The Beacon Volume 6, Issue 4

• 2021 IACUC Deadline and Meeting Dates
• Upcoming Facility Inspections
• Policy Updates/April-June

2021 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.

IACUC Leadership and OARS Staffing Changes

Our IACUC Chair, Dr. Gary Cline, has retired from Yale and is moving onto exciting new adventures. Thank you to Gary for your many years of service to the IACUC and OARS. Your extensive knowledge and openness to reduce regulatory burden on our researchers will be missed! The IACUC will continue to thrive with Dr. Adam Wisnewski serving as IACUC Chair alongside Dr. Shannon Whirledge as Vice Chair.

After many dedicated years of service, Associate Director, Claudia Swanson retired from Yale on September 30th, 2021, and has moved to Arizona! Thank you, Claudia, for everything you have done for the IACUC and OARS. Your vast experience and willingness to always help will be missed! Associate Director, Dr. Shri Balakrishna will be assuming most of Claudia’s responsibilities.

Research Liaison, Bryan Brown, has accepted a new IACUC Coordinator position within OARS to expand his knowledge and experience in other areas of the office. The office is currently hiring for the Research Liaison position. Bryan will continue to work with investigators on protocol related issues until the position has been filled.

Updated Reporting Animal Welfare Concerns Sign

View the Reporting Animal Welfare Concerns sign, with updated contact information for the new IACUC Chair, Adam Wisnewski.

Upcoming Facility Inspections

• October 2021: LSOGB/LSOG1/LCI/LEPH
• November 2021: AMIS/WC/GSF/WWW/LSOG4

Please check your spaces periodically to ensure fulfillment of IACUC expectations. The list that IACUC utilizes to document findings is available on the OARS web section.

AAALAC Site Visit Outcome

Our triennial AAALAC re-accreditation site visit was a success! We want to take this opportunity to thank you all for contributing to a successful AAALAC site visit last week. The site visitors were effusive with their praise of the laboratories they visited and research staff they met in the facilities. They specifically commented on the openness and transparency of the labs, the robust training program (which includes a great deal of lab-based training), and the obvious collaborative relationship the research community has with OARS, YARC, EHS, VCS and the clinical veterinarians. We couldn’t have received such high praise without your attentiveness and cooperation. Thank you, again.

AAALAC did leave us with several suggestions that we will be addressing. In addition to a few facility-management matters that YARC is addressing and should not impact the research community, the following observations were made during the site visit.

Inconsistent environmental enrichment. Overall, AAALAC was pleased with our robust environmental enrichment program, but inconsistences were noted in the provision of enrichment for rodents on studies involving behavioral testing and among our aquatics species colonies.

Age limit for tail-snipping for genotyping. Peer-reviewed studies have shown that tail-snipping for genotyping should be performed no later than 17 days of age for mice, due to pain associated with traumatizing the tail vertebrae when ossified. We will be updating the Rodent Identification and Genotyping policy to align with current literature, permitting tail-snipping of mice through 17 days, and requiring anesthesia and analgesia if performing this procedure after 17 days.

Assessment of hand-washed equipment. While AAALAC was satisfied with our proactive approach to validating different sanitation methods for sanitizing hand-washed equipment in the laboratories (see the Sanitation Methods for Hand-Washed Equipment instructions), the site visitors pointed out that the Guide (p. 73) states that, “regular evaluation of sanitation effectiveness is recommended.”

Approval of new laboratory locations. AAALAC pointed out that new animal use areas should be added to protocols via “significant modification,” and that these locations should be inspected prior to approval.

Surgery-related safety issues. On the facility tours, the following surgery-related safety issues were noted:

• Improper PPE for rodent surgical procedures. As per the Surgery: Rodent, Survival, and Non-Survival policy, the “surgeon must wear gloves and a gown” for rodent non-survival surgery and “sterile gloves, clean gown or lab coat, face mask, and cap” for rodent survival surgery.
• Un-weighed charcoal canisters. As per the Anesthetic Vaporizer and Ventilator Maintenance policy, “If charcoal canisters are used for scavenging waste gases, they must be weighed prior to use and the date and weight recorded on the canister.” See below for more information.

Over the next few months, we will be working on resolving these issues. As we reach out to specific laboratories that may be affected by these process changes, we encourage you to provide any feedback that will help us meet these expectations but do so with minimal, ideally no, increased regulatory burden on the research community.

Compliance Corner

Use of MS-222

Please ensure when mixing compounds (e.g., MS-222) into solution that proper handling and PPE is followed. At minimum, gloves should be worn, and compounds should be handled in a chemical fume hood when mixing into solution.

Charcoal Canister

Recently, the IACUC has been made aware of noncompliance involving the use of charcoal canisters and there was an un-weighed canister noted during the AAALAC site visit. To prevent and/or minimize human exposure to waste anesthetic gases, the following maintenance guidelines must be observed if using a charcoal canister as a scavenging device:

• Documentation of initial weight of canister.
• Documentation of weight before each use. All weights should be recorded on the canister or in an easily accessible log kept near the vaporizer.
• The canister must be replaced when the weight of the canister reaches the maximum weight specified by the manufacturer.
• If the charcoal canister has holes on the bottom of the canister, the canister must be held in a wire basket to allow air exchange to occur. The canister cannot be used when on its side.
• Dispose of spent canisters as per EHS instructions.

Policy Updates-July-September

Clinical Signs of Pain and Disease in Rodents

• This document describes species-specific clinical manifestations of pain and/or disease, though it is important to keep in mind that many of these signs are nonspecific or may occur due to general ill health.
• Many species can mask clinical signs of pain, distress and disease, and signs can vary by species (with individual variation, as well). Therefore, it is imperative to understand normal behavior for that species/animal and to closely observe for clinical signs and behaviors that may indicate pain or disease.
• The presence of any of these clinical signs may be useful for determining pain categories and setting criteria for experimental and humane endpoints.

Antibody Production: Polyclonal

• This policy provides information to investigators for in vivo production of custom polyclonal antibodies. Commercially supplied polyclonal antibodies that are available “off the shelf” from vendors and not produced specifically for the purposes of your research are exempt from this policy.
• For those investigators who wish to outsource the custom production of polyclonal antibodies, the investigator should select a vendor from the IACUC approved contract laboratories or specifically request and justify the use of an alternate vendor.
• An approved contract lab must have OLAW Assurance and AAALAC Accreditation. Contract labs without AAALAC Accreditation may be added to the list if their Standard Operating Procedures for producing antibodies (e.g., Use of CFA, etc.) are consistent with Yale Policies and Procedures.
• If using an unapproved contract lab, the investigator must complete the Application for Permission to Have Custom Antibodies Manufactured. IACUC approval must be obtained before any custom antibodies are ordered from an unapproved vendor.

Anesthetic Vaporizer and Ventilator Maintenance

• This policy was developed to ensure the proper functioning of anesthetic machines and limit exposure to waste gases.
• Vaporizers that do not receive periodic service have the potential to leak anesthetic gases which pose both a potential occupational health hazard to personnel and can result in the incorrect amount of anesthetic agent being delivered to the animal.
• It’s also important to remember that the use of a charcoal canister scavenging device must include the following:
  • Documentation of initial weight of canister.
  • Documentation of weight before each use. All weights should be recorded on the canister or in an easily accessible log kept near the vaporizer.
  • The canister must be replaced when the weight of the canister reaches the maximum weight specified by the manufacturer.

Adverse Events

• Institutions are expected to self-report to adverse events to OLAW, such as conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures resulting in actual harm or death to animals.
• The IACUC, through OARS, should be notified in real-time of unexpected and unplanned situations outside of the morbidity or mortality described in the approved protocol, so that a timely resolution to an adverse event may be achieved.
• Adverse events are situations that result in death or significantly greater than anticipated physical harm, health deterioration, or pain and/or distress to the animal, as judged by the investigator, veterinary staff, or animal care staff.

Maintaining Colonies of Genetically Modified Animals

• Generation or acquisition of genetically modified animals requires approval by the IACUC. If no abnormal phenotype is expected, the number of lines used in the protocol should be counted in the variables section of the experiment. No specific listing or justification of lines with normal phenotypes is required.
• If the investigator is aware of any undocumented health-related issues or clinically manifested phenotype relating to the strain, these should be described in the protocol, including a plan to manage them.
• If a new strain is generated, the investigator should have a process in place to monitor the newly generated animals to assess health related issues.

Media and Animal Research

• Appropriate oversight of all media provides for the safety of research animals and protects the confidentiality and integrity of research.
• Media covered by this document includes but is not to be limited to newspapers, magazines and other written/online media, television and radio, photographs, digital images or video, and all social media involving vertebrate animals, alive or dead, in vivarium facilities, laboratory spaces or field studies.
• Use of recording devices, such as cameras, video recorders, tape recorders, cell phones, tablets, etc., in a secured animal facility must receive prior approval from the Director, Yale Animal Resources Center, or designee, with the following exceptions:
  1. The PI or authorized designee requiring such images to document procedures or outcomes, or to otherwise support research data.
  2. Authorized personnel utilizing such images to assist in the clinical diagnosis of disease, to monitor the health and/or wellbeing of the animals, to monitor surgical procedures, or to observe behavior of animals that are being socially housed to determine compatibility.
  3. Authorized personnel requiring such images to document compliance-related incidents.
  4. Authorized external visitors utilizing images to document inspection findings (e.g., USDA, AAALAC).
• Any and all requests for interviews by TV, radio, print, or online media should be forwarded to the Yale Office of Public Affairs and Communication at opac@yale.edu or 203-432-1345.

Sanitation Methods for Hand-washed Equipment

• Proper sanitation of animal use equipment is important to minimize the potential spread of pathogens from animal to animal and minimize animal odors/residues that may influence research outcomes (e.g., behavioral testing).
• Effectiveness of sanitation methods can be based on testing for the presence of ATP on surfaces (a surrogate for residual microbiological or animal material contamination). Acceptable levels are based on hospital safety standards (<300 RLU per 100 sq. cm., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5584088/).
• Laboratories handwashing animal use equipment should use a method proven to be effective. If research staff request a method of cleaning other than the ones we have validated in this document, a minimum of two passing results will be required.

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

Stay safe, everyone!
~OARS Team