Dr. A. Nonymouse has multiple protocols and uses some unique mouse lines to accomplish their research. Dr. Nonymouse maintains their unique mouse lines on a departmentally funded breeding protocol as the mouse lines are not available from commercial vendors. During a Post Approval Monitoring (PAM) walkthrough, a PAM Compliance Analyst noticed a cage side rodent medical record (a.k.a., pink card) indicating that a survival surgery had been performed. When reviewing the protocol listed on the cage card, it was discovered that the cage was assigned to the breeding protocol, which doesn't include survival surgeries. After discussing the case with the Nonymouse Laboratory, it was determined that the mice were used for studies approved on a different protocol - the PI's experimental protocol.
- What step(s) need to be taken?
- The PI needs to submit a self-report to the IACUC describing what occurred (i.e., a failure to transfer animals prior to initiating procedures).
- The PI needs to sign an IACUC form stating that the lab will not make the same error in the future.
- The lab must transfer all of their animals to the CCM holding protocol while the incident is investigated by the IACUC.
Learner Feedback: The use of animals assigned to the wrong protocol needs to be discussed by the IACUC Chairs Subcommittee. Providing a PI self-report by selecting the IACUC Self-Report form on the IACUC Forms page, with a plan to prevent future incidents aids in the discussion of the incident. Option B is not correct, though certain non-compliance events may involve laboratory personnel signing off that they have read and understood policies, SOPs, protocol changes, etc. Prior to asking the laboratory for any kind of follow-up action items, the IACUC would first seek to collect more information on what occurred. Option C is not correct, as it would be an unnecessarily punitive measure that could place a substantial burden on the laboratory as well as CCM. In instances such as these the goal isn’t to punish laboratories or delay research, but to ensure that the IACUC has all the information it needs to help the laboratory identify a viable corrective action plan.
- How are cages transferred to different protocols?
- In AOPs, submit a transfer request.
- Cross out the old protocol and write the desired protocol on the cage card and cage side documentation.
- Remove all cage side documentation so that the protocol assignment is ambiguous.
Learner Feedback: Please see the CCM website -> Resources -> AOPs Information -> Submitting Animal Transfer for details on how to complete a transfer. Please note that transfers can take up to 2 business days as they are subject to veterinary review, so please plan accordingly! If you have any questions, please contact CCM_AOPS_Support@northwestern.edu. Option B is not correct, as the animals would not be appropriately accounted for in AOPs. Per the regulatory bodies, although animal number justifications are estimated, we are required to accurately track animal use numbers. Crossing out the protocol at the cage level is not appropriate until the transfer is approved by CCM reviewers. The cage card protocol will be updated after approvals are issued, transfer is marked completed in AOPS and updated barcode stickers are printed and placed on the cages. Labs can update the number of animals per cage using AOPS or using the tablet. As a cage remains active in the facility, the animal numbers within can change frequently. The number of animals in each cage is accurate at the time of cage creation. If a lab is wishing to transfer them to an alternative protocol, they should ensure the cages being transferred have an accurate count in each cage within AOPS prior to the transfer submission being made. That will ensure the correct usage is applied to the receiving study. Option C is not correct, as all animals must be identified and be assigned to an animal study protocol at all times. If separating animals, please be sure to fill out the separation cage card as described on the CCM website under Resources, SOPs, Cage Cards, CCM Separated Card.
- When can I perform procedures on the cage that I wish to transfer?
- When the transfer in AOPs is approved (not merely submitted), as signified by the availability of an updated barcode label with the new protocol number.
- As soon as I submit the transfer request.
- Prior to submitting the transfer request, as long as the transfer request is submitted prior to deactivating the cage card.
Learner Feedback: Please review the animal transfer process on the CCM Website under Billing & Procurement -> Animal transfers. If you have any questions, please contact CCM_AOPS_Support@northwestern.edu. Option B is not correct, since transfers are subject to veterinary review to ensure that the transfer is appropriate and must be approved prior to initiating studies. Option C is not correct, since transfers must be approved prior to initiating the new studies.
Dr. A. Nonymouse and Dr. W. Ildcat are collaborating on a project that uses a strain of mice that Dr. A. Nonymouse developed and bred in house. Each PI has their own protocol to accomplish their specific aims of the project.
- What steps need to be taken for Dr. Ildcat to utilize Dr. Nonymouse's strain?
- Dr. Ildcat must identify the strain in the approved animal study protocol.
- Dr. Nonymouse or lab member with transfer rights must submit a lab animal transfer in AOPS.
- Dr. Ildcat’s lab must wait for CCM approval of the transfer prior to initiating.
- All of the above.
Learner Feedback: Regardless of species, animal transfers must be complete prior to initiating work described on the animal study protocol to which the animals are being transferred. Please be sure to check that the animals are assigned to the correct protocol and verify that the correct procedures are approved on the protocol prior to initiating work.
When reconciling the protocol's approved animal numbers with the animal usage tracked in AOPS, what animals need to be counted?
- All animals used in association with each approved protocol must be counted. This holds true for research, testing, teaching, and holding protocols.
- Neonates not yet weaned or used prior to weaning, including any pups generated and not used.
- All zebrafish after 72 hours fertilization.
- All of the above.
Learner Feedback: Per the Policy on Animal Numbers Justification and Accounting for Animals, identifying and tracking animal use is necessary to ensure that the number of animals used does not exceed the animal numbers approved in the ASP. These activities are also required to fulfill federal obligations for reporting animal use numbers and to assure compliance with IACUC approved protocols with the following exceptions:
Embryos/fetal mammals are not counted, however, their use must be justified in the ASP if they are manipulated or used in any way before birth.
Stillborn or cannibalized animals do not need to be counted.
Please see the CCM website, navigating to Resources, AOPS Information, and a presentation on Self-Reporting Culled Pre-Adults discussing how to count animals used prior to weaning in AOPS.
When preparing a de novo and adjusting the protocol for the next three years of animal studies, what changes to animal numbers does the IACUC expect to see?
- Remove all completed experimental groups.
- Add experimental groups to be completed over the next three years.
- Include any animal numbers and their related experimental groups for animals currently on study.
- All of the above.
Learner Feedback: The correct answer is All of the above. A de novo, also known as a triennial renewal, should be updated for what the laboratory plans to complete over the next three-year approval period. A de novo may be initiated 90 days prior to the expiration of a protocol as long as there is not a pending amendment open for the protocol. Since the de novo may be reviewed while the protocol is still active, there is an understanding that there may be some overlap between the work actively being completed on the existing protocol and de novo approval. Therefore, it is recommended to adjust the de novo for what the laboratory plans to complete during the next three-year approval period, and to include any on-going studies. For example, if a lab currently has 100 animals on study while the de novo is under review, and the lab plans to use an additional 1,000 animals during the next three-year approval period, then the laboratory should ensure that the protocol has 1,100 animals justified on the de novo submission. Please see our de novo guide and/or reach out to the IACUC Office for assistance with your de novo submission.
Dr. A. Nonymouse was previously approved to bring mice to his laboratory space in Building A. However, the University received a grant to upgrade the research areas, causing Dr. Nonymouse to move his laboratory space to Building B. Does IACUC approval for animal use automatically transfer to the new building?
Learner Feedback: No. OLAW FAQ E1 indicates that the IACUC is responsible for oversight of all animal study-related activities regardless of how long or where the activity occurs. Inspection must occur prior to use of the space and subsequently semi-annually. Even though a laboratory may have been previously approved to utilize a space in one building, IACUC approval would not automatically transfer to an equivalent space in a different building. A change in laboratory location amendment must be submitted and approved prior to use for each applicable protocol.
Dr. A. Nonymouse recently received approval for a new procedure that allows the lab to either shave or use a chemical depilatory agent to remove the hair on their mice prior to conducting the rest of the procedure. When using a chemical depilatory agent, how long should the substance remain on the animal's skin to be effective and safe for the animal?
A. 5 minutes
B. They do not need to remove the depilatory agent - it is not harmful
C. 15-30 seconds
D. 2 minutes
Learner Feedback: 15-30 seconds. Chemical depilatory agents can harm an animal's skin if left on for an extended contact time. Per the Guidelines on the Use of Chemical Depilatory Agents: Apply a thin, solid layer of the agent to the desired area using a gloved finger or a cotton swab, allowing a contact time of 15-30 seconds (do not leave animals unattended during this time). Once the contact time has been reached, wipe the area with a clean cotton swab/gauze with warm water until all the agent has been removed. These steps may be repeated one additional time if subsequent hair removal is required. For more information, please refer to the aforementioned guideline on the CCM website (Resources/SOPs/Veterinary Services/Rodents).
Dr. A. Nonymouse conducts survival surgeries on rodents and will often complete five surgeries in one day. How should Dr. Nonymouse prepare their surgical instruments for the day?
A. Autoclave separate instrument packs for each animal.
B. Autoclave one instrument pack to be used for all animals - re-sterilization of instruments is not required for animals from the same cage.
C. Autoclave one instrument pack to be used for all animals, re-sterilizing with a hot bead sterilizer between animals and utilizing tips-only technique.
D. A hot bead sterilizer may be used as the sole means to sterilize the instruments.
E. Both A and C.
Learner Feedback: Both A and C are correct. Per the Guidelines for Rodent Survival Surgery, it is acceptable to utilize a new sterile instrument pack for each animal; alternatively, tips-only technique may be used for subsequent animals, but instrument tips must be sterilized between animals using hot bead sterilization or a chemical sterilant. All chemicals must be rinsed from instruments with sterile water or saline before contacting animals. B is incorrect as all rodent survival surgeries must be performed using aseptic technique, but as stated in answer C, a hot bead sterilizer may be used in between animals for a tips-only technique approach for multiple animals. D is incorrect - a hot bead sterilizer may not be used as the sole means to sterilize instruments. All rodent surgeries must start with fully sterilized instruments, through means such as an autoclave or a chemical sterilant (e.g., ethylene oxide) for materials that cannot withstand dry heat sterilization per the Guidelines for Sterilization of Surgical Supplies.
Dr. A. Nonymouse is onboarding new staff members and training them in new procedures. A new staff member would like to use their cell phone to record the procedure for reference. What should Dr. Nonymouse consider regarding the recording of animals used in research?
A. Videos and photographs must be produced with attention to professional conduct and concern for animal welfare.
B. Videos and photos should contain only the area of research interest.
C. Never store the audiovisual recordings on an unsecured cloud or social media account.
D. Advanced notification to IACUC Office and CCM is required if visual and/or audio will be presented outside of NU; this activity must be approved by the IACUC Office in consultation with CCM.
E. All of the above.
Learner Feedback: Answer E is correct! Photographs, videos, or other digital media must be taken with attention to professional conduct and concern for animal welfare. Audiovisual recordings of animals or animal research should not be automatically directed or posted to an external site (e.g., the Cloud, social media accounts) as they can be used out of context by those who oppose working with animals in biomedical research. More detail can be found in the IACUC Policy on Photography and Videotaping Animals or Vivarium, which applies to anyone accessing CCM, satellites, laboratory spaces, or any other space in which research animals are used. Dr. Nonymouse could request a Post-Approval Monitoring education event for his lab members to learn more!