Institutional Animal Care
Announcements
The IACUC provides the following new information regarding principles of animal care and use. Please subscribe to the IACUC Listserv to receive USF IACUC news.
REVISIONS TO APPROVED IACUC "PRINCIPLES AND PROCEDURES"
August 23, 2024, IACUC MEETING
III.29. The IACUC, assisted by the staff of Research Integrity & Compliance and Comparative Medicine, conduct observational post approval monitoring (PAM) and periodic audits of active animal use protocols, inspects satellite facilities, and inspects laboratories outside of managed animal facilities wherein animals are used. These audits, and inspections, and observational PAM serve as an additional review of the effectiveness of the animal care and use program, and are initiated during each semi‐annual inspection of facilities and program by the IACUC, or whenever necessary. The IACUC encourages an educational partnership with investigators when conducting PAM, and also uses PAM at the initiation of protocols to ensure sufficient investigator preparation to successfully carry out the scope of research work involving animals. These audits, inspections, and observational PAM ensure that in managed facilities, satellite facilities, and in laboratories wherein animals are used, sufficient animal care and clinical oversight is provided and recorded, that animal pain, distress, or discomfort are anticipated, avoided, or alleviated, that work areas are uncluttered and adequately decontaminated, that current supplies and procedures are used, that appropriately sanitized/sterilized instruments are used, and that the risks of all hazards are minimized. In determining which protocols to audit, satellite facilities and laboratories to conduct PAM, the IACUC is especially interested in ensuring the good practices of protocols involving satellite animal housing, USDA research pain category E procedures, survival surgery, the administration or use of hazardous materials, or the use of controlled substances. In addition, in accordance with the VA Handbook, during each semi-annual Program Review, the IACUC must ensure that IACUC records representing at least 5 percent of the total active VA projects, or a minimum of five protocols, are randomly reviewed to determine if appropriate documentation of initial review, approval letter(s), annual and triennial approvals, modifications, and investigator correspondence are present, and present their semi-annual summaries to the IACUC. Adverse or unanticipated events involving animals are reported to and investigated by the IACUC, with measures taken to prevent recurrence. Adverse events and corrective measures to prevent recurrence are documented and may be reported to OLAW, AAALAC, and USDA in accordance with the “NIH Guideline for Assessment and Reporting of Adverse Events, Unexpected Outcomes, and Animal Welfare Concerns”. Increased risk procedures for adverse events (e.g., longitudinal surgical studies involving large USDA regulated species) are observed by veterinarians and animal care staff with findings reported to the IACUC. Reporting significant adverse events to the IACUC, OLAW, AAALAC, and USDA fosters protection of the integrity and creditability of the institution and demonstrates a culture of care. The IACUC evaluates whether an incident or multiple incidents over time collectively indicate a more significant concern. Activating the adverse event assessment and reporting plan ensures that appropriate steps have been taken to determine whether the event/concern indicates changes are necessary to minimize further risks, if a single incident may or may not be an indicator of a larger issue, and ensures that appropriate actions have been taken and that key program personnel and oversight bodies are fully informed.
REVISIONS TO APPROVED IACUC "PRINCIPLES AND PROCEDURES"
July 26, 2024, IACUC MEETING
VIII.8. To become eligible for IACUC certification, all new research personnel must provide six completed documents to Research Integrity & Compliance: a) Facility Orientation of Research Staff form, or Orientation of Field & Wildlife Staff form, or Orientation Research Personnel Using Animal Tissue Outside Facilities form), b) Health and Risk Assessment for Employee Safety in the Care and Use of Animals form, c) Certificate of completion for the AALAS Learning Library(LL) course entitled “Laws, Regulations, Policies, and the Guide – USF Orientation Lessons”, d) Curriculum vitae or resume, and if planning to use rodents e) a certificate of completion of the AALAS LL course entitled “Basic Rodent Biomethodologies”, and f) a certificate of attending “Basic Rodent Biomethodologies – Wet Lab Training”, other than the PI. Completion of the AALAS LL biomethodology course is required prior to wet lab training attendance. If planning to use nonrodent USDA regulated species (e.g., swine), all personnel must upload to their ARC profile a certificate of completion for the AALAS LL course relevant to that species (e.g., “Introduction to Swine”) prior to IACUC approval, and a certificate of completion of CM in person training in the basic biomethodology of that species prior to animal use.
VIII.9. Principal Investigators proposing rodent survival surgical procedures and all personnel intending to contribute to the performance of such procedures must provide the IACUC with a certificate of completion for the AALAS (LL) course entitled “Aseptic Technique in Rodent Survival Surgical Procedures” as an upload to the appropriate section of their ARC profile. All personnel intending to directly implement rodent survival surgical procedures must provide the IACUC with a certificate of completion of wet lab training in such procedures provided by CM as an upload to the appropriate section of their ARC profile, prior to IACUC protocol approval. Completion of the AALAS LL aseptic surgery course is required prior to wet lab training attendance. If IACUC certified Comparative Medicine staff will serve as the surgeon(s), AALAS didactic tutorial and wet lab aseptic surgical training of only the PI need be provided. Personnel proposing survival surgical procedures in nonrodent USDA regulated species (e.g., swine) must upload to their ARC profile a certificate of completion of the AALAS LL course “Large Animals Surgery: Aseptic Technique and Anesthesia” prior to IACUC approval, and undergo post approval monitoring (PAM) regarding aseptic surgical technique in that species. Comparative Medicine provides training to researchers conducting survival surgical procedures to ensure that good surgical technique is practiced, including, asepsis, gentle tissue handling, minimal dissection of tissue, appropriate use of instruments, effective hemostasis, and correct use of suture materials and patterns.
REVISIONS TO APPROVED IACUC "PRINCIPLES AND PROCEDURES"
March 22, 2024, IACUC MEETING
X.4. If the IACUC suspends an activity involving animals, the Institutional Official, in consultation with the IACUC, shall review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation to USDA/APHIS and PHS/OLAW, AAALAC, and the federal and/or major agency funding that activity. Whenever an IACUC protocol is suspended by the IACUC, this is also communicated to the departmental chairperson.
REVISIONS TO APPROVED IACUC "PRINCIPLES AND PROCEDURES"
OCTOBER 27, 2023, IACUC MEETING
VIII.9. Principal Investigators proposing rodent survival surgical procedures and all personnel intending to contribute to the performance of such procedures must provide the IACUC with a certificate of completion for the AALAS (LL) course entitled “Aseptic Technique in Rodent Survival Surgical Procedures” as an upload to the appropriate section of their ARC profile. All personnel intending to directly implement rodent survival surgical procedures must provide the IACUC with a certificate of completion of wet lab training in such procedures provided by CM as an upload to the appropriate section of their ARC profile, prior to IACUC protocol approval. Completion of the AALAS LL aseptic surgery course is required prior to wet lab training attendance. If IACUC certified Comparative Medicine staff will serve as the surgeon(s), AALAS didactic tutorial and wet lab aseptic surgical training of only the PI need be provided. Personnel proposing survival surgical procedures in USDA regulated species must upload to their ARC profile a certificate of completion of CM in person training in aseptic surgical technique in that species, prior to IACUC protocol approval. Comparative Medicine provides training to researchers conducting survival surgical procedures to ensure that good surgical technique is practiced, including, asepsis, gentle tissue handling, minimal dissection of tissue, appropriate use of instruments, effective hemostasis, and correct use of suture materials and patterns.
XII.7. Preemptive and/or post-operative/post-procedural analgesia must be administered for an appropriate interval and recorded on forms provided by Comparative Medicine whenever procedures are identified that are assumed to produce more than momentary or slight pain and discomfort, unless the protocol precludes such practice (USDA category E), the investigator has justified such in writing, and the IACUC has approved such practices.
XII.9. Comparative Medicine maintains an inventory of animal use regarding the potential for pain or discomfort. Vertebrate animals used in research, teaching or testing must be assigned to one of three pain categories of research. USDA category C involves procedures which produce no pain or distress, or no more than momentary or slight pain or distress, and involve no use of pain-relieving drugs (e.g., unrestrained observation, brief restraint for physical examination, phlebotomy, injection of non-noxious material, tagging/punching of the peripheral ear pinna of mice, and euthanasia using species- and age-appropriate methods described in IACUC Principles and Procedures XX followed by tissue derivation). USDA category D involves procedures, which produce more than momentary or slight pain, discomfort or distress, which is alleviated by the use of appropriate anesthetics/analgesics and/or tranquilizer drugs, or other methods for relieving pain or distress (e.g., solitary, subcutaneous flank tumor models that are not locally invasive or distantly metastatic, surgical or invasive procedures conducted while the patient animal is maintained at a surgical plane of general anesthesia). USDA category E involves procedures, which produce pain discomfort, or distress, which cannot or is not alleviated by the administration of appropriate anesthetics and/or analgesics or other methods of relieving pain or distress (e.g., tumor studies that can be locally invasive or distantly metastatic, certain behavioral studies, injection of immunogenic emulsions containing complete Freund’s adjuvant, monoclonal antibody ascites production, survival analysis).
XII.10. When proposing USDA category E activities involving animals where painful or stressful outcomes are anticipated or possible, the PI must define in writing the clinical criteria which will be used to ensure timely intervention and treatment, or removal of the animals from the study, either in advance of, or immediately after recognition of the discomfort, or the specific clinical end point at which euthanasia of the animals will be accomplished. The earliest possible clinical endpoint that will contribute to the resolution of the hypothesis must be separately identified and utilized for each vertebrate species requested in the application. If avoidance or alleviation of animal pain or discomfort adversely affects the protocol, the PI must provide a detailed justification of why treatments cannot be initiated. When identifying the earliest clinical endpoint in applications to the IACUC, the PI should consider proposing both early notification criteria (e.g., tumor diameter) which when met causes staff to alert the PI to consider whether study objectives have been met, and also later exclusion criteria (e.g., larger tumor diameter, and/or complications referable to the tumor) which when met requires the euthanasia of the animal. When identifying the earliest clinical endpoint, the PI should refer to section C.2.c. of the ARENA/OLAW Guidebook entitled "Humane Endpoints” viewable at http://grants.nih.gov/grants/olaw/GuideBook.pdf
XII.12. The written justification for the use of animals involved in USDA category E procedures must separately identify and utilize for each vertebrate species requested in the application the earliest possible clinical end point that will contribute to the resolution of the hypothesis. If death is determined to be the earliest possible endpoint that will contribute to the specific aims of the research, then a written justification of why an earlier clinical endpoint is inadequate for resolving the proposed hypothesis must be included in the IACUC application. When determining the earliest possible clinical endpoint for a proposed research activity, the applicant PI should refer to the guidelines reviewed in “Humane Endpoints for Animals Used in Biomedical Research and Testing”, vol. 41(2), 2000, published by the Institute for Laboratory Animal Research, National Research Council and viewable at http://grants.nih.gov/grants/olaw/GuideBook.pdf
REVISIONS TO APPROVED IACUC "PRINCIPLES AND PROCEDURES"
MAY 26, 2023, IACUC MEETING
III.25. Inter‐institutional collaborations involving animal use have the potential to create ambiguities about the responsibility for animal care and use, and IACUC oversight. If activities involving animals are to be conducted at another institution and supported by University funds, there should be a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) which specifies responsibility of offsite animal care and use, animal ownership, and IACUC review and oversight. When applicable, this written understanding should indicate that the collaborating institution has an assurance on file with the PHS, that its program for animal care and use is accredited by AAALAC International, that their IACUC has approved the proposed animal use, and that the USF IACUC will be informed of any issues, concerns or verified noncompliance related to the activity conducted at the collaborating institution. In order to ensure clear definition and understanding of the planned collaboration, whenever the collaborating institution has agreed to perform a significant portion of the animal use aspects of a research grant or contract awarded to the University, the University’s IACUC should be provided with written evidence that the collaborating institution’s IACUC has approved the activity. These documents must be received from the collaborating institution prior to initiating any work. In addition, the IACUC must be informed of any issues raised by the collaborating institution’s IACUC during their inspection of the activity, program, or facility while hosting the research activity. Although the IACUC does not review the animal use aspects of custom commercial polyvalent or monoclonal antibodies by commercial vendors, whenever PHS funds are used to arrange for such, the vendor must have an assurance on file with OLAW and should provide a copy of such to the PI, and if an international vendor, is subject to USDA importation regulations. The IACUC recognizes that wild vertebrate animals owned, housed and cared for by institutions (e.g., zoological parks, aquariums) neighboring the university and its affiliates may, on occasion, benefit from the emergency animal medical diagnostic or therapeutic capabilities of the animal program and its facilities. To ensure that all such emergency animal medical inter-institutional collaborative efforts are appropriately conducted, a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) should be established in advance by the owner of the hosting facility (e.g., CAMLS) with the neighboring institution (e.g., zoological park or aquarium), which specifies responsibilities of animal care and ownership, mechanisms of IACUC reporting, and the source(s) of equipment, supplies, and professional technical support of diagnostic or therapeutic procedures. A proposed use of privately‐owned animals at a private facility for university research must be proposed as an IACUC protocol, and is in part declared by checking “no” to item 6.1.1, checking “yes” to item 6.1.3, describing the private facility in item 6.4.1, attaching to item 6.4.2 a Memorandum of Understanding between the university and the private facility indicating that the private facility is responsible for animal ownership, care and oversight responsibilities, attaching to item 6.4.3 a letter from the private facility indicating they anticipate the presence of the research, and attaching to item 6.4.4 a copy of the informed consent form to be used in the research, if applicable. The PI of such an approval is required to report to the IACUC the number of animals used in research, and any adverse events occurring during the research.
REVISIONS TO APPROVED IACUC "PRINCIPLES AND PROCEDURES"
APRIL 28, 2023, IACUC MEETING
III.16. Changes that are reviewed administratively include a change in the certified research personnel other than PI, title, funding source other than federal sources, or strain of the same species if justified in writing. Requests to add new research personnel are reviewed via administrative review by Research Integrity & Compliance.
III.17. Changes that are reviewed by documented veterinarian verification and consultation (VVC) as authorized by the IACUC are changes (a) to anesthesia, analgesia, sedation, or experimental substances, (b) in AVMA approved methods of euthanasia, (c) in duration, frequency, type, or number of procedures performed on an animal, (d) increasing animal numbers, and (e) to change or add federal funding. Such changes must be justified in writing, within the scope of the original study objectives, and conform to Comparative Medicine (CM) Standard Operating Procedures viewable at https://www.usf.edu/research-innovation/research-support/comparative-medicine/documents/cmdc/c096-req-relocate-reassign-research-animals.pdf and to CM drug formularies viewable at https://www.usf.edu/research-innovation/research-support/comparative-medicine/anesthesia.aspx. Request to change or add federal funding to a research or teaching protocol must be accompanied by portions of the grant narrative identified in III.10, above. The veterinarian serves as a subject matter expert and verifies compliance of the requested Protocol Change with this IACUC Principle. This consultation with the veterinarian is documented in the ARC protocol history. The veterinarian may refer any requested Protocol Change to the IACUC for full committee review (FCR) or designated member review (DMR).
Post 2022 AAALAC site visit - Suggestions for Improvements
Waste Anesthetic Gas Scavenging in Mice/ Use of MS-222 in Amphibian, Fish, or Reptiles
ALL PRINCIPAL INVESTIGATORS USING ANIMALS
AAALAC site visitors completed their assessment of the University of South Florida’s program and facilities for animal care and use October 31-November 2, 2022, and made the following suggestions for improvement that may be relevant to your research methods involving animals.
Waste Anesthetic Gas Scavenging in Mice
If you own an isoflurane anesthesia machine in your basic laboratory, please attach to your laboratory-based isoflurane anesthesia machine the new sign #SC 279, which reads “Before opening induction chambers, first purge with a 1.5-L/min oxygen flush for > 2 seconds“, and the new sign #SC 280, which reads “Scavenging cannisters must be positioned upright with vent holes un-occluded“.
These enhanced practices will contribute to effective waste anesthetic gas scavenging during murine isoflurane anesthesia.
Use of MS-222 in Amphibian, Fish, or Reptiles
If you use MS-222 in euthanizing amphibian, fish, or reptiles, please review revised SOP 806 shown with tracked changes.
These enhanced practices will contribute to the safe preparation and use of pharmaceutical grade MS-222.
ARCHIVE - Announcements & Current Topics in Animal Care & Use (2010 - 2022)