The Beacon Volume 5, Issue 5

December 2020 Newsletter

• 2021 IACUC Deadline and Meeting Dates
• Update on IACUC and OARS “Business as Usual”
• CITI Program Training
• NIH All About Grants
• Lab-Based Training Logs
• PQFs (Personnel Qualification Forms)
• Policy Updates October/November
• Guideline Updates October/November
• Compliance Corner

Announcements & Reminders

2021 IACUC Deadline and Meeting Dates *please note the website has not yet been updated with the 2021 information listed below.

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.

**Please note that significant modifications will not be reviewed during the week of December 21st, 2020, due to the holiday/recess schedule.

If you need to submit a modification, please do so by December 15th, 2020. Any modifications received after the 15th will be sent out for review on January 5th, 2021.

Update on IACUC and OARS “Business as Usual”

As the University’s response to the spread of COVID-19 continues to evolve, so does the IACUC and OARS management of the institution’s regulatory responsibilities.

As you are most likely already aware, the IACUC approved an extension through the end of 2020 that facility managers (or designees) and PIs/Lab Managers with satellite housing may conduct self-assessments of their own facilities and laboratories. You all have done an amazing job with this. Thank you!

OARS will notify PIs and lab managers at the beginning of each month that a lab audit is due. Please use the Yale Laboratory Self-Evaluation Checklist for guidance or the fillable version Yale Laboratory Self-Evaluation Checklist_fillable (must be logged into CAS). Please send all findings with plan for correction to iacucinspects@yale.edu.

This initiative is limited to rodents, aquatics, and other non-USDA-covered species. Inspections of USDA-covered species will continue to be conducted by the IACUC.

CITI Program Training

CITI Program, in collaboration with the Association of American Medical Colleges (AAMC), has launched an online course to train students, staff and faculty to return to their campuses safely after closures due to COVID-19. The free course, offered through their online learning platform, is available to any medical school or research institution. This course is voluntary.

If you are interested in the course, please register at CITI Program.

NIH All About Grants

This podcast discusses considerations for alternatives to animals in grant applications. In the most recent episode of the All About Grants podcast, OLAW’s Dr. Neera Gopee and the National Center for Advancing Translational Sciences’ Dr. Christine Livingston will discuss the following.

• 3Rs
• Vertebrate Animals Section of grant applications
• Helpful resources and relevant policies
• Role of IACUCs and peer review
• Alternatives to animals in research

Visit this Extramural Nexus article for more information, including links to related podcasts and activities by the Advisory Committee to the NIH Director working group on Enhancing Rigor, Transparency, and Translatability in Animal Research.

Lab-Based Training Logs

The lab-based training logs are intended to be used by PIs or their designees to document training performed by research personnel.

Please ensure that training requirements for any PQF approved on or after April 1st, 2020, are fulfilled and documented on the lab-based training log. We will be collecting and archiving the logs in early 2021 to confirm that training has been completed.

If you do not have a training template, please contact OARS at IACUC@yale.edu and your inquiry will be directed to the appropriate OARS staff member. If you have any questions or concerns, please feel free to contact Troy Hallman directly at troy.hallman@yale.edu.

PQFs (Personnel Qualification Forms)

The release of the MAPS Training Module has been delayed to early 2021, thus you will need to complete PQFs (and lab-based training logs, as stated above) for a few more months. Stay tuned for more information.

Please ensure that any PQFs that have been submitted, have no outstanding requirements that need to be met prior to PQF approval.

If you are receiving reminders about your PQF submission, please address the issues as soon as possible.

If you are unsure of your PQF status, please contact OARS at IACUC@yale.edu.

Policy Updates October/November

Transportation of Animals ^Revised

• Previously, there were two separate transportation policies describing intra-institutional and inter-institutional transportation of animals. The two policies were combined into one called “Transportation of Animals.”

Guideline Updates October/November

Experimental Allergic (Autoimmune) Encephalomyelitis (EAE) in Rodents

• Reviewed and no changes were made.

Administration of Experimental Agents ^Revised

In the parenteral section describing routes of administration, “Intravenous” was changed to “Intravascular.”

• “Intracardiac” was added as a method of access. This method requires anesthesia.

Compliance Corner

SI vs. DSP

There are two mechanisms by which researchers can specify non-standard or special treatment of their animals.

A Special Instruction (SI) is directly related to the research being conducted and must be reviewed and approved by the IACUC as part of the IACUC protocol. An example would be the provision of a special diet that is a required as part of an experiment (e.g., doxycycline).

SIs can be submitted via MAPS as part of a new or 3-year renewal protocol submission or as a modification to an approved protocol for review by the IACUC. Upon approval of the SI, OARS will then generate forms for YARC Operations with the pertinent information.

A Deviation of Standard Practice (DSP) is not directly related to the research being conducted and is not part of the approved protocol. An example would be a request to use a different type of bedding or enrichment than normally supplied by YARC.

DSPs are, as the name implies, deviations from YARC’s standard practices. Consequently, the lab works directly with YARC (Facility Manager(s), Veterinarians and YARC Operations) to establish a DSP.

Once approved, both SI and DSP forms are kept in the animal room and accompanying cage card stickers are generated by YARC. When a researcher wishes to “use” an SI or DSP, the appropriate sticker must be placed on the affected cages.

Importantly, when the lab is responsible for what is described in the SI, for example, providing a special diet, a Variation of Standard Care (VSC) form must be completed and kept in the binder with the SI and stickers.

Examples of DSPs and SIs are below:

Deviation From Standard Practice

• Bedding: Special
• Cage: Covering front of cages with towel
• Direct Care: Provided by Researcher
• Do No Enter – Experiment in Progress (procedure room, short duration)
• Enrichment: Extra
• Enrichment: Wooden blocks
• Food: Breeder diet
• Health Issues Expected
• Notify PI: Health concerns
• Notify PI: Non-compliant
• PI provides husbandry
• Save: Dead pups/animals

Special Instructions

• Cage Density
• Death as an Endpoint
• Enrichment: None
• Environment: housing in out-of-range temperature, humidity, or lighting
• Fluid Regulation
• Food Regulation
• Non-Standard YARC Caging
• Policy Exemption
• Sanitation Interval
• Single Housing
• Special Diet
• Special Water

Please contact OARS (iacuc@yale.edu) with any questions or concerns.

Have a safe and happy holiday!
~OARS Team