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Announcement Archive (2010 - 2022)

Announcements & Current Topics in Animal Care & Use

The IACUC, Comparative Medicine, and Research Integrity and Compliance provide all personnel with the following new information regarding animal care and use.

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 鈥淪pecial Husbandry鈥�, 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鈥檚 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 na茂ve 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-na茂ve 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鈥恑nstitutional 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鈥檚 IACUC should be provided with written evidence that the collaborating institution鈥檚 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鈥檚 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鈥檚 adjuvant, monoclonal antibody ascites production, survival analysis).

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
DECEMBER 11, 2020, IACUC MEETING

III.30. 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鈥恆nnual inspection of facilities and program by the IACUC, or whenever necessary. 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, Pain Category C 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.

XII.9. Comparative Medicine maintains an inventory of animal use regarding the potential for pain or discomfort. In their application for animal use, PIs designate the described animal use to one of three categories of research. Research Pain Category A (USDA C) involves procedures, which produce momentary, slight, or no pain, discomfort or distress (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 (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/analgesics (e.g., tumor studies, certain behavioral studies, injection of immunogenic emulsions containing complete Freund鈥檚 adjuvant, monoclonal antibody ascites production, survival analysis).

XXII.6. All newly constructed or renovated animal facilities must be incorporated into the animal care and use program administered by Comparative Medicine. To consider sites for inclusion in the program, prior to occupancy of a newly constructed facility, or the re-occupancy of an expanded/renovated facility, and the implementation of full Comparative Medicine animal care and use services, the IACUC will review the proposed site and determine both facility and program readiness for facility inclusion. Facilities added or expanded and approved by the IACUC for inclusion in the program will be reported in the subsequent annual reports to OLAW and AAALAC.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
SEPTEMBER 25, 2020, IACUC MEETING

III.11. The IACUC meeting schedule is viewable online. When additional IACUC meetings are required, reasonable notice is given to the IACUC and public by posting a notice online, at least 72 hours in advance of the special meeting. IACUC members are required to attend each monthly meeting and must notify the IACUC administrative staff of planned absences prior to protocol review assignments. IACUC members or alternates may attend monthly meetings, and may participate in semiannual reviews of program and/or facilities, remotely conducted by telecommunications in accordance with criteria provided in NOT-OD-06-052 (e.g., semiannual review of the Florida Keys Marine Laboratory satellite facility, or during a pandemic).

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
MAY 29, 2020, IACUC MEETING

III.12. New IACUC applications are reviewed either by full IACUC committee review (FCR) or using a designated member review (DMR) process. Each IACUC application is designated a protocol type by the applicant PI as either 鈥渞esearch or teaching鈥�, 鈥渨ildlife鈥�, 鈥渕urine colony only鈥�, 鈥渁ntiserum production only鈥�, or 鈥渢issue use only鈥�. The protocol type 鈥渞esearch or teaching鈥� describing Research Pain Category B and C procedures and ACORP applications, not previously proposed and approved as a prior IACUC application, are added as an agenda item to the next regular IACUC meeting for FCR. Protocol types research or teaching鈥� that are third year renewals (i.e., replacing an expiring, previously approved protocol), and new 鈥渞esearch or teaching鈥� protocol applications describing only Research Pain Category A procedures (ACORP pain category C), 鈥渨ildlife鈥� applications, 鈥渕urine colony only鈥� applications, 鈥渁ntiserum production only鈥� applications, and 鈥渢issue use only 鈥渁pplications are all subject to DMR.

III.14. The protocol type 鈥渞esearch or teaching鈥� describing Research Pain Category B and/or C procedures, and ACORP applications, not previously approved, are added as an agenda item to the next regular IACUC meeting. Each protocol added as an agenda item to the IACUC meeting is presented by a primary reviewing IACUC member using entries made directly on the IACUC application. After verbally presenting their findings regarding the application to a quorum of the IACUC members, the primary reviewing IACUC member proposes a motion to either approve the application, require modifications to secure approval of the application, or disapprove the application. IACUC members listed as participating personnel on the IACUC application must leave the room during the presentation and discussion of the protocol and are not permitted to participate or vote. No IACUC member participates in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC. IACUC members who have a conflicting interest in a proposed protocol do not contribute to the constitution of a quorum. After discussion and a motion is made, the motion is seconded, and the full IACUC committee votes. If the approved motion is 鈥淩equires Modification to Secure Approval,鈥� it is understood that all members of the IACUC, in attendance or not, forgo a full review of the to鈥恇e revised application in favor of the designated primary reviewing IACUC member鈥檚 review. All IACUC members have agreed in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use this designated member review subsequent to full committee review when modification is needed to secure approval. This understanding is part of each IACUC member鈥檚 initial orientation to regulatory processes, processes that are agreed upon in advance in writing using a form entitled 鈥淥rientation and Certification of New IACUC Members鈥�. This form documents the use of designated member review subsequent to full committee review of a protocol application, which all IACUC members agree to by unanimous vote. New ACORP applications and ACORP applications found to 鈥淩equire Modification to Secure Approval鈥� are reviewed by a minimum of two designated reviewing members affiliated with the VA. Once members have chosen this designated鈥恗ember review, then the primary reviewer(s) assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any member may request to view/review the modified application, or may request full committee review of the application.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
FEBRUARY 28, 2020, IACUC MEETING

XX.3. Acceptable, conditionally acceptable, and unacceptable euthanasia agents, methods and techniques have been described by the American Veterinary Medical Association Guidelines on Euthanasia, 2020, viewable at . These recommendations provide the basis for acceptable euthanasia techniques and are adopted as such. These recommendations and those in the Guideline of the American Society of Mammalogists for the Use of Wild Mammals in Research, the Guidelines for Use of Fishes in Research, the Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research, and the Guidelines to the Use of Wild Birds in Research provide the basis for acceptable euthanasia techniques of wild, avian, aquatic, and ectothermic animals, and are adopted as such. Specific Principles and Procedures regarding historically common euthanasia techniques follow.

XX.5. Carbon dioxide inhalation is an acceptable euthanasia method with condition for many species in accordance with the AVMA Guidelines for the Euthanasia of Animals: 2020 Edition.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
NOVEMBER 15, 2019, IACUC MEETING

III.12. New IACUC applications are reviewed either by full IACUC committee review (FCR) or using a designated member review (DMR) process. Each IACUC application is designated a protocol type by the applicant PI as either 鈥渞esearch or teaching鈥�, 鈥渨ildlife鈥�, 鈥渕urine colony only鈥�, 鈥渁ntiserum production only鈥�, or 鈥渢issue use only鈥�. The protocol type 鈥渞esearch or teaching鈥� describing Research Pain Category B and C procedures and ACORP applications are added as an agenda item to the next regular IACUC meeting for FCR. Protocol types research or teaching鈥� describing Research Pain Category A procedures 鈥渨ildlife鈥�, 鈥渕urine colony only鈥�, 鈥渁ntiserum production only鈥�, and 鈥渢issue use only鈥� are subject to DMR.

III.13. Protocols subject to DMR, are reviewed as follows. Within 3 days of receipt of the new application, any member of the full IACUC can ask for clarifications or revisions of the IACUC application, or can call for a review of the application at the next regular IACUC meeting. If FCR is called, the clarified or revised IACUC application is reviewed by the full IACUC. If there are no clarifications, revisions or full IACUC review requests within three days of receipt of the application, the application is reviewed by a designated IACUC member. The designated member reviewer assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for FCR. Members for DMR are appointed by the IACUC Chair. Annually or whenever the IACUC membership changes the IACUC Chair provides the Research Integrity and Compliance administrative staff with a spreadsheet/grid with DMR assignments. The IACUC Chair reviews research protocol categories/areas of expertise (e.g., murine colony only, tissue use only, procedural changes, etc.), determines which IACUC member(s) can be tasked for a specific DMR role, depending on the nature of the application or proposed modification, and matches the IACUC member for DMR to their area of expertise. At any time during this process, any IACUC member may request to view/review the modified application, or may request FCR of the application. When considered complete and appropriate, the designated member reviewer approves the application, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any IACUC application that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any animal use.

III.14. The protocol type 鈥渞esearch or teaching鈥� describing Research Pain Category B and/or C procedures, and ACORP applications are added as an agenda item to the next regular IACUC meeting. Each protocol added as an agenda item to the IACUC meeting is presented by a primary reviewing IACUC member using entries made directly on the IACUC application. After verbally presenting their findings regarding the application to a quorum of the IACUC members, the primary reviewing IACUC member proposes a motion to either approve the application, require modifications to secure approval of the application, or disapprove the application. IACUC members listed as participating personnel on the IACUC application must leave the room during the presentation and discussion of the protocol and are not permitted to participate or vote. No IACUC member participates in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC. IACUC members who have a conflicting interest in a proposed protocol do not contribute to the constitution of a quorum. After discussion and a motion is made, the motion is seconded, and the full IACUC committee votes. If the approved motion is 鈥淩equires Modification to Secure Approval,鈥� it is understood that all members of the IACUC, in attendance or not, forgo a full review of the to鈥恇e revised application in favor of the designated primary reviewing IACUC member鈥檚 review. All IACUC members have agreed in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use this designated member review subsequent to full committee review when modification is needed to secure approval. This understanding is part of each IACUC member鈥檚 initial orientation to regulatory processes, processes that are agreed upon in advance in writing using a form entitled 鈥淥rientation and Certification of New IACUC Members鈥�. This form documents the use of designated member review subsequent to full committee review of a protocol application, which all IACUC members agree to by unanimous vote. New ACORP applications and ACORP applications found to 鈥淩equire Modification to Secure Approval鈥� are reviewed by a minimum of two designated reviewing members affiliated with the VA. Once members have chosen this designated鈥恗ember review, then the primary reviewer(s) assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any member may request to view/review the modified application, or may request full committee review of the application.

III.29. If test substance(s) that are potentially hazardous are to be administered to animals, prior authorization of use of the test substance(s) by the appropriate Safety Committee is required before approval by the IACUC. Approval of the IACUC application involving hazardous materials not previously proposed by the PI and approved by the IACUC, can be contingent on a pre-performance meeting involving the PI and relevant staff that represents the applicant鈥檚 laboratory, Comparative Medicine, the IACUC, and the appropriate Safety Committee(s). This pre-performance meeting may be helpful to ensure that all involved personnel are aware of the precautions, containment practices, facilities, protective devices, disposal and decontamination procedures, and other necessary safety procedures that must be followed to protect personnel, and prevent accidental animal exposure to the hazardous material. The IACUC may also require a pre-performance meeting whenever an applicant PI proposes infrequently used species or techniques, or proposes surgical or teaching procedures involving anesthetized non-rodent mammals. This pre-performance meeting may take place before or after IACUC approval of the protocol at the discretion of the IACUC, but must occur before initiation of the IACUC approved activity, and ensures that appropriate personnel, equipment, supplies, recordkeeping, and practices of animal care and use have been identified and will be employed.

III.30. 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, and inspect laboratories outside of the animal facilities where animals are used (e.g., observational PAM of FKML). 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鈥恆nnual inspection of facilities and program by the IACUC, or whenever necessary. These audits, inspections, and observational PAM ensure that 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 and laboratories to inspect, the IACUC is especially interested in ensuring the good practices of protocols involving satellite animal housing, Pain Category C 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.

VII.1. Health Administrations and Environmental Health & Safety offices offer to all personnel who will be working with animals, information regarding health monitoring, potential zoonosis, and health assessments, immunizations, and safety procedures relating to their animal contact and/or exposures. Field studies are also reviewed by these offices to ensure that the proposed field study does not compromise the health and safety of persons in the field.

XII.10. When proposing Research Pain Category C 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鈥� viewable at .

XII.12. The written justification for the use of animals involved in Research Pain Category C 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 鈥淗umane Endpoints for Animals Used in Biomedical Research and Testing鈥�, vol. 41(2), 2000, published by the Institute for Laboratory Animal Research, National Research Council and viewable at .

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JUNE 28, 2019, IACUC MEETING

III.21. IACUC applications describing mentorship of precollege students are reviewed by the IACUC if the PI attaches all applicable school, county, and/or state forms, including parental permission, the precollege student is certified for animal use within the PI鈥檚 laboratory, and the PI assures that they or their designated staff who are named on the application will continually directly supervise the precollege student while an animal care staff member is available in the facility during the conduct of the proposed research involving animals. As USF Policy 6-038 prohibits minors from working or volunteering in an animal housing or use area, requests to certify precollege students as qualified for unescorted access to an animal facility are not granted.

IV.5. The applicant Principal or Secondary Investigator must have a faculty appointment with the University or an appropriate appointment with the James A. Haley Veteran鈥檚 Administration Medical Center, H. Lee Moffitt Cancer Center and Research Institute, or New College of Florida. Extramural research interests involving animals may be led by an extramural IACUC certified scientist, assuming the extramural entity has a written understanding on file with a program member institution, all costs of infrastructural services are fully reimbursed, and in the event resources become limited, faculty and intramural scientist interests are shown priority.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
MAY 17, 2019, IACUC MEETING

III.19. Changes that are considered significant requiring FCR or DMR include those that change (a) from non-survival to survival surgery, (b) resulting in greater pain, distress, or degree of invasiveness, (c) new housing or use location outside of Comparative Medicine managed facilities, (d) species, (e) study objectives, (f) Principal Investigator, or (g) impacting personnel safety. When the change request is for a new species, Research Integrity & Compliance first validates that that the PI and staff ARC profiles identify the new species of interest, and if the request is for unvaccinated or uncharacterized carnivores, pregnant sheep, goats, cattle, or nonhuman primates, that a new updated Health and Risk Assessment for Employee Safety in the Care and Use of Animals form has been completed and uploaded to ARC by the PI and staff. Changes considered significant requiring FCR or DMR are reviewed by the full IACUC membership. Within 3 days of receipt, any member of the full IACUC can ask for clarifications or revisions of the Protocol Change, or can call for FCR at the next regular IACUC meeting. If there are no clarifications/revisions or FCR requests within three days of receipt of the protocol change, it is reviewed by a designated IACUC member. If clarifications/revisions are requested, the PI will be given the opportunity to respond and incorporate these changes into the approved protocol. When revisions are incorporated, the revised Protocol Change is reviewed by a designated IACUC member assigned by the IACUC chair. When considered complete and appropriate, the designated member reviewer approves the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any Protocol Change that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any changes.

VII.3. Individuals determined to be at risk as determined by completion of the Health and Risk Assessment for Employee Safety in the Care and Use of Animals form are encouraged to complete a Health History Assessment form and consult with a health provider. When special considerations are declared, including the proposed use of infectious agents requiring biosafety level III containment, or the use of unvaccinated or uncharacterized carnivores, pregnant sheep, goats, cattle, or nonhuman primates, , which require additional health services, Research Integrity & Compliance ensures that at-risk personnel make arrangements for health services, and receives written confirmation that health services have been initiated, documentation of which is uploaded to the researcher鈥檚 profile in the ARC system.

VIII.4. All research personnel must complete the AALAS Learning Library course entitled 鈥淟aws, Regulations, Policies, and the Guide 鈥� USF Orientation Lessons鈥� and provide the certificate of completion, which documents that they have received training in animal care and use legislation, IACUC function, ethics of animal use and the concepts of the Three Rs, methods for reporting concerns about animal use, occupational health and safety issues pertaining to animal use, animal handling, aseptic surgical technique, anesthesia and analgesia, and euthanasia.

VIII.6. All new personnel using live vertebrate animals must complete a Health and Risk Assessment for Employee Safety in the Care and Use of Animals form. Annually, all research personnel must review their Health and Risk Assessment for Employee Safety in the Care and Use of Animals form, and when declaring any changes, must upload to ARC the updated, completed form.

VIII.10. Principal Investigators and all personnel proposing to use immune deficient mice must upload to their ARC profile a certificate of completion for the AALAS LL course entitled 鈥淗andling and Use of Immune Deficient Mice鈥�. All personnel intending to directly handle and use immune deficient mice must also upload a certificate of completion of CM in person training in such procedures, prior to protocol approval. Personnel proposing physical methods of euthanasia without the benefit of anesthesia (e.g., decapitation, cervical dislocation) must upload to their ARC profile a certificate of training and proficiency is such procedures, prior to IACUC protocol approval. Personnel proposing physical methods of euthanasia without the benefit of anesthesia (e.g., decapitation, cervical dislocation) must upload to their ARC profile a certificate of training and proficiency is such procedures, prior to IACUC protocol approval. Comparative Medicine offers formal hands鈥恛n wet鈥恖aboratory training. Curricula may vary depending on need as requested by research faculty or staff, or as required by the IACUC, and may include basic animal needs, proper animal handling, routes and methods of substance administration, proper pre鈥恜rocedural and post鈥恜rocedural care, aseptic surgical technique, methods of anesthesia and analgesia, use of equipment, and methods of euthanasia. Attendance and curricula are documented.

XII.19 Physical restraint is defined as the use of manual or mechanical means to limit some or all of an animal鈥檚 movement for the purpose of examination, sample collection, drug administration, therapy, or experimental manipulation. In some cases, personnel safety may also necessitate the physical restraint of an animal. Prolonged restraint is defined as physical restraint of a conscious animal lasting >30 minutes. Prolonged restraint, including chairing of non鈥恏uman primates, should be avoided unless it is justified in writing, essential for achieving research objectives, and approved by the IACUC. Chairing of non鈥恏uman primates is considered prolonged restraint regardless of duration. When proposing prolonged restraint, the IACUC application must include (1) a scientific justification for the use of prolonged restraint, (2) a description of the restraint device, (3) a description of acclimation procedures to condition the animal to prolonged restraint, (4) the maximum amount of time the animal may be restrained, (5) a description of how the animal will be observed and monitored during restraint, (6) when the duration of prolonged restraint is 鈮�6 hours, a description of when food and water will be given, how body weight will be monitored, and how hydration status will be monitored. Physical restraint that is <30 minutes, and does not cause distress or discomfort to the animal is not considered prolonged, and as such, a detailed description is not required in the IACUC application.

XVI.1. Major surgery penetrates and exposes a body cavity (e.g., laparotomy, thoracotomy, craniotomy), produces impairment of physical or physiologic function (e.g., joint replacement, limb amputation) or involves extensive tissue dissection or transection.

XVI.2. Multiple survival surgical procedures on a single animal are discouraged but may be permitted if scientifically justified by the applicant and approved by the IACUC.

XVI.3. Multiple survival surgical procedures may be justified if they are related components of a research project, if they conserve scarce animal resources, or if they are needed for clinical reasons. Cost savings is not an adequate reason for performing multiple major survival surgical procedures.

XVI.4. If multiple survival surgical procedures are approved by the IACUC, particular attention must be provided by the research staff to animal health and well-being through frequent and continuing evaluations, and the IACUC must evaluate outcomes of multiple surgical procedures.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
MARCH 22, 2019, IACUC MEETING

III.13. Protocol types 鈥渨ildlife鈥�, 鈥渕urine colony only鈥�, 鈥渁ntiserum production only鈥�, and 鈥渢issue use only鈥� are subject to DMR as follows. Within 3 days of receipt of the new application, any member of the full IACUC can ask for clarifications or revisions of the IACUC application involving 鈥渨ildlife鈥�, 鈥渕urine colony only鈥�, 鈥渁ntiserum production only鈥�, or 鈥渢issue use only鈥�, or can call for a review of the application at the next regular IACUC meeting. If FCR is called, the clarified or revised IACUC application is reviewed by the full IACUC. If there are no clarifications, revisions or full IACUC review requests within three days of receipt of the application, the application is reviewed by a designated IACUC member. The designated member reviewer assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for FCR. Members for DMR are appointed by the IACUC Chair. Annually or whenever the IACUC membership changes the IACUC Chair provides the Research Integrity and Compliance administrative staff with a spreadsheet/grid with DMR assignments. The IACUC Chair reviews research protocol categories/areas of expertise (e.g., murine colony only, tissue use only, procedural changes, etc.), determines which IACUC member(s) can be tasked for a specific DMR role, depending on the nature of the application or proposed modification, and matches the IACUC member for DMR to their area of expertise. At any time during this process, any IACUC member may request to view/review the modified application, or may request FCR of the application. When considered complete and appropriate, the designated member reviewer approves the application, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any IACUC application that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any animal use.

III.14. The protocol type 鈥渞esearch or teaching鈥� is added as an agenda item to the next regular IACUC meeting. Each new research, or teaching, or other protocol type added as an agenda item to the IACUC meeting is presented by a primary reviewing IACUC member using entries made directly on the IACUC application. After verbally presenting their findings regarding the application to a quorum of the IACUC members, the primary reviewing IACUC member proposes a motion to either approve the application, require modifications to secure approval of the application, or disapprove the application. IACUC members listed as participating personnel on the IACUC application must leave the room during the presentation and discussion of the protocol and are not permitted to participate or vote. No IACUC member participates in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC. IACUC members who have a conflicting interest in a proposed protocol do not contribute to the constitution of a quorum. After discussion and a motion is made, the motion is seconded, and the full IACUC committee votes. If the approved motion is 鈥淩equires Modification to Secure Approval,鈥� it is understood that all members of the IACUC, in attendance or not, forgo a full review of the to鈥恇e revised application in favor of the designated primary reviewing IACUC member鈥檚 review. All IACUC members have agreed in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use this designated member review subsequent to full committee review when modification is needed to secure approval. This understanding is part of each IACUC member鈥檚 initial orientation to regulatory processes, processes that are agreed upon in advance in writing using a form entitled 鈥淥rientation and Certification of New IACUC Members鈥�. This form documents the use of designated member review subsequent to full committee review of a protocol application, which all IACUC members agree to by unanimous vote. New ACORP applications and ACORP applications found to 鈥淩equire Modification to Secure Approval鈥� are reviewed by a minimum of two designated reviewing members affiliated with the VA. Once members have chosen this designated鈥恗ember review, then the primary reviewer(s) assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any member may request to view/review the modified application, or may request full committee review of the application.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
FEBRUARY 22, 2019, IACUC MEETING

III.5. All live vertebrate animal use, including field studies, conducted by University faculty, students, or staff, or supported by University funds, must first be described in a draft IACUC application using the ARC system and be pre鈥恟eviewed by University veterinarians prior to its submission to the IACUC for full committee review (FCR) or designated member review (DMR), as appropriate. All vertebrate animal use must be proposed to, and approved by the IACUC as an IACUC protocol prior to the initiation of that activity, regardless of where it will be performed. Activities involving wild animals in natural settings (field studies) that will not alter or influence the activity of the study animals or other species in the study area (i.e., unobtrusive observational studies), will not impact the animal鈥檚 environment, and will not impact the health or safety of involved personnel need not be proposed to the IACUC. An IACUC protocol application or aspect of an application that describes procedures not previously encountered or that have the potential to cause pain or distress that cannot be reliably predicted or controlled, may be proposed as a limited pilot study, designed to assess both the procedure鈥檚 effects on the animals and the skills of the research team conducted under IACUC oversight. In such cases, the IACUC will require the protocol to be limited to and conducted as a pilot study, which stipulates the number of animals to be used, and the recordkeeping, oversight, and IACUC reporting intervals and content requirements to be used regarding outcomes. It is the Principal Investigators responsibility for submitting an outcome report of the pilot study to the IACUC in the timeframe requested by the IACUC. The outcome report will be used to by the IACUC as follows: to evaluate whether a subsequent larger study is justified; whether to release pilot study status and permit protocol modifications allowing a subsequent larger study; and used to define clinical endpoints.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
OCTOBER 26, 2018, IACUC MEETING

III.24. The University IACUC does not regulate activities involving animals conducted wholly by non-University personnel, off campus, and not supported by University funds. However, in order to document that appropriate practices of acquisition, use, and disposition of vertebrate animal tissues are followed, and with appropriate consideration of occupational health and safety, and public relations issues associated with their use, an IACUC 鈥渢issue use only鈥� application can be submitted whenever vertebrate animal tissues are requested from another institution, or IACUC-approved protocol, or other source. These requests for the use of animal tissues are reviewed by the IACUC using the designated member review process. Tissue uses that will not impact the health or safety of involved personnel need not be proposed to the IACUC.

V.5. To ensure appropriate veterinary clinical care and medical management of all animals, veterinarians are authorized to assess animal conditions, treat animals, relieve animal pain, and/or euthanize animals. Although veterinary, animal care, and husbandry staff may make contributions to research protocols involving animals, the PI and associated research staff named on the IACUC-approved protocol serve as the primary attending clinicians of all animals housed on behalf of that protocol. As such, the PI must provide coordinated planning, clear direction, and prepared leadership for all protocols under their direction. The PI must ensure that all practices of animal care and use meet or exceed the requirements of applicable principles and procedures and are in accordance with current established veterinary medical and nursing procedures. The PI and research staff are responsible for providing adequate clinical oversight, and post-operative or post-procedural care of the animals, for anticipating and alleviating animal pain or discomfort whenever possible, for identifying the earliest possible clinical endpoint that contributes to the specific aims of the research, and for maintaining complete animal medical records, with entries made in sufficient detail and at intervals specified by these IACUC Principles and Procedures.

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 鈥淟aws, Regulations, Policies, and the Guide 鈥� USF Orientation Lessons鈥�, d) Curriculum vitae or resume, and if planning to use rodents, other than the PI, e) a certificate of completion of the AALAS LL course entitled 鈥淏asic Rodent Biomethodologies鈥�, and f) a certificate of attending 鈥淏asic Rodent Biomethodologies 鈥揥et Lab Training鈥�. Completion of the AALAS LL biomethodology course is required prior to wet lab training attendance. If planning to use USDA regulated species, all personnel must upload to their ARC profile a certificate of completion of CM in person training in the basic biomethodology of that species.

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 鈥淎septic Technique in Rodent Survival Surgical Procedures鈥� 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), only AALAS didactic tutorial training of 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.

VIII.10. Personnel proposing to use immune deficient mice must upload to their ARC profile a certificate of completion for the AALAS LL course entitled 鈥淗andling and Use of Immune Deficient Mice鈥�, and a certificate of completion of CM in person training in such procedures, prior to protocol approval. Personnel proposing physical methods of euthanasia without the benefit of anesthesia (e.g., decapitation, cervical dislocation) must upload to their ARC profile a certificate of training and proficiency is such procedures, prior to IACUC protocol approval. Personnel proposing physical methods of euthanasia without the benefit of anesthesia (e.g., decapitation, cervical dislocation) must upload to their ARC profile a certificate of training and proficiency is such procedures, prior to IACUC protocol approval. Comparative Medicine offers formal hands鈥恛n wet鈥恖aboratory training. Curricula may vary depending on need as requested by research faculty or staff, or as required by the IACUC, and may include basic animal needs, proper animal handling, routes and methods of substance administration, proper pre鈥恜rocedural and post鈥恜rocedural care, aseptic surgical technique, methods of anesthesia and analgesia, use of equipment, and methods of euthanasia. Attendance and curricula are documented.

X.5. In the event that an IACUC-approved protocol expires, or is closed by the PI, or for any reason animals which had been maintained under a formerly approved protocol remain within the facilities, but are not described in an IACUC-approved protocol, the IACUC will serve written notification of non-compliance to the PI, that the subject animals are considered in Comparative Medicine 鈥渃aretaker status鈥� not available for research use until resolution of non-compliance, and request that the PI either submit a new application for animal use, identify the IACUC-approved protocol which now describes the use of these animals, or formally request in writing that the closed protocol be reopened and reviewed. Absence of a written response to this written notification of noncompliance in excess of thirty days can result in the removal, reassignment, or euthanasia of the subject animals. Requests by the PI for additional animals and/or services will not be filled by Comparative Medicine until all animals are described by an IACUC-approved protocol. The PI of a federal grant (e.g., NIH, NSF, VA) supported protocol with animals placed in 鈥渃aretaker status鈥� must provide Comparative Medicine with a source of funding other than the federal grant that will support the animals while in 鈥渃aretaker status鈥� until resolution of the noncompliance.

XIX.1. Adequate animal care includes adequate animal medical record keeping. Although veterinary, animal care, and husbandry staff may make contributions to research protocols involving animals, the PI and associated research staff named on an IACUC-approved protocol serve as the primary attending clinicians of all animals housed on behalf of that protocol. As such, research staff are responsible for providing adequate clinical oversight, and post-operative or post-procedural care of the animals, for anticipating and alleviating animal pain or discomfort whenever possible, and for maintaining complete animal medical records, with entries made in sufficient detail and at intervals specified by these IACUC Principles and Procedures. (Refer to SOP #012 Animal Medical Records and SOP #427 Food and Fluid Regulation in Mice and Rats).

XIX.12. The PI and associated research staff should maintain written records of activities whenever painful or stressful outcomes are anticipated or possible in any animal. Records should be kept within the animal facility on forms provided by Comparative Medicine, with entries that describe when the painful or stressful outcome is first recognized, what treatments are instituted, and when the discomfort is resolved, or when the animal is euthanatized. Whenever food or fluid regulation in rodents are conducted, written records must be kept in accordance with SOP #427 鈥淔ood and Fluid Regulation in Mice and Rats鈥� on form CMDC #245 鈥淔ood and Fluid Regulation Record鈥� in the housing room book.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
SEPTEMBER 28, 2018, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JUNE 22, 2018, 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 the animal component for their research project to the IACUC using the VA Animal Component entitled "Animal Component of Research Proposal" (ACORP) viewable at http://www.research.va.gov/programs/animal_research/. 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 ACORP applications to the IACUC will be assigned a primary reviewer that is a VA resident scientist or administrator familiar with the ACORP format 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.

III.14. The protocol type "research or teaching" is added as an agenda item to the next regular IACUC meeting. Each new research, or teaching, or other protocol type added as an agenda item to the IACUC meeting is presented by a primary reviewing IACUC member using entries made directly on the IACUC application. After verbally presenting their findings regarding the application to a quorum of the IACUC members, the primary reviewing IACUC member proposes a motion to either approve the application, require modifications to secure approval of the application, or disapprove the application. IACUC members listed as participating personnel on the IACUC application must leave the room during the presentation and discussion of the protocol and are not permitted to participate or vote. After discussion and a motion is made, the motion is seconded, and the full IACUC committee votes. If the approved motion is "Requires Modification to Secure Approval," it is understood that all members of the IACUC, in attendance or not, forgo a full review of the to鈥恇e revised application in favor of the designated primary reviewing IACUC member's review. New ACORP applications and ACORP applications found to "Require Modification to Secure Approval" are reviewed by a minimum of two designated reviewing members affiliated with the VA. Once members have chosen this designated鈥恗ember review, then the primary reviewer(s) assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any member may request to view/review the modified application, or may request full committee review of the application.

III.30. 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, and inspect laboratories outside of the animal facilities where 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鈥恆nnual inspection of facilities and program by the IACUC, or whenever necessary. These audits, inspections, and observational PAM ensure that 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 and laboratories to inspect, the IACUC is especially interested in ensuring the good practices of protocols involving satellite animal housing, Pain Category C 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.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
APRIL 27, 2018, IACUC MEETING

III.13. Protocol types "wildlife", "murine colony only", "antiserum production only", and "tissue use only" are subject to DMR as follows. Within 3 days of receipt of the new application, any member of the full IACUC can ask for clarifications or revisions of the IACUC application involving "wildlife", "murine colony only", "antiserum production only", or "tissue use only", or can call for a review of the application at the next regular IACUC meeting. If FCR is called, the clarified or revised IACUC application is reviewed by the full IACUC. If there are no clarifications, revisions or full IACUC review requests within three days of receipt of the application, the application is reviewed by a designated IACUC member. The designated member reviewer assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for FCR. At any time during this process, any IACUC member may request to view/review the modified application, or may request FCR of the application. When considered complete and appropriate, the designated member reviewer approves the application, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any IACUC application that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any animal use.

III.14. The protocol type "research or teaching" is added as an agenda item to the next regular IACUC meeting. Each new research, or teaching, or other protocol type added as an agenda item to the IACUC meeting is presented by a primary reviewing IACUC member using entries made directly on the IACUC application. After verbally presenting their findings regarding the application to a quorum of the IACUC members, the primary reviewing IACUC member proposes a motion to either approve the application, require modifications to secure approval of the application, or disapprove the application. IACUC members listed as participating personnel on the IACUC application must leave the room during the presentation and discussion of the protocol and are not permitted to participate or vote. After discussion and a motion is made, the motion is seconded, and the full IACUC committee votes. If the approved motion is "Requires Modification to Secure Approval," it is understood that all members of the IACUC, in attendance or not, forgo a full review of the to鈥恇e revised application in favor of the designated primary reviewing IACUC member's review. Once members have chosen this designated鈥恗ember review, then the primary reviewer assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any member may request to view/review the modified application, or may request full committee review of the application.

III.16. Protocol Changes to existing protocols are reviewed administratively and by a veterinarian to determine significance on a case鈥恇y鈥恈ase basis.

III.17. Changes that are handled administratively as an amendment 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. Amendments proposed to an IACUC protocol are submitted by direct modification of the approved protocol. Requests to add new research personnel are reviewed first by Research Integrity & Compliance to validate that all documents required of IACUC certification have been completed and submitted via the ARC system. This initial review includes obtaining written confirmation from USF Medical Health Administration that additional health services have been completed, whenever required. Subsequent to this confirmation, the request is reviewed to ensures that all documents required of IACUC certification are complete, that the researcher's profile identifies a new species of interest, and that a current Health and Risk Assessment for Employee Safety in the Care and Use of Animals form has been signed by the requesting PI.

III.18. Changes that are handled 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 /research鈥恑nnovation/comparative鈥恗edicine/sop.aspx and to CM drug formularies viewable at /research鈥恑nnovation/comparative鈥恗edicine/anesthesia鈥恆nalgesia鈥恡herapeutics.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).

III.19. Changes that are considered significant requiring FCR or DMR include those that change (a) from nonsurvival to survival surgery, (b) resulting in greater pain, distress, or degree of invasiveness, (c) housing or use location outside of Comparative Medicine managed facilities, (d) species, (e) study objectives, (f) Principal Investigator, or (g) impacting personnel safety. Changes considered significant requiring FCR or DMR are reviewed by the full IACUC membership. Within 3 days of receipt, any member of the full IACUC can ask for clarifications or revisions of the Protocol Change, or can call for FCR at the next regular IACUC meeting. If there are no clarifications/revisions or FCR requests within three days of receipt of the protocol change, it is reviewed by a designated IACUC member. If clarifications/revisions are requested, the PI will be given the opportunity to respond and incorporate these changes into the approved protocol. When revisions are incorporated, the revised Protocol Change is reviewed by a designated IACUC member assigned by the IACUC chair. When considered complete and appropriate, the designated member reviewer approves the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any Protocol Change that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any changes.

III.20. Amendments and Protocol Changes may be communicated to the funding agency at the discretion of the PI. After three years all continuing studies must be completely re鈥恉escribed in a new application to the IACUC.

III.30. 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, and inspect laboratories outside of the animal facilities where 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鈥恆nnual inspection of facilities and program by the IACUC, or whenever necessary. These audits, inspections, and observational PAM ensure that 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 and laboratories to inspect, the IACUC is especially interested in ensuring the good practices of protocols involving satellite animal housing, Pain Category C procedures, survival surgery, the administration or use of hazardous materials, or the use of controlled substances. In addition, in accordance with the VA Handbook, the IACUC ensures that IACUC records representing at least 5 percent of the total active VA projects, or a minimum of five protocols are randomly reviewed annually to determine if appropriate documentation of initial review, approval letter(s), annual and triennial approvals, modifications, and investigator correspondence are present.

VIII.8. To become eligible for IACUC certification, all new research personnel must provide five 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 course entitled "Laws, Regulations, Policies, and the Guide 鈥� USF Orientation Lessons", d) Curriculum vitae or resume, and if planning to use rodents, other than the PI, e) "Basic Rodent Biomethodologies 鈥� Wet Lab Training".

VIII.10. All new personnel, other than the PI, requesting IACUC certification must also upload the certificate of completion of hands鈥恛n training in basic animal use methodology provided by Comparative Medicine or IACUC certified personnel with species experience (e.g., wildlife) to their ARC profile. Comparative Medicine offers formal hands鈥恛n wet鈥恖aboratory training. Curricula may vary depending on need as requested by research faculty or staff, or as required by the IACUC, and may include basic animal needs, proper animal handling, routes and methods of substance administration, proper pre鈥恜rocedural and post鈥恜rocedural care, aseptic surgical technique, methods of anesthesia and analgesia, use of equipment, and methods of euthanasia. Attendance and curricula are documented.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JANUARY 18, 2018, IACUC MEETING

IX.2. Deficiencies in animal care, use, recordkeeping, or treatment, and adverse events in animal care or use must be reported, and can be reported to Comparative Medicine veterinarians, or administrative staff, or to the IACUC c/o Research Integrity & Compliance, or directly to the IACUC Chairperson, or IACUC Vice Chairperson, or to the Institutional Official of the Animal Care and Use Program.

Revisions Approved to IACUC "Principles and Procedures"
August 25, 2017, IACUC Meeting

V.9. Typical HVAC system performance in Florida, when providing the Guide's recommended fresh-air changes per hour, may result in an occasional relative humidity reading that exceeds the Guide's recommended humidity range for brief periods in an individual housing room (i.e., less than 10 consecutive days). Facility managers should notify the Assistant Director whenever relative humidity readings are less than 20% humidity or greater than 80% humidity for a period of 10 days or more. Facility Managers should also notify the Assistant Director whenever relative humidity readings are less than 15% humidity or greater than 85% humidity for more than 2 days. The Assistant Director will notify physical plant staff and ask that they evaluate HVAC system performance. If relative humidity readings remain out of range one week after notifying physical plant, the Assistant Director will ask the PI to consider whether these conditions, or the use of portable humidifiers/dehumidifiers or air conditioners, introduce variables that may affect the integrity of their research.

Limitations in HVAC system performance may result in temperature and humidity readings higher than the Guide's recommendation for storage of natural ingredient diets. Facility managers should notify the Assistant Director whenever temperature readings are greater than 74 degrees Fahrenheit or greater than 70% relative humidity for more than 2 days. The Assistant Director will notify physical plant staff and ask that they evaluate HVAC system performance. If relative humidity readings remain out of range one week after notifying physical plant, the Assistant Director will consider whether these conditions, or the use of portable humidifiers/dehumidifiers or air conditioners, introduce variables that may affect the integrity of the feed. Feed is utilized in a first-in, first-out manner to minimize the duration of storage.

XV.10. Log entries describing survival surgical procedures in any species must be kept by the PI, in the animal facility, on a Surgical Record form, Record of General Anesthesia form, or Rodent Surgery Procedural Record form provided by Comparative Medicine. Any surgical event or procedure (survival or non-survival) involving that requires a surgical plane of anesthesia must be kept by the PI, in the animal facility, on at least one of the forms listed above. Log entries must include, as a minimum, the following, (A) a pre-operative assessment, (B) an anesthetic plan, (C) records of the induction and of the monitoring of general anesthesia, (D) a brief description of the surgical procedures performed, (E) an intraoperative assessment, (F) a record of recovery from anesthesia (or method of euthanasia while the animal is anesthetized), (G) a post-operative assessment, and (H) any complications, treatments, and/or plans, as requested on the appropriate form.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JULY 28 2017, IACUC MEETING

III.31. A bell jar may only be used for murine euthanasia, not for murine anesthetic procedures. The bell jar should not be pre-charged, but instead isoflurane-soaked material should be placed in the bell jar immediately prior to placement of the separator and mouse, which should remain in the bell jar until breathing has ceased, after which the mouse should be removed immediately and an approved secondary physical method of euthanasia performed (e.g., cervical dislocation, decapitation, exsanguination, bilateral thoracotomy).

Revisions Approved to IACUC "Principles and Procedures"
February 24, 2017, IACUC Meeting

III.31. Applications proposing to house animals for >12 hours at satellite facilities outside of Comparative Medicine鈥恗anaged animal facilities must describe in appropriate sections of the application (e.g., "Special Husbandry") methods that will be used for ensuring and recording animal health and environmental quality, including whenever relevant, (1) how animals will be transported to the satellite facility, (2) the transport enclosure(s) that will be used, (3) the period of time that the animals will be housed, (4) the caging/aquaria/primary enclosure(s) that will be used, (5) the intervals of oversight and methods for maintaining appropriate living conditions that contribute to the animal's health and well鈥恇eing, including their diet and frequency of feeding, (6) how primary and secondary environmental conditions will be maintained, cleaned, sanitized, and/or controlled, (7) the factors that will be monitored to ensure that these methods of animal maintenance will contribute to the health and well鈥恇eing of the animals (e.g., appearance, behavior, activity, growth), (8) that oversight and care will be documented on forms provided by Comparative Medicine, (9) an emergency/disaster response plan that takes into account both personnel and animals, and (10) that the PI will assist with tracking satellite-housed research activities by reporting the initiation of each episode of satellite facility animal housing to the IACUC c/o Research Integrity & Compliance at intervals appropriate to the study, but at least semiannually. Reported animal numbers are tabulated by Comparative Medicine. Laboratories outside of animal facilities where procedures involving animals are proposed, described in item 6.3.1 of an IACUC application, are reviewed by Comparative Medicine veterinarians prior to IACUC approval of the application to ensure proposed laboratories are appropriately located and equipped for the proposed use.

V.6. Current USP grade pharmaceutical and biological products must be used in animal therapeutic applications, and in all aspects of animal research whenever available. Use of non鈥恜harmaceutical鈥恎rade substances in animals requires written scientific justification to the IACUC, and a written assurance that non鈥恜harmaceutical鈥恎rade substance preparation, reconstitution, and/or compounding will result in substances that are sterile, safe, effective, and of an appropriate composition (e.g., purity, concentration, pH, osmolality) and shelf鈥恖ife, that such preparations will be composed by appropriately trained and experienced personnel, and that adverse animal welfare outcomes related to non鈥恜harmaceutical grade substance use will result in its cessation of use, and a written notification by the PI to the IACUC describing the circumstances of the adverse event. Biologics, especially those originally derived from, or serially passaged-through rodents, have the potential to surreptitiously transmit rodent pathogenic agents. Characterizations of rodent biologics as pathogen-free are associated with the IACUC protocol describing their use by uploading such documentation to item 15.13.2b.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
DECEMBER 16, 2016, IACUC MEETING

XX.5. Decapitation or cervical dislocation of deeply sedated or anesthetized rodents and other small animals is an acceptable method of euthanasia when justified, and approved by the IACUC prior to their use. A request to perform decapitation or cervical dislocation without sedation or anesthesia requires a strong written scientific justification explaining the experimental design that necessitates this method of euthanasia. Whenever physical methods of euthanasia without the benefit of anesthesia (e.g., decapitation, cervical dislocation) are proposed in an IACUC application, proficiency in such methods is documented by uploading Comparative Medicine certificate of training and proficiency to the individual's ARC personnel profile before the associated protocol application is IACUC approved.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
NOVEMBER 18, 2016, IACUC MEETING

VIII.9. Principal Investigators proposing 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 Learning Library (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 survival surgical procedures must provide the IACUC with a certificate of completion of wet lab training in such procedures provided by Comparative Medicine as an upload to the appropriate section of their ARC profile, prior to IACUC protocol approval. If IACUC certified Comparative Medicine staff will serve as the surgeon(s), only AALAS didactic tutorial training of the PI need be provided. Comparative Medicine provides training to researchers conducting surgical procedures as requested by research faculty or staff, or required by the IACUC, 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. Attendance and curricula are documented. Completion of the AALAS LL course entitled "Aseptic Technique in Rodent Survival Surgical Procedures" is required prior to wet lab training attendance.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
OCTOBER 28, 2016, IACUC MEETING

VIII.10. Personnel requesting IACUC certification with less than one year experience in vertebrate animal care and use, as declared in their ARC personnel profile, must also upload the certificate of completion of hands-on training in basic animal use methodology provided by Comparative Medicine or IACUC certified personnel with species experience (e.g., wildlife) to their ARC profile. Comparative Medicine offers formal hands-on wet-laboratory training. Curricula may vary depending on need as requested by research faculty or staff, or as required by the IACUC, and may include basic animal needs, proper animal handling, routes and methods of substance administration, proper pre-procedural and post-procedural care, aseptic surgical technique, methods of anesthesia and analgesia, use of equipment, and methods of euthanasia. Attendance and curricula are documented.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JULY 22, 2016, IACUC MEETING

III.16. Amendments to existing protocols (i.e., a change in the certified research personnel other than PI, title, funding source other than federal sources, or addition of another strain of the same species if justified in writing, are reviewed by a designated IACUC member assigned by the IACUC chair within 7 days of receipt, and approval communicated to the full IACUC membership at its next regular monthly meeting. Amendments proposed to an IACUC protocol are submitted by direct modification of the approved protocol. Requests to add new research personnel are reviewed first by Research Integrity & Compliance to validate that all documents required of IACUC certification have been completed and submitted via the ARC system. This initial review includes obtaining written confirmation from USF Medical Health Administration that additional health services have been completed, whenever required. Subsequent to this confirmation, the request is reviewed by a designated IACUC member who ensures that all documents required of IACUC certification are complete, that the researcher's profile identifies a new species of interest, and that a current Health and Risk Assessment for Employee Safety in the Care and Use of Animals form has been signed by the requesting PI. Requests to change and/or add federal funding agency sources of support (e.g., PHS, NSF and DOD) to an existing protocol other than a "murine colony only" protocol must be accompanied by the grant proposal, with all approved revisions, and submitted as Procedural Changes and are subject to full IACUC review.

III.17. Procedural Changes, such as requests for additional animals to be made available to the protocol, a change in species, a change in Principal Investigator familiar with the approved scope of work, or use of an additional laboratory or relocation of an existing laboratory for an approved activity outside of animal facilities, or change/addition of a federal agency funding sources for an existing IACUC-approved protocol (other than a "murine colony only" protocol), or the use of conventional therapeutics, drugs, analgesics, or anesthetics) may be proposed to the IACUC. Such proposals must be justified in writing and within the scope of the original research hypothesis. The IACUC administrative staff must forward the electronic form of the Procedural Change to the full IACUC membership for their consideration. Changes proposed to an IACUC protocol are submitted by direct modification of the approved protocol with a justification provided for each change proposed. Procedural changes are subject to full IACUC review.

III.29. The IACUC, assisted by the staff of the Divisions of Research Integrity & Compliance and Comparative Medicine, conduct post-approval monitoring and periodic audits of active animal use protocols, and inspect laboratories outside of the animal facilities where animals are used. These audits and inspections 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. These audits and inspections ensure that 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 and laboratories to inspect, the IACUC is especially interested in ensuring the good practices of protocols involving satellite animal housing, Pain Category C procedures, survival surgery, the administration or use of hazardous materials, or the use of controlled substances. In addition, in accordance with the VA Handbook, the IACUC ensures that IACUC records representing at least 5 percent of the total active VA projects, or a minimum of five protocols are randomly reviewed annually to determine if appropriate documentation of initial review, approval letter(s), annual and triennial approvals, modifications, and investigator correspondence are present.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JUNE 24, 2016, IACUC MEETING

VIII.9. Principal Investigators proposing survival rodent aseptic surgical procedures and research personnel intending to contribute to the implementations of such procedures must provide the IACUC with a certificate of completion for the AALAS Learning Library (LL) course entitled "Aseptic Technique in Rodent Survival Surgical Procedures" and for wet lab training in such procedures, prior to IACUC protocol approval. Comparative Medicine provides training to researchers conducting surgical procedures as requested by research faculty or staff, or required by the IACUC, 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. Attendance and curricula are documented. Completion of the AALAS LL course entitled "Aseptic Technique in Rodent Survival Surgical Procedures" is required prior to wet lab training attendance.

VII.2. New research and animal care personnel must submit a completed Health and Risk Assessment for Employee Safety in the Care and Use of Animals form to the ARC system. Every six years, all IACUC-certified personnel must provide a revised Health and Risk Assessment for Employee Safety in the Care and Use of Animals form. Personnel whose duties require access to an animal facility but whose duties do not include working with animals must submit a completed Personnel Entering Animal Facilities Health and Risk Assessment to the IACUC.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
MAY 20, 2016, IACUC MEETING

III.16. Amendments to existing protocols (i.e., a change in the certified research personnel other than PI, title, funding source other than federal sources, addition of another strain of the same species if justified in writing, or the use of conventional therapeutics, drugs, analgesics, or anesthetics) are reviewed by a designated IACUC member assigned by the IACUC chair within 7 days of receipt, and approval communicated to the full IACUC membership at its next regular monthly meeting. If an amendment is proposed to a paper IACUC protocol, A Request to Amend an Animal Use Protocol form must be submitted in both an electronic and written form which includes the PI's signature. Amendments proposed to an e-IACUC protocol are submitted by direct modification of the approved protocol. Requests to add new research personnel are reviewed first by Research Integrity & Compliance to validate that all documents required of IACUC certification have been completed and submitted via the ARC system. This initial review includes obtaining written confirmation from USF Medical Health Administration that additional health services have been completed, whenever required. Subsequent to this confirmation, the request is reviewed by a designated IACUC member who ensures that all documents required of IACUC certification are complete, that the researcher's profile identifies a new species of interest, and that a current Health and Risk Assessment for Employee Safety in the Care and Use of Animals form has been signed by the requesting PI. Requests to change and/or add federal funding agency sources of support (e.g., PHS, NSF and DOD) to an existing protocol other than a "murine colony only" protocol must be accompanied by the grant proposal, with all approved revisions, and submitted as Procedural Changes and are subject to full IACUC review.

III.17. Procedural Changes, such as requests for additional animals to be made available to the protocol, a change in species, a change in Principal Investigator familiar with the approved scope of work, or use of an additional laboratory or relocation of an existing laboratory for an approved activity outside of animal facilities, or change/addition of a federal agency funding sources for an existing IACUC-approved protocol (other than a "murine colony only" protocol) may be proposed to the IACUC. Such proposals must be justified in writing and within the scope of the original research hypothesis. If a change is proposed to a paper IACUC protocol, A Request for a Procedural Change to an Animal Use Protocol form must be submitted in both an electronic and written form which includes the PI's signature. The IACUC administrative staff must forward the electronic form of the Procedural Change to the full IACUC membership for their consideration. Changes proposed to an e-IACUC protocol are submitted by direct modification of the approved protocol with a justification provided for each change proposed. Procedural changes are subject to full IACUC review.

XVI.4. If multiple major survival surgical procedures are approved by the IACUC, particular attention must be provided by the research staff to animal health and well-being through frequent and continuing evaluations, and the IACUC must evaluate outcomes of multiple surgical procedures.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JANUARY 22, 2016, IACUC MEETING

IV.6. All industry-sponsored protocols will be subject to IACUC fees for the review and continued oversight of animal research. (Investigators are encouraged to charge the IACUC fees as direct cost in their budgets).

XVI.6 A regulated animal will only be permitted to undergo multiple major survival surgical procedures in separate unrelated research protocols after the IO submits a request to the USDA/APHIS and receives approval.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
NOVEMBER 20, 2015, IACUC MEETING

IV.6. Industry-sponsored protocols not supported by awards made to the University, Moffitt, or Haley VA via their offices of Sponsored Research may be subject to IACUC fees for the review and continued oversight of animal research.

V.7. Comparative Medicine has authority to establish fee rates for services rendered, to invoice for, and to collect compensation from grant, contract, departmental, or other accounts for services rendered to partially meet the costs of administering the Animal Care and Use Program, and are listed at Services, Per Diems, Equipment, and Fees. Comparative Medicine will not fill requests for animals or service under a specific IACUC-approved protocol until an association between fiscal support, an IACUC protocol, and an account is assured in writing. A Research Services Agreement and/or a letter on company letterhead indicating a commitment to fund a proposal may be used to document corporate support. A memorandum from the departmental Chairperson or other signature authority on the account may be used to document departmental support of a proposal. The PI must ensure that all costs invoiced to a grant account are allocable to the purpose of the grant. Costs allocable to one protocol may not be shifted to another in order to meet deficiencies caused by overruns, or for other reasons of convenience. Rotation of charges among protocols or accounts by month, or the monthly percent distribution of charges among accounts without establishing that the rotation schedule or percent distribution credibly reflects the relative benefit to each protocol and grant account is unacceptable. Although Principle III.27 permits multiple accounts, including multiple PHS agency research grant accounts in support of murine colony only approvals, the PI must ensure that the proportion of colony costs reimbursed by each account accurately reflects the relative benefit of the colony to the specific aims of each supporting grant account. Comparative Medicine will also not honor requests for animals or services under an IACUC-approved protocol until all pre-performance safety and logistical meetings have occurred and been documented in writing by Comparative Medicine.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JULY 24, 2015, IACUC MEETING

III.17. Procedural Changes, such as requests for additional animals to be made available to the protocol, a change in species, a change in Principal Investigator familiar with the approved scope of work, or change/addition of a federal agency funding sources for an existing IACUC-approved protocol (other than a "murine colony only" protocol) may be proposed to the IACUC. Such proposals must be justified in writing and within the scope of the original research hypothesis. If a change is proposed to a paper IACUC protocol, A Request for a Procedural Change to an Animal Use Protocol form must be submitted in both an electronic and written form which includes the PI's signature. The IACUC administrative staff must forward the electronic form of the Procedural Change to the full IACUC membership for their consideration. Changes proposed to an e-IACUC protocol are submitted by direct modification of the approved protocol with a justification provided for each change proposed. Procedural changes are subject to full IACUC review.

III.19. Amendments and Procedural Changes to existing protocols may be communicated to the funding agency at the discretion of the PI. Changes, such as a change in the scope of the original hypothesis or a change from the original specific aims of the research, cannot be amended to an existing IACUC-approved protocol, but must be described on a new e-IACUC application. After three years all continuing studies must be completely re-described in a new application to the IACUC.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JUNE 26, 2015, IACUC MEETING

V.10. Although physical separation of animals by species is recommended to prevent interspecies disease transmission and to eliminate the potential for anxiety and physiologic and behavioral changes due to interspecies conflict, the IACUC acknowledges that it is possible to achieve these aims by other means. Multiple species will only be housed in the same room when there is no added risk of disease transmission between species. When multiple rodent species are held in the same room, a separate air supply will be maintained by means such as the use of individually ventilated microisolator cages that are delivered HEPA-filtered separate ventilation. Different species will not be visually connected in adjacent cages, and all primary enclosures of one species will be opened/changed one cage at a time in accordance with standard procedures. The changing station or biosafety cabinet will then be decontaminated in accordance with standards, followed by a glove change prior to all primary enclosures of the second species being opened/changed one cage at a time in accordance with standards.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
APRIL 24, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
MARCH 27, 2015, IACUC MEETING

III.16. Amendments to existing protocols (i.e., a change in the certified research personnel other than PI, title, funding source other than federal sources, addition of another strain of the same species if justified in writing, use of an additional laboratory or relocation of an existing laboratory for an approved activity outside of animal facilities, or the use of conventional therapeutics, drugs, analgesics, or anesthetics) are reviewed by a designated IACUC member assigned by the IACUC Chair within 7 days of receipt, and approval communicated to the full IACUC membership at its next regular monthly meeting. If an amendment is proposed to a paper IACUC protocol, A Request to Amend an Animal Use Protocol form must be submitted in both an electronic and written form which includes the PI's signature. Amendments proposed to an e鈥怚ACUC protocol are submitted by direct modification of the approved protocol. Requests to add new research personnel are reviewed first by Research Integrity & Compliance to validate that all documents required of IACUC certification have been completed and submitted via the ARC system. This initial review includes obtaining written confirmation from USF Medical Health Administration that additional health services have been completed, whenever required. Subsequent to this confirmation, the request is reviewed by a designated IACUC member who ensures that all documents required of IACUC certification are complete, that the researcher's profile identifies a new species of interest, and that a current Health and Risk Assessment for Employee Safety in the Care and Use of Animals form has been signed by the requesting PI. Requests to change and/or add federal funding agency sources of support (e.g., PHS, NSF and DOD) to an existing protocol other than a "murine colony only" protocol must be accompanied by the grant proposal, with all approved revisions, and submitted as Procedural Changes and are subject to full IACUC review.

III.18. Procedural Changes are reviewed by the full IACUC membership. Within 3 days of receipt, any member of the full IACUC can ask for clarifications or revisions of the Procedural Change, or can call for a review of the Procedural Change at the next regular IACUC meeting. If there are no clarifications/revisions or full IACUC review requests within three days of receipt of the revised Procedural Change, it is reviewed by a designated IACUC member. If clarifications/revisions are requested, the PI will be given the opportunity to respond and incorporate these changes into the approved protocol. When changes are incorporated, the revised Procedural Change is reviewed by a designated IACUC member assigned by the IACUC Chair. When considered complete and appropriate, the designated member reviewer approves the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any Procedural Change that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any changes.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
FEBRUARY 27, 2015, IACUC MEETING

XV.10 & XIX.10 Log entries describing survival surgical procedures in any species must be kept by the PI, in the animal facility, on a Surgical Record form, Record of General Anesthesia form, or Rodent Surgical/Procedural Record form provided by Comparative Medicine. Any surgical event or procedure (survival or non-survival) involving USDA regulated species that requires a surgical plane of anesthesia must be kept by the PI, in the animal facility, on at least one of the forms listed above. Log entries must include, as a minimum, the following, (A) a pre-operative assessment, (B) an anesthetic plan, (C) records of the induction and of the monitoring of general anesthesia, (D) a brief description of the surgical procedures performed, (E) an intraoperative assessment, (F) a record of recovery from anesthesia (or method of euthanasia while the animal is anesthetized), (G) a post-operative assessment, and (H) any complications, treatments, and/or plans, as requested on the appropriate form.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JANUARY 23, 2015, IACUC MEETING

III.21. IACUC applications describing teaching or training laboratories must assure the IACUC in writing, under whichever Section of the Application is deemed appropriate, that they or their designated IACUC-certified staff who are named on the application will continually directly supervise the students attending the laboratory, and that prior to the lab commencing, will discuss with the students the potential risks and hazards as associated with their involvement in the laboratory involving animals, and will document this discussion by having all attending students complete a Student Safety in Teaching Laboratories Involving Animals form which the PI will sign and provide to the IACUC before the lab commences.

VII.2. New research and animal care personnel must submit a completed Health and Risk Assessment for Employee Safety in the Care and Use of Animals form to the ARC system. Every three years, all IACUC-certified personnel must provide a revised Health and Risk Assessment for Employee Safety in the Care and Use of Animals form. Personnel whose duties require access to an animal facility but whose duties do not include working with animals must submit a completed Personnel Entering Animal Facilities Health and Risk Assessment to the IACUC.

VIII.7. All new personnel using live vertebrate animals must complete the appropriate orientation form. Personnel requiring access to an animal facility must complete the Facility Orientation of Research Staff form and contact the local facility manager so that a general orientation and protocol-specific, and/or species-specific training can be ensured or arranged. Personnel planning studies of wildlife in natural setting must complete an Orientation of Field & Wildlife Research Staff form. Personnel planning studies that only use animal tissues in areas outside of animal facilities must complete an Orientation of Research Personnel Using Tissues Outside of Animal Facilities form.

VIII.14. Research personnel are kept apprised of updates that reflect changes in Standard Operating Procedures, IACUC Principles, processes, technology, legislation, and other relevant areas by transmitting such updates by email to all IACUC certified faculty and staff, and by posting such updates at http://www.research.usf.edu/dric/iacuc/announcements.asp.

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 (Research Pain Category C), the investigator has justified such in writing, and the IACUC has approved such practices.

XII.11. The PI and associated research staff must maintain written records of activities whenever procedures are assumed to produce more than momentary or slight pain and discomfort requiring the administration of analgesia. Records must be kept within the animal facility on forms provided by Comparative Medicine (e.g., Progress Notes form, or Surgical Record form, or Record of General Anesthesia form, or Rodent Surgical/Procedural Record form), with entries that describe when the painful or stressful outcome is first recognized, what treatments are instituted, and when the discomfort is resolved, or when the animal is euthanatized.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JUNE 27, 2014, IACUC MEETING

III.16 Requests to amend change and/or add PHS federal funding agency sources of support (e.g., PHS, NSF, DOD) to an existing protocol other than a "murine colony only" protocol must be accompanied by the grant proposal, with all approved revisions, and submitted as Procedural Change and are subject to full IACUC review.

III.17 Procedural Changes, such as requests for additional animals to be made available to the protocol, a change in Principal Investigator familiar with the approved scope of work, or change/addition of a federal agency funding source for an existing IACUC-approved protocol (other than a "murine colony only" protocol) may be proposed to the IACUC.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
MAY 16, 2014, IACUC MEETING

III.18. Procedural Changes are reviewed by the full IACUC membership. Within 3 days of receipt, any member of the full IACUC can ask for clarifications or revisions of the Procedural Change, or can call for a review of the Procedural Change at the next regular IACUC meeting. If there are no clarifications/revisions or full IACUC review requests within three days of receipt of the revised Procedural Change, it is reviewed by a designated IACUC member. If clarifications/revisions are requested, the PI will be given the opportunity to respond and incorporate these changes into the approved protocol. When changes are incorporated, the revised Procedural Change is reviewed by a designated IACUC member. When considered complete and appropriate, the designated member reviewer approves the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any Procedural Change that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any changes.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
APRIL 25, 2014, IACUC MEETING

III.10. The narrative of the PHS funding agency grant, with all approved revisions, that will support the proposed animal use must accompany the protocol application to the IACUC (other than a murine colony only application), as an electronic-version uploaded to the e-IACUC application. The PHS funding agency grant narrative should include the face page and research plan of the grant application, which describe the specific aims of the research and the methods involving vertebrate animals, and species of animals that will be used. Protocol applications with other proposed sources of funding (e.g., non-PHS, departmental or corporate) need not be accompanied by a grant proposal, but Comparative Medicine will not fill requests for animals or service under a specific IACUC-approved protocol until an association between fiscal support, an IACUC protocol, and an account or purchase order number is assured in writing. The primary reviewing member of the IACUC must compare the e-IACUC application and the PHS funding agency grant proposal and ensure that they are comparable in scope, (i.e., the protocol represents an aspect of the grant proposal or matches it entirely). Approval of an IACUC protocol application, other than a murine colony only application, with proposed support from a PHS funding agency, is contingent on comparable protocol and proposal titles and narratives.

III.18. Procedural Changes are reviewed by the full IACUC membership. Within 3 days of receipt, any member of the full IACUC can ask for clarifications or revisions of the Procedural Change, or can call for a review of the Procedural Change at the next regular IACUC meeting. If there are no clarifications/revisions or full IACUC review requests within three days of receipt of the revised Procedural Change, it is reviewed by a designated IACUC member. If clarifications/revisions are requested, the PI will be given the opportunity to respond and incorporate these changes into the approved protocol. When changes are incorporated, the revised Procedural Change is reviewed by a designated IACUC member. When considered complete and appropriate, the designated member reviewer approves the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any Procedural Change that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any changes.

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"
JANUARY 24, 2014, IACUC MEETING

III.25. Inter鈥恑nstitutional 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 involving University personnel, or 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"
December 13, 2013, IACUC Meeting

XVII.3. Investigators who plan to utilize one of the sample protocols for antiserum production described in CM SOP #023 can submit a modification of the core "antisera production only" to the IACUC via Comparative Medicine for e-IACUC approval and in doing so will comply with these Principles and Procedures. This application requests that all administrations, observations, phlebotomies, and treatments of rabbits used for antisera production be made and recorded by staff of Comparative Medicine. The PI who is submitting the modification provides the immunizing antigen to the Manager, 974-9806, who in turn coordinates the service.

Revisions Approved to IACUC "Principles and Procedures"
October 25, 2013, IACUC Meeting

III.10. The narrative of the PHS funding agency grant, with all approved revisions, that will support the proposed animal use must accompany the protocol application to the IACUC, as an electronic-version uploaded to the e-IACUC application. The PHS funding agency grant narrative should include the face page and research plan of the grant application, which describe the specific aims of the research and the methods involving vertebrate animals, and species of animals that will be used. Protocol applications with other proposed sources of funding (e.g., non-PHS, departmental or corporate) need not be accompanied by a grant proposal, but Comparative Medicine will not fill requests for animals or service under a specific IACUC-approved protocol until an association between fiscal support, an IACUC protocol, and an account or purchase order number is assured in writing. The primary reviewing member of the IACUC must compare the e-IACUC application and the PHS funding agency grant proposal and ensure that they are comparable in scope, (i.e., the protocol represents an aspect of the grant proposal or matches it entirely). Approval of an IACUC protocol application, other than a murine colony only application, with proposed support from a PHS funding agency, is contingent on comparable protocol and proposal titles and narratives.

III.16. Amendments to existing protocols (i.e., a change in the certified research personnel other than PI, title, funding source other than PHS agency sources, addition of another strain of the same species if justified in writing, use of an additional laboratory or relocation of an existing laboratory for an approved activity outside of animal facilities, or the use of conventional therapeutics, drugs, analgesics, or anesthetics) are reviewed by the IACUC within 7 days of receipt, and approval communicated to the full IACUC membership at its next regular funding agency sources of support to an existing protocol other than a "murine colony only" protocol must be accompanied by the grant proposal, with all approved revisions, and are subject to full IACUC review.

III.27. The title and narrative (i.e., specific aims, research plan and methods, and species of animals to be used) of an IACUC application must match the title and narrative of the PHS funding agency grant or contract that supports the proposed research activity involving animals. If an activity involving animals that is described in an IACUC-approved protocol is supported by multiple grants with different titles (e.g., one research grant, one postdoctoral fellowship, and departmental funds), or a grant is awarded later during the 3-year approval period of the IACUC protocol that supports the approved activity involving animals (i.e., grant not funded during year one of the protocol, but awarded during year two), the PI must inform the IACUC by modifying the e-IACUC protocol. A single IACUC protocol cannot be used to represent the animal use activities of multiple PHS agency research grants or contracts each with budgets to purchase, maintain, and use animals. A single research grant or contract may be represented by more than one IACUC-approved protocol.

Revisions Approved to IACUC "Principles and Procedures"
September 27, 2013, IACUC Meeting

VII.7. Animals administered uncharacterized primary human tumor resections, tissue explants, blood, or other patient-derived xenografts are housed in ABSL-2 containment in accordance with SOP 408.

VIII.19. All permanent animal care program staff are required to be certified by the IACUC, to prepare for and receive certification by the American Association for Laboratory Animal Science (AALAS), and may make direct technical contributions to approved protocols as stipulated in IACUC Principle V.5 when assigned by Comparative Medicine management. To ensure appropriately trained and experienced animal care staff are assigned protocol-specific duties, Comparative Medicine management maintains a table of degrees and certifications earned (CMDC 184) and a log of wet-lab species-specific trainings and documented proficiencies in methods of surgical, anesthetic, and technical procedures (CMDC 183) for each of its staff.

Revisions Approved to IACUC "Principles and Procedures"
August 23, 2013, IACUC Meeting

VI.1. Preclinical studies evaluating medical devices, investigational human or animal drugs, biological or electronic products, or food additives that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration (FDA) should be conducted in accordance with Title 21 Code of Federal Regulations Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies (GLP Study) viewable at http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr58_99.html.

VI.2. Applicants must declare in the e-IACUC application whether a proposed study will be conducted in accordance with 21 CFR 58 regulations, and attach a copy of the GLP Study protocol generated jointly by the GLP Testing Facility and study sponsor.

VI.4. The PI and GLP Testing Facility management must contact Comparative Medicine and declare in advance their intention to perform a GLP Study, and receive written approval of the GLP Study protocol from the Director of Comparative Medicine, as well as approval of the matching IACUC protocol from the IACUC before initiating any work.

VI.5. The GLP Study Director and QAU must be identified by the GLP Testing Facility management, and all provisions regarding record-keeping, auditing, data archiving and retrieval, test instrument calibration, and test article identification, handling, and storage accomplished or described in the GLP Study protocol in accordance with 21 CFR 58.

VI.6. The final report and all data resulting from the GLP Study must be filed with the GLP Testing Facility.

XX.8. Carbon dioxide inhalation is an acceptable method of rodent euthanasia, but is not an acceptable technique with rabbits or larger animals. Compressed carbon dioxide in gas cylinders is the only acceptable source of carbon dioxide for euthanasia and generation of CO2 by any other means such as dry ice or antacids is unacceptable. Sudden exposure to high concentrations of CO2 may be distressful to some species. Exposure of rodents to gradually increasing concentrations of CO2 (i.e., displacement rate from 10% to 30% using an appropriate pressure reducing regulator and flow meter) may help avoid or minimize discomfort or distress. Euthanasia by inhalation of any gaseous agent must be followed by the assurance of the cessation of cardiovascular and respiratory movements by observation at room air for at least 10 minutes, or by employing a secondary method of euthanasia such as cervical dislocation, decapitation, or bilateral thoracotomy. Death must be verified prior to carcass disposal.

Revisions Approved to IACUC "Principles and Procedures"
June 28, 2013, IACUC Meeting

III.16. Amendments to existing protocols (i.e., a change in the certified research personnel other than PI, title, funding source other than federal or major agency sources, addition of another strain of the same species if justified in writing, use of an additional laboratory or relocation of an existing laboratory for an approved activity outside of animal facilities, or the use of conventional therapeutics, drugs, analgesics, or anesthetics) are reviewed by the IACUC within 7 days of receipt, and approval communicated to the full IACUC membership at its next regular monthly meeting. If an amendment is proposed to a paper IACUC protocol, A Request to Amend an Animal Use Protocol form must be submitted in both an electronic and written form which includes the PI's signature. Amendments proposed to an e-IACUC protocol are submitted by direct modification of the approved protocol. Requests to add new research personnel are reviewed first by Research Integrity & Compliance to validate that all documents required of IACUC certification have been completed and submitted via the ARC system. This initial review includes obtaining written confirmation from USF Medical Health Administration that additional health services have been completed, whenever required. Subsequent to this confirmation, the request is reviewed by a designated IACUC member who ensures that all documents required of IACUC certification are complete, that the researcher's profile identifies a new species of interest, and that a current Health and Risk Assessment for Employee Safety in the Care and Use of Animals form has been signed by the requesting PI. Requests to amend federal or major funding agency sources of support to an existing protocol other than a "murine colony only" protocol must be accompanied by the grant proposal, with all approved revisions, and are subject to full IACUC review.

VII.3. Individuals determined to be at risk as determined by completion of the Health and Risk Assessment for Employee Safety in the Care and Use of Animals form are offered the opportunity to complete a Health History Assessment form and consult the occupational health physician. When special considerations (e.g., use of nonhuman primates) or clinical conditions require additional health services, Research Integrity & Compliance ensures that at-risk personnel make arrangements for services at USF Medical Health Administration and/or the occupational health physician, as required. When additional health services are required, USF Medical Health Administration provides Research Integrity & Compliance with written confirmation that health services have been completed, documentation of which is uploaded to the researcher's profile in the ARC system.

VIII.3. All personnel involved in live vertebrate animal use, treatment, or care must be certified by the IACUC as qualified to perform their duties, and named on the IACUC protocol application(s) to which they will contribute. The IACUC oversees and evaluates the effectiveness of the training program at least semiannually. All program personnel training must be documented.

VIII.16. The IACUC annually re-certifies all research and animal care personnel as to the adequacy of their training and experience using animals. A change in the certified personnel contributing to an IACUC approved animal use must be declared in advance by the PI and approved by the IACUC prior to such personnel making contributions to protocol(s), using processes delineated in IACUC Principle III.16.

Revisions Approved to IACUC "Principles and Procedures"
May 24, 2013, IACUC Meeting

VIII.18. Principal Investigators can request that visiting scientists be granted escorted hands-on access to animals and/or animal facilities in order to collaborate, assist, or instruct in the PI's IACUC-approved activities by providing the IACUC chair via email at iacuc@research.usf.edu with (1) a memorandum naming the visiting scientist, naming the institution from which he/she originates, identifying the dates of their planned presence within facilities, and assuring that the PI or their designated IACUC-certified staff will continually escort the visiting scientist during the conduct of activities involving animals, and (2) a letter on letterhead from the visitor's originating institution which documents that the visiting scientist originates from an institution with an OLAW assurance or an AAALAC accreditation if applicable, and that the visiting scientist is certified for animal care and use activities by the originating institution's IACUC. Additional documentation of completion of health care services by the visiting scientist may be requested by the IACUC when considering such requests for access to animals and/or animal facilities. Once the required documentation is reviewed and approved by the IACUC Chair or his designee the visit can proceed.

Revisions Approved to IACUC "Principles and Procedures"
March 22, 2013, IACUC Meeting

IACUC Principles and Procedures of Animal Care and Use have been updated throughout to reflect the new business processes associated with the Applications for Research Compliance (ARC) system electronic platform that is now in place for submission of new IACUC applications.

Mouse colony applications, animal tissue only, and antisera production only applications are now being reviewed using the designated member review process as described below. All research/teaching and wildlife applications will go through full committee review.

III.13. Protocol types "murine colony only," "antiserum production only," and "tissue use only" are subject to a designated member review process. as follows. Within 3 days of receipt of the new application, any member of the full IACUC can ask for clarifications or revisions of the e-IACUC application involving "murine colony only," "antiserum production only," or "tissue use only," or can call for a review of the application at the next regular IACUC meeting. If full committee review is called, the clarified or revised e-IACUC application is reviewed by the full IACUC. If there are no clarifications, revisions or full IACUC review requests within three days of receipt of the application, the application is reviewed by a designated IACUC member. The designated member reviewer assumes the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any IACUC member may request to view/review the modified application, or may request full committee review of the application. When considered complete and appropriate, the designated member reviewer approves the application, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any e-IACUC application that is added as an agenda item to the next regular IACUC meeting, or not approved by the designated member reviewer, is then reviewed by the full IACUC at the next regular monthly meeting. Written IACUC approval is required prior to implementing any animal use.

Revisions Approved to IACUC "Principles and Procedures"
October 26, 2012, IACUC Meeting

VII.2. New research and animal care personnel must submit a completed Health and Risk Assessment for Employee Safety in the Care and Use of Animals form to the ARC system. Every three years, all IACUC-certified personnel must provide a revised Health and Risk Assessment for Employee Safety in the Care and Use of Animals form. Personnel whose duties require access to an animal facility but whose duties do not include working with animals must submit a completed Personnel Entering Animal Facilities Health and Risk Assessment form to Comparative Medicine at least triennially.

VII.3. Individuals determined to be at risk as determined by completion of the Health and Risk Assessment for Employee Safety in the Care and Use of Animals form are offered the opportunity to complete a Health History and Assessment form and consult the occupational health physician. When special considerations (e.g., use of nonhuman primates) or clinical conditions require additional health services, Research Integrity & Compliance ensures that at-risk personnel make arrangements for services at USF Medical Health Administration and/or the occupational health physician, as required.

Revisions Approved to IACUC "Principles and Procedures"
September 28, 2012, IACUC Meeting

III.11. The applicant PI can annually renew an IACUC-approved protocol for up to a total of two additional one-year renewals, if re-approved by the IACUC. Any changes to the IACUC-approved protocol must be within the scope of the original hypothesis and proposed work, and described on either a Request to Amend an Animal Use Protocol or a Request for a Procedural Change to an Animal Use Protocol. Amendments to existing protocols (i.e., a change in the certified research personnel other than PI, title, funding source other than federal or major agency sources, addition of another strain of the same species if justified in writing, or the use of conventional therapeutics, drugs, analgesics, or anesthetics) are reviewed by the IACUC within 7 days of receipt, and approval communicated to the full IACUC membership at its next regular monthly meeting. Requests to amend federal or major funding agency sources of support to an existing protocol other than a Murine Colony protocol must be accompanied by the grant proposal, with all approved revisions, and are subject to full IACUC review. Procedural changes, such as requests for additional animals to be made available to the protocol, or a change in Principal Investigator familiar with the approved scope of work, can be proposed to the IACUC, but must be justified in writing, within the scope of the original research hypothesis, and involve the original species. A Request for a Procedural Change to an Animal Use Protocol must be submitted in both an electronic and written form which includes the PI's signature. The IACUC administrative staff must forward the electronic form of the Procedural Change to the full IACUC membership for their consideration. Within 3 days of receipt, any member of the full IACUC can ask for clarifications or revisions of the Procedural Change , or can call for a review of the Procedural Change at the next regular IACUC meeting. A clarified or revised Procedural Change is redistributed to the full IACUC for review. If there are no clarifications/revisions or full IACUC review requests within three days of receipt of the revised Procedural Change , the revised Procedural Change is reviewed by three assigned IACUC members within seven days of receipt. When unanimously agreed upon, the primary reviewers approve the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Any Procedural Change that is added as an agenda item to the next regular IACUC meeting, or not unanimously approved by the primary reviewers, is reviewed by the full IACUC committee at the next regular monthly meeting. Written IACUC approval is required prior to implementing any changes. Amendments and changes to existing protocols may be communicated to the funding agency at the discretion of the PI. Changes, such as , a change in the scope of the original hypothesis, or a change from the original specific aims of the research, or a change in procedures which exceeds the limits set by the Request for a Procedural Change to an Animal Use Protocol , or a change from the originally proposed species to research, teaching, or testing protocols using animals cannot be amended to an existing IACUC-approved protocol, but must be described on a new Application for the Use of Animals in Research, an Application for the Study of Wild Animals In or From Natural Settings, an Application to Establish/Maintain a Murine Colony, or an Application for Antisera Production. The PI must obtain prior approval from the funding agency for changes in scope, aims, objectives, or purpose of the research involving animals. These changes in research involving animals and verification of IACUC approval of the newly established protocol must be reported to the funding agency. After three years all continuing studies must be completely re-described in a new application to the IACUC.

Revisions Approved to IACUC "Principles and Procedures"
July 27, 2012, IACUC Meeting

V.9. Current USP grade pharmaceutical and biological products must be used in animal therapeutic applications, and in all aspects of animal research whenever available. Use of non鈥恜harmaceutical鈥恎rade substances in animals requires written scientific justification to the IACUC, and a written assurance that non鈥恜harmaceutical鈥恎rade substance preparation, reconstitution, and/or compounding will result in substances that are sterile, safe, effective, and of an appropriate composition (e.g., purity, concentration, pH, osmolality) and shelf鈥恖ife, that such preparations will be composed by appropriately trained and experienced personnel, and that adverse animal welfare outcomes related to non鈥恜harmaceutical grade substance use will result in its cessation of use, and a written notification by the PI to the IACUC describing the circumstances of the adverse event.

eIACUC Training Workshop
July 13, 2012

The Intro to eIACUC for Investigators & Study Staff training workshop will provide participants with a comprehensive review of the eIACUC system to assist with the transition from a paper-based system to the new electronic system. Please see Intro to eIACUC flyer about the upcoming training date/location and to reserve your seat. Additional workshop sessions will be scheduled; stay tuned for future announcements.

To request additional group training workshops for your department/College please contact iacuc@research.usf.edu.

Going Electronic with eIACUC
July 6, 2012

Research Integrity and Compliance is pleased to announce that the University of South Florida's (USF) faculty and staff will soon be able to submit their Institutional Animal Care and Use Committee (IACUC) protocols electronically allowing the transition from a paper submission process to a simpler, more efficient electronic IACUC (eIACUC) submission. Using eIACUC, researchers will be able to submit new animal protocols, conveniently request protocol changes, update study teams, and complete annual reviews and protocol three year renewals. The system guides each user through customized menus so that they can take the appropriate action specific to the documents at hand. The benefits of using this new web-based software include Efficient Submission and Review of Protocols, Accessibility, Transparency and User Friendly Format. A soft rollout on August 15, 2012 will allow researchers to begin using the new electronic system. Full implementation for all new IACUC research protocol will occur on January 1, 2013 at which time paper submissions of new research protocols will no longer be accepted. As part of the new eIACUC implementation DRIC will also be launching a robust training program allowing a seamless transition from a paper based system into the new eIACUC system. We are looking forward to a mutually beneficial partnership with each and every one of our investigators.

Revisions Approved to IACUC "Principles and Procedures"
June 22, 2012, IACUC Meeting

III.18. Inter鈥恑nstitutional 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 involving University personnel, or 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.

VIII.3. All personnel involved in live vertebrate animal use, treatment, or care must be certified by the IACUC as qualified to perform their duties. The IACUC oversees and evaluates the effectiveness of the training program at least semi-annually. All program personnel training must be documented.

VIII.4. Every three years, all research personnel must complete the AALAS Learning Library course entitled "Laws, Regulations, Policies, and the Guide - USF Orientation Lessons" and provide the certificate of completion, which documents that they have received training in animal care and use legislation, IACUC function, ethics of animal use and the concepts of the Three Rs, methods for reporting concerns about animal use, occupational health and safety issues pertaining to animal use, animal handling, aseptic surgical technique, anesthesia and analgesia, and euthanasia.

VIII.5. New Principal and Secondary Investigators, and other research personnel with a significant history of work with the species requested, which has been documented by the publication of multiple, peer-reviewed reports of research involving the requested species, are required to provide a copy of their curriculum vitae to document this prior experience.

VIII.6. All new personnel using live vertebrate animals must complete a Health and Risk Assessment for Employee Safety in the Care and Use of Animals form.

VIII.7. All new personnel using live vertebrate animals must complete a Request for the Orientation and Certification of New Research Personnel Using Animals and contact the local facility manager so that a general orientation and protocol-specific, and/or species-specific training can be ensured or arranged. During orientation, facility managers and training coordinators must complete an Orientation of Research Staff or Orientation of Animal Care Staff form, as appropriate.

VIII.8. To become eligible for IACUC certification, all new personnel must provide four completed documents:

Request for the Orientation and Certification of New Research Personnel Using Animals form and an Orientation of Research Staff form,
Health and Risk Assessment for Employee Safety in the Care and Use of Animals form,
Certificate of completion for the AALAS Learning Library course entitled "Laws, Regulations, Policies, and the Guide - USF Orientation Lessons," and
Curriculum vitae or resume.

VIII.9. Comparative Medicine provides training to researchers conducting surgical procedures as requested by research faculty or staff, or required by the IACUC, 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. Attendance and curricula are documented.

VIII.10. Comparative Medicine offers formal hands-on wet-laboratory training. Curricula may vary depending on need as requested by research faculty or staff, or as required by the IACUC, and may include basic animal needs, proper animal handling, routes and methods of substance administration, proper pre-procedural and post-procedural care, aseptic surgical technique, methods of anesthesia and analgesia, use of equipment, and methods of euthanasia. Attendance and curricula are documented.

VIII.11. Pre-performance meetings of protocols conducted in accordance with IACUC Principle III.21 must ensure and document that:

personnel contributing to protocols involving hazardous material have been/are provided safety training, clearly defined procedures, appropriate personal protective equipment, understand the hazards involved, and are proficient in implementing required safeguards,
personnel contributing to protocols involving surgical procedures conducted in nonrodent mammals have been/are provided training in good surgical technique, including, asepsis, gentle tissue handling, minimal dissection of tissue, appropriate use of instruments, effective hemostasis, and correct use of suture materials and patterns,
personnel contributing to protocols involving infrequently used species or techniques have been/are provided training in appropriate practices of animal care and use, recordkeeping, and use of appropriate supplies and equipment.

VIII.12. Comparative Medicine provides training and/or coordinates and provides technical assistance with species-specific or protocol-specific techniques whenever new or infrequently used species or techniques are introduced or re-introduced to campus, or additional individual instruction is requested by research faculty or staff, and/or required by the IACUC.

VIII.13. Research personnel intending to request, possess, or use any controlled substance in research or teaching involving animals must also first register with Comparative Medicine c/o the Assistant Director by completing a Certification of Research Personnel Using Controlled Substances form in accordance with IACUC Principles and Procedures XIV.2.

VIII.15. PIs are responsible for annually reviewing their certification status, and for declaring any updates or changes to their status.

VIII.16. The IACUC annually re-certifies all research and animal care personnel as to the adequacy of their training and experience using animals.

Revisions Approved to IACUC "Principles and Procedures"
May 25, 2012, IACUC Meeting

V.9. Current USP grade pharmaceutical and biological products must be used in all aspects of animal care and use.

V.11. Population density and housing space can affect animal reproduction, metabolism, immune responses, and behavior. Comparative Medicine ensures that all standard operating procedures are in accordance with the animal housing space recommendations given in the Guide, viewable at http://www.nap.edu/catalog.php?record_id=12910 with the following variances. Static microisolator caging for mice provides 63 in2 of floor space, sufficient for four adult mice, or one female with nursing litter and her monogamous male mate, or five mice that are each <25 g body weight. Individually ventilated caging (IVC) microisolator caging for mice provides 79 in2 of floor space, sufficient for five adult mice each >25g body weight. Males of aggressive strains (e.g., BALB/c, SJL, and FVB) may need to be housed at even lower densities. Mice may be bred in a male to female ratio of 1:1, 1:2, or 1:3. If mice are bred in a 1:1 monogamous ratio, the male and female breeders and their litter of pups may be kept together continuously until the pups are weaned. Given the strong postpartum estrous, and relatively short 21 day gestation and 21 day lactation of mice, a female that is continuously housed with a male may be pregnant with her next litter while nursing a current litter. Consequently, pups of continuously housed monogamous breeders must be weaned promptly at 21 days of age, or whenever the subsequent litter is born, whichever is earliest. If mice are bred in a 1:2 or 1:3 harems, each female must be removed to a separate cage when observed to be pregnant, except when nursling mice are euthanatized promptly by postnatal day 7 (e.g., as a source of cells or tissues), in which case the harem may be housed continuously together. Weanlings are counted as adults at 28 days of age or at weaning, whichever is earliest. Whenever Comparative Medicine staff find overcrowded mouse microisolators with occupants that exceed these limits, the cages are flagged by a notice on the cage and an email is sent to the principal investigator and/or research staff immediately and, if no response, 24 hours later. The research laboratory must correct housing densities of mice that exceed the limits set herein within 48 hours, or Comparative Medicine will separate the animals as deemed appropriate, and a charge will be made to the principal investigator's research account.

XI.5. Shipment of animals to or from other institutions must be requested in writing using a Request to Ship Mice To Another Institution, a Request to Ship Rats To Another Institution, or a Request to Receive Animals From Another Institution form, approved by the Director or Associate Director of Comparative Medicine or designee, and arranged and accomplished by Comparative Medicine, in compliance with AWA, and the International Air Transport Association Live Animal Regulations (IATA 2011).

XII.9. Comparative Medicine maintains an inventory of animal use regarding the potential for pain or discomfort. In their application for animal use, PIs designate the described animal use to one of three categories of research. Research Pain Category A involves procedures, which produce momentary, slight, or no pain, discomfort or distress (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 involves procedures, which produce more than momentary or slight pain, discomfort or distress, which is alleviated by the use of appropriate anesthetics/analgesics (e.g., surgical or invasive procedures conducted while the patient animal is maintained at a surgical plane of general anesthesia). Research Pain Category C involves procedures, which produce pain discomfort, or distress, which cannot, or is not alleviated by the administration of appropriate anesthetics/analgesics (e.g., tumor studies, certain behavioral studies, injection of immunogenic emulsions containing complete Freund's adjuvant, monoclonal antibody ascites production, survival analysis).

XV.2. Survival surgical procedures involving USDA regulated species must be conducted within accredited surgical facilities, where separate areas are provided for pre-operative animal preparation, surgeon's pre-operative scrub, the operating room, and for post-operative monitoring and care of the involved animal(s). The surgeon must wear sterile surgical gloves, gown, cap, and mask when conducting major, survival surgical procedures involving USDA regulated species. Accredited surgical facilities are available within the Surgical Core Laboratory of the College of Medicine and the Center for Advanced Medical Learning and Simulation (CAMLS).

XV.4. Preparation of the surgical site for mammalian survival procedures should include clipping or shaving the surgical site with enough border area to keep hair from contaminating the incision site. Hair removal should be performed in a room remote from the operating room. The surgical site should be scrubbed at least twice with a germicidal scrub, being careful to scrub from the center of the site toward the periphery. The site can then be rinsed with a 70% alcohol and then painted with dilute tamed iodine solution. Note that alcohol will contribute to hypothermia in rodents if used too liberally. Subsequently, the surgical site should be surrounded with sterile drapes. This not only helps prevent stray hair from entering the surgical field, but also provides an area on which to lay sterile instruments during surgery.

XV.5. For all vertebrate survival surgical procedures, the surgeon must wear sterile surgical gloves, a clean laboratory coat, and a surgical mask during survival procedures.

XV.7. For all species, in-date and USP grade anesthetics, analgesics, pharmacologics, and supplies must be used. If volatile anesthetics are used, appropriate scavenging must be in use. Preemptive and/or postoperative/postprocedural analgesia must be administered whenever procedures are identified that are assumed to produce more than momentary or slight pain and discomfort for an appropriate interval, unless the protocol precludes such practice (Pain Category C research), the investigator has justified such in writing, and the IACUC has approved such practice.

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 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 or Associate Director of Comparative Medicine.

May 15, 2012
ALL PRINCIPAL INVESTIGATORS USING ANIMALS

1. Please know that the James A. Haley VA Hospital animal facility will close effective July 1st to permit a major renovation of VAH building #2, which is tentatively expected to last > 2 years, with completion sometime in mid-2015. All research and teaching projects involving animals formerly conducted within that facility will be relocated to other facilities managed by the division during this period of facility renovation.

2. The fee schedule for services provided by Comparative Medicine effective July 1st for FY12-13, is viewable at: http://www.research.usf.edu/cm/docs/cmdc/C017_Services_Per_Diems_Equip_Fees.pdf.

3. Revised form CMDC #139 entitled "Rodent Surgery/Procedural Record," which is to be used to document preemptive analgesia, anesthesia, recovery, postoperative analgesia, complications or treatments, as well as suture/staple removal in accordance with revised SOP 412 entitled "Rodent Surgery." This revised form and others used in animal medical recordkeeping are viewable at: http://www.research.usf.edu/cm/animal-medical-recordkeeping.asp.

4. Please note the following changes to Standard Operating Procedures, as follows, viewable at: http://www.research.usf.edu/cm/sop.asp.

SOP 400 entitled "Rodent Husbandry" has been revised to permit the housing of 5 mice/cage in IVC microisolators; the 4 mice/cage limit in static microisolators remains in effect.
SOP 412 entitled "Rodent Surgery" has been revised so that sterile surgical gloves and a surgical mask are now required during survival surgical procedures, and medical recordkeeping entries are now required on form CMDC #139, as described above.
SOP 403 entitled "Rodent Enrichment" has been revised to stipulate that IACUC approval is "required for exemptions from the default policy of an enriched rodent environment, but that varied implementation of enrichment can be requested of the facility manager by the PI to meet with the aims of study (e.g., igloos instead of nestlets for mouse imaging studies) without IACUC review.
SOP 101 entitled "Compatibility Testing of Rabbits" has been created to establish a process of socially housing compatible rabbits.
SOP 028 entitled "Thermal Regulation of the Anesthetized Patient" has been revised to permit the use of electric heating pads as an indirect heat source partially underlying microisolators containing post-operative/procedural rodents recovering from anesthesia.
SOP 024 entitled "Use of In-Date Medical and Research Supplies in Animal Care and Use" has been revised to stipulate that sterile intravenous fluids in multi-dose containers (e.g., isotonic saline) are considered expired 28 days after first opened.
SOP 018 entitled "Necropsy and Post Mortem Examination" has been revised to indicate that cork boards may only be used for post mortem procedures and only when a clean, impervious, disposable pad is used to cover the cork board surface during necropsies or tissue derivations.

Revisions Approved to IACUC "Principles and Procedures"
November 18, 2011, IACUC Meeting

II.1. The Institutional Official is appointed by the University President and is the administrative official responsible for the Animal Care and Use Program. Overall program direction is a shared responsibility of the Institutional Official, Directing Veterinarian, and Institutional Animal Care and Use Committee (IACUC). The Institutional Official has appointed an IACUC and alternates which is responsible for oversight and evaluation of the animal care and use program, its procedures and facilities to ensure that they are consistent with the recommendations of the Guide, AWA, PHS Policy, University Policy #0-308, and the IACUC Principles and Procedures, and are fully accredited by AAALAC.

V.7. The Director of Comparative Medicine has management and administrative authority regarding all aspects of animal care and use, including the procurement, placement, management, husbandry, monitoring, use, and movement of animals involved in research and teaching, and regarding the use of all rooms, areas, and equipment within animal facilities on the University campuses, and at University-affiliated hospitals or research institutes.

IX.3. This reporting-feedback mechanism of observations made regarding the practices of animal care and use within these laboratories, contributes an important oversight, assists in the continuous development of the animal program, and includes a mechanism for anonymity viewable at https://secure.ethicspoint.com/domain/en/report_custom.asp?clientid=14773.

XIV.2. Any faculty member requesting, possessing, or using any controlled substance in research or teaching must be registered with the Division of 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 in research must re-certify with Comparative Medicine using a Certification of Research Personnel Using Controlled Substances form, and if controlled substance use in research does not involve animals an Application for the Use of Controlled Substances in Research Not Involving Animals form, must be submitted.

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 or an Application for the Use of Controlled Substances in Research Not Involving Animals , 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.

IX.2. Deficiencies in animal care, use, recordkeeping, or treatment, and adverse events in animal care or use must be reported, and can be reported to Comparative Medicine veterinarians (745-4361, 974-9260, 974-4935, 974-3836), or administrative staff (974-9842, 947-9876), or to the IACUC c/o Research Integrity & Compliance (974-0954, 974-3234, 974-7106), or directly to the IACUC Chairperson (974-1547), or IACUC Vice Chairperson (745-3028), or to the In

Revisions Approved to IACUC "Principles and Procedures"
June 24, 2011, IACUC Meeting

III.18. If activities involving animals are to be conducted at another institution by University personnel, or supported by University funds, that institution must provide the IACUC with a letter on official letterhead that indicates they are anticipating the presence of the research protocol, and when applicable, that they have an assurance on file with the PHS, and that their IACUC has approved the proposed animal use. 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.

Revisions Approved to IACUC "Principles and Procedures"
May 20, 2011, IACUC Meeting

III.3. The IACUC consists of not less than five members, each of whom fulfill one or more membership category(s), either (1) a Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine who has direct or delegated program responsibility for activities involving animals at the institution, (2) a practicing scientist experienced in research involving animals, (3) a member who is not affiliated with the University other than as a member of the IACUC and is not a member of the immediate family of a person who is affiliated with University, and (4) a member whose primary concerns are in a nonscientific area and who represents general community interests. IACUC membership includes at least one representative from the College of Health Sciences, the College of Arts and Sciences, the James A. Haley Veteran's Administration Hospital, and the H. Lee Moffitt Cancer Research Center. IACUC membership includes a biologist who can provide the IACUC with an understanding of the nature and impact of proposed field investigations, the housing and care of the species to be studied, and the risks associated with maintaining wild vertebrates in captivity.

III.4. IACUC members and alternates are appointed by the Institutional Official, and are listed on the IACUC rosters submitted to the PHS. Multiple alternates are appointed to fulfill one or more of the four specific membership categories mentioned above. An alternate may serve for any regular member provided the alternate fulfills the specific membership requirement(s) of the regular member for whom he/she is substituting. IACUC members must attend each regular monthly meeting and must notify the IACUC administrative staff of planned absences prior to protocol review assignments. When an IACUC member is unable to attend a meeting after protocol review assignments have been made, the IACUC member must submit a Primary Review of an IACUC Application for each assigned protocol to the IACUC administrative staff prior to the monthly meeting. When a regular member is unavailable to serve, the IACUC administrative staff identify an alternate that fulfills the same membership requirement(s) of the absent regular member and arranges for their participation to ensure that the committee is properly constituted at all times. Although members and alternates may not contribute to a quorum or act in an official IACUC capacity at the same time, alternates are encouraged to attend all IACUC meetings. Alternates receive the same training and orientation as IACUC members, and are expected to "vote their conscience" as opposed to representing the position of the regular member. The Institutional Official can dismiss IACUC members or alternates absent from more than three regular (or assigned) monthly meetings in a calendar year.

III.14. The IACUC meeting schedule is viewable at http://www.research.usf.edu/cm/calendar.htm. When additional IACUC meetings are required, reasonable notice is given to the IACUC and public by posting a notice to http://www.research.usf.edu/cm/calendar.htm, at least 72 hours in advance of the special meeting. IACUC members are required to attend each monthly meeting and must notify the IACUC administrative staff of planned absences prior to protocol review assignments. . Each Application for the Use of Animals in Research, or Application for the Study of Wild Animals In or From Natural Settings, or Application to Establish/Maintain a Murine Colony, or Application for Antisera Production is presented by a primary reviewing IACUC member using the form entitled Primary Review of an Application to the IACUC. Each review of an application by an IACUC member must be forwarded as an electronic-version to Research Integrity & Compliance c/o IACUC@research.usf.edu no later than prior to the scheduled meeting time. After verbally presenting their findings regarding the application to a quorum of the IACUC members, the primary reviewing IACUC member proposes a motion to either approve the application, require modifications to secure approval of the application, or disapprove the application. IACUC members listed as participating personnel on the face page of an IACUC application must leave the room during the presentation and discussion of the protocol and are not permitted to participate or vote. After discussion, the motion is seconded, and the full IACUC committee votes. If the approved motion is "Requires Modification to Secure Approval," it is understood that all members of the IACUC, in attendance or not, forgo a full review of the to-be-revised application in favor of the designated member review. Once members have chosen designated-member review, then the reviewer(s) assume the responsibility for the full committee in granting unanimous approval, requiring modification, or returning the protocol for full review. At any time during this process, any member may request to view/review the modified application, or may request full committee review of the application. New IACUC members must be informed and agree to this process.

III.23. The IACUC reviews the animal care and use program and inspects animal facilities, and laboratories outside of facilities where animals are used at least every 6 months. During these reviews and inspections the Semi-Annual Program and Facility Review Report is completed. Deficiencies identified are classified as either "major" (i.e., those which affect animal welfare), or "minor," and a schedule by which corrections will be accomplished is assigned. Each semi-annual report is reviewed and signed by a majority of IACUC members, includes any dissenting views or opinions, and is submitted to the Institutional Official for his review and signature. Each report includes changes made to the program and an itemization of improvements that need to be made to the facilities. Comparative Medicine provides a draft of responses to items of noncompliance to the IACUC Chairperson who in turn provides the Institutional Official with a detailed written assurance of how all items of noncompliance were resolved in a timely manner, when so accomplished. IACUC members must attend and contribute to inspections and must notify the IACUC administrative staff of planned absences prior to an inspection as assigned by the Chairperson. The Institutional Official can dismiss IACUC members and alternates that do not contribute to inspections.

VII.3. Individuals determined to be at risk as a result of the Health and Risk Assessment for Employee Safety in the Care and Use of Animals form are offered the opportunity to complete a Health History Assessment form and consult the occupational health physician.

VII.7. Research and animal care personnel must consult the occupational health physician whenever research is proposed that involves unvaccinated or uncharacterized carnivores, pregnant sheep, goats, cattle, or nonhuman primates.

IX.5. Reports of concerns regarding animal welfare are immediately forwarded to Comparative Medicine for assurance by the veterinarians that a concern for animal welfare is not ongoing. A veterinarian can interrupt any activity that jeopardizes the welfare of an animal.

Revisions Approved to IACUC Applications and Forms
May 20, 2011, IACUC Meeting
Application for the Use of Animals in Research

Page 1, Section 6. CERTIFICATION - Revised in response to the USDA recommendation that multiple databases be searched for alternatives to animal use.

Page 2, Section 8. JUSTIFICATION FOR THE USE OF ANIMALS - Now requires a brief lay description of both the purpose and overall scope of work in terms that a high school senior can understand.

Page 2, Section 9. JUSTIFICATION FOR THE USE OF ANIMALS - Now allows for a more detailed chronological description of experimental procedures involving animals without the former restriction of using lay language and terms.

Page 12, Appendix D, SURGERY, Section 11- Revised to read "...and indicate that skin sutures or staples will be removed at approximately 10 - 14 days post-operatively."

Application to Establish/Maintain a Murine Colony

Page 1, Section 6. CERTIFICATION - Revised in response to the USDA recommendation that multiple databases be searched for alternatives to animal use.

Application for the Study of Wild Animals In or From Natural Settings

Page 1, Section 5. CERTIFICATION - Revised in response to the USDA recommendation that multiple databases be searched for alternatives to animal use.

Page 3, Section 10. JUSTIFICATION FOR THE USE OF ANIMALS - Now requires a brief lay description of both the purpose and overall scope of work in terms that a high school senior can understand.

Page 14, Appendix D, SURGERY, Section 11 - Revised to read "...and indicate that skin sutures or staples will be removed at approximately 10 - 14 days post-operatively."

Application for Antisera Production

Page 1, Section 5. CERTIFICATION - Revised in response to the USDA recommendation that multiple databases be searched for alternatives to animal use.

Important Message to All Principal Investigators
March 25, 2011

Please share the following information with your research staff.

PRINCIPAL INVESTIGATORS USING ANIMALS: CHANGES TO BILLING PRACTICES WILL AFFECT USF-BASED ACCOUNTS EFFECTIVE MAY 1, 2011.
USF Audit & Control has recommended improvements to the internal billing practices used by the Division of Comparative Medicine. Such improvements will affect only USF-based accounts supporting research involving animals (e.g., USF grant, USF Research Foundation, USF Foundation, departmental, rebate, and/or start-up accounts), but will not affect H. Lee Moffitt Cancer Center-based accounts or James A. Haley VA Hospital-based accounts supporting such research. Effective May 1, 2011, Principal Investigators (PI) that use USF-based accounts to partially reimburse Comparative Medicine for animal service costs will no longer be mailed, and asked to review and sign a paper "Uniform Charge Document" but will instead be electronically transmitted by email each month a summary statement of the services provided to their IACUC-approved protocols, including per diems incurred, animals ordered, supplies purchased, and technical services provided. Each PI may designate office/laboratory personnel to receive and review these electronic monthly statements. An approval by the PI of each monthly statement will no longer be required. Seven (7) calendar days after electronic delivery of monthly statements, funds will be electronically transferred to the division's auxiliary account. Requests by the PI or designee for clarification/revision to a monthly statement must be received by Comparative Medicine prior to this transfer of funds. To ensure receipt and timely review of these electronic monthly statements prior to the transfer of funds, you may wish to designate one or more recipients from among the faculty/staff in your office/laboratory who can review monthly statements in your absence. Please respond prior to APRIL 8, 2011, to Comparative Medicine accountants Everett White at ewhite@research.usf.edu (974-5221) or Rosemarie Louis-Charles at rosemarielc@research.usf.edu (974-8117) indicating the name(s) of faculty/staff that should receive electronic monthly statements in addition to the PI. If you have any questions regarding this improvement to billing practices affecting only USF-based accounts, please contact Dr. Engelman at robert.engelman@moffitt.org (745-4361).

Revisions Approved to IACUC "Principles and Procedures"
December 17, 2010, IACUC Meeting

III.9. Applicants must submit their application in its final form to Research Integrity and Compliance prior to the IACUC submission deadline in order to make that month's IACUC meeting agenda. Submission deadlines to the IACUC are established by the Division of Research Integrity & Compliance, and are dates by which the application must be received in final form. Applications not submitted within sixty (60) days of receipt of the veterinary pre-review are not eligible for inclusion in an IACUC agenda, and to become eligible must be resubmitted for a second veterinary pre-review prior to submitting to Research Integrity and Compliance for inclusion on an agenda. Conflict of Interest (COI) Disclosure Form must also be submitted for each new IACUC application. An electronic version of the application and COI disclosure form can be submitted to IACUC@research.usf.edu via electronic mail provided the signature pages are electronically signed by the principal investigator or hard copies of the signature pages are mailed/faxed to Research Integrity & Compliance at MDC 35, 974-7091. Applications will not receive full IACUC approval until the Conflict of Interest (COI) disclosure form has been submitted for each new application and renewal. See more information regarding COI and the COI disclosure form.

IV.5 Monthly, Research Grants and affiliated hospital Research Administrations will communicate to Comparative Medicine, the University, or Research Foundation, or affiliated hospital grant account or purchase order number assigned or associated with each research award involving animals received that month. Comparative Medicine will not fill requests for animals or service under a specific IACUC-approved protocol until an association between fiscal support, an IACUC protocol, and an account or purchase order number is assured in writing. A Research Services Agreement and/or a letter on company letterhead indicating a commitment to fund a proposal may be used to document corporate support. A memorandum from the departmental Chairperson or other signature authority on the account may be used to document departmental support of a proposal.

XI.4 Transfer of animals from one IACUC-approved research use (excluding murine production as described in an IACUC-approved Application to Establish/Maintain a Murine Colony, 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 Reassign Research Animals form , the reassignment is justified in writing, and approved by both the originating and reassigned PIs, and the Program Coordinator . . .

Revisions Approved to IACUC Applications and Forms
December 17, 2010, IACUC Meeting

Application for the Use of Animals in Research
Page 1, Section 5. LOCATION - The following text was added: NOTE - Animal removal/relocation from a facility requires PRIOR APPROVAL.

Page 1, Section 5. Location - ACH was removed as a choice for where the protocol will be conducted.

Application to Establish/Maintain a Murine Colony
Page 1, Section 5. Location - ACH was removed as a choice for where the protocol will be conducted.

IMPORTANT NOTICE TO ALL PRINCIPAL INVESTIGATORS
The following revision to IACUC "Principles and Procedures"
was approved at the June 25, 2010, IACUC Meeting

Principle and Procedure XX.8. has been revised to replace "prolonged" with "at least 10 minutes" so that the XX.8 reads:

"Carbon dioxide inhalation is an acceptable method of rodent euthanasia, but is not an acceptable technique with rabbits or larger animals. Compressed carbon dioxide in gas cylinders is the only acceptable source of carbon dioxide for euthanasia and generation of CO2 by any other means such as dry ice or antacids is unacceptable. Sudden exposure to high concentrations of CO2 may be distressful to some species. Exposure of rodents to increasing concentrations of CO2 (e.g., 33% achieved after 1 minute) may help avoid or minimize discomfort or distress. Euthanasia by inhalation of any gaseous agent must be followed by the assurance of the cessation of cardiovascular and respiratory movements by observation at room air for at least 10 minutes, or by employing a secondary method of euthanasia such as cervical dislocation, decapitation, or bilateral thoracotomy. Death must be verified prior to carcass disposal."

On June 25, 2010, a revised Application for the Use of Animals in Research, Application to Establish/Maintain a Murine Colony, and Application for the Study of Wild Animals in or from Natural Settings was approved by the IACUC and posted to the USF web site.

These revised application forms are acceptable for use now.

On or after October 25, 2010, the IACUC will require that the revised application forms be used for all submissions.

Revisions Approved to IACUC "Principles and Procedures"
June 25, 2010, IACUC Meeting

III.2. Replace "withhold approval of" with "disapprove" so that III.2 reads: "The IACUC has authority to review, approve, or require modification in order to secure approval, or disapprove proposed research or teaching using vertebrate animals...."

III.6, Revised to include a statement that VA R&D review must be secured prior to IACUC review so that III.6 reads: "Principal Investigators (PI) developing applications for VA funded Merit Review grants, which are reviewed and approved by the VA Central Office, must submit the animal component for their research project to the IACUC using the VA Animal Component entitled "Animal Component of Research Proposal" (ACORP). VA R&D review must be secured prior to IACUC review. All ACORP applications to the IACUC will be assigned a primary reviewer that is a VA resident scientist or administrator familiar with the ACORP format 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."

III.9. Revised to include a statement that a Conflict of Interest Form is required to be submitted with an IACUC application so that III.9 reads: "Applicants must submit their application in its final form to Research Integrity & Compliance prior to the IACUC submission deadline in order to make that month's IACUC meeting agenda. Submission deadlinesto the IACUC are established by the Division of Research Integrity & Compliance, and are dates by which the application must be received in final form. A Conflict of Interest (COI) Disclosure Form must also be submitted for each new IACUC application. An electronic version of the application and COI disclosure form can be submitted to IACUC@research.usf.edu via electronic mail provided the signature pages are electronically signed by the principal investigator or hard copies of the signature pages are mailed/faxed to Research Integrity & Compliance at MDC 35, 974-7091. Applications will not receive full IACUC approval until the Conflict of Interest (COI) disclosure form has been submitted for each new application and renewal. See more information regarding COI and the COI disclosure form."

III.11 Revised to remove "On the day of receipt" so that III.11 reads: "The IACUC administrative staff must forward the electronic form of the request to the full IACUC membership for their consideration."

VIII.11 Revised to include the word "current" so that VIII.11 reads: "Individuals who comply with these Principles and Procedures will be granted a certification number by Comparative Medicine to be used in applications for use of animals in research. Research staff or other individuals involved in animal care and use activities suspended by the IACUC can have their certifications revoked by the IACUC. Individuals without a current certification number can be denied access to the services and facilities of Comparative Medicine."

IX.2 Contact information updated so that IX.2 reads: "Deficiencies in animal care, use, recordkeeping, or treatment, and adverse events in animal care or use must be reported, and can be reported to Comparative Medicine veterinarians (745-4361, 974-9260), or administrative staff (974-9842, 947-9876), or to the IACUC c/o Research Integrity & Compliance (974-0954, 974-3234, 974-7106), or directly to the IACUC Chairperson (974-1547), or IACUC Vice Chairperson (745-3028), or to the Institutional Official of the Animal Care and Use Program, (974-5570)."

XX.8. Revised to replace "prolonged" with "at least 10 minutes" so that XX.8 reads: "Carbon dioxide inhalation is an acceptable method of rodent euthanasia, but is not an acceptable technique with rabbits or larger animals. Compressed carbon dioxide in gas cylinders is the only acceptable source of carbon dioxide for euthanasia and generation of CO2 by any other means such as dry ice or antacids is unacceptable. Sudden exposure to high concentrations of CO2 may be distressful to some species. Exposure of rodents to increasing concentrations of CO2 (e.g., 33% achieved after 1 minute) may help avoid or minimize discomfort or distress. Euthanasia by inhalation of any gaseous agent must be followed by the assurance of the cessation of cardiovascular and respiratory movements by observation at room air for at least 10 minutes, or by employing a secondary method of euthanasia such as cervical dislocation, decapitation, or bilateral thoracotomy. Death must be verified prior to carcass disposal."

Revisions Approved to IACUC Applications and Forms
June 25, 2010, IACUC Meeting

Application for the Use of Animals in Research
Page 2, Section 9, second sentence add the word "pain" preceding the word "Categories" to read: "Section 9 or Section 11 of the application should contain an explanation/rationale for assigning the specific number of animals to the different pain Categories in Section 10."

Page 3, add "Pain" to the heading at the top of the page.

Page 3, Section 10, add the word "pain" preceding the word "Categories".

Page 3, Section 11, second sentence add the word "pain" preceding the word "Categories" to read "Section 9 or Section 11 of the application should contain an explanation/rationale for assigning the specific number of animals to the different pain Categories in Section 10."

Appendix G, under section heading Training, second paragraph, fourth sentence, change from submit request to Compmed@research.usf.edu to VHATAMIACUCtraining@va.gov .

Application to Establish/Maintain a Murine Colony
Page 2, Section 9, Justification for The Colony, be revised to ask the PI to identify method of identifying animals that are subjected to tissue sampling for genotyping: "Briefly describe the unique genetic and other characteristics of each strain or line that will need to be established as a colony, and why the colony must be established locally. Describe how each colony will be monitored from a genetics perspective. Describe the method for identification of individual animals subjected to tissue sampling for genotyping (e.g., tail tattoo, marking, or tag). Describe the rationale used to estimate the anticipated size of each colony as indicated above as the total number of animals of each strain or line requested."

Page 2, Section 9 where appropriate add the word "pain" preceding the word "Categories."

Application For the Study of Wild Animals in or From Natural Settings
On page 1, Section 5, update the references as follows: Conduct will be in accordance with the "Guidelines of the American Society of Mammalogists for the Use of Wild Mammals in Research," "Guidelines for the Use of Fishes in Research," "Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research," "Guidelines to the Use of Wild Birds in Research," DEA regulations, IACUC Principles & Procedures, PHS policy, AWA, Guide, and AAALAC guidelines. This project was designed with the consultation of a veterinarian.

Section 7, where appropriate add the word "pain" preceding the word "Categories."

Page 6. Section 28, add the word "pain" preceding the word "Category C."

Important Message to All Principal Investigators
February 3, 2010

Please share the following information with your research staff.

Draft IACUC application appendixes describing mouse imaging methodologies, specifically magnetic resonance imaging (MRI), ultrasound, ultrasound-guided injections, fluorescence, and bioluminescence have been posted to the website. These can be used as guides when developing new applications or when requesting procedural changes to existing applications that involve these methods. These draft mouse imaging appendixes are viewable online.

Important Message to All Principal Investigators
January 27, 2010

Forms used by research staff requesting Comparative Medicine and/or IACUC services are frequently improved, revised or updated in accordance with regulations.

Whenever Comparative Medicine/IACUC forms are used, research personnel should always refer to the Comparative Medicine website to obtain the current version. Forms should not be downloaded and saved or copied and distributed since obsolete versions are not acceptable, and their use may delay service.

Some commonly used forms that are subject to frequent revisions are listed below (with links to the website location in the titles):

Personnel Certification

Request for the Orientation of New Research Personnel Using Animals
Health and Risk Assessment for Employee Safety in the Care and Use of Animals
Orientation of Research Personnel

Shipping/Relocating or Reassigning Animals

Request to Reassign Research Animals
Request to Relocate Research Animals
Request to reassign Locally Produced Mice to a Research Protocol

IACUC Applications

Application for the Use of Animals In Research
Application for the Study of Wild Animals In or From Natural Settings
Application to Establish/Maintain a Murine Colony
Application for Use of Animal Tissues

Please help us give you the best service possible by using the Comparative Medicine website and always remember to "refresh" your browser when referring to a cached "favorite" or "saved" website link.

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Institutional Animal Care

Announcement Archive (2010 - 2022)

Revisions Approved to IACUC "Principles and Procedures"February 25, 2022, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"November 19, 2021, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"October 22, 2021, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"July 23, 2021, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"May 21, 2021, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"February 26, 2021, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"January 22, 2021, IACUC Meeting

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"DECEMBER 11, 2020, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"SEPTEMBER 25, 2020, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"MAY 29, 2020, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"FEBRUARY 28, 2020, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"NOVEMBER 15, 2019, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JUNE 28, 2019, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"MAY 17, 2019, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"MARCH 22, 2019, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"FEBRUARY 22, 2019, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES" OCTOBER 26, 2018, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"SEPTEMBER 28, 2018, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JUNE 22, 2018, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"APRIL 27, 2018, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JANUARY 18, 2018, IACUC MEETING

Revisions Approved to IACUC "Principles and Procedures"August 25, 2017, IACUC Meeting

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JULY 28 2017, IACUC MEETING

Revisions Approved to IACUC "Principles and Procedures"February 24, 2017, IACUC Meeting

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"DECEMBER 16, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"NOVEMBER 18, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"OCTOBER 28, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JULY 22, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JUNE 24, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"MAY 20, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JANUARY 22, 2016, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"NOVEMBER 20, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JULY 24, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JUNE 26, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"APRIL 24, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"MARCH 27, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"FEBRUARY 27, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JANUARY 23, 2015, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JUNE 27, 2014, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"MAY 16, 2014, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"APRIL 25, 2014, IACUC MEETING

REVISIONS APPROVED TO IACUC "PRINCIPLES AND PROCEDURES"JANUARY 24, 2014, IACUC MEETING

Revisions Approved to IACUC "Principles and Procedures"December 13, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"October 25, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"September 27, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"August 23, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"June 28, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"May 24, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"March 22, 2013, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"October 26, 2012, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"September 28, 2012, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"July 27, 2012, IACUC Meeting

eIACUC Training WorkshopJuly 13, 2012

Going Electronic with eIACUCJuly 6, 2012

Revisions Approved to IACUC "Principles and Procedures"June 22, 2012, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"May 25, 2012, IACUC Meeting

May 15, 2012ALL PRINCIPAL INVESTIGATORS USING ANIMALS

Revisions Approved to IACUC "Principles and Procedures" November 18, 2011, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"June 24, 2011, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"May 20, 2011, IACUC Meeting

Important Message to All Principal InvestigatorsMarch 25, 2011

Revisions Approved to IACUC "Principles and Procedures"December 17, 2010, IACUC Meeting

IMPORTANT NOTICE TO ALL PRINCIPAL INVESTIGATORSThe following revision to IACUC "Principles and Procedures"was approved at the June 25, 2010, IACUC Meeting

Revisions Approved to IACUC "Principles and Procedures"June 25, 2010, IACUC Meeting

Revisions Approved to IACUC Applications and FormsJune 25, 2010, IACUC Meeting

Important Message to All Principal InvestigatorsFebruary 3, 2010

Important Message to All Principal InvestigatorsJanuary 27, 2010