The Beacon Volume 6, Issue 3
- 2021 IACUC Deadline and Meeting Dates
- Upcoming Facility Inspections
- New Research Liaison Department Assignments
- AAALAC Site Visit
- Rodent Genotyping Announcement
- Surgery Templates
- SI vs. DSP
- Lab-Based Training
- Medical Clearance Updates
- Policy Updates/April-June
2021 IACUC Deadlines and Meeting Dates
|Date of Expiring Protocols||Submission Deadline||IACUC Meeting Date|
|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.
August 2021: TAC/CCC/309 Edwards/LSOG SB
September 2021: BCMM/SHM IG-BG/SHM BW/CMHC
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.
Reminder-Discontinued Regulatory Services and DoRC Email Accounts
The Regulatory Services (firstname.lastname@example.org) and the Division of Research Congruency (email@example.com) e-mail accounts were phased out in the first quarter of 2021. All requests/inquiries should be sent directly to the OARS e-mail address at firstname.lastname@example.org. Please ensure that the subject line clearly indicates the intent and urgency of the inquiry.
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
In the last two years, there have been several cases of noncompliance involving improper rodent genotyping and identification techniques here at Yale. With such a high frequency of noncompliance, this appears to be a university-wide issue, not isolated to just a few labs.
As such, the IACUC simplified the policy and is requiring retraining of all study staff and principal investigators of rodent protocols. A Qualtrics survey/quiz was recently distributed to all rodent users to review the policy and complete a short quiz.
As an FYI, all methods of rodent identification or genotyping must be approved in the IACUC protocol prior to initiating collection of any tissue. Your Research Liaison is always ready to assist you with all protocol revisions.
View the updated Yale Rodent Identification and Genotyping policy.
For consistency and reduction in regulatory burden, OARS has consolidated multiple rodent surgery record- keeping templates into one. The new template includes check boxes to select drugs administered and combines intra-op and post-op monitoring. We strongly encourage use of the updated template to ensure compliance with regulatory requirements and to facilitate meeting expectations. You can soon find the new template on our website or contact your Research Liaison directly. The templates will be placed under the “IACUC Endorsed Documents” section here: https://your.yale.edu/research-support/animal-research/policies-procedures-guidelines-and-instructions.
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. Please feel free to reach out to the animal room technician or facility manager for additional guidance.
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
- 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
In the December 2020 newsletter, we notified the research community that the release of a new training competencies module in MAPS to document training was delayed until early 2021. Following its “go-live” release (possibly within the next several weeks), the competencies module will replace the Personnel Qualification Form (PQF) for new employees. We are also creating user training courses for the competencies, which will be offered on the Yale Training and Certification website soon.
In early 2021, OARS sent out a reminder that lab-based training logs are intended to be used by PIs or their designees to document training performed by research personnel. Training requirements for any PQF approved on or after April 1st, 2020, should be documented on the lab-based training log. As we transition to the competencies module in MAPS, we may collect and archive the training logs to confirm that trainings were completed.
Additionally, as we prepare for the transition to the competencies module, we are working with our TMS (Yale’s Training Management System) partners to re-organize courses and requirements to “feed” data to MAPS. Concurrently, we have been collaborating with our Employee Health partners to refine the medical surveillance program. Together we have shifted from six medical clearance levels to four, based on species and risk, and are making each of the new clearance levels their own requirement in TMS.
Much of these efforts occur behind the scenes and are not visible to the research community; however, we have found some unanticipated issues when we started entering the new clearance levels into TMS.
For example, previously completed requirements may show as incomplete, or there may be issues registering for courses that have medical clearance as a prerequisite. If you run into either of these issues, or any others within TMS, please contact OARS at email@example.com and we will correct the issue as soon as possible. The Medical Surveillance Forms can be found on our website.
That said, we ask for your patience, understanding and cooperation during this transition period.
Reminder- Anesthetic Vaporizer Servicing
The IACUC’s Anesthetic Vaporizer and Ventilator Maintenance Policy ensures 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 has required calibration at least once every 12 months with appropriate documentation.
Recognizing the impact of the restrictions for contractors/service providers, the IACUC had authorized an extension of the deadline through June 2021 for servicing vaporizers that appear to be functioning correctly. 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 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.
Tumor Policy – Mice and Rats REVIEWED
- This document provides guidelines for defining humane endpoints for spontaneous and experimentally induced neoplasia in mice of the genus Mus and rats of the genus Rattus.
- The protocol should include the expected onset and nature of clinical signs and adverse effects in the selected animal species, including the tumor type, growth rate, tissue targets, metastasis and local tissue invasion, ulceration, and induction of cachexia.
- All tumor study endpoints should describe a tumor burden limited to the minimum required for a valid scientific outcome.
Acclimation and Habituation REVIEWED
- According to the Guide for the Care and Use of Laboratory Animals, new animals should be given a period for physiologic, behavioral, and nutritional acclimation before their use and the length of this acclimation period will depend on the type and duration of animal transportation, the species, and the intended use of the animals.
- Habituating animals to routine husbandry or experimental procedures should be encouraged whenever possible as it may assist the animal to better cope with a captive environment by reducing stress associated with novel procedures or people.
- All laboratory animals intended for use in survival procedures requiring a combined anesthesia and anesthetic recovery period longer than 15 minutes must be acclimated in a Yale animal facility for at least 2 days prior to initiating the anesthetic procedure.
- Animals may be identified in several ways including colored stains, ear notches/punches, tags, tattoos, subcutaneous transponder, etc.
- As a method of identification for small rodents, toe clipping should be used when no other individual identification method is feasible.
- Some identification methods can be combined as a genotyping procedure. A table for “Acceptable Combinations of Identification and Genotyping” was added for clarification.
- No more than 5mm of the distal end of the tail is permitted for removal. Tail biopsies may be performed up to 21 days of age.
- Tail biopsies performed after 21 days of age must be justified and approved by the IACUC and require anesthesia combined with analgesia. Refer to the Anesthesia and Analgesia Policies respectively for more information.
Social Housing REVISED
In the Institutional Policy section, the following statements were updated for clarification:
- Depending on the species, socially housed animals can share space such that the amount of space required per animal may be less with increasing group size, i.e. groups may be housed at slightly higher stocking densities than recommended to permit social housing (Guide p. 55).
- Housing animals in isolation is discouraged and requires approval from both the IACUC and a clinical veterinarian. In the absence of other animals, enrichment should be offered such as positive interaction with the animal care staff and additional enrichment items or addition of a companion animal in the room or housing area (Guide p. 64).
- If socially compatible and of an equivalent health status (as determined by a clinical veterinarian), animals assigned to different PIs/protocols may be group housed.
- Developing a stable social hierarchy may entail antagonistic interactions between pair or group members. These dominance behaviors should not be confused with aggression nor be the sole reason for stopping attempts at social housing. Also, all members of a social species may not necessarily be socially compatible and, thus, forcing social housing can adversely affect wellbeing (Guide p. 64).
In the section describing swine, the following statement was added:
- If research needs and/or incompatibility prevent group housing, other social housing methods (e.g., touch bar panels) will be used.
NHP Food and Fluid Regulation REVIEWED
- Regulation of food or fluid intake may be required for the conduct of some physiological, neuroscience, and behavioral research protocols.
- The objective when these studies are being planned and executed should be to use the least restriction necessary to achieve the scientific objective while maintaining animal well-being.
- A system of daily monitoring procedures is essential for animals that are food or fluid regulated.
NHP Housing REVISED
A section describing requirements and recommendations for housing small NHPs such as Marmosets and Tamarins was added.
Single or pair housed marmosets:
- can be housed in ½ of a standard marmoset caging unit, which is 5.8 sq. ft. and 30.4 in tall. Although allowing animals to have access to a full unit is desirable, being housed in ½ of a caging unit meets the requirements.
- the AWARs state that the use of innovative primary enclosures that do not precisely meet the floor area and/or height requirements but do provide the animals with sufficient volume of space to express species-typical behavior may be used when approved by the IACUC.
- the Guide states that floor area alone may not be sufficient in determining adequate cage size, specifically for arboreal species (i.e., marmosets) where the use of the vertical dimensions is greater than that of the floor.
- Marmosets live in family groups within which are a single breeding male and breeding female. The family, consisting of parents and older offspring, cooperatively raises the offspring of the breeding female and this alloparenting is important for the future parenting success of both females and males after removal from the family group and becoming breeders themselves
- Family groups live in very close proximity to one another, regardless of floor space, upon which they are rarely found due to their arboreal nature. For these reasons, the IACUC allows family groups to be housed in an individual standard YARC housing unit.
Animal Acquisition REVIEWED
- All animals must be acquired lawfully, and the receiving institution should ensure that all procedures involving animal procurement are conducted in a lawful manner.
- Procurement of animals should be linked to the prior approval of animal use and number by the IACUC.
- Animals acquired from either an approved commercial vendor or a non-approved vendor/institution must be processed through the Yale Animal Resources Center (YARC) Business Office following appropriate YARC procedures.
Instead of submitting requests to use alternative anesthetics not described in the policy, the following statement was added:
- Another option is to contract with Veterinary Clinical Services (VCS) to manage anesthesia and anesthetic monitoring on behalf of the lab. In such cases, drugs and monitoring plans are described in VCS SOPs and do not need to be specifically described in the IACUC protocol.
Under the “Policy Requirements” section, the following statement was added:
- When administering inhalant anesthetics using a closed-circuit system, animals must be mechanically ventilated if the duration of anesthesia is expected to last more than 1 hour.
Anesthesia Monitoring of NHPs REVISED
- A table listing ranges for various parameters for rhesus/cyno macaques, and marmosets was added. This table includes:
- Heart rate, respiratory rate, end tidal CO2, oxygen saturation, temperature, blood pressure, hematocrit, total protein, and blood glucose
The following statements were updated for clarification:
- All surgical procedures, and for imaging procedures lasting more than 1 hour (sedation to recovery). VCS will provide anesthesia and anesthesia monitoring for these procedures. Research staff may be permitted to perform these responsibilities once they have demonstrated proficiency.
- Prior anesthesia machine setup and leak testing. Machine setup and leak testing for anesthesia machines with ventilator functions are distinct for each machine type.
The following was added under the section describing “Induction and maintenance of general anesthesia”:
- Intravenous anesthesia: Constant rate infusions (CRI’s) using single agent or combinations of propofol, dexmedetomidine, ketamine, and/or fentanyl, along with other appropriate drugs that become available, are recommended for surgical procedures beyond short term procedures such as wound repair.
- Ventilation. All machines used by VCS allow automated ventilation using a variety of modes. Ventilation is recommended if end-tidal carbon dioxide levels exceed physiologic parameters with spontaneous ventilation. Hyperventilation to induce end tidal carbon dioxide levels of 30-35 mm Hg can be used to reduce cerebral circulation in craniotomies.
- Nausea: Anti-emetics may be given prior to surgery and at recovery based on the procedure and animal history of vomiting or delayed return to feeding.
- Proficiency in procedures such has stereotaxic placement and suturing, and thorough preanesthetic planning will reduce anesthetic time.
- Magnetic resonance imaging (MRI). MRI compatible equipment, including an MRI compatible anesthetic machine with capacity to ventilate, is available. Use of this equipment is limited to VCS, unless the lab has been trained in its use.
The following was added under the “Analgesia” section:
- Analgesia should include appropriate combinations of pre-emptive opioid anesthesia (typically using buprenorphine), short- and/or long-acting local anesthesia (prior to incision and during closure), non-steroidal anti-inflammatory drugs, or intravenous opioids such as fentanyl. Choice of analgesics is guided by surgical procedure, individual needs, and veterinary consultation.
- Postoperative analgesia for a minimum of 48 hours post-surgery according to policy guidelines.
General Health – All Species REVISED
The following species were removed from the document:
As always, please contact OARS (firstname.lastname@example.org) with any questions, suggestions, or concerns.