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Current Topics in Animal Care & Use
The IACUC, Comparative Medicine, and Research Compliance provide all IACUC-certified personnel with the following new information regarding animal care and use.
Revisions Approved to IACUC Policies at the February 22, 2008 IACUC Meeting
IV.4. The applicant Principal or Secondary Investigator must have a faculty appointment with the University or an appropriate appointment with the James A. Haley Veteran’s Administration Medical Center, H. Lee Moffitt Cancer Center and Research Institute, or New College of Florida.
VII.2. New research and animal care personnel must submit a completed Health and Risk Assessment form to Comparative Medicine. 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 Comparative Medicine at least triennially.
XI.4. Transfer of animals from one IACUC-approved research use (excluding mouse production as described in an IACUC-approved Application to Establish/Maintain a Mouse Colony) 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. An approved reassignment of animals from one IACUC-approved research protocol to a new IACUC protocol becomes effective on the date of the transfer, and all animal per diem, identifying cards, and inventories are changed to reflect this reassignment. Reassignment of naïve mice originating from an IACUC-approved mouse colony protocol to an initial IACUC-approved research protocol is accomplished by notifying the facility manager, who completes a Request to Reassign Locally Produced Mice to a Research Protocol 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 the Program Coordinator of Comparative Medicine if the reassignment necessitates a physical relocation of mice. Requests for reassignment of non-naïve rodents with respect to major medical, surgical, research or teaching procedures from an approved research protocol to a mouse colony protocol requires IACUC review and approval.
CURENT TOPICS IN ANIMAL CARE AND USE 11/07
During its November 5th-7th evaluation of the program and facilities for animal care and use, visitors from the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) asked that the number of animals requested in an application to the IACUC be justified statistically whenever possible.
On November 16th, at its regular monthly meeting, the IACUC considered and approved the following revision to item 11, page 3 of the Application for the Use of Animals in Research.“Briefly describe using statistical analysis, whenever possible, the rationale used to determine the total number of each species of animals declared above in response to item #10 that will be needed for use during the 3-year approval period of this protocol. Section 9 or Section 11 of the application should contain an explanation/rationale for assigning the specific number of animals to the different Categories in Section 10. (Note: For complicated experimental designs, it may be helpful to the IACUC if this explanation indicates the # of animals needed for each experimental group, the # of groups required, and the analyses conducted using each group. Alternatively, it may be helpful to the IACUC if a flow chart depicting the sequence of events and the number of animals required for each step is shown.)”
Note that deleted from this item in the application to the IACUC was the option of providing a rationale for the number of animals requested based on “prior experience or other methods".
Henceforth, in all submissions to the IACUC using the Application for the Use of Animals in Research, please describe the rationale used to determine the number of animals requested using statistical analysis whenever possible.
CURENT TOPICS IN ANIMAL CARE AND USE 09/07
Forms Revised at the September 28, 2007 IACUC Meeting:
The following forms were revised by the IACUC at its September 28th meeting and are now available on the Comparative Medicine Website:
Application for the Use of Animals in Research
• Section 7a. "…to verify unnecessary duplication" has been removed.
• Section 14 the word "intentional" has been added and the question now reads "Is Animal death (excluding death from euthanasia) an intentional endpoint in this protocol?"
• Sections 9 & 11, added the sentence "Section 9 or Section 11 of the application should contain an explanation/rationale for assigning the specific number of animals to the different Categories in Section 10."
• Section 18 "fluid, food, or caloric restriction..." has been added to the list of examples of Special Husbandry.
• Appendix A, Section 1 now reads "Does this protocol involve food, fluid or caloric restriction?"
• Appendix B, Section 1 examples of responses have been added to both the text and table.
• Appendix D, Item 1 "pre-emptive analgesia" has been added to the pre-operative medications to be listed by the applicant.Application for Antisera Production
• Section 4 has been revised to remove Freund's Adjuvant from the choices of less inflammatory adjuvants listed on the application.
• Section 5 was added so that if Freund's adjuvant is required a literature search must be conducted for alternatives and its use must be scientifically justified.Request to Amend an Animal Use Protocol
The form has been revised so that a member of the IACUC can review and approve amendments instead of only the chairperson.Request for a Procedural Change to an Animal Use Protocol
The last paragraph has been revised to more accurately describe the process of the review of procedural changeRevisions Approved to IACUC Policies at the September 28, 2007 IACUC Meeting:
• Replace Vice President for Research with Institutional Official throughout the policy
• Update the regulatory, guidance, and training links throughout policy.
• Section III, item 11 is revised so amendments can be reviewed and approved by an IACUC member (previously reviewed by the Chairperson).
BEGINNING JULY 1, 2007 - ALL PRINCIPAL INVESTIGATORS MUST COMPLETE AND RETURN THE
REQUEST FOR THE ANNUAL RE-CERTIFICATION OF RESEARCH PERSONNEL USING ANIMALS
Incomplete forms will be returned to the Principal Investigator and Annual Re-Certification compliance will not be confirmed until all required information has been provided.
The Principal Investigator will certify that all research personnel using animals within their laboratory meet the following requirements:
- Are LISTED legibly on the form (Additional forms may be used as needed to include all personnel)
- DEGREE included (If none, please indicate status, such as student, volunteer, etc.)
- IACUC CERTIFICATION NUMBER (required for all personnel listed)
- Review Comparative Medicine Current Topics webpage - CHECKED
- Understand the GUIDE For the Care and Use of Laboratory Animals, ANIMAL WELFARE ACT Title 9 CFR Subchapter A, PHS POLICY On Humane Care and Use of Laboratory Animals, IACUC POLICIES, and Standards of Accreditation by the AAALAC - CHECKED
- UNDERSTAND that preclinical studies that support or are intended to support permit applications to the FDA should be conducted in accordance with Title 21 CFR, Part 58, GOOD LABORATORY PRACTICE… CHECKED
- Have received adequate PROTOCOL and SPECIES specific TRAINING - CHECKED
- Have ACCESS to and ASSIST with research or teaching involving animals in the FACILITIES INDICATED - CHECKED
- And research involving animals is supported by the LISTED IACUC APPROVED PROTOCOLS
ADDITIONAL NEW INFORMATION REQUIRES THAT THE PRINCIPAL INVESTIGATOR CERTIFY THAT ALL RESEARCH PERSONNEL:
- Have had NO CHANGES, or have HAD CHANGES during the past 12 months in research duties and/or associated hazards that could result in possible exposures requiring additional occupational health care services
If any research personnel or duties and/or associated hazards have changed; all three sections of page 2 must be completed for each research individual as follows:- FIRST SECTION Requires name(s) and information check marked regarding the type of change(s)
- SECOND SECTION Provides information on the change(s) in status of personnel OTHER THAN A HEALTH CONDITION
- THIRD SECTION Provides personnel contact information for the Occupational Health Care Physician concerning any CHANGES IN HEALTH
NEW FEES FOR SERVICES, PER DIEMS & PORTABLE EQUIPMENT
The newly revised fee schedule is attached, and is also available on the Comparative Medicine website at http://www.research.usf.edu/cm/ppd_a.htm.
Fee increases that will take effect July 1, 2007 are as follows:
Comparative Medicine Announcement January 16, 2007 - Murine Norovirus:In its efforts to continue to provide research faculty with a service of specific pathogen-free (SPF), viral antibody-free (VAF) animal procurement, husbandry, health surveillance, and quality control that contributes to research data integrity and reproducibility, effective January 16, 2007, Comparative Medicine will begin efforts to exclude an additional, newly recognized murine pathogen from all mice held on behalf of research faculty in the Stabile Research Building animal facility.
Certainly you will recall that the difficulty of infectious agents, apart from the obvious potential for clinical morbidity and mortality of unique models, is that they interfere with the normative responses of even asymptomatic mice, including altering numerous cell biological responses in vitro, resulting in data variation and the misinterpretation of results.
The following pathogen summary has been added to the Infectious Agent Exclusion List for Mice, viewable at http://www.research.usf.edu/cm/AnimalHealthSurveillance.htmMURINE NOROVIRUS
Etiology: MNV, genus Calicivirus; “Norwalk-like”; non-enveloped; multiple serotypes; tropism for macrophages and dendritic cells.
Transmission: fecal shedding, possibly oral and respiratory; very low infective dose, persistent in environment, requires = 10 mg/liter of chlorine to inactivate; widespread serologic evidence of exposure in conventional colonies (>20%).
Clinical: disease described only in strains lacking components of the innate immune system (i.e., STAT1, a/ß and ?-interferon receptors).
Pathology: STAT1 nullizygous mice develop pneumonia, liver fibrosis, and loss of splenic architecture; RT-PCR detection of virus in multiple organs including the intestines, and in feces; RAG2 nullizygous mice become persistently infected, but with limited mortality following oral innoculation; wild-type 129 mice remain asymptomatic and lack tissue pathology after oral inoculation.
Significance: newly recognized pathogen; widespread serologic evidence of exposure; interference with inter-institutional transfers.
If sentinels representing mice held on your behalf show evidence of exposure to MNV and efforts to exclude it from your housing room are planned, Comparative Medicine will contact you regarding steps to be taken.
Certainly, every effort will be made to avoid interfering with the successful progress of your research.
No changes in husbandry procedures or primary enclosures are recommended at this time.
Regardless, if for any reason you wish to consider a change in primary enclosure, both sterile and clean caging can be provided in accordance with appropriate husbandry fees viewable at http://www.research.usf.edu/cm/ppd_a.htm
CURENT TOPICS IN ANIMAL CARE AND USE 10/06
Forms Revised at the October 27, 2006 IACUC Meeting:
The following application form was revised by the IACUC at its October 27th meeting and is now available on the Comparative Medicine Website or at any of our facilities:
- Application for the Use of Animals in Research
Revisions Approved to IACUC Policies at the October 27, 2006 IACUC Meeting:
III.19. 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 federal or major 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 completing and submitting a Request to Amend an Animal Use Protocol form. A single IACUC protocol cannot be used to represent the animal use activities of multiple research grants or contracts each with budgets to purchase, maintain, and use animals, unless written assurance of appropriate cost allocation is provided by an administrator responsible for the distribution of the funds, whose appointment is with the University or the affiliated institution where the funds are deposited, and this assurance is copied to the Institutional Representative (i.e., the Vice President for Research). A single research grant or contract may be represented by more than one IACUC-approved protocol.
CURENT TOPICS IN ANIMAL CARE AND USE 09/06
Revisions Approved to IACUC Policies at the September 22, 2006 IACUC Meeting:
III.2. The IACUC has authority to review, approve, or require modification in order to secure approval, or withhold approval of proposed research or teaching using vertebrate animals, review the facilities and program for animal care and use, including laboratories outside of animal facilities where procedures are performed, review and, if warranted, investigate concerns involving the care and use of animals, prepare written reports of its evaluations, make recommendations to the Vice President for Research concerning any aspect of the animal care and use program, and suspend any activity involving animals that does not conform to the Guide, AWA, PHS Policy or the IACUC Policies.
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 and pre-reviewed by University veterinarians prior to its submission to the IACUC for full committee consideration by attaching an electronic-version of it to an e-mail addressed to CompMed@research.usf.edu . All vertebrate animal use must then be proposed to, and approved by the IACUC on either an 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 Mouse Colony, an Application for Antisera Production, or an Application for Use of Animal Tissues, prior to the initiation of that activity, regardless of where it will be performed.
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 Chairperson 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 Mouse Colony protocol must be accompanied by the grant proposal, with all approved revisions, and are subject to full IACUC review. Procedural changes, including requests for additional animals to be made available to the protocol, 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. On the day of receipt, the IACUC administrative staff must forward the electronic form of the request to the full IACU membership for their consideration. The IACUC Chair, the Associate Director of Comparative Medicine, and a third IACUC member are assigned as primary reviewers of each request. Within 3 days of receipt, any member of the full IACUC can call for a review of a request for a procedural change at the next regular IACUC meeting. A request for procedural change not added as an agenda item to the next regular IACUC meeting is reviewed by the IACUC Chair, and the two assigned IACUC members within 7 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. Requested changes added as agenda items to the next regular IACUC meeting, or not unanimously approved by the primary reviewers, are 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 PI, 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 Mouse 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.
III.14. All live vertebrate animals used in research, teaching, or testing at the University, or at University-affiliated hospitals or institutes, or by University faculty at other sites other than studies of wild animals in natural settings, must be procured by the Division of Comparative Medicine, and housed and cared for within one of the AAALAC-accredited animal facilities managed by Comparative Medicine, unless declared in writing under item 14, page 4 of the Application for the Use of Animals in Research, and approved by the IACUC.
III.15. 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 animal tissues are followed, and with appropriate consideration of occupational health and safety, and public relations issues associated with their use, an Application for Use of Animal Tissues must be submitted whenever 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 Comparative Medicine within 7 days of receipt, forwarded to the IACUC Chairperson for approval, and approval communicated to the full IACUC at the next regularly scheduled meeting.
III.16. Use of tissues from animals euthanatized for other purposes or derived from other sources (i.e., slaughter-house, or biological supply houses) reduces the overall number of animals used in research and teaching, and is encouraged by the IACUC. When working under an IACUC-approved Application for Use of Animal Tissues, animals may not be euthanatized for the sole purpose of deriving the tissues, and no protocol-specific ante mortem manipulations may be part of the protocol. Tissues may only be derived as a by-product from animals euthanatized under other IACUC-approved protocols, or from other sources (e.g., slaughter-house tissues).
V.3. In accordance with the recommendations made in the Occupational Health and Safety in the Care and Use of Research Animals, Comparative Medicine requires a Health and Risk Assessment for each research and animal care staff member, and all personnel whose duties require access to animal facilities (e.g., physical plant personnel).
V.4. In accordance with the recommendations in the Occupational Health and Safety in the Care and Use of Research Animals, and those in the Biosafety in Microbiological and Biomedical Laboratories, occupational health care services are required for personnel proposing animal use involving infectious agents that need biosafety level 3 containment, or involving unvaccinated or uncharacterized carnivores, pregnant sheep, goats or cattle, or nonhuman primates. Health Administration, Infectious Diseases, College of Medicine contributes to the comprehensive occupational health care services offered to all individuals involved in such animal care and use.
V.9. Current pharmaceutical and biological products must be used in all aspects of animal care and use.
V.13. Prior to departure of employment, faculty must complete an out-processing checklist with the Assistant Director, which delineates the affected IACUC protocols, describes the final disposition of animals, the disposition of any PI-owned equipment and supplies, ensures that all costs will be covered, and ensures that access to animal facilities has been withdrawn.
VI.2. Applicants must declare on item #15, page 4 of the Application for the Use of Animals in Research whether a proposed study will be conducted in accordance with 21 CFR 58 regulations, and attach a copy of the GLP Study protocol.
VII.1. Comparative Medicine, Health Administration, and an occupational health physician offer to all personnel who will be working with animals information regarding health monitoring, potential zoonoses, and health assessments and immunizations relating to their animal contact and/or exposures.
VII.2. Personnel whose duties require access to an animal facility and new research and animal care personnel must submit a completed Health and Risk Assessment s form to Comparative Medicine.
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 will be offered the opportunity to complete a Comprehensive Health Assessment form.
VII.4. Information regarding potential zoonosis and practices of personnel hygiene which limit exposure and risk of contracting zoonosis are provided. The nature of noxious, toxic, hazardous, infectious or carcinogenic agents or compounds when used are posted on the door of the room containing the animal collection exposed to such agents.
VII.5. Individuals are expected to notify their supervisor of suspected health hazards. Whenever work related accidents, injuries, or illnesses occur, individuals are required to report these to their supervisor.
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.
VIII.5. 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 arranged. During orientation, facility managers and training coordinators must complete an Orientation of Research Staff or Orientation of Animal Care Staff form, as appropriate. 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 Surgical Core Manager by completing a Certification of Research Personnel Using Controlled Substances form in accordance with Policy XIV.2.
VIII.13. Comparative Medicine reviews all applications for animal tissue use to ensure that practices of acquisition, use, and disposition of vertebrate animal tissues are appropriately described, and appropriate occupational health and safety issues are considered.
VIII.14. PIs and relevant staff not previously certified for live animal use are assigned a registration number by Comparative Medicine. A registration number is assigned to an investigator for each tissue application and is good for the life of the protocol (i.e., 3 years).
IX.6. All reports of alleged animal welfare concern, deficiency, or noncompliance are forwarded to the IACUC c/o Research Integrity & Compliance. The subject Principal Investigator is informed of the allegation in writing by the IACUC Chairperson and may be asked to respond in writing and/or invited to meet with the IACUC to respond to questions regarding the alleged deficiency.
XI.4. Transfer of animals from one IACUC-approved research use (excluding mouse production as described in an IACUC-approved Application to Establish/Maintain a Mouse Colony) 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. An approved reassignment of animals from one IACUC-approved research protocol to a new IACUC protocol becomes effective on the date of the transfer, and all animal per diem, identifying cards, and inventories are changed to reflect this reassignment. Reassignment of naïve mice originating from an IACUC-approved mouse colony protocol to an initial IACUC-approved research protocol is accomplished by notifying the facility manager, who completes a Request to Reassign Locally Produced Mice to a Research Protocol 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 the Program Coordinator of Comparative Medicine if the reassignment necessitates a physical relocation of mice.
XIV.4. Registered faculty must procure all controlled substances from the Division of Comparative Medicine. Controlled substance distribution to faculty located at All Children’s Hospital and the J.A. Haley V.A. Hospital are made through the Facility Manager at those locations; all other distributions are from the College of Medicine Facility, c/o the Surgical Core Manager at MDC 20, phone 974-5001, or fax 974-7552.
XVII.1. When designing an antiserum production protocol, the applicant for animal use is directed to SOP #023 Production of Polyclonal Antibodies in Rabbits and reviews of adjuvants and procedures of polyclonal antibody production, such as Antibodies: A Laboratory Manual, E. Harlow, & D. Lane, Cold Spring Harbor Laboratories, 1988, and those published by the National Research Council, National Academy of Science in the Institute of Laboratory Animal Research (ILAR) Journal, volume 37, number 3, pages 93-124, 1995; and volume 46, number 3, pages 241-257 and pages 269-279, 2005.
XVII.10. Euthanasia: Animals will be euthanatized by administering either 150 mg/kg Pentobarbital or 1 ml/4.5 kg Euthasol IV, or if requested by the PI, will be deeply anesthetized with 40-45 mg/kg Ketamine and 5-8 mg/kg Xylazine IM, exsanguinated, and death assured by the absence of cardiovascular and respiratory movements. Death, other than death from euthanasia, is not an endpoint.
XVII.11. Test Substances: Adjuvants and antigenic substances will be administered. When using Freunds’ adjuvants, complete Freund's adjuvant (CFA) will be used only for the primary immunization. Incomplete Freund's adjuvant (IFA) will be used in the subsequent immunizations. CFA and IFA will only be administered by the subcutaneous or intramuscular routes. Intraperitoneal, intravenous, or footpad injections are not acceptable routes of administration. Alternative adjuvant systems should be considered whenever possible. The Ribi adjuvant system consists of monophosphoryl lipid A, synthetic trehalose dicorynomycolate, and cell wall skeleton, and recommendations of the manufacturer are followed (Ribi Immunochem Research, Inc., 406-363-6214). The Titermax adjuvant system consists of a block copolymer CRL-8941, and recommendations of the manufacturer are followed (Hunter’s Titermax 800-345-2987).
XVII.14. Maximal volume of antigen-adjuvant emulsion per site, maximal number of sites of administration/animal, the gauge of needle to be used for each route are; for subcutaneous, 200 µl/site at <12 sites/animal using a 23-25 g. needle; for intradermal, 100 µl/site at <10-12 sites/animal using a 25 g. needle; and for intramuscular, 500 µl/site at <3 sites/animal using a 23-25 g. needle.
XVII.17. Specimen Collection, Ante Mortem: Blood (5-10 ml) is drawn prior to immunizations, and 12-14 days following each immunization. Animals are carefully restrained, and in some cases tranquilized with 1-3 mg/kg Acepromazine IM for phlebotomies. Blood is drawn from the marginal ear veins or auricular artery using a 25 g. needle/butterfly. When an adequate titre is detected, approximately 2.5 ml/lb (5.5 ml/kg) body weight of blood is collected every 14 days as needed. Additional immunizations and bleedings at appropriate intervals that reflect this schedule may be performed to ensure that this animal use results in the production of a high titre of useful antibody. Terminal exsanguination of anesthetized animals by cardiac puncture using an 18 g. needle is accomplished when a sufficient volume of high titre antigen-specific antiserum has been collected.
XXIII.24. The PI must assist the University with tracking its field research activities by reporting episodes of wild animal use, the approximate range of taxa, and the approximate number of animals encountered or used to the IACUC c/o Research Integrity & Compliance at intervals appropriate to the study, but at least once each year. Reported animal numbers are tabulated by Comparative Medicine.
CURENT TOPICS IN ANIMAL CARE AND USE 04/06
Forms Revised at the April 28, 2006 IACUC Meeting:
- Request to Amend An Animal Use Protocol
- Application for the Use of Animal Tissues
CURENT TOPICS IN ANIMAL CARE AND USE 02/06
Revisions Approved to IACUC Policies at the February 24, 2006 IACUC Meeting:
III.8. The electronic version of a draft application must be submitted for veterinary pre-review to CompMed@research.usf.edu by the veterinary pre-review submission deadline viewable at http://www.research.usf.edu/cm/calendar.htm. University veterinarians are required to provide applicants, by return e-mail within 7 days, with comments and suggestions that may help the IACUC better understand the proposed research involving animals. Applicants may choose to revise their IACUC application by incorporating changes suggested by veterinarians. Making any addendum, change, or elaboration suggested by the veterinarians does not in any way guarantee or constitute an approval by the IACUC, but should help the IACUC understand better the research plan involving animals.
III.9. Applicants must submit their application in its final form to Research Integrity & Compliance at MDC 35 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, are viewable at http://www.research.usf.edu/cm/calendar.htm, and are dates by which the application must be received in final paper form. An electronic version of the application can be submitted to IACUC@research.usf.edu , but at least the original cover page signed by the principal investigator must be mailed to Research Integrity & Compliance at MDC 35.
III.10. The narrative of the federal or major funding agency grant, with all approved revisions, that will support the proposed animal use must accompany the protocol application to the IACUC, either as an electronic-version submitted to IACUC@research.usf.edu or as a paper copy mailed c/o Research Integrity & Compliance at MDC 35. The federal or major 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., 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 protocol application and the federal and major 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 an Application to Establish/Maintain a Mouse Colony, with proposed support from a federal or major funding agency is contingent on comparable protocol and proposal titles and narratives.
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 Chairperson 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 Mouse Colony protocol must be accompanied by the grant proposal, with all approved revisions, and are subject to full IACUC review. Procedural changes, including requests for additional animals to be made available to the protocol, 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. On the day of receipt, the IACUC administrative staff must forward the electronic form of the request to the full IACU membership for their consideration. The IACUC Chair, the Associate Director of Comparative Medicine, and a third IACUC member are assigned as primary reviewers of each request. Within 3 days of receipt, any member of the full IACUC can call for a review of a request for a procedural change at the next regular IACUC meeting. A request for procedural change not added as an agenda item to the next regular IACUC meeting is reviewed by the IACUC Chair, and the two assigned IACUC members within 7 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. Requested changes added as agenda items to the next regular IACUC meeting, or not unanimously approved by the primary reviewers, are reviewed by the full IACUC committee at the next regular monthly meeting. 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 PI, 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 Mouse 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.
III.20. 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 is contingent on a pre-performance meeting involving the PI and relevant staff that represents the applicant’s laboratory, the Division of Comparative Medicine, the IACUC, and the appropriate Safety Committee(s). This pre-performance meeting is required in order 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.22. 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, the Vice President for Research, 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 Vice President for Research 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 or send their alternate as assigned by the Chairperson. The Vice President for Research can dismiss IACUC members and alternates that do not contribute to inspections.
XII.7. 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 (Category C research), the investigator has justified such in writing, and the IACUC has approved such practices. The selection of an appropriate analgesic involves consideration of the level of animal pain anticipated or presumed, the species involved, and the experimental protocol. Severe pain, such as may occur during the post-operative period, can be alleviated by the administration of narcotic analgesics, (e.g., buprenorphine, an opioid partial agonist). Non-steroidal anti-inflammatory drugs, with or without the infusion of local anesthetics, can control mild to moderate pain, in some species, though is contra-indicated in others. Selection of an appropriate route of administration also involves consideration of the recipient species. For example, oral analgesic drug delivery to rodents (e.g., acetaminophen elixir added to the drinking water of rats) may not afford detectable analgesia.
XIII.1. In designing the experimental protocol, the applicant investigator is obligated to consult a USF veterinarian regarding research animal issues, including anesthesia and analgesia. The applicant investigator is compelled to institute adequate practices of anesthesia and analgesia. 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 (Category C research), the investigator has justified such in writing, and the IACUC has approved such practice.
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 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.
XV.5. For all vertebrate survival surgical procedures, the surgeon must wear sterile gloves and a clean laboratory coat, and a surgical mask is recommended during major procedures.
XV.6. Surgical procedures involving non-USDA species must be conducted in a designated, uncluttered area, on a bench top or hood surface top, which has been cleaned and treated with an appropriate disinfectant (i.e., Clidox®, Clorox®, Sporicidin®, etc) prior to any procedure. , . Alcohol as a sole disinfectant of the work surface is not appropriate. (Refer to SOP #412 Rodent Surgery).
XV.7. For all species, in-date 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 (Category C research), the investigator has justified such in writing, and the IACUC has approved such practice.
XV.9. Mammalian post-operative recovery must incorporate the use of an approved ancillary heat source or in an otherwise warm environment, and under direct supervision until the patient animal has fully recovered from anesthesia (i.e., sternal recumbency and intentional movement).
XV.10. Log entries describing surgical events or procedures requiring a surgical plane of anesthesia involving USDA regulated species must be kept by the PI, in the animal facility, on a Surgical Record form, or Record of General Anesthesia form, or Rodent Surgical/Procedural Record form (provided by Comparative Medicine). 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.
XV.11. Post-operatively/procedurally, following recovery from a surgical plane of anesthesia, nonrodent mammals must be clinically evaluated (e.g., heart or pulse rate, respiratory rate, mucous membrane color or capillary refill time, and body temperature) and observations recorded by the research staff at least once between post-operative/procedural days 1-3. Daily entries of animal health assessment must be made on post-operative days 1, 2, and 3 for all USDA regulated species. This must be done in the medical log, on forms provided by Comparative Medicine. In addition, the dose and route of all post-operative/procedural analgesics, antibiotics, and treatments, and the date of skin suture removal, when applicable, must be noted.
XV.13. Nonmammalian surgical procedures are conducted in a designated, uncluttered area, which has been cleaned and treated with an appropriate disinfectant (i.e., Clidox®, Clorox®, or Sporicidin®) prior to any procedure. Alcohol as a sole disinfectant of the work surface is not appropriate.
XIX.5. Although an animal medical record may be initially established by Comparative Medicine, it is maintained by the PI and associated research staff. Individual animal medical records of all nonrodent mammals must at least include an Arrival Status form that describes the condition and characteristics of each animal upon arrival, and Progress Notes forms that record items described in IACUC Policy XIX., each provided by Comparative Medicine.
XIX.6. Log entries that must be made by the PI and research staff on Progress Notes forms provided by Comparative Medicine include describing all procedures, substance administrations, tissue collections, observations, treatments, or uses involving USDA regulated species. Procedures or assessments that are approved by the IACUC must be performed and recorded by the PI and research staff at intervals indicated in the approved protocol. Logs maintained for USDA regulated species must be kept by the research staff in the animal facility.
XIX.7. Medical records of all USDA regulated species must also include weekly entries made by the research staff on Progress Notes forms, which at least summarize, an impression of overall condition, food and water intake, and voidings, any clinical abnormalities or complications, any treatments administered in response to observed abnormalities, and any experimental procedures.
XIX.8. Medical records of nonrodent mammalian species, with the exception of nonhuman primates, must include a monthly clinical entry re-characterizing the condition of the animal, conducted by the veterinary and/or animal care staff. Nonhuman primate medical record entries will occur in conjunction with tuberculin skin testing and physical examinations. Entries re-characterizing the condition of non-rodent mammals should include the animal’s body weight, body temperature, heart or pulse rate, respiratory rate, and mucous membrane color or capillary refill time, and are logged on Progress Notes forms.
XIX.9. When clinical abnormalities are recognized in USDA regulated species, the PI and research staff must make entries in the medical record, which at least document, the abnormal physical/physiological parameters observed, a description of specimens taken for diagnosis, the laboratory/diagnostic findings, and treatment(s) initiated.
XIX.10. Log entries describing surgical events or procedures requiring a surgical plane of anesthesia involving USDA regulated species must be kept by the PI, in the animal facility, on a Surgical Record form, or Record of General Anesthesia form, or Rodent Surgical/Procedural Record (provided by Comparative Medicine). Log entries must include, as a minimum, the following, (A) a pre-operative/procedural assessment, (B) an anesthetic plan, (C) records of the induction and of the monitoring of general anesthesia, (D) a brief description of the surgical or other procedure(s) performed, (E) an intra-operative/procedural assessment, (F) a record of recovery from anesthesia (or method of euthanasia while the animal is anesthetized), (G) a post-operative/procedural assessment, and (H) any complications, treatments, and/or plans, as requested on the appropriate form.
XIX.11. Post-operatively/procedurally, following recovery from a surgical plane of anesthesia, nonrodent mammals must be clinically evaluated (e.g., heart or pulse rate, respiratory rate, mucous membrane color or capillary refill time, and body temperature) and observations recorded by the research staff at least once between post-operative/procedural days 1-3. Daily entries of animal health assessment must be made on post-operative days 1, 2, and 3 for all USDA regulated species. This must be done in the medical log, on forms provided by Comparative Medicine. In addition, the dose and route of all post-operative/procedural analgesics, antibiotics, and treatments, and the date of skin suture removal, when applicable, must be noted.
XIX.14. Research staff must make entries to the medical records of USDA regulated species that summarize the clinical diagnostic and necropsy findings of an unanticipated animal morbidity or mortality that occurs unrelated to the protocol, so that research methods can be refined.
XIX.15The final disposition of USDA regulated species must be clearly described in the animal’s medical record and filed with the facility manager of Comparative Medicine when completed.
XXIV.1. No member of the IACUC may participate in the review, discussion, or vote of a project or activity in which he/she has a conflicting interest. The IACUC member will be requested to leave the room prior to the discussion, review, and vote of the project and cannot be counted toward the quorum. The excused member can be recalled to provide information that is requested by the IACUC.
XXV.1. University research records are subject to both federal and state laws. Requests for information under the federal Freedom of Information Act (FOIA) should be made to Research Integrity & Compliance at 974-3234. Requests for information under the Florida Public Records Law should be made to USF General Counsel at 974-2734.
CURENT TOPICS IN ANIMAL CARE AND USE 10/05
Revisions Approved to IACUC Policies at the October 28, 2005 IACUC Meeting:
V.12 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.
V.13 When faculty anticipate relocating to another institution, prior to departure, faculty must complete an out-processing checklist with the Assistant Director, which delineates the affected IACUC protocols, describes the final disposition of animals, the disposition of any PI-owned equipment and supplies, ensures that all costs will be covered, and ensures that access to animal facilities has been withdrawn.
CURENT TOPICS IN ANIMAL CARE AND USE 09/05
Revisions Approved to IACUC Policies at the September 23, 2005 IACUC Meeting:
IV.4. The applicant Principal or Secondary Investigator must have a faculty appointment with the University or an appropriate VA appointment with the James A. Haley Veteran's Administration Medical Center.
CURENT TOPICS IN ANIMAL CARE AND USE 08/05
Revisions Approved to IACUC Policies at the August 26, 2005 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 Chairperson 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 Mouse Colony protocol must be accompanied by the grant proposal, and are subject to full IACUC review. Procedural changes, including requests for additional animals to be made available to the protocol, 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. On the day of receipt, the IACUC administrative staff must forward the electronic form of the request to the full IACUC membership for their consideration. The IACUC Chair, the Associate Director of Comparative Medicine, and a third IACUC member are assigned as primary reviewers of each request. Within 3 days of receipt, any member of the full IACUC can call for a review of a request for a procedural change at the next regular IACUC meeting. A request for procedural change not added as an agenda item to the next regular IACUC meeting is reviewed by the IACUC Chair, and the two assigned IACUC members within 7 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. Requested changes added as agenda items to the next regular IACUC meeting, or not unanimously approved by the primary reviewers, are reviewed by the full IACUC committee at the next regular monthly meeting. Changes, such as a change in PI, 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 Mouse 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.
CURENT TOPICS IN ANIMAL CARE AND USE 03/05
Revisions Approved to IACUC Policies at the February 25, 2005 IACUC Meeting:
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. The Director or Associate Director can interrupt any activity that jeopardizes the welfare of an animal.
V.7. The Director of Comparative Medicine has management and administrative authority regarding 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.
CURRENT TOPICS IN ANIMAL CARE AND USE 09/04
Revisions Approved to IACUC Policies at the September 24, 2004 IACUC Meeting:
X.4. If the IACUC suspends an activity involving animals, the Institutional Official, in consultation with the IACUC, shall review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation to USDA/APHIS and PHS/OLAW, AAALAC, and the federal and/or major agency funding that activity.
IX.4. Such reports, suggestions, complaints, or compliments are made with protection of the reporting individual from any discrimination or reprisal.
CURRENT TOPICS IN ANIMAL CARE AND USE 06/04
Revisions Approved to IACUC Policies at the May 28, 2004 IACUC Meeting:
III.1. New IACUC members are required to complete the two web-based training modules viewable at http://www.researchtraining.org/ entitled “Essentials for IACUC Members” and “Working with the IACUC”. IACUC members with VA affiliation must also complete “Working with the VA IACUC” viewable at http://www.researchtraining.org/. New IACUC members are required to attend a formal session of orientation and training by the IACUC administrative staff regarding the functions of the IACUC, and the regulations, policies and procedures that govern the University’s Animal Care and Use Program, as itemized in PHS Policy IV.B.1-8. IACUC members or alternates that do not comply with training requirements are provided written notification from the IACUC Chairperson that training requirements must be completed within 30 days. Failure to comply after said written notification can result in dismissal from the IACUC by the Vice President for Research.
III.4. IACUC members and alternates are appointed by the Vice President for Research, and are listed on the IACUC rosters submitted to the PHS. A specific one-to-one designation of IACUC members and alternates is made to ensure that the committee is properly constituted at all times. An alternate may not contribute to the formation of a quorum or vote unless the member for whom they substitute is not available. 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. IACUC members must attend each regular monthly meeting or send their alternate. IACUC members must notify the IACUC administrative staff of planned absences prior to protocol review assignments. When both an IACUC member and their alternate are 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. The Vice President for Research can dismiss IACUC members and alternates absent from more than three regular monthly meetings in a calendar year.
III.20. 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 is contingent on a pre-performance meeting involving staff that represents the applicant’s laboratory, the Division of Comparative Medicine, the IACUC, and the appropriate Safety Committee(s). This pre-performance meeting is required in order 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.22. 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, the Vice President for Research, 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 the Vice President for Research, and copies the IACUC Chairperson, 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 or send their alternate as assigned by the Chairperson. The Vice President for Research can dismiss IACUC members and alternates that do not contribute to inspections.
V.8. 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 policies 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 Policies.
VIII.5. All new personnel 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 arranged. During orientation, facility managers and training coordinators must complete a Orientation of Research Staff or Orientation of Animal Care Staff form, as appropriate. 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 Surgical Core Manager by completing a Certification of Research Personnel Using Controlled Substances form in accordance with Policy XIV.2.
VIII.7. Comparative Medicine must coordinate additional assistance with species-specific or protocol-specific techniques whenever new or infrequently used species or techniques are introduced or re-introduced to campus, and/or whenever additional individual instruction is requested by research faculty or staff, and/or whenever additional individual instruction is required by the IACUC or veterinarians. Comparative Medicine maintains a data base of training accomplished for each IACUC certified individual to ensure taht all faculty and staff are appropriately trained and experienced. Comparative Medicine utilized the training database whenever making work assignments, to ensure that selected IACUC certified individuals are appropriately trained and experienced for their assignments.
IX.1. Reporting concerns, deficiencies, or observations made regarding the adequacy or appropriateness of the facilities, program, policies, or procedures contributes to the oversight, development, and improvement of the program for animal care and use, and contributes to the resolution of the concern or deficiency.
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 (745-6852, 974-9260, 974-4935, 974-9842), or administrative staff (974-7556, 974-9876), or to the IACUC c/o Research Compliance (974-0954, 974-7104, 974-7106), or directly to the IACUC Chairperson (972-2000 X7961), or IACUC Vice Chairperson (979-7202), or to the Institutional Official of the Animal Care and Use Program, the Vice-President for Research(974-5481).
IX.3. This reporting-feedback mechanism of observations made regarding the practices of animal care and use within these laboratories, contributes an important oversight, and assists in the continuous development of the animal program.
IX.4. Such reports, suggestions, complaints, or compliments are made with complete anonymity and protection of the reporting individual from any discrimination or reprisal.
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. The Director or Associate Director can interrupt any unapproved activity that jeopardizes the welfare of an animal.
IX.6. All reports of alleged animal welfare concern, deficiency, or noncompliance are forwarded to the IACUC c/o Research Compliance. The subject Principal Investigator is informed of the allegation in writing by the IACUC Chairperson and may be invited to meet with the IACUC to respond to questions regarding the alleged deficiency.
IX.7. The IACUC deliberates regarding the reported alleged deficiency at its next regularly scheduled monthly meeting, or the IACUC Chairperson can call an emergency quorum to discuss the issue in advance of a regular meeting if deemed necessary. The IACUC Chairperson can choose to invite involved personnel to the meeting to whom questions can be directed. The IACUC reports the findings of its deliberations to the PI and the Vice President of Research.
IX.8. Any serious or continuing non-compliance with PHS Policy, any serious deviation from the provisions of the Guide, and any suspension of any activity by the IACUC is communicated by Comparative Medicine via telephone to the Office of Laboratory Animal Welfare (OLAW) in a timely manner. After IACUC review, institutional resolution, and reporting to the Vice President for Research, the Vice President for Research submits a formal report describing the circumstances and actions taken to OLAW and other relevant agencies.
XII.10. When proposing Research 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 humane euthanasia of the animals will be accomplished. The earliest possible clinical endpoint that will contribute to the resolution of the hypothesis must be identified and utilized. If avoidance or alleviation of animal pain or discomfort adversely affects the protocol, the PI must provide a detailed justification of why treatments cannot be initiated. When identifying the earliest clinical endpoint in applications to the IACUC, the PI should consider proposing both early notification criteria (e.g., tumor diameter) which when met causes staff to alert the PI to consider whether study objectives have been met, and also later exclusion criteria (e.g., larger tumor diameter, and/or complications referable to the tumor) which when met requires the euthanasia of the animal. When identifying the earliest clinical endpoint, the PI should refer to section C.2.c. of the ARENA/OLAW Guidebook entitled "Humane Endpoints” viewable at http://grants1.nih.gov/grants/olaw/GuideBook.pdf, and to the “Guidelines for Completing an Application to the IACUC” viewable at http://www.research.usf.edu/cm/applicationsb.htm.
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 must 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. The Program Coordinator will not approve a Request to Relocate Research Animals that lists mammals, which have undergone general anesthesia within 14 days of the date requested for animal relocation.
XIX.10. Log entries describing surgical events or procedures requiring a surgical plane of anesthesia involving nonrodent mammalian species must be kept by the PI, in the animal facility, on a Surgical Record form or a Record of General Anesthesia (provided by Comparative Medicine). Log entries must include, as a minimum, the following, (A) a pre-operative/procedural assessment, (B) an anesthetic plan, (C) records of the induction and of the monitoring of general anesthesia, (D) a brief description of the surgical or other procedure(s) performed, (E) an intra-operative/procedural assessment, (F) a record of recovery from anesthesia (or method of euthanasia while the animal is anesthetized), (G) a post-operative/procedural assessment, and (H) any complications, treatments, and/or plans, as requested on the Surgical Record form or the Record of General Anesthesia.
XIX.11. Post-operatively or following recovery from a surgical plane of anesthesia, the heart or pulse rate, respiratory rate, mucous membrane color or capillary refill time, and body temperature of nonrodent mammals must be recorded by the research staff at least once between post-operative/procedural days 1-3. Daily entries must be made on post-operative days 1, 2, and 3. This must be done in the medical log, on forms provided by Comparative Medicine. In addition, the dose and route of all post-operative/procedural analgesics, antibiotics, and treatments, and the date of skin suture removal, when applicable, must be noted.
CURRENT TOPICS IN ANIMAL CARE AND USE 03/04
Revisions Approved to IACUC Policies at the March 26, 2004 IACUC Meeting:
IACUC Policy III.1 is revised to read as follows:
III.1. New IACUC members are required to complete the two web-based training modules entitled "Essentials for IACUC Members", and "Working with the IACUC" viewable at http://www.researchtraining.org/. IACUC members with VA affiliation must also complete "Working with the VA IACUC", viewable at http://www.researchtraining.org/ . New IACUC members are required to attend a formal session of orientation and training by the IACUC Coordinator regarding the functions of the IACUC, and the regulations, policies and procedures that govern the University's Animal Care and Use Program, as itemized in PHS Policy IV.B.1-8.
New IACUC Policy V.11:
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/readingroom/books/labrats/, with the following variances. 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. Males of aggressive strains (e.g., BALB/c, SJL, 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 as a source of cells or tissues promptly by postnatal day 7, 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.
Policy XXIII.24 is revised to read:
XXIII.24. The PI must assist the University with tracking its field research activities by reporting episodes of wild animal use, the approximate range of taxa, and the approximate number of animals encountered or used to the IACUC c/o Comparative Medicine at CompMed@research.usf.edu or by telephone 979-6744, at intervals appropriate to the study, but at least once each year.
CURRENT TOPICS IN ANIMAL CARE AND USE 11/03
Revisions Approved to IACUC Policies at the November 14, 2003 IACUC Meeting:
III.13. 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, and by posting a printed announcement at UPC 523, University Professional Center, 3500 E. Fletcher Ave., at least 72 hours in advance of the special meeting. IACUC members are required to attend each monthly meeting or to send their designated alternate who is prepared to “vote their conscience” as opposed to representing the IACUC member’s review(s) of their assigned IACUC application(s). 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 Mouse 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 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.
CURRENT TOPICS IN ANIMAL CARE AND USE 8/03
Forms Revised On or Before the August 22, 2003 IACUC Meeting:
- Request to Amend an Animal Use Protocol
- Request for a Procedural Change to an Animal Use Protocol
Revisions Approved to IACUC Policies at the August 22, 2003 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 minor, 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, 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 Chairperson 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 Mouse Colony protocol must be accompanied by the grant proposal, and are subject to full IACUC review. Minor procedural changes, including requests for additional animals to be made available to the protocol, 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. The IACUC Chair, and two assigned IACUC members review requests for procedural changes within 7 days of receipt, and when unanimously agreed upon, approves the change, and this approval is communicated to the full IACUC membership at its next regular monthly meeting. Requested changes not unanimously approved by the reviewers, are submitted to the full IACUC committee to be reviewed at the next regular monthly meeting. Amendments and minor changes to existing protocols may be communicated to the funding agency at the discretion of the PI. Major changes (e.g., 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 Mouse Colony, or an Application for Antisera Production. The PI must obtain prior approval from the funding agency for major changes in scope, aims, objectives, or purpose of the research involving animals. Major 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.
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.
X.6. The PI is responsible for ensuring that adequate fiscal support has been retained, and is available for the procurement, care, and use of all animals registered under their IACUC-approved protocol(s) in their name. The PI must ensure that all costs invoiced to a grant account are allocable to the purpose of the grant. Cost 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 by month without establishing that the rotation schedule credibly reflects the relative benefit to each protocol is unacceptable. In the event that invoices served by Comparative Medicine to the PI remain unapproved for payment for longer than 30 days after the date of the invoice, accounting in Comparative Medicine will consider said invoices as past due, and inform the PI that payment must be received within another 30 days. In the absence of payment, all protocols of the involved PI can be interrupted by the IACUC, and animals can be reassigned, removed, or euthanatized. Requests for additional animals and/or services will not be filled by Comparative Medicine until full payment has been received.
XX.5. Decapitation or cervical dislocation of deeply sedated or anesthetized rodents and other small animals is an acceptable method of euthanasia when justified to, 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. Staff who intend to perform decapitation or cervical dislocation without sedation or anesthesia must have demonstrated competence under the observation of the Comparative Medicine Training Coordinator.
CURRENT TOPICS IN ANIMAL CARE AND USE 6/03
Revisions Approved to IACUC Policies at the May 23, 2003 meeting:
III.1. New IACUC members are required to complete the three web-based training modules entitled “Essentials for IACUC Members”, “Working with the IACUC”, and “Working with the VA IACUC” viewable at http://www.researchtraining.org/. New IACUC members are required to attend a formal session of orientation and training by the IACUC Coordinator regarding the functions of the IACUC, and the regulations, policies and procedures that govern the University’s Animal Care and Use Program, as itemized in PHS Policy IV.B.1-8.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 of an Application to Establish/Maintain a Mouse Colony, 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. The Mouse Models Core Laboratory, which provides genetic engineering mouse services, must request and receive from faculty requesting services a copy of their Application to Establish/Maintain a Mouse Colony and Non-Exempt Recombinant DNA Registration that describes the genotype or line and demonstrates IACUC and IBC approvals prior to beginning work. Once founders have been identified, the Mouse Models Core completes and submits a Request to Reassign Research Animals so that founders are transferred to the PI’s mouse colony protocol, and all subsequent costs of housing, care, and health evaluations are billed to the PI who requested core services. All colonies of locally produced or maintained mice must be represented by an IACUC-approved Application to Establish/Maintain a Mouse Colony. Mouse colony protocols must be amended using a Declaration of Emergent Phenotype and Request for a Procedural Change to a Mouse Protocol, whenever aspects of the emergent phenotype, recurring clinical condition(s), or an unanticipated outcome are recognized that were not described in the original Application to Establish/Maintain a Mouse Colony (refer to IACUC Policy XII.13). Research uses of locally produced unique lines of mice must be described in an Application for the Use of Animals in Research, and the produced mice transferred to the approved research protocols using a Request to Reassign Research Animals form. Such protocols describing the research uses of locally produced mice must also be amended using a Declaration of Emergent Phenotype and Request for a Procedural Change to a Mouse Protocol whenever aspects of the emergent phenotype, recurring clinical condition(s), or an unanticipated outcome are recognized.
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 minor, 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, 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 Chairperson 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 Mouse Colony protocol must be accompanied by the grant proposal, and are subject to full IACUC review. Minor procedural changes, including requests for up to 30% more animals to be made available to the protocol, can be proposed to the IACUC at its next regular monthly meeting, but must be justified in writing, within the scope of the original research hypothesis, involve the original species, and remain within the original Category of Research. Amendments and minor changes to existing protocols may be communicated to the funding agency at the discretion of the PI. Major changes (e.g., 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 Mouse Colony, or an Application for Antisera Production. The PI must obtain prior approval from the funding agency for major changes in scope, aims, objectives, or purpose of the research involving animals. Major 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.
III.13. The IACUC meeting schedule is viewable at http://www.research.usf.edu/cs/iacucschedule.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/cs/iacucschedule.htm, and by posting a printed announcement at UPC 523, University Professional Center, 3500 E. Fletcher Ave., at least 72 hours in advance of the special meeting. IACUC members are required to attend each monthly meeting or to send their designated alternate who is prepared to “vote their conscience” as opposed to representing the IACUC member’s review(s) of their assigned IACUC application(s). 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 Mouse 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 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, approve pending minor clarification, 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.
III.19. 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 federal or major 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 fun
