IACUC
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"
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/comparative-medicine/documents/cmdc/c096-req-to-reassign-researchanimals.doc and to CM drug formularies viewable at https://www.usf.edu/research-innovation/comparativemedicine/anesthesia-analgesia-therapeutics.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.
Revisions Approved to IACUC "Principles and Procedures"
February 25, 2022, IACUC Meeting
III.15. Any changes to the IACUC-approved protocol must be within the scope of the original hypothesis and proposed work and must be described by direct modification of the protocol using the ARC system.
Revisions Approved to IACUC "Principles and Procedures"
November 19, 2021, IACUC Meeting
V.2. Comparative Medicine provides veterinary oversight of animal health and well-being, guidance and assistance with veterinary medical and surgical techniques, services of disease surveillance, diagnosis and treatment, animal husbandry and nutrition, zoonosis control, hazard containment, and sanitation. Comparative Medicine (CM) provides and documents animal facility environmental and animal health surveillances in accordance with CM SOPs. If research aims require a change to the timing of surveillances conducted by CM staff, or if surveillances are to be shared or delegated in part to research staff, the surveillance schedule proposed must first be described in writing by the PI in Appendix 13 “Special Husbandry”, accompanied by documentation of research staff training regarding animal oversight responsibilities and recordkeeping, and IACUC approved. If IACUC approved, CM signage must inform all personnel of the approved surveillance schedule.
Revisions Approved to IACUC "Principles and Procedures"
October 22, 2021, IACUC Meeting
III.6. Principal Investigators (PI) developing applications for VA funded Merit Review grants, which are reviewed and approved by the VA Central Office, must submit an eIACUC application via the ARC platform. VA R&D review must be secured prior to IACUC review, and must reflect an assurance from the VA that all participating personnel are documented as IACUC certified, with species-specific technical experience, and other training (e.g., aseptic surgery). All VA applications to the IACUC will be assigned a primary reviewer that is a VA resident scientist or faculty familiar with the VA application and a regular member or alternate member of the IACUC. PIs developing applications for the Department of Defense may submit applications for review using the Department of Defense Animal Use Protocol.
IV.2. Research Integrity & Compliance maintains both paper and electronic files of IACUC protocols and modifications, and notifies applicants of IACUC actions. Principal Investigators developing applications for VA funded Merit Review grants, which are reviewed and approved by the VA Central Office, must submit an eIACUC application via the ARC platform. All VA applications to the IACUC will be assigned a primary reviewer that is a VA resident scientist or faculty familiar with the VA format and a regular member or alternate member of the IACUC.
Revisions Approved to IACUC "Principles and Procedures"
July 23, 2021, IACUC Meeting
XIV.2. Any faculty member requesting, possessing, or using any controlled substance requiring a Schedule II-V registration in preclinical research or teaching involving animals must be registered with Comparative Medicine c/o the Assistant Director at MDC 20, phone 974-9876, or fax 974-9432 using a Certification of Research Personnel Using Controlled Substances form (refer to SOP #014 Controlled Substances). Every two years as part of a program-wide biennial inventory of controlled substances, all personnel possessing or using controlled substance requiring a Schedule II-V registration in preclinical research must re-certify with Comparative Medicine using a Certification of Research Personnel Using Controlled Substances form.
XIV.3. Registrants must be faculty members, and are responsible for all aspects of these Principles and Procedures. Registrants must identify the controlled substance use in an approved IACUC protocol, the individual(s) responsible for assisting in their compliance with these Principles and Procedures, the location where the controlled substance will be securely stored, and ensure that complete records will be maintained. Faculty must ensure controlled substances are stored in an area of limited access securely locked in a substantially constructed cabinet. Controlled substances must be secured behind two locks. Laboratory doors can be considered one lock, if doors of unattended labs are kept locked.
XIV.4. Registered faculty must procure all controlled substances from Comparative Medicine. Controlled substance distributions to faculty using animals are made through the Facility Manager at the location where animals are housed and used.
XIV.5. The University holds and recognizes one institutional DEA registration for preclinical research protocols (i.e. a Schedule II-V registration), with the Director of Comparative Medicine as the institutional licensee. Faculty requiring a DEA Schedule I registration for use of Schedule I controlled substances named in an IACUC approved protocol, and those requiring DEA registrations for use of scheduled substances in non-preclinical research not involving animals (i.e. Schedule I or Schedule II-V registrations), must notify Research Integrity & Compliance in advance of their intent to register with the DEA.
XIV.6. Each vial of controlled substance procured under the University’s institutional DEA Schedule II-V registration for preclinical research is assigned a unique identifying code that corresponds to that substances Schedule, Federal Drug Code number, and a consecutive vial inventory number.
XIV.7. Comparative Medicine maintains records of all Schedule II-V controlled substance distributions to PIs for use in preclinical research involving animals. These records consist of a chronological log of all controlled substance dispersals indexed by substance and PI.
III.7. PIs that intend to create, or have others create mice locally by pronuclear microinjection of DNA, or by blastocyst microinjection of embryonic stem cells that have been electroporated with DNA, or by other methods of genetic engineering involving recombinant DNA, must first secure IACUC approval, which describes the genotype or line of mice to be created, and is contingent on approval of a Non-Exempt Recombinant DNA Registration application by the Institutional Biosafety Committee. All colonies of locally produced or maintained mice must be represented by an approved IACUC murine colony only protocol. Murine colony only protocols must be amended by direct modification of an approved IACUC protocol, whenever aspects of an emergent phenotype, recurring clinical condition(s), or unanticipated outcome are recognized that were not described in the original application (refer to IACUC Principles and Procedures XII.13). Research uses of locally produced unique lines of mice must be described in an IACUC research protocol, and the produced mice transferred to the approved research protocols using a Request to Relocate &/or Reassign Research Animals form. Such protocols describing the research uses of locally produced mice must also be similarly amended or electronically modified, as appropriate, whenever aspects of the emergent phenotype, recurring clinical condition(s), or an unanticipated outcome are recognized.
XI.3. Movement of animals within animal housing rooms is discouraged. Movement of animals between animal housing rooms of a single facility, or between separate facilities is discouraged, and permitted only when requested in writing using a Request to Relocate &/or Reassign Research Animals form, and approved by Comparative Medicine.
XI.4. Transfer of animals from one IACUC-approved research use (excluding murine production as described in an IACUC-approved murine colony only application, and excluding murine imaging referenced in the originating protocol and described in the Small Animal Model and Imaging Core protocol) to another is permitted only when requested in writing using a Request to Relocate &/or Reassign Research Animals form, the reassignment is justified in writing, and approved by both the originating and reassigned PIs, and Comparative Medicine. An approved reassignment of animals from one IACUC-approved research protocol to a new IACUC protocol becomes effective on the date of the transfer, and all animal per diem, identifying cards, and inventories are changed to reflect this reassignment. Reassignment of naïve mice originating from an IACUC-approved murine colony only protocol to an IACUC-approved research protocol is accomplished by notifying the facility manager, who completes a Request to Relocate &/or Reassign Research Animals form, who adjusts all animal per diem, identifying cards, and inventories to reflect this reassignment, which becomes effective on the date of the transfer, and who secures prior approval from Comparative Medicine if the reassignment necessitates a physical relocation of mice. Requests for reassignment of non-naïve rodents with respect to major medical, surgical, research or teaching procedures from an approved research protocol to a murine colony only protocol requires IACUC review and approval.
XV.12. Post-operative and post-procedural care for all mammalian species during and subsequent to recovery from general anesthesia includes appropriate analgesia and nursing care, monitoring physiological functions, monitoring behavior, observing for any complications, and appropriate record keeping. To ensure sufficient post-operative/procedural clinical oversight and patient care, mammals recovered from general anesthesia should remain housed within the facility where the surgery or procedure involving general anesthesia was performed for a minimum of 14 days after the date of the procedure. A Request to Relocate &/or Reassign Research Animals that lists nonrodent mammals, which have undergone general anesthesia within 14 days of the date requested for animal relocation, must be approved by the Director of Comparative Medicine or designee.
Revisions Approved to IACUC "Principles and Procedures"
May 21, 2021, IACUC Meeting
III.26. 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.
Revisions Approved to IACUC "Principles and Procedures"
February 26, 2021, IACUC Meeting
XI.1. All transportation of animals, including intra-institutional transportation, should occur only when essential since any transit time introduces risks of exposure to environmental extremes, crowding, infectious agents, and possible zoonosis, which can affect animal and public welfare, and the consistency of results. (Refer to SOP #007 Transportation, Relocation, or Reassignment of Animals). Transportation of rodents in private vehicles is discouraged because of potential biosecurity, zoonotic, allergenic, safety, health, and liability risks. IACUC approved protocols that describe in item 6.1.2 and 6.3.1 that rodents will be transported in a private vehicle from a vivarium to a basic laboratory, must also state that (1) delivery will be direct so as to minimize transit time, (2) rodents will be contained in either a disposable rodent shipping container, a rodent microisolator, or an individually-ventilated rodent cage, (3) containers or cages with be covered with a disposable drape or gown and secured during transit (e.g., bungee cord), (4) rodents will be protected against environmental extremes (e.g., direct sunlight), (5) only personnel IACUC approved on the protocol will be in the private vehicle during rodent transport, (6) personnel smoking, eating, or drinking will not occur when animals are in the private vehicle, (7) the private vehicle will be sanitized using a disinfectant after every rodent transport, and that (8) the private vehicle owner acknowledges and accepts responsibility for any damage to their vehicle during rodent transport.
Revisions Approved to IACUC "Principles and Procedures"
January 22, 2021, IACUC Meeting
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. Research Pain Category A (USDA 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). Research Pain Category B (USDA 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., surgical or invasive procedures conducted while the patient animal is maintained at a surgical plane of general anesthesia). Research Pain Category C (USDA 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).
ARCHIVE - Announcements & Current Topics in Animal Care & Use (2010 - 2020)