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 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)