
  AALAS Branch meetings and the annual national
  AALAS meeting (CVMO briefing)

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ACOS and AO for RD

• 1200.7, item 6b(5)(c). Once the annual proposed
  Veterinary Medical Unit (VMU) budget is prepared
  by research administrators with input from the
  VMO, the proposed budget should be submitted to
  the IACUC for comments, and then submitted to the
  RD Committee for review and final approval.
  (1200.7, item 6b(5)(c))

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ACOS and AO for RD

• 1200.7, item 7i. Operating Costs Recovery.
  Investigators using animals must be charged a
  pro-rated share of total animal care costs. An
  annual review of rates by the veterinarian and
  research administrators is recommended so that
  revisions can be made to maintain the financial
  health of the VMU, unless local subsidies are
  provided. Charges for animal care must be based
  on projected operating costs, plus caging and
  equipment replacement and other reserves, less
  the amount received in cost center 105 funding.

56
ACOS and AO for RD

• 1200.7, item 7i(1). The IACUC, with the
  assistance of the veterinarian, is charged with
  recommending changes in per diem rates to the RD
  Committee. The RD Committee must approve the
  rates before they are finally adopted.
• 1200.7, item 7i(2) The IACUC and/or research
  administrators must notify the RD Committee when
  investigators become more than 3 months
  delinquent in per diem payments.

57
ACOS and AO for RD Art of Managing Risk

• 1200.7, item 8g. Mandated Reporting of
  Deficiencies. As a condition of extending the
  privilege of conducting animal research to
  individual medical centers, VA Central Office
  expects that the IACUC and institutional
  administrators will avoid any appearance of
  hiding or suppressing deficiencies.

IMPORTANT
58
ACOS and AO for RD Art of Managing Risk

• 1200.7, item 8c(1) The ACOS for RD and AO for
  RD should not serve as voting members on the
  IACUC, and when in attendance, need to be very
  sensitive to the occurrence or appearance of
  conflict of interest relative to their
  supervisory, managerial, or fiscal authority.
  They should avoid intervention or participation
  in deliberations involving entities in which they
  have financial or economic interests, except to
  provide information as requested by the IACUC.

IMPORTANT
59
ACOS and AO for RD COI Problems
ACOS for RD
AO for RD

• ACOS/AO influence
• Bonuses and evaluations
• End of year funds for equipment
• Bridge funding
• Lab space
• Office space
• Foundation support

IACUC Chair
IACUC Members
VMO
IACUC Coord
VMU Superv
60
Animal Facility Supervisor
61
Animal Facility Supervisor

• Critically important position- assuring adequate
  daily care of animals requires huge investment of
  time and effort.
• In a larger program it is impossible for the
  veterinarian to directly supervise the animal
  care staff, monitor animal care daily, and still
  meet other obligations.
• The supervisor must be skilled in animal care
  practices, and be able to manage and supervise
  people effectively.

62
Animal Facility Supervisor- 1200.7

• 6c. The VMU Supervisor. Each facility with an
  active program of animal research must assign the
  responsibility of overseeing daily husbandry and
  other care duties to a single individual. The
  organizational title of this position is
  Supervisor, VMU.
• 6c(1) Qualifications. Through training and/or
  experience, the VMU supervisor must possess
  adequate knowledge and skills in laboratory
  animal science and technology, record keeping,
  and personnel management to direct the day-to-day
  operations of the VMU such that the food, water,
  and housing provided to all animals is
  appropriate.

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Animal Facility Supervisor 1200.7

• 6c(3) Primary Duties. The VMU Supervisors
  responsibilities include, but are not limited to
• Schedule work assignments and monitor the quality
  and quantity of work performed.
• Provide training for employees, preferably with
  the goal of preparing the employees to take and
  pass AALAS certification examinations.
• Instruct/assist research technicians and
  investigators in the performance of routine
  techniques for animal experimentation.
• Maintain essential records (e.g., animal
  inventories, procurement records, etc.).

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Animal Facility Supervisor- 1200.7

• Ensure the maintenance of a sound program of
  animal husbandry and a stable animal environment
  (temperature, lighting, and ventilation)
• Promptly report malfunctions to proper
  authorities.
• Note and report abnormal behavior or illness in
  animal subjects.
• Record and report misuse of animals during
  experimentation or deviation from approved
  protocols to the VMO or other member of the IACUC.

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Animal Facility Supervisor- Qualifications

• Certification by the American Association for
  Laboratory Animal Science (AALAS) at any level is
  helpful critical in gaining needed knowledge
  and skills. (1200.7, item 6c(1)(a))
• Should have at least 1 year of relevant
  experience working with laboratory animals in a
  biomedical research setting. (1200.7, item
  6c(1)(a))

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Animal Facility Supervisor- SOPs

• 7c. Standard Operating Procedures (SOPs). The VMU
  Supervisor, with guidance and assistance from the
  VMO or VMC, must develop a manual of SOPs setting
  forth schedules and methods of cleaning animal
  housing and research areas, feeding and watering
  practices, staff training, equipment maintenance
  and related activities. At a minimum, the SOP
  manual must be reviewed annually by the VMU
  supervisor and the VMO, or VMC, to determine the
  need for any changes in procedures. NOTE This
  SOP manual should be reviewed and approved by the
  IACUC at least annually.

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Veterinary Technicians- Leveraging Expertise

• Veterinary technicians have different skill sets
  from typical animal facility supervisors
  training in anesthesia, surgical support,
  postoperative care, medical care, medical
  record-keeping.
• The supervisor/veterinary technician combination
  strengthens both the animal care and medical care
  aspects of the program.

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Animal Care Staff
Keystone
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Animal Care Staff

• If animals are not cleaned, fed, and watered, the
  program collapses.
• Caretakers are often overlooked, underpaid,
  under-trained, and under-appreciated.
• Caring for animals requires many observational
  and intellectual skills, but the pay has
  traditionally been similar to that paid at
  fast-food restaurants.
• The cost of training new personnel is high (time
  and effort).

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Animal Care Staff

• Training is critical to employee satisfaction and
  retention.
• VA receives free technician accounts on the AALAS
  training website- www.aalaslearninglibrary.org
• Institution should pay for AALAS training
  materials and test fees, and reward success in
  passing certification exams.

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Animal Care Staff- 1200.7

• Inadequate caretaker staffing is a serious,
  reportable, deficiency. (item 8d(1)(d)3a(5))
• Although not stated directly, all animal care
  staff should be supervised by the VMU supervisor-
  the performance appraisal should be done by the
  supervisor/VMO, and funding for the position
  should come through the animal facility.

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Summary- A Successful Animal Care and Use Program
Requires a Team Approach and Tremendous Resources

• CEO/Institutional Official
• IACUC and Attending Veterinarian
• IACUC Coordinator
• Research Administrators
• Animal Facility Supervisor
• Animal Care Staff
• Investigators