APSU IACUC Minutes from 2-6-07 Members Present: Members Absent: Sarah Lundin-Schiller, Chair Gilbert Pitts, Biology Philenese Slaughter, Library (non-scientist) Paul Nicodemus, Psychology Chiu-Fu Sheng, Student Representative Jack Caldwell, Agriculture Charles Pinder, Dean Graduate Studies (Ex officio) Jenifer Kennedy, Director Grants & Sponsored Programs (Ex officio) Ben Howard, D.V.M. (unaffiliated veterinarian) Amanda Fant, D.V.M. (affiliated veterinarian) Meeting called to order: 2:00 PM Quorum Status: 5 voting members required; 6 present. Old Business: 1) EEC Inspection Report was signed by members present and this was sent to be placed on file in Grants Office. 2) Minutes of 1-16-07 Approved; 6 in favor and 0 opposed; Also on file in Grants Office. New Business: 1) Protocol 07-005, Dr. Chad Brooks; Committee voted 6-0 to return for revision. The following items need to be clarified or revised: check the room number of the SSC animal facility; correct if necessary. Section IIB. Detail the volume of each injection given to the mice. Section IIB. Clarify numbers of animals; it is suggested that you state you will use 10 infected; 10 non-infected and that all organs will be analyzed from all animals. Section II B. Item 1, second sentence – correct “were” to “will be”. Section IIB. Add to the procedures the information which is given later in the form about taking ear punch biopsy twice per week. Section III B. Clarify sentence about LPS or omit. Give explanation of why the proposed species is most appropriate. Section IIIC. Provide a reference that ten mice is the statistical standard for all vaccine challenge experiments. Section IVD. Clarify handling procedure or other procedures that will help to reduce discomfort, distress, pain, and injury. Omit “None needed”. Section VB. Describe the carcass disposal procedure. Section VI. List the actual modules of the Research Training that you and your student have completed. 2) Report on Occupational Health and Safety in the Care & Use of Animals. Subcommittee is making progress in assessing current needs based on animals being used here at APSU and gathering resources many of which can be posted on the IACUC website for animal users to access. Dr. Caldwell reports that Chad Pugh spoke with Agricultural Extension Officer and found that they did not have any Occupational Health and Safety training videos or other materials currently available for farm workers. Dr. Caldwell was going to continue checking with the Extension office in Nashville. 3) Report on Role of IACUC in overseeing research involving wildlife Dr. Pitts provided a written report attached below reporting on the use of wildlife in research and the role that the IACUC plays in overseeing such research. It is clear that at most institutions researchers using wild animals are required to complete a protocol and receive IACUC approval prior to research. We will need to develop or adopt an appropriate form for researchers here at APSU. The information gathered by Dr. Pitts and others on the committee will also be made available to all researchers through the website. Meeting adjourned at 3:00 PM Use of Wildlife in Research and IACUC Role in Overseeing Report Attached Below REPORT ON THE USE OF WILDLIFE IN RESEARCH Presented by Gilbert Pitts to the APSU IACUC committee on 6FEB2007 I found statements at the University of Minnesota stating the responsibility of IACUC in overseeing animal research. I found excellent information regarding the oversight of wildlife studies at the University of Kansas, and the University of Kentucky. I sent e-mails to OLAW and the University of Kentucky requesting information concerning the care and use of wild animals. I am still awaiting a response from OLAW. Dr. Larry Iten from the University of Kentucky has already responded. He will send me a copy of an approved field research protocol so that we can see their procedure. University of Minnesota 2. What is subject to review 2.1 Summary The IACUC has a broad responsibility. Generally, the committee reviews any use of live animals in research, teaching, service or display by faculty, staff, or students affiliated with the University of Minnesota, regardless of where the activity occurs and of the activity's funding source. In short, all animals used by University personnel for University purposes or owned by the University of Minnesota come within the scope of the IACUC's review. These animals are involved in a variety of uses and in a range of disciplines. 2.2 Research Many of the animals covered in IACUC review are used in research, including agricultural research (such as the study of food and fiber production or diet manipulation) as well as medical, biological, and behavioral research. Most of these animals are acquired and housed by the University, but some are free-ranging wildlife, or client-owned animals. 2.3 Teaching Animals used in educational settings are also protected by IACUC review. Examples include those used to teach agricultural techniques, animal husbandry, and medical and veterinary procedures. 2.4 Service and Display Animals that perform tasks or appear in exhibits or demonstrations are also covered. Examples include the horses used by the St. Paul mounted police, the animals kept at the Raptor Center, and fish in tanks in University buildings. University of Kentucky http://www.research.uky.edu/ORI/univet/resources/Handbook/hb-policies-field-research.htm Animal Resources and Procedures Handbook University of Kentucky POLICIES/PROCEDURES PERTAINING TO: FIELD RESEARCH, AND CARE AND USE OF LOWER ANIMALS All vertebrate animals used in teaching or research at the University of Kentucky must be used according to a protocol approved by the Institutional Animal Care and Use Committee. Field Research The IACUC has developed the following policy regarding field research: It is the policy of the University of Kentucky that every research project involving animals, including field research, must be conducted under a protocol approved by the Institutional Animal Care and Use Committee. This policy does not apply to research or teaching which involves observation of animals in their natural habitat when they are not captured or subjected to unnatural environment or treatments. Appropriate permits or licenses and close adherence to applicable federal and state laws and regulations must be practiced. Kentucky statutes governing wildlife regulations are available from the Office of the University Veterinarian. Various professional societies have developed standards for the conduct of field research. Following are the names of four sets of guidelines now available from the Office of the University Veterinarian on request. They are excellent references and the appropriate one(s) should be read by an investigator prior to using animals. l. ACCEPTABLE FIELD METHODS IN MAMMALOGISTS. Prepared by the American Society of Mammalogists. 2. GUIDELINES FOR USE OF FISHES IN FIELD RESEARCH (1987). Prepared by the American Society of Ichthyologists and Herpetologists, the American Fisheries, the American Institute of Fisheries Research Biologists. 3. GUIDELINES FOR USE OF LIVE AMPHIBIANS AND REPTILES IN FIELD RESEARCH (1987). Prepared by the American Society of Ichthyologists and Herpetologists, the Herpetologists' League, the Society for the Study of Amphibians and Reptiles. 4. GUIDELINES TO USE OF WILD BIRDS IN RESEARCH (1997). Prepared by the American Ornithologists' Union, the Cooper Ornithological Society, Wilson Ornithological Society. University of Kansas http://www2.ku.edu/~acu/fld_study.shtml Note: The powerpoint presentation is attached at the end of this document. Field Biology IACUC Requirements At its December 2004 meeting, the KU Institutional Animal Care and Use Committee (IACUC) approved revised procedures for investigators (faculty, staff, students) whose field research involves live vertebrates. The resources on this page will assist investigators in preparing a Statement of Field Research on Live Vertebrates and related forms required by the University and funding agencies. Investigators are encouraged to begin by viewing our PowerPoint presentation The University of Kansas IACUC and Field Research. Netscape Users: If upon clicking the presentation you get a browser window containing what seems a jumbled mass of letters and other text characters, it means you do not have your browser configured to use PowerPoint or PowerPoint Viewer for presentations. Reconfigure your browser. With newer operating systems, you may be able to click the link and hold the right mouse button down (Macintosh users- just hold the one button down), getting a menu of options, of which one will be to save the file to your drive. In that case, do so and then open it with either of the two programs mentioned. This issue does not affect users of Explorer, which comes preconfigured to correctly render PowerPoint presentations. As you move through the presentation, you should take time to download and examine links to professional society guidelines applicable to your study. The last slide of the presentation contains links to the forms you are required to complete and submit to the KU IACUC prior to commencement of your study. For convenience, these forms also are linked to this page, below, for future reference. Checklist of IACUC Requirements for Field Research Statement of Field Research on Live Vertebrates Health Assessment Form Periodic Health Review Form Requirements for Field Research Approval I. II. Institutional Animal Care and Use Committee (IACUC) Approval – All live vertebrate field research performed under the auspices of the University of Kansas, Lawrence campus must receive approval from the IACUC prior to initiating animal work. To secure approval, a Statement of Field Research form must be completed. In all instances, Principal Investigators are responsible for certifying familiarity with guidelines specific to their field of study (see below). A. Full Field Research. In the case of hands-on field research performed by KU scientists, the entire Statement of Field Research form must be completed. Orientation and a Health Assessment Form must also be completed. B. KU Funding of Another Institution’s Field Research. If the University of Kansas, Lawrence campus, funds another institution’s field research, answer questions #1-5, question #7, and sign the Statement of Field Research form. Submit this document with a copy of the other institution’s completed and approved field statement. This must include the corresponding approval letter signed by the chairperson or other authorized signatory of the other institution’s IACUC. C. Observation Only. When field research involves SOLELY observation of undisturbed animals, an accelerated review process can be initiated. Complete Questions #1-4, Question #6, and Question #12 on the Statement of Field Research. Sign and submit to the IACUC. A Health Assessment Form must be completed. Mentors must provide proper instruction and oversight of all students and others assisting in Observation Only studies. Specific Requirements A. Attend Field Research Orientation – An orientation tailored specifically for field research will be coordinated on an as-needed basis for those participants who plan to work with vertebrates in the field. When an orientation session needs to be scheduled, the Principal Investigator will send a written request to the IACUC at least two weeks in advance of anticipated need-date. To be included in the request are days and times when participants can be available for a 1.5-hour block of time to attend. Orientation is held in the Animal Care Unit conference room. This orientation will be unique to your project, and will involve such things as Animal Care Unit facilities you may need (if any), special health considerations including allergies, hantavirus, histoplasmosis, etc. B. Completion of a Health Assessment form – These forms will be provided to participants at the beginning of each orientation session. Alternatively, the form can be found at the Animal Care Unit website (www.ku.edu/~acu/acu.html) “Forms” link (Health Assessment Form). Completed forms should be sent to Watkins Health Center. Due to confidentiality issues, Watkins Health Center cannot accept electronic submission of medical history forms. Please do not send completed forms to Watkins electronically. NOTE: The University’s occupational health program requires that participant health status be evaluated on an annual basis. In each subsequent year of involvement in field research, participants are required to complete a Periodic Health Review form. The IACUC Coordinator will contact the Principal Investigator annually to determine the active status of participants listed on their Statements of Field Research and coordinate completion of Periodic Health Review forms as needed. C. Review Class-Specific Guidelines – It is the Principal Investigator’s responsibility to be familiar with the guidelines applicable to a given project and for these to be reflected clearly in the Statement of Field Research form submitted to the IACUC. By signing the Statement of Field Research form, you certify that you, and other persons actively involved in this research, have read and are familiar with all applicable guidelines. Guidelines can be found at the following web addresses. Guidelines for Proper Care and Use of Wildlife in Field Research. The Wildlife Society: National Wildlife Federation, 1412 16th Street N.W., Washington, D.C. 20036. The Wildlife Biologic Society: 7101 Wisconsin Ave. #611, Washington D.C. 22014. http://www.nwhc.usgs.gov/pub_metadata/field_manual/chapter_6.pdf Guidelines to the Use of Wild Birds in Research. The Ornithological Council: Providing Scientific Information about Birds. Special Publication 1997. Second Edition 1999. Edited by Abbot S. Gaunt & Lewis W. Oring http://www.nmnh.si.edu/BIRDNET/GuideToUse/tableofcontents.htm Guidelines for the Use of Fishes in Research, American Society of Ichthyologists and Herpetologists, American Fisheries Society, American Institute of Fishery Research Biologists. American Fisheries Society, 5410 Grosvenor Lane, Bethesda, MD 20814. Copyright 2004. http://www.fisheries.org/html/Public_Affairs/Sound_Science/Guidelines2004.shtml Guidelines for the Capture, Handling, and Care of Mammals, as approved by the American Society of Mammalogists, prepared by the Animal Care and Use Committee. http://www.mammalogy.org/committees/commanimalcareuse/98acucguidelines.PDF Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research. Revised by the Herpetological Animal Care and Use Committee (HACC) of the American Society of Ichthyologists and Herpetologists, 2004. http://www.asih.org/pubs/ASIH_HACC_Final.PDF IACUC Proposal Number: Statement of Field Research on Live Vertebrates University of Kansas, Lawrence 1. Principal Investigator: 2. Project Title or Course Name and Number: 3. Contact Information (Complete grid below): Office Phone Department 4. Emergency Contact Information (Name / Phone Number) Type of Project: Select the type of project by placing an ‘X’ in the box to the left of the appropriate row of the table provided below. For those projects listed as ‘other,’ please state the purpose of the field research. Research involving more than just observation Observation ONLY – If research involves SOLELY observation of undisturbed animals, complete Questions #6 and #12, sign/date and submit to the IACUC via the Animal Care Unit. Teaching Other: 5. Category: Select the category listed below by placing an ‘X’ in the appropriate row of the table provided below. New Proposal Periodic Review* Modification to Secure Approval Resubmission to New Granting Agency Revision All field research is reviewed on a 2.5 year basis. New and/or revised text should be indicated in bold text. Question #7 must be completed and a signature of compliance provided. Revised information must be indicated in bold text in the narrative of this Animal Use Statement. KU Funding of another Institution’s Field Research Answer questions #1-5, question #7, and provide a signature. Submit this document with a copy of the other institute’s completed and approved field statement. This must include the corresponding approval letter signed by the chairperson or other authorized signatory of the other institution’s IACUC. *If this is a periodic review, please provide the following information: Total Number Number of animals used/trapped since last IACUC review: Number of animals collected (brought to KU) since last IACUC review: 6. Species Used: The following grid must be completed. Place an ‘X’ in the box to the left of the row which best describes the type of research. Descriptions of procedure classes are available at the Animal Care Unit website: www.ku.edu/~acu/acu.html. Class of Research # of Animals Used and/or Collected* Type of Study Broad scale faunal study Study targets several particular species or higher taxa (provide additional information below) * Number provided must correspond with justification of numbers provided in the response to Question #9b. In some instances, such as broad-scale faunal studies or seine hauls, numbers may be estimated. If your study targets several particular species or higher taxa, please list here: 7. Funding Sources: Title of Grant Proposal or Source of Funds (If personal or departmental funds will be used, please state) Date Submitted Agency Submitted To Account or Project # (where applicable) The National Science Foundation requires that each Institutional Animal Care and Use Committee review proposals for field research. To facilitate uniform standards for this work, NSF encouraged professional societies in the various vertebrate disciplines to prepare class-specific guidelines. Allen Press, Inc distributed these with mailings of professional journals beginning in December 1987. These guidelines can also be found on the web. Principal Investigators (PI) can consult the website of the societies relevant to their study for access to guidelines. It is the Principal Investigator’s responsibility to be familiar with the guidelines applicable to a given project. By signing below, the PI indicates that all of the above statements are true (and accurately reflect statements in the application for funds to support this research), and that the PI and other persons actively involved in this research have read, and are familiar with all applicable guidelines. Place an ‘X’ in the first column next to each guideline that has been reviewed as part of this research: Guidelines for Proper Care and Use of Wildlife in Field Research. The Wildlife Society: National Wildlife Federation, 1412 16th Street N.W., Washington, D.C. 20036. The Wildlife Biologic Society: 7101 Wisconsin Ave. #611, Washington D.C. 22014. http://www.nwhc.usgs.gov/pub_metadata/field_manual/chapter_6.pdf Guidelines to the Use of Wild Birds in Research. The Ornithological Council: Providing Scientific Information about Birds. Special Publication 1997. Second Edition 1999. Edited by Abbot S. Gaunt & Lewis W. Oring http://www.nmnh.si.edu/BIRDNET/GuideToUse/tableofcontents.htm Guidelines for the Use of Fishes in Research, American Society of Ichthyologists and Herpetologists, American Fisheries Society, American Institute of Fishery Research Biologists. American Fisheries Society, 5410 Grosvenor Lane, Bethesda, MD 20814. Copyright 2004. http://www.fisheries.org/html/Public_Affairs/Sound_Science/Guidelines2004.sht ml Guidelines for the Capture, Handling, and Care of Mammals, as approved by the American Society of Mammalogists, prepared by the Animal Care and Use Committee. http://www.mammalogy.org/committees/commanimalcareuse/98acucguidelines .PDF Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research. Revised by the Herpetological Animal Care and Use Committee (HACC) of the American Society of Ichthyologists and Herpetologists, 2004. http://www.asih.org/pubs/ASIH_HACC_Final.PDF All appropriate permits for collecting and or operating at the site of this field study have or will be obtained prior to the start of the study. ______________________________________ _____________________________ Signature of Principal Investigator Date Question #8: Scientific Objective – State the scientific objective of the study Question #9: Rationale Question #9a: State rationale for using live animals. Question #9b: State your rationale for the numbers of animals used and/or collected. The rationale must correspond with the total number of animals provided in the response to Question #6. In some instances, such as broad-scale faunal studies or seine hauls, numbers may be estimated. Question #10: Narrative Description - Supply a complete narrative description of all proposed use of animals in the study. This should include a description of any techniques described in the Class of animal research pertinent to your study Questions #11a through #11g: Describe each of the following as they apply to the proposed study. IF AN ITEM IS NOT APPLICABLE, THIS SHOULD BE STATED AS THE ANSWER TO THE QUESTION: Question #11a: Live Trapping - Include type of trap used, length of time animals will remain in the trap (provide range), what type of survival support is provided in the trap (e.g.: type of bedding to be used, water, food, water change when collecting fish, etc.), what provisions will be made to protect animals in live traps in the event of inclement weather, how will animals be sheltered from direct sun, etc. Question #11b: Captivity – If held in captivity longer than 12 hours, how long and under what conditions. Question #11c: Surgical Procedures - Provide a description of surgical procedures to be performed, pre-operative preparation and post-surgical care. Aseptic technique must be used for all survival surgeries. When applicable, provide a description of aseptic technique used in the field. Complete Anesthetics, Supplemental Anesthetics, and Analgesics grids below as well. Anesthetics: If anesthetics are used, complete the grid below: Procedure Duration Anesthetic Requiring of Agent(s) to be Species Anesthetic Anesthesia Used (Indicate Survival or Non-Survival) Route Of Admin. Dosage (mg/kg) Supplemental Anesthetics. Animals anesthetized for one hour or longer may require supplemental anesthesia. Complete the grid below for each procedure requiring supplemental anesthesia. List the following: species, what agent(s) will be used, route of administration, and dosage. *Supplemental Anesthetic Route of Dosage Agent(s) to be Used Administration (mg/kg) Species * For each supplemental anesthetic listed, describe the method used to determine the need for supplemental anesthesia Method Used: Analgesics: If analgesics are used following surgery, complete the grid below: Analgesic Agent Route of Administration Dosage Frequency or Duration of Administration Species Question #11d: Administration of Compounds - Using a separate line on the grid below for each compound and species, list the following: species, compound to be administered, dose or dose range (e.g. mg/kg) and/or volume, site, route (p.o., i.p., i.m., s.c., etc.) and schedule to be used. Species Compound to be Route Schedule Dose / Range Site Administered* Volume * For each compound listed above, list potential toxic or immunological effects. If not applicable, please state. Answer: Question #11e: Euthanasia Procedures - Provide method of euthanasia for each species or other taxonomic level. If more than one euthanasia method will be used per species, these should be listed separately in the grid below. Where applicable, include drug dosage and route of administration. If a physical method of euthanasia will be used, provide reference to the most recent applicable professional society guidelines (e.g.: thoracic compression, gunshot, cervical dislocation, decapitation, etc.). Route of Method of Drug Dosage Administration Decapitation (Where applicable) (Where applicable) (Where applicable) Species Method Used Question #11f: Controlled Substances or Hazardous Materials – If controlled substances or hazardous materials are used, describe precautions taken for personnel and animals. Question #11g: Biopsy Techniques - Describe in detail any biopsy techniques such as tissue collection, blood collection, etc. When collecting blood, provide the following information: Site, quantity per bleed, frequency of bleeding, how long/total number of bleeds. If collecting tissue, provide the following: age of animal tissue being collected from, method used to collect tissue (i.e.: toe clip, ear punch, etc.), amount of tissue to be collected. Question #12: Training Requirements Principal Investigators and participants must complete the following: 1. Field Research Orientation* Orientation tailored specifically for field research will be coordinated on an as needed basis for those participants who plan to work with vertebrates in the field. When an orientation session needs to be scheduled, the Principal Investigator will need to send a written request to the IACUC at least two weeks in advance of anticipated need-date (iacuc@mail.ku.edu). To be included in the request are days and times when participants can be available for a 1.5-hour block of time to attend. Orientation is held in the Animal Care Unit conference room. This orientation will be unique to your project, and will involve such things as Animal Care Unit facilities you may need (if any), special health considerations including allergies, hantavirus, histoplasmosis, etc. 2. Annual Occupational Health Screening Investigator and Participant’s Name Field Research Orientation Annual Occupational Health Screening * Participants involved SOLELY in observation of undisturbed animals, as indicated in Question #4 of this document, do not need to complete the field research orientation training requirement. An annual occupational health screening is required for this group. Posted: January 24, 2007 The Office of Laboratory Animal Welfare, NIH, the Scientists Center for Animal Welfare (SCAW), the University of Tennessee Health Science Center, and the Animal Care Division, Animal and Plant Health Inspection Service of the U.S. Department of Agriculture will present an IACUC-Advanced Workshop. The workshop will be held March 9, 2007 at The Peabody Court Hotel in Memphis, TN. IACUC-Advanced was developed by the Scientists Center for Animal Welfare to train individuals concerned with science and appropriate animal welfare. This may include experienced IACUC members and administrators, principal investigators, attending veterinarians, regulatory personnel and laboratory animal care staff. The regional workshop format lets small groups discuss specific advanced topics that are relevant to IACUC functions. The conference agenda and a registration form are available on the SCAW website at http://www.scaw.com/conference.htm .