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Update on AAALAC, IACUC/SRS, and 1200.7

Update on AAALAC, IACUC/SRS, and 1200.7. Mike Fallon, DVM, PhD, dACLAM CVMO, VACO Michael.fallon@med.va.gov www.researchtraining.org. Presentation Goals. Cover important features of new 1200.7 Communicate trends in AAALAC citations of VA animal research programs

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Update on AAALAC, IACUC/SRS, and 1200.7

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  1. Update on AAALAC, IACUC/SRS, and 1200.7 Mike Fallon, DVM, PhD, dACLAM CVMO, VACO Michael.fallon@med.va.gov www.researchtraining.org

  2. 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

  3. 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)

  4. 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

  5. 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)

  6. …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.

  7. …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.

  8. 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

  9. 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…

  10. 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.

  11. 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.

  12. 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!

  13. 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

  14. 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.

  15. 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 specialty…to the extent allowed by VA policy, VA veterinarians should be considered for recruitment, retention, performance, and other types of incentive allowances…

  16. 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.

  17. "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.

  18. It's time to clean me up!!! Me too!!! Rotavirus MHV Pinworms SDAV Sendai

  19. 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…

  20. 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.

  21. IACUC Review of CS Use in Animals New version 3 of ACORP addresses controlled drug issues in item X.1.

  22. Joint IACUCs and Sharing Documents • New language in 8.b.(1)(a) relaxed vs. older language …The affiliate’s 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.

  23. Conflict of Interest in IACUC Reviews 8.c. Avoiding Conflicts of Interest in IACUC Reviews. …The ACOS/R&D and AO/R&D 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

  24. 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.

  25. 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

  26. 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)

  27. Also Available- OHS Brochure Customize as Needed

  28. 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.

  29. 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…

  30. Specific, Detailed Guidance on When to Report Deficiencies 8.g. MandatedReporting 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…

  31. 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/R&D and Medical Center Director. The following agencies and offices must be notified…

  32. 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

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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@med.va.gov).

  38. 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.

  39. ResearchTraining.Org Cumulative and New Site Users Cumulative UserRegistrations Monthly New Registrations 1/2003 1/2002 1/2001 7/2002 7/2003 1/2004 7/2001

  40. 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.

  41. 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.

  42. 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.

  43. 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

  44. 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.

  45. 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)

  46. 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-studyanimals 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.

  47. 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/R&D. • Use a subcommittee of the SRS to review ACORP Appendix 3 and SOPs

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