Update on AAALAC, IACUC/SRS, and 1200.7

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Update on AAALAC, IACUC/SRS, and 1200.7

• Mike Fallon, DVM, PhD, dACLAM
• CVMO, VACO
• Michael.fallon_at_med.va.gov
• www.researchtraining.org

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Presentation Goals

• Cover important features of new 1200.7
• Communicate trends in AAALAC citations of VA
  animal research programs
• Suggest methods of integrating IACUC and SRS
  (IBC) reviews of animal studies involving
  hazardous agents
• Provide info on tools for complying more easily

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Before we begin

• New draft Handbook, new ACORP files, new
  semi-annual IACUC report files, OHS brochure, and
  this presentation is available at
  www.researchtraining.org (click on "animal
  research" link at bottom of the page)

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VHA Handbook 1200.7"Use of Animals in Research"

• Status completed concurrence process, now being
  formatted for issue
• Focus compliance with PHS Policy and USDA Animal
  Welfare Act Regulations in VA settings
• Purpose provide guidance in complying with
  myriad of regulations and policies in animal
  research

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1200.7 Hot Issues HVAC Failures

• Repeated catastrophic HVAC failures related to
  reheat valves that fail "on" despite the presence
  of 24/7 high temperature alarms
• ORO now investigating recurrences
• Oct 27, 2003 memo from Dr. Miller (Deputy
  Undersecretary for Health for Operations and
  Management)

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HVAC equipment must be designed, maintained and
operated so as to "failsafe" within acceptable
temperature conditions for laboratory
animals. Animal facilities will include
appropriate alarm systems Research personnel
will periodically conduct realistic drills to
assess 24/7 response team training and
effectiveness.
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HVAC equipment must be designed, maintained and
operated so as to "failsafe" within acceptable
temperature conditions for laboratory
animals. Animal facilities will include will
include appropriate alarm systems Research
personnel will periodically conduct realistic
drills to assess 24/7 response team training and
effectiveness.
Important in ALL recent animal loss tragedies
due to overheating, FMS personnel were alerted by
high temperature alarms, but could not respond
effectively.
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1200.7 Language on HVAC Problems

• 7.b.(2) Animal Facility HVAC Equipment and
  Testing.
• All heating, ventilation, and air conditioning
  reheat boxes serving one or more rooms or groups
  of rooms housing animals must be designed so that
  they fail in the off or "safe" position

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• 7.b.(2) Animal Facility HVAC Equipment and
  Testing.
• Catastrophic air handler failures occur despite
  the presence of high temperature alarms in animal
  rooms thus the ability of hospital personnel to
  detect high temperatures in animal rooms does not
  eliminate the need to comply

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• 7.b.(2) Animal Facility HVAC Equipment and
  Testing.
• To test the ability of facilities management
  personnel to properly detect and respond to
  elevations in animal room temperatures, at least
  once every fiscal year research personnel will
  purposely overheat a temperature sensor without
  notifying engineering or facilities management
  personnel in advance. The response will be
  carefully noted, and will form the basis of a
  report to the IACUC at the next convened meeting.
  

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• 7.b.(2) Animal Facility HVAC Equipment and
  Testing.
• Unannounced repeat tests must be conducted
  monthly until the IACUC approves the adequacy of
  the response. The IACUC minutes must reflect all
  reviews of testing. Repeated deficiencies may be
  considered reportable, as described in paragraph
  8.g. in this handbook.

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The Bottom Line

• VA can no longer tolerate catastrophic loss of
  animals due to fail-on reheat box malfunctions
• If your reheat boxes fail-on, THEY NEED TO BE
  REFITTED OR REPROGRAMMED!

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Shortly

• Feedback on station data provided will be
  forthcoming
• Note Some station responses suggest that FMS
  personnel do not understand that reheat boxes
  must fail-off even if alarm systems are installed

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PHS Assurances- Par. 4.b.(1)

• Compliance with PHS Policy is mandated whether or
  not PHS funds are accepted by an individual VA
  facility.
• All VA animal research must be covered by a PHS
  Assurance.
• Local VA medical centers may be covered by their
  affiliate's PHS Assurance in lieu of having their
  own PHS Assurance. The text in the affiliate's
  Assurance document must make it clear that the VA
  medical center animal research program is covered
  as part of the affiliate's Assurance.

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Shortage of Lab Animal Vets

• 6.b.(4) Retention and Bonus Pay. The National
  Research Council publication "National Needs and
  Priorities for Veterinarians in Biomedical
  Research" documents a continuing deficit of
  trained veterinarians entering the laboratory
  animal medicine specialtyto the extent allowed
  by VA policy, VA veterinarians should be
  considered for recruitment, retention,
  performance, and other types of incentive
  allowances

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Contacting the CVMO

• 6.d Contact with CVMO. If (any employee) has
  not been able to solve local problems regarding
  the ethical treatment and use of animals by
  working through local chains of command, he/she
  may contact the CVMO directly to discuss
  concerns, solicit guidance, or seek information
  without requesting or receiving local permission
  to do so. Consistent with USDA Animal Welfare
  Act Regulations (9 CFR Part 2, Section 2.32) and
  Title 5 (Part III, Subpart A, Chapter 23, Section
  2302), actions may not be taken against an
  employee for the act of contacting the CVMO.

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"Dirty Animals"

• 7.e. Animal Health. all research animals should
  be as free as possible of infectious agents known
  to be capable of adversely 1) affecting
  experimental studies, or 2) the ability of VA
  investigators to exchange animals with colleagues
  at other institutions as part of collaborative
  investigations. In general, if a practical means
  of diagnosing and eradicating an infection in an
  animal exists, steps should be taken to do so,
  and animals should be kept free from further
  infection.

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It's time to clean me up!!!
Me too!!!
Rotavirus
MHV
Pinworms
SDAV
Sendai
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Adoption of Research Animals as Pets

• 7.i. Adoption of Research Animals as Pets.
  Unless a waiver is requested in writing and
  approved by the CVMO, research animals may be
  adopted as pets only if all of the following
  circumstances are true

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Controlled Substances Paragraph 7.o.

• All controlled substances must be ordered by the
  local VA Pharmacy, and also received by the
  pharmacy for disbursement to research personnel.
• Controlled substances may not be purchased by
  research personnel directly from a vendor or
  received directly from a vendor, and controlled
  substances not purchased and received by the VA
  pharmacy are not permitted on VA property.

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IACUC Review of CS Use in Animals

• New version 3 of ACORP addresses controlled drug
  issues in item X.1.

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Joint IACUCs and Sharing Documents

• New language in 8.b.(1)(a) relaxed vs. older
  language
• The affiliates IACUC must agree to provide
  copies of IACUC minutes, semi-annual IACUC
  reports, AAALAC correspondence, USDA
  correspondence, copies of IACUC files on VA
  investigators Documents must be provided in
  their entirety, or the affiliate must agree to
  allow review of un-redacted documents by VA
  personnel during normal business hours.

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Conflict of Interest in IACUC Reviews

• 8.c. Avoiding Conflicts of Interest in IACUC
  Reviews.
• The ACOS/RD and AO/RD should not serve as
  voting members on the IACUC
• no IACUC member may participate in the IACUC
  review or approval of a research project in which
  the member is personally involved in the project
• IACUC members should not participate in the
  IACUC review or approval of a research project in
  which the member has a financial conflict

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Semi-Annual IACUC Reviews
Highly recommended !!
Compliant semi-annual IACUC review forms now
appear as Appendix E in 1200.7, except they are
not official forms. The process of receiving
approval for a "form" is so odious that these
"forms" appear in narrative form. Unofficial
forms that match 1200.7 language appear on the
website. Other forms may be used.
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The Animal Component of Research Protocol (ACORP)
The ACORP forms now appear as Appendix D in
1200.7, except they are not official forms
either. Unofficial forms (version 3) that include
all required review items in 1200.7 appear on the
website. 1200.7 review items must be addressed by
IACUCs after January 1, 2005
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Occupational Health and Safety

• OHS policy for those personnel exposed to
  animals, unfixed animal tissues or allergens now
  appears as Appendix C in 1200.7. A turn-key
  solution to creating a compliant OHSP is provided
  there.

Special thanks to Dr. Dave Delong (VMO
Minneapolis)
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Also Available- OHS Brochure Customize as Needed
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New IACUC Requirement in1200.7

• 8.d.(1)(b) As part of the Program review, the
  IACUC shall randomly review IACUC records
  representing at least 10 of the total active
  projects to determine if appropriate
  documentation of initial review, approval
  letter(s), annual and triennial approvals,
  modifications, and investigator correspondence
  are present.

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When is an ACORP Needed for JIT?

• 8.d.(2)(f) Guidance for Completing Merit Award
  Forms. The yes checkbox for animal use on form
  1313-1 of the VA application should be checked,
  and an ACORP must be submitted for just-in-time
  review upon request if any of the following
  apply
• 8.d.(2)(g) Additional Guidance for Completing
  Merit Award Forms. The no checkbox for animal
  use on form 1313-1 should be checked if animal
  use is limited to one or all of the following
  circumstances

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Specific, Detailed Guidance on When to Report
Deficiencies

• 8.g. Mandated Reporting of Deficiencies. VACO
  expects that the IACUC and institutional
  administrators will avoid any appearance of
  hiding or suppressing deficiencies. The goal is
  best achieved by prompt reporting of deficiencies
  before others outside of the program do so.
• 8.g.(1) The main categories of deficiencies
  that must be reported to outside authorities and
  the elements needed in the report are as follows

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To Whom, and When

• 8.g.(4) Deficiencies meeting any of the criteria
  in paragraph 8.g.(1) must be reported in writing
  within 15 business days through the ACOS/RD and
  Medical Center Director. The following agencies
  and offices must be notified

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Mice and Rats 8.j.(1) and 8.j.(4)

• No longer must mice and rats be included on the
  USDA Annual Report Form instead, report their
  use in the VA VMU Annual Report.

No!
Yes!
Mice and Rats
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Mandatory Training

• 8.k. Mandatory Training. Through IACUC oversight,
  each VA medical center must ensure that all
  personnel involved with animal research receive
  training to competently and humanely perform
  their duties related to animal research. This
  mandate extends to IACUC members, veterinarians,
  veterinary technicians, husbandry staff, research
  technicians, investigators, and all others that
  perform procedures or manipulations on laboratory
  animals.

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• 8.k.(1) Prior to approving any protocol, the
  IACUC must ensure that all staff listed on the
  protocol have been adequately trained (see USDA
  Animal Welfare Act Regulations and Standards,
  Section 2.32 (a) Principle 8, U.S. Government
  Principles For The Utilization And Care Of
  Vertebrate Animals Used In Testing, Research, And
  Training). As a minimum, the training utilized
  must cover all topics listed in USDA Animal
  Welfare Act Regulations, Section 2.32 (c).
  IACUC members must also be trained on topics
  pertinent to their committee tasks.

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• 8.k.(2) Free web-based training that helps meet
  this mandate has been developed by ORD for both
  research staff and IACUC members (see Appendix A
  for website and contact information). ORD
  web-based training must be utilized on an annual
  basis to help demonstrate compliance with federal
  animal research training mandates unless
  alternate and equivalent annual training approved
  by the CVMO has been adopted (see paragraph
  8.k.(4)). 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.

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• 8.k.(2)(a) Investigators and research staff who
  utilize laboratory animals must pass the exam
  covering the "Working with the VA IACUC" web
  course plus the exam for any species-specific web
  course that covers the species proposed for use.
•  
• 8.k.(2)(b) IACUC members must pass the exam
  covering the "Essentials for IACUC Members" web
  course.

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• 8.k.(3) Husbandry staff may access web-based
  training developed for them by the American
  Association for Laboratory Animal Science (AALAS)
  at www.aalaslearninglibrary.org. As part of a
  licensing agreement, some free registrations for
  this site can be obtained through the CVMO's
  office. Requirements for husbandry staff
  training should be set by the local IACUC in
  consultation with the attending veterinarian and
  VMU supervisor.

Note if you have not requested free AALAS
registrations for your husbandry staff, contact
Dr. Debra Hickman (Portland VMO) immediately
(debra.hickman_at_med.va.gov).
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Why Annual Training Mandate?

• Training for blood-borne pathogen, chemical
  hazards communication, radiation safety, GCP have
  annual refresher requirement.
• Passing score on exam is sufficient to renew
  certificate
• Convenient for researchers and administrators-
  server keeps all the records.

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ResearchTraining.Org Cumulative and New Site
Users
Cumulative User Registrations
Monthly New Registrations
1/2003
1/2002
1/2001
7/2002
7/2003
1/2004
7/2001
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AAALAC Emerging Issues

• OHSP for personnel exposed to animals, animal
  tissues or allergens must be risk-based and must
  include all employees exposed, regardless of pay
  source

Guidance- follow language in Appendix C of 1200.7
and implement the prototype program described,
including the annual questionnaire.
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AAALAC Emerging Issues

• Detailed reviews of IACUC records are performed
  during site visits, usually of highest-risk
  protocols

Guidance- as required by 1200.7, spot check 10
of IACUC folders during semi-annual reviews, and
pay particular attention to survival surgery
protocols and USDA category E protocols.
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AAALAC Emerging Issues

• There is inadequate follow-up after deficiencies
  are identified on semi-annual reviews.

Guidance- use VA "unofficial" forms for
semi-annual review, and discuss progress toward
making corrections as an item of business in
every IACUC meeting.
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AAALAC Emerging Issues

• Animals are not being carefully tracked by
  protocol to prevent the use of more animals than
  approved by the IACUC

Guidance- time to invest in some animal research
management software that will couple ordering to
IACUC animal use caps
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AAALAC Emerging Issues

• Oversight of animal procedures in laboratories
  outside the animal facility is inadequate

Guidance- the new ACORP requests such locations
in item Q. Make sure the IACUC reviews these
areas, and additional spot checks are recommended.
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Interaction of IACUC and SRS/IBC

• Oversight of the use of hazardous agents in
  animals can be problematic because both the IACUC
  and the SRS must be involved
• ACORP Appendix 3 (Test Substances) prompts
  detailed information about which hazardous agents
  will be used in animals and which husbandry staff
  might be at risk of exposure
• The SRS must review the use of such agents in
  research areas (incl. VMU)

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ACORP Hazardous Agent Requirements

• Appendix D, 4.h.(2)(a) Before any animal
  experiments involving any hazardous agents are
  performed, SOPs designed to protect all animal
  facility staff as well as non-study animals will
  be developed and approved by the appropriate VA
  or affiliated university safety committee and the
  IACUC and
• 4.h.(2)(b) All staff that might be exposed to
  these agents will be informed of possible risks
  and will be properly trained to follow the SOPs
  to minimize the risk of exposure.

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Possible Solutions

• Dual review of ACORP Appendix 3 and required SOPs
  by IACUC/SRS
• Cross-member representation on IACUC and SRS
• 6.b.(6)(k) Duties of veterinarian serving as a
  member of the Biosafety Committee as a liaison to
  the IACUC, if requested by the ACOS/RD.
• Use a subcommittee of the SRS to review ACORP
  Appendix 3 and SOPs

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michael.fallon_at_med.va.gov researchtraining_at_comc
ast.net