The Beacon Volume 6, Issue 2
May 2021 Newsletter
- 2021 IACUC Deadline and Meeting Dates
- Update on IACUC and OARS
- New Research Liaison Department Assignments
- AAALAC Site Visit
- Lab-Based Training Logs
2021 IACUC Deadlines and Meeting Dates
|Date of Expiring Protocols||Submission Deadline||IACUC Meeting Date|
|Expiring May 31, 2021||31-Mar-21||14-Apr-21|
|Expiring June 30, 2021||28-Apr-21||12-May-21|
|Expiring July 31, 2021||26-May-21||9-Jun-21|
|Expiring August 31, 2021||30-Jun-21||14-Jul-21|
|Expiring September 30, 2021||28-Jul-21||11-Aug-21|
|Expiring October 31, 2021||25-Aug-21||8-Sep-21|
|Expiring November 30, 2021||29-Sep-21||13-Oct-21|
|Expiring December 31, 2021||27-Oct-21||10-Nov-21|
|Expiring January 31, 2022||24-Nov-21||8-Dec-21|
|Expiring February 28, 2022||15-Dec-21||12-Jan-22|
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 email@example.com.
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.
The IACUC has extended laboratory self-assessments through March 2021 and will reassess how to move forward at the April IACUC meeting. The IACUC and OARS continue to look for safe ways to return to the normal inspection process. 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 assessment is due. Please use the Yale Laboratory Self-Evaluation Fillable Checklist Form (must be logged into CAS) for guidance. Please send the completed checklists with all findings and plan for correction to firstname.lastname@example.org.
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.
Reminder - Discontinuing Regulatory Services and DoRC Email Accounts
The Regulatory Services (email@example.com) and the Division of Research Congruency (firstname.lastname@example.org) e-mail accounts will be phased out in the first quarter of 2021. This change will provide for more timely triaging of email requests, thus better serving the Yale animal research faculty and staff. All future requests/inquiries should be sent directly to the OARS e-mail address at email@example.com. Please ensure that the subject line clearly indicates the intent and urgency of the inquiry.
OARS Staffing Changes
As you know, Matt Seager left the University to pursue new endeavors with NIH. The office has since gained a new Research Liaison, Rosemary Coolon, who will be joining the team in early May 2021. Up until that time, if you have protocol needs or questions, please reach out to firstname.lastname@example.org for those departments listed under Rosemary’s name in the table below. Welcome, Rosemary!
Our Administrative Assistant, Isabella Murphy, left the University in March to pursue her passion of working with Epoch Times. Thank you, Isabella, for everything you did for OARS and the IACUC!
New Research Liaison Department Assignments
Many of you have already been contacted by your new research liaison for those departments that have changed. The new department assignments are listed below and will be followed from this point on.
AAALAC Site Visit
Our triennial AAALAC re-accreditation site visit will be during Fall 2021. 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 they request to visit
OARS has been receiving a spike of non-compliance incidents regarding toe and tail clipping, where procedures are being performed beyond the age limitations for genotyping.
If you were unable to genotype your animals due to the COVID shutdown and are now resuming studies, you MUST comply with the Rodent Identification & Genotyping Policy. Inability to gain access to your animals during the shutdown is not justification for going outside of the policy requirements.
As a reminder, oral swabs (saliva) and ear punch tissue may be collected at any age for genotyping purposes. Tail biopsies performed after 21 days of age MUST be justified and approved in your protocol, and MUST be performed using anesthesia, pre-emptive opioid injection +/- a local anesthetic, followed by post-operative analgesics for a minimum of 48 hours. Toe clipping is ONLY acceptable for neonatal mice up to 12 days of age and for rats no older than 7 days.
To ensure that animals do not experience any unanticipated or unalleviated pain or distress, it is imperative that you consult with Veterinary Clinical Services prior to performing genotyping on older animals, as well as with OARS to ensure your protocol is updated.
OARS will be implementing a genotyping training module over the next several months to assist the research community in remaining compliant with the Rodent Identiﬁcation & Genotyping Policy going forward. Stay tuned!
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 Spring 2021 to confirm that training has been completed and to be able to “credit” current research staff with training competencies fulfilled by previous training. Without these lab-based training logs, additional “new” training may be required in order to complete the new training competencies.
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 Layne Ochman (email@example.com) or Troy Hallman (firstname.lastname@example.org).
Reminder - Update to Anesthetic Vaporizer Servicing
The IACUC’s Anesthetic Vaporizer and Ventilator Maintenance Policy ensure the proper functioning of anesthetic machines to provide appropriate anesthesia to research animals and limit exposure to waste gases to research personnel. Vaporizers that do not receive periodic service have the potential to leak anesthetic gases, which poses an occupational health risk to personnel, as well as delivering an incorrect dose to the animals. As such, the IACUC have required calibration at least once every 12 months with appropriate documentation.
Recognizing the impact of the restrictions for contractors/service providers, the IACUC has authorized an extension of the deadline for servicing vaporizers that appear to be functioning correctly through June 2021. OARS will be following up with labs in July and August to ensure calibration and certification has been completed for any vaporizers that are due, or overdue, for servicing.
In an effort to outline appropriate guidelines and recommendations for recalibration certification of anesthetic vaporizer machines, please let us know which vendors you use. OARS will be reviewing and updating the Anesthetic Vaporizer and Ventilator Maintenance Policy soon and would like to include the vendors manufacturer guidelines for re-calibration certification.
Analgesia Policy Revised
- All surgical procedures require multimodal analgesia, i.e. a combination of at least two different drugs from the opioids, NSAID, and local anesthetic drug groups.
- Buprenorphine extended release called Ethiqa XR™ is now available as an injectable for mice and rats.
- The analgesia tables for mice and rats have been updated with the doses for Ethiqa XR™.
- At this time, Ethiqa XR™ may only be administered to mice and rats.
- All analgesic administration must be documented either in the animal’s clinical record, anesthesia chart, and/or post-procedure care log.
- 12-hour dosing means exactly that—it is considered non-compliant to administer analgesics prescribed for 12-hour dosing after 13 hours. Administering on this schedule may require dosing outside of normal business hours.
- Language to describe thermal support of anesthetized birds was added.
- In the Institutional Policy section, the term “procedures” was replaced with “anesthetic sessions.”
- Appropriate thermal support is required for any anesthetic session (induction to recovery) lasting 15 minutes or longer in rodents and rabbits and 30 minutes or longer in animals >5 kg.
- Light bulbs or heat lamps and over-the-counter electric heating pads may NOT be used in anesthetized animals.
- Rodents housed at Yale University receive food and water ad libitum as normal husbandry practice in order to ensure the health and well-being of animals and comply with federal requirements.
- Deviation from this practice requires written scientific justification and IACUC approval prior to implementation.
- Fasting rodents weighing less than 100 grams for more than 16 hours is associated with physiologic stress and should be avoided unless scientifically justified.
- Other rodents larger than 100 grams should not be fasted for more than 24 hours without scientific justification.
- For food and/or fluid regulation greater than 24 hours, animals must be closely monitored for clinical signs of pain and disease including daily observations, with written records maintained by the investigator.
- In the Institutional Policy section, the following statement was added: “If an FDA-approved injectable formulation is commercially available, it is NOT acceptable to purchase USP grade powders and constitute in the lab.”
- In order to meet current veterinary standard practices, any solution (drug and diluent) administered to an animal for a survival procedure by any route (excluding orally or topically) must be sterile and pharmaceutical grade (or USP grade, FDA-, or NANDA-approved)—unless specifically approved by the IACUC.
- Because diluting a drug may change the pH or other characteristics of the solution, potentially changing the potency/efficacy of the diluted drug, the expiration date for drug dilutions is 30 days after the solution is made, or the actual expiration date of the drug or diluent if less than 30 days.
- When a drug or other agent is diluted or compounded, the container must have appropriate labeling to avoid incorrect dosing of an animal. Information that is required includes:
- Name of the drug(s)
- Concentration of the drug(s)
- Expiration date
- Approval to use an individual or a class of non-pharmaceutical grade experimental compound must be scientifically justified and must address the criteria expected from the IACUC for review.
- The definition for pharmaceutical-grade compound was updated to now read: “any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a recognized compendia (e.g., United States Pharmacopeia-National Formulary (USP/NF) or British Pharmacopeia(BP)).”
- A class of drugs is defined as a group of drugs expected to have the same biological effect, affect the same body system or signaling pathway, and/or exert their effects by the same/similar mechanism of action.
- Investigators can request IACUC approval for the use of an entire class of drugs. Approval for a class of drugs is limited to drugs that are NOT classified as hazardous agents. If any member of the class is classified as a hazardous agent, its use must be approved by the IACUC individually.
- If an individual has a concern it can be made anonymously. Whether or not made anonymously, all reviews and investigations will be dealt with confidentially to the extent reasonably possible.
- 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.
Emergency Response Instructions Reviewed
- This document is posted throughout all buildings that house animals.
- This plan is activated if any of the following conditions apply, but are not limited to: fire alarm, Yale alert, explosions, hazardous material incidents, biological, chemical or radiation threats, personal assault, or natural disasters such as earthquakes, tornado, hurricanes, or floods.
- First priority is human safety and second priority is animal welfare.
Housing Policy Reviewed
- Unless the contrary is approved by the IACUC, all animals will be housed in YARC-managed or YARC-authorized enclosures under required space, density, and environmental parameters.
- This policy relates to all species housed in YARC facilities or laboratories. For additional housing information for mice, rats and aquatics see housing – mice, housing - rats, housing - aquatics.
- When applicable, it is the expectation that all YARC housing standard operating procedures (SOPs) will be followed.
As always, please contact OARS (email@example.com) with any questions, suggestions, or concerns.