The Beacon Volume 3, Issue 2
September 2018 Newsletter
- Director’s Message
- AAALAC Site Visit
- Updated Reporting Animal Welfare Concerns Signs and others
- IACUC Meeting
- MAPS Development
- Internal Audit
- New and Updated Policies and Standard Procedures
- Office Hours
- Contact Us
With the start of a new academic year, the Office of Animal Research Support is reinitiating our newsletter, The Beacon. Instead of distributing large quarterly newsletters that are usually delayed because we keep adding more articles, we are now going to send much more concise and focused groupings of topics each month. In general, those topics will be:
- IACUC Meeting. Committee decisions that directly impact the animal research community will be announced and explained.
- MAPS Development. OARS and the Office of Research Enterprises (OREO) are continually investigating ways to improve your experience with MAPS. We will notify you of upcoming releases and how you will be affected.
- Policy and Procedure Updates. The IACUC typically revises and reapproves a few policies at each monthly meeting. Additionally, we always have more than a few standard procedures in various stages of review. With the newsletter, we will inform the community of any policy changes that may impact your current practices and/or standard procedures that may be used when writing or modifying protocols.
- Special Topics and Announcements. If an event of interest occurred in the last month or will occur in the next month, we will notify you of those activities. For example, Yale is hosting AAALAC for its triennial site visit on October 15-17, 2018.
- Office Hour Schedule. OARS staff will host office hours from 3:00-4:00pm on the 2nd and 4th Thursdays of the month. In general, this will be an opportunity to ask questions or seek advice verbally, although we may schedule a specific topic to be discussed or presented.
If you wish OARS to cover any other topics as a recurring article or as a one-shot, please let me know directly at email@example.com.
Our triennial AAALAC re-accreditation site visit will be October 15th through 17th. AAALAC accreditation is a means by which the University demonstrates a high standard of animal welfare, effective practices regarding care, and conscientious use—all coordinated to enhance the quality of the research.
During the site visit, the AAALAC Council members and consultants will visit:
- All animal housing areas—both YARC- and PI-managed facilities
- All areas where USDA species are used
- Most “special use” areas, e.g. imaging, behavioral testing cores, use of prolonged restraint
- As many survival surgery laboratories as time permits
- Any additional laboratories that they request to visit
There will be a Town Hall Meeting on Tuesday October 2nd from 3:00-4:00pm in TAC N107. Jim Macy and I will focus on the areas that will be visited and when, what they will be looking for, what questions the site visitors will ask, and hopefully convince you that you should not feel obligated to reschedule any procedures. Please mark your calendars.
The following signs have been updated and posted, as applicable:
Reporting Animal Care and Use Concerns must be posted in a prominent location in all animal housing areas, whether YARC- or PI-managed. This sign should also be posted in any area where animals are otherwise used (e.g. laboratories). The PHS Policy and the Animal Welfare Act Regulations establish guidelines that the IACUC is responsible for the review of concerns involving the care and use of animals in research, teaching and testing. While the IACUC is responsible for the review of these concerns, it is an institutional responsibility and a responsibility of the Yale research community to bring forth any concerns related to the treatment of animals.
Reporting Animal Care and Use Concerns
Have a Concern and/or Question about Animal Care or Use
Yale University ensures that no individual will be discriminated against or be subject to any reprisal for raising a concern or reporting violations to any regulation or standard pertaining to an animal cared for or used under our Animal Program umbrella.
A concern or report can be made anonymously.. Whether or not made anonymously, all reviews and investigations will be dealt with confidentially to the extent reasonably possible.
Dependent upon the type of rodent CO2 euthanasia set-up used in your laboratory (Vet Equip fixed flow or an adjustable flowmeter), the Instructions for Rodent Euthanasia with a CO2 Chamber Using a Pre-set Vet-Equip Flow Meter or Instructions for Rodent Euthanasia with a CO2 Chamber Using an Adjustable Flow Meter must be posted near every CO2 set-up.
The October 2018 VCS On-Call Schedule for “other species” (all species except nonhuman primates) includes contact information for veterinarians who are on-service and on-call in October. This should be posted in PI-managed housing areas and may be posted in general laboratories.
The Institutional Animal Care and Use Committee met on September 12th and made the following decisions that may impact the animal research community:
- Protocol approval and pending PQFs. When a protocol is ready to be approved, personnel will be removed if there is not an approved PQF for that person. Once training requirements are completed, that person will be added back to the protocol when his/her PQF is approved. OARS can administratively add this person, so there is no need for an official modification.
- Adding animal numbers is now easier than before. Consistent with guidance from OLAW-NIH, the IACUC has authorized OARS to administratively approve requests for additional animals if the rationale falls within five “pre-approved” justifications. There is no need for an official modification if the only change to the protocol is to add more animals. Please see the Changes to Approved IACUC Protocols policy for details. As a reminder, also described in this policy is the Veterinary Verification and Consultation (VVC) process, which allows VCS veterinarians to approve certain changes to your protocol “on the spot” to be more flexible with handling emergent events. Under VVC, the veterinarian is serving as a subject matter expert to verify that compliance with an approved IACUC policy or proposed change is appropriate for the animal(s) in the specific circumstance (changing doses of drugs, extending or adding a timepoint, adding a different technique within a procedure, etc.).
Members of the IACUC are reappointed or newly appointed every September 1st. This year, we added three new scientist members for a new total membership of 20 members, consisting of 10 scientists, 2 non-scientists, 2 public members, 3 veterinarians, a representative from EHS, and the Chair and Vice Chair. The 18 members affiliated with Yale represent the following units:
Academic and Research Departments
- Anesthesiology (1)
- Cardiology (2)
- Comparative Medicine (2)
- Ecology and Evolutionary Biology (1)
- Endocrinology (1)
- Epidemiology - Microbial Diseases (1)
- Immunobiology (2)
- Obstetrics, Gynecology and Reproductive Sciences (2)
- Occupational Medicine (1)
- Peabody Museum (1)
Administrative and Support Units
- Environmental Health and Safety (1)
- Office of Animal Research Support (Troy Hallman)
- Office of Sponsored Projects (1)
- YSM Library (1)
MAPS Release #4 is scheduled to go live in October. System enhancements that will directly impact the animal research community include:
- The autogenerated emails you (PIs and Admin Contacts) receive from MAPS will be more instructional and direct you to what action is required.
- The “non-science” screens (e.g. funding, housing, etc.) have been simplified and will require significantly less unnecessary (i.e. not required) information than has been requested in the current and previous protocol forms.
- The 3-year renewal feature will allow the PI or authorized research staff to create a copy of the current version of the approved protocol, make necessary changes (add/remove personnel, funding and experiments, reconsider how many animals are needed, etc.), and then submit an updated protocol for its 3-year de novo review. As your protocols are approaching their 3-year anniversaries, the protocol liaisons will reach out to you to begin the renewal process.
Throughout most of FY19, Yale University Audit & Quality Assurance audited IACUC and OARS policies and processes. Their findings and recommendations focused on training, personal
qualification forms (PQFs) and approving personnel for facility access. The findings were discussed at the September IACUC meeting and a few changes were made to the current processes. The IACUC’s decision to remove personnel from protocols if they do not have an approved PQF was based on the audit findings.
Another audit mandate was to remove a person’s facility access if they do not keep up with annual (NHP users) and triennial (all other animal users) medical clearance. Yale’s Training Management System (TMS) is programmed to send automated reminders at 60 and 30 days prior to the due date, and a final reminder that one’s medical clearance has expired. OARS is establishing a process to add a personal reminder after expiration, with facility access being withdrawn after 30 days post-expiration.
Several policies and procedures were reapproved by the IACUC and resulted in minimal or no revisions. These include the following:
- Mice and Rat Body Condition Scoring
- Anesthetic Vaporizer and Ventilator Maintenance
- Policy and Procedure for Using the Mouse Ascites Method for the Production of Monoclonal Antibodies
- Non-pharmaceutical Grade Compounding Procedure: Sodium Pentobarbital
- Maintaining Colonies of Genetically Modified Animals
- NHP Bite-Scratch Procedure
- NHP Transport Policy
Policies and procedures that were approved with significant changes or are new, include:
- Cost cannot be the sole justification for not using pharmaceutical-grade anesthetics.
- Ketamine/diazepam is no longer considered appropriate surgical anesthesia for guinea pigs.
- The dose of ketamine/xylazine for hamsters has been updated.
- Several doses of various combinations of anesthesia for NHPs have been revised.
- Surgeries with NHPs lasting longer than 2 hours now require mechanical ventilation.
- Tricaine-S (Western Chemical, Inc.) is the only acceptable formulation of MS-222 for aquatic species anesthesia. Finquil® is no longer available and was removed from the policy.
Anesthesia Policy and Guidelines for NHPs NEW
This document, created by VCS in collaboration with PIs and anesthesiology experts, describes the minimum requirements for monitoring anesthetized NHPs and general guidelines for surgical procedures.
- Certain types of significant changes to an IACUC protocol can be approved by a VCS veterinarian by way of the Veterinary Verification and Consultation (VVC) process.
- Certain justifications for increasing animal numbers can bypass IACUC review and be approved administratively by OARS.
- The process required for euthanizing mice and rats was refined, including the steps VCS will take if the lab is unavailable.
- The Verification of Death section was updated to be more concise.
- All of the species tables now include a column that indicates if that specific type of euthanasia requires a secondary physical method.
- The time frames for proper rodent euthanasia (specifically the dwell time for neonates) using CO2 in the lab were updated to align with VCS standards.
Adverse Events REVISED
- Clarification to indicate that the IACUC, through OARS, should be notified in real-time of any unexpected and unplanned situations.
- Expectations for handling the animal during an adverse event and self-reporting were updated to reflect the current requirements.
The minimum recordkeeping requirements now include that intra-operative, immediate post-operative through sternal recovery, and the first 72 hours of post-operative monitoring must be recorded.
Scientific justification is only required for housing in cages with wire bottoms, not other types of special housing.
A Standard Procedures (SP) Library has been created to allow investigators to select IACUC-approved, commonly used procedures to be added to their protocols. Being pre-approved, there is no need to re-write that procedure or for the IACUC to re-review that procedure. When adding a new procedure building block, select “Approved Standard Procedures” to be presented with the list of “pre-approved” procedures.
Upcoming standard procedures include:
Includes lateral saphenous vein, ear vein, and jugular vein techniques.
- Includes the caudal fin technique.
- This procedure can also be used for small wild fish in field studies.
The next few months of OARS Office hours will be held in BCMM 201 form 3:00-400pm on the following Thursdays:
- October 11th – Q&A about the AAALAC Site Visit (Troy Hallman)
- October 25th – MAPS Release #4 walkthrough (Protocol Liaisons)
- November 8th – Open
- November 22nd – Cancelled (Thanksgiving)
- December 13th – Open
- December 27th – Cancelled (Winter Break)
To reach someone at OARS, email or call them directly or contact the Office at firstname.lastname@example.org or 203-785-5992. Please visit the Animal Research support page for additional info and guidance, including submission of documents for IACUC review, policies and procedures, animal-related training, how to report animal welfare concerns, and who to contact in OARS, so that we can provide you whatever assistance you may need.