IACUC

Announcements

The IACUC provides the following new information regarding principles of animal care and use.


Revisions Approved to IACUC "Principles and Procedures"
May 17, 2019, IACUC Meeting

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.

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’s profile in the ARC system. 

VIII.4. 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.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 “Handling and Use of Immune Deficient Mice”. 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‐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.

XII.19 Physical restraint is defined as the use of manual or mechanical means to limit some or all of an animal’s 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‐human primates, should be avoided unless it is justified in writing, essential for achieving research objectives, and approved by the IACUC. Chairing of non‐human 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 ≥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 “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.  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 “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.  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 “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 primary reviewing IACUC member’s 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’s initial orientation to regulatory processes, processes that are agreed upon in advance in writing using a form entitled “Orientation and Certification of New IACUC Members”. 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 “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‐member 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‐reviewed 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’s 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’s 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 “tissue use only” 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 “Laws, Regulations, Policies, and the Guide – USF Orientation Lessons”, 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 “Basic Rodent Biomethodologies”, and f) a certificate of attending “Basic Rodent Biomethodologies –Wet Lab Training”. 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 “Aseptic Technique in Rodent Survival Surgical Procedures” as an upload to the appropriate section of their ARC profile. All personnel intending to directly implement rodent survival surgical procedures must provide the IACUC with a certificate of completion of wet lab training in such procedures provided by CM as an upload to the appropriate section of their ARC profile, prior to IACUC protocol approval. Completion of the AALAS LL aseptic surgery course is required prior to wet lab training attendance. If IACUC certified Comparative Medicine staff will serve as the surgeon(s), 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 “Handling and Use of Immune Deficient Mice”, 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‐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.

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 “caretaker status” 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 “caretaker status” must provide Comparative Medicine with a source of funding other than the federal grant that will support the animals while in “caretaker status” 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 “Food and Fluid Regulation in Mice and Rats” on form CMDC #245 “Food and Fluid Regulation Record” in the housing room book.


Revisions Approved to IACUC "Principles and Procedures"
September 28, 2018, 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-reviewed 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's environment, and will not impact the health or safety of involved personnel need not be proposed to the IACUC.


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‐be 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‐member 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‐annual 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.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‐reviewed 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 then 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.

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 "research or teaching", "wildlife", "murine colony only", "antiserum production only", or "tissue use only". The protocol type "research or teaching" is added as an agenda item to the next regular IACUC meeting for FCR. Protocol types "wildlife", "murine colony only", "antiserum production only", and "tissue use only" are subject to DMR.

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‐be revised application in favor of the designated primary reviewing IACUC member's review. Once members have chosen this designated‐member 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‐by‐case 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‐innovation/comparative‐medicine/sop.aspx and to CM drug formularies viewable at /research‐innovation/comparative‐medicine/anesthesia‐analgesia‐therapeutics.aspx. Request to change or add federal funding to a research or teaching protocol must be accompanied by portions of the grant narrative identified in III.10, above. The veterinarian serves as a subject matter expert and verifies compliance of the requested Protocol Change with this IACUC Principle. This consultation with the veterinarian is documented in the ARC protocol history. The veterinarian may refer any requested Protocol Change to the IACUC for full committee review (FCR) or designated member review (DMR).

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‐described 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‐annual 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 – USF Orientation Lessons", d) Curriculum vitae or resume, and if planning to use rodents, other than the PI, e) "Basic Rodent Biomethodologies – Wet Lab Training".

VIII.10. All new personnel, other than the PI, requesting IACUC certification 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"
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‐managed 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‐being, 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‐being 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‐pharmaceutical‐grade substances in animals requires written scientific justification to the IACUC, and a written assurance that non‐pharmaceutical‐grade 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‐life, that such preparations will be composed by appropriately trained and experienced personnel, and that adverse animal welfare outcomes related to non‐pharmaceutical 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

III.31. Applications proposing to house animals for >12 hours at satellite facilities outside of Comparative Medicine‐managed 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‐being, 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‐being 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."


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‐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.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‐institutional collaborations involving animal use have the potential to create ambiguities about the responsibility for animal care and use, and IACUC oversight. If activities involving animals are to be conducted at another institution 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.


ARCHIVE - Announcements & Current Topics in Animal Care & Use (2010 - 2013)