The Beacon Volume 7, Issue 2

• 2021 IACUC Deadline and Meeting Dates
• Research Liaison Department Assignments
• Support and Instructions
• Upcoming Facility Inspections
• Policy Updates/January-April 2022

2022-2023 IACUC Deadlines and Meeting Dates

Investigators are encouraged to submit protocols that are due for 3-year renewal early to allow time for pre-review of the protocol by the research liaisons and veterinarians. This will help expedite the review and approval of the protocol. Should you have any questions, please contact OARS at iacuc@yale.edu.

Controlled Substance Inventory

All controlled substance logs have transitioned to online Integrator. Please work with your EHS safety advisor if you have questions about using Integrator to log the control substance usage. OARS will no longer be checking the control substances usage logs during lab assessments or comparative review meetings; instead, EHS will continue to keep track of control substances working solutions from stock and usages in Integrator, along with your annual inventory logs.

Change to Analgesia Policy

The following statement was added to the Analgesia Policy. Please make note of the change.

“The use of topical local anesthetics is prohibited. Lidocaine and bupivacaine must only be used in an injectable solution.”

Adding Locations to Protocols

NIH notice NOT-OD-14-126 provides guidance that the IACUC must approve, by full committee review (FCR) or designated member review (DMR), any changes “in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC.” At the regularly scheduled October 13th, 2021, IACUC meeting, the Committee approved the following changes for reviewing and approving locations added to protocols:

• If the proposed animal use location is not part of the animal program overseen by the IACUC, then the location will be added to the protocol as a significant modification and reviewed by DMR process. As with other significant modifications, the Committee will have an opportunity to call for FCR of the modification. The protocol modification will not be approved until the new location is assessed by one or more IACUC members or a research liaison (IACUC-delegated ad hoc consultants).
• If the animal use location is already part of the animal program overseen by the IACUC, then the location will be added to the protocol administratively, as is the current process. Examples include new procedure spaces in a YARC-managed vivarium and/or adding a laboratory location that is already used by another laboratory and approved on another protocol.

Upcoming USDA Inspection

Our USDA Veterinary Medical Officer will be conducting the annual site visit within the next few months. She will be visiting animal facilities and laboratories housing, or using, USDA-covered species. The site visit will also include an extensive review of protocols and records.

Please prepare animal areas by taking the following preparatory actions:

• Discard all expired drugs including anesthetic, analgesics, topicals, etc. Alternatively, please label “Expired, do not use” and segregated from in-date stock.
• All food and edible enrichment must be within the “best by” date and stored in a plastic container or otherwise stored with an air-tight seal.
• Make sure that all surgery, health, procedure, and water/food regulation records are well organized, complete, and available if the inspector wishes to view them.
• If you take USDA species up to your lab, procedural or behavioral testing areas, be sure that they are maintained in appropriate clean caging and away from hazards and the space is appropriately cleaned/sanitized.
• Please do not remove items from the animal’s caging (water bowls, enrichment, etc.) or separate group-housed animals unless authorized by a Clinical Veterinarian.

We are typically informed the morning the USDA inspector plans to arrive to begin the inspection. We will send out a similar message that morning, notifying everyone. If you have any questions or concerns, please do not hesitate to contact the Office of Animal Research Support (OARS) at (203) 785-5992 or email Troy Hallman directly (troy.hallman@yale.edu)

Annual TMS Compliance Assessment and Medical Clearance

In 2020, OARS and Employee Health updated the “animal use” questions in the annual TMS Compliance Assessment. This refinement will help assign people to appropriate medical clearance for the types of animals they use. We have been identifying many expired medical clearance approvals because the annual compliance assessment has not been updated in a timely manner. Medical clearance by Employee Health is the institution’s one mechanism to help keep everyone safe when they work with animals. If your job has changed, including if you now work with a new species or if you no longer enter animal facilities, please be sure to update your annual TMS Compliance Assessment.

Anesthesia Monitoring

We would like to remind all staff on protocols that an anesthesia log confirming depth of anesthesia every 15 minutes must be kept for all non-surgical, survival procedures (e.g., imaging, complex injections, recordings) requiring anesthesia lasting longer than 15 minutes. These logs will be reviewed on semi-annual lab assessments and should be maintained for 1 year. The anesthesia log can soon be found on the OARS website. In the meantime, please reach out to your Research Liaison if you need to obtain a log.

Change in Regulatory Requirement for USDA Annuals

As we mentioned previously, as of December 27th, 2021, annual reviews of protocols utilizing USDA-covered species are no longer required. A complete review of IACUC-approved protocols will be conducted now at 3-year intervals, harmonizing the USDA’s new expectations with that of the National Institutes of Health (NIH).

NOTE: Annual protocol check-in notifications will be sent to allow you to report any adverse events you have incurred over the year. There is no need to respond to the notifications unless you have an adverse event to report, or if you are requesting changes to be made to your protocol.

Support Emails

In effort to help facilitate appropriate distribution of email requests for support, please follow the guidance below:

Please contact MAPS Support at IACUC.Support@yale.edu

• MAPS access issues
• MAPS security issues (e.g., inability to see a specific protocol)
• Inability to create or submit a protocol or modification

Please contact your Research Liaison or IACUC@yale.edu for the following:

• How to use MAPS (e.g., initial submissions or modifications)
• Protocol content (e.g., editing or concerns)
• Assistance in answering reviewer questions
• AALAS or TMS access

Special Instructions and Variation of Standardized Care Forms

When your protocol or modification is approved with a Special Instruction (SI), it is the PI’s/lab’s responsibility to fill out the associated Variation of Standardized Care (VSC) form in the animal room. If the activity described in the SI is not documented on the VSC form, it will be recorded by OARS as an incident. Please remember that if the incident is federally funded, then it may be reportable to the NIH. Please contact the animal facility manager or animal care technician if you have any questions regarding a VSC.

Upcoming Facility Inspections

May 2022: AMI, GSF, WC
July 2022: ESC, LSOG4, MEC, SHM4, YSB

Facilities are typically inspected during the last two weeks of the month, approximately 9:00 A.M. to 11:30 A.M.

Please check your spaces periodically to ensure fulfillment of IACUC expectations. The Inspection Checklist the IACUC utilizes to document findings is available on the OARS website.

IMPORTANT: If you have locked cabinets, drawers, or boxes that contain drugs or materials with expiration dates, please make sure that they are unlocked and ready for the IACUC to inspect the contents. If you do not want to leave the container unlocked and unsupervised, then the IACUC’s expectation is that you be readily available to open them. Contact iacuc-inspects@yale.edu with your contact information and the areas of interest.

Policy Updates/January-April 2022

Surgery: Non-Rodent Survival and Non-Survival ^REVIEWED

• All survival surgery in non-rodent mammals must be performed in accordance with the following:
  • aseptic technique
  • proper use of pharmaceutical agents, including anesthetics and analgesics
  • appropriate post-operative care
  • documentation
• Survival surgery must be conducted in a dedicated facility for major surgeries or an approved space for minor surgical procedures.
• To conduct non-survival surgery using rodents, all personnel must complete the Rodent Advanced competency. For those individuals that will be performing survival surgery, personnel are required to complete the Rodent Survival Surgery competency. All course requirements are outlined in the Animal Care and Use Training Policy.

Anesthesia Policy ^REVIEWED

• Those using animals in research should select appropriate anesthetics that reflect professional veterinary judgment and that best meets clinical and humane requirements, as well as the needs of the research protocol.
• The selection depends on many factors, such as:
  • species
  • age
  • strain or stock of the animal
  • type and degree of pain
  • likely effects of particu¬lar agents on specific organ systems
  • nature and length of the surgical or pain-inducing procedure
  • safety of the agent, particularly if a physiologic deficit is induced by a surgical or other experimental procedure
• Pharmaceutical-grade anesthetics must be used whenever available, including non-survival procedures.
• Regardless of the method of anesthesia used and before any potentially painful procedure is initiated, the effectiveness of the anesthetic dose must be assessed by applying a noxious stimulus (e.g., toe pinch) to which there is no response as evaluated by at least two parameters
• When administering inhalant anesthetics using a re-breathing circuit system, animals must be mechanically ventilated if the duration of anesthesia is expected to last more than 1 hour.

Death as an Endpoint ^UPDATED

• Removed duplicate statements.
• Reworded and/or moved content to different sections for better clarity.
• Added the following section about surrogate markers:
  • Body temperature
  • Inability to eat or drink
  • Inability to right itself
  • Weight loss

Mouse Ascites Methods for Monoclonal Antibody Production ^UPDATED

• Removed duplicate statements
• Reworded and/or moved content to different sections for better clarity

Physical Restraint ^UPDATED

• Removed duplicate statements
• Reworded and/or moved content to different sections for better clarity
• Combined the sections describing brief restraint (<15 minutes) and prolonged restraint (>15 minutes) into one “Physical Restraint” section.

Standard Procedure Updates

These are pre-approved standardized procedures that are implemented into MAPS so that investigators may select from a library and add it to the protocol. Being that these procedures are pre-approved, there is not a need for investigators to re-write procedure details, nor for the IACUC to re-review that procedure.

The following approved standard procedures have been reviewed and re-approved with no changes made:

• Blood Collection in Guinea Pigs
• Blood Collection in Hamsters
• Rotarod Testing
• Elevated Maze Plus
• Fin Clipping in Zebrafish
• Forelimb Grip Strength
• Open Field or Locomotor Activity

As always, please contact OARS (iacuc@yale.edu) with any questions, suggestions, or concerns.

Stay safe, everyone!
~OARS Team