ࡱ>  bjbj 0s_s_*?x --8dk!8 5-:o-o-o-c2B45p+i-i-i-i-i-i-i$npqHQi551|c255Qi--o-o-xjB???5-Ro-o-+i?5+i??ucD"fpu6d&ijHkdq6qLff&qf`55?55555QiQic;555k5555q555555555 :  Form Used for: Request for IACUC Revision/Amendment Handwritten Submissions are Not Accepted A. ADMINISTRATIVE DATA: Project Title: FORMTEXT       Protocol #: Cell will expand. Place  X in Appropriate Box Below: PI Info Principal Investigator(s)( Faculty( Staff( Student( External FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT        FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT      UNE Department: FORMTEXT       FORMTEXT      UNE Mailing Address*: FORMTEXT      UNE Telephone*: FORMTEXT      Fax: FORMTEXT      Email: FORMTEXT       Amendment request for: (Please Check the boxes that apply) & Change in personnel (Please fill in section B & G) & Increase in approved animal numbers (Please fill in section C) & Additional strain or species request (Please fill in section C & D) & Change/modify/add a new procedure (Please fill in section E) **Please Only Fill in Sections Applicable to your Revision/Amendment Request ** B. CHANGES IN PERSONNEL: 1. Change in personnel or personnel roles. Explain specific role(s) of new personnel in this project and describe the experience with the specific procedures to be performed and/or who will train AddDeleteNamePRNSpecific role(s)/procedure(s)Specific experience with the procedures and species and/or who will train FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX  FORMCHECKBOX  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       *All personnel that have direct contact with animals must complete the CITI training before conducting research involving animals must complete the CITI training before conducting research involving animals. Please provide most recent date of training in Section G. C. REQUEST FOR INCREASE IN APPROVED ANIMAL NUMBERS: Are you requesting to increase previously approved animal numbers on your protocol?Yes If Yes, please complete questions below  No   1) Number of animals approved for use on this protocol:  FORMTEXT       2) Additional number of animals needed for remainder of this study:  FORMTEXT       3) Enter total number of animals needed: (Line 2 +Line 4) TOTAL:  FORMTEXT       Please justify the need for an increased in the number of approved animals. The justification of the number of animals per group must be based on one of the following: A. statistical power calculations (please provide detail), B. past experience of the investigator, C. search of the relevant literature where more than one report has used the same or similar techniques to those proposed in the protocol (briefly discuss result of the search (cell will expand)  D. REQUEST FOR ADDITIONAL ANIMAL STRAIN/SPECIES: Are you requesting the addition of a new species  FORMCHECKBOX  or strain  FORMCHECKBOX  What is the new strain(s)/species needed: (cell will expand)  Please justify the need for an additional strain/species: (cell will expand)  Do these studies involve the use of genetically modified animals?YESNO If yes, please describe any phenotypic consequences of the genetic manipulations to the animals also describe any special care or monitoring that the animals will require in the box below: (Cell will expand)  Specific Source of Animals (Vendor or Investigator and Institution Name): Animals to be used:Genus (e.g., Mus)Species (e.g., musculus):Strain/Subspecies (e.g., C57BL6)SexApproximate Age, Weight, or SizeSource(s) (e.g., name of vendor)12The animal facility manager must be consulted with to determine if the facility has the resource capability to support the study. If animals will be housed in lab or anywhere else outside the central facility ( for more than 12 hours, please provide building and room number. (Primary Housing Location(s): Location(s) Where Procedures Will Be Conducted:  Ifyou plan to use the behavioral core (BC) space (with or without BC equipment), and /or personnel from BCfor any procedures/testing you must consult withthe BC,  HYPERLINK "mailto:behaviorcore@une.edu" behaviorcore@une.edu, prior to submission to the IACUC for approval.If you will only borrow equipment (without needing the BC space, you can skip this section). Will you be using equipment and space within the Թϱ Behavioral Core?Will you be using space (without equipment) within the Թϱ Behavioral Core?Will you be needing assistance from any personnel from the Թϱ Behavioral Core?If yes to any one of the above, please provide date of consult with the Behavioral Core: E. REQUEST TO CHANGE/MODIFY/ADD A NEW PROCEDURE Please provide a brief synopsis of the proposed change. (cell will expand)  Are you proposing a new surgical procedure?YESNO If yes, please complete the following questions: 1) Identify and describe the surgical procedure(s) to be performed. Include preoperative procedures (e.g., fasting, analgesic loading), monitoring/supportive care during surgery, and postoperative care. Include aseptic methods to be utilized. (Cell will expand)  2) Where will surgery be performed and postoperative care provided (building and rooms)?  3) ) Please provide the appropriate USDA pain category associated with the new procedure. The addition of Category D and E procedures requires a literature search (see below). Category E animals also require justification  4). Please specify the anesthetics, analgesic, sedatives of tranquilizers that are to be used. Include the name of the agent(s), the dosage, route, and schedule of administration. For pain category E, if not planning to administer these please provide a scientific justification to explain why the use of anesthetics, analgesics, sedatives of tranquilizers is contraindicated:  For information regarding the pain and distress classifications use the following links:  HYPERLINK "http://www.esf.edu/animalcare/documents/USDApainLevels.pdf" http://www.esf.edu/animalcare/documents/USDApainLevels.pdf  HYPERLINK "http://www.mtu.edu/research/administration/integrity-compliance/pdf/Pain_and_Distress_Categories.pdf" http://www.mtu.edu/research/administration/integrity-compliance/pdf/Pain_and_Distress_Categories.pdf For proposed changes that include the addition of Category D and E procedures: Does the proposed study unnecessarily duplicate previous experiments?YESNODatabases searched (at least two reference sources must be used). [List date range and keywords used, per USDA requirement 9CFR Part 2, Subpart C -2.31(d)(l)(iii), pub.8/31/89}: 5) VETERINARY CONSULT: It is highly advisable to consult our consulting veterinarian, Dr. Arthur Lage, prior to submitting a new protocol. If you are planning to conduct any procedures that fall into USDAs Classification D or E, you MUST consult with the veterinarian prior to submitting a protocol. Dr. Lage can be contacted at:  HYPERLINK "mailto:artlage123@gmail.com" artlage123@gmail.com or 617 699-2256 Please provide date of consult 6) If, your proposed changes involve the use of biological/radioactive/hazardous materials please complete the following: Use of agents requires approval of a separate review committee(s) or department listed below. Attach documentation of approval for the use of recombinant DNA or potential human pathogens. *Approval from the appropriate committee must be forwarded to the IACUC to obtain final approval * X All That Apply (Category of MaterialName of Material HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl5/sections/SectionII-BiologicalRiskAssessment.pdf" Risk Group Category (Place X in Box Below)Approving CommitteeDate of ApprovalCommittee Tracking # (If known) FORMTEXT      Radioactive Materials FORMTEXT      ///////////////////////////////RSC FORMTEXT       FORMTEXT       FORMTEXT      Recombinant DNA * FORMTEXT      ////////////////////////////////IBC FORMTEXT       FORMTEXT       FORMTEXT      Hazardous Materials/Chemicals FORMTEXT      /////////////////////////////////CES&H FORMTEXT       FORMTEXT       FORMTEXT      Biological Agents FORMTEXT      1 2IBC3 4  Study conducted at  HYPERLINK "http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s4.htm" Animal Biosafety Level*: Place  X Below: Level # FORMTEXT      1 FORMTEXT      2 FORMTEXT      3* FORMTEXT      4* FORMTEXT      * At present, UNE is not set up for ABSL level 3 or 4 research. If you are planning on conducting ABSL level 3 or 4 research at another location/facility, please fill in the following: Name of Facility: FORMTEXT      Location: FORMTEXT      Contact Person: FORMTEXT       Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated with this study in the space below. Also describe methods for removal of radioactive waste and, if applicable, the monitoring of radioactivity. 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Material Sterile or Attenuated:  Yes *  FORMTEXT      No FORMTEXT      If derived from rodents, has the material been MAP/RAP tested? (MAP - Mouse Antibody Production; RAP - Rat Antibody Production) Information can be found at http://www.idexxbioresearch.com/radil/Biological_Materials/IMPACT_-_The_MAP_Alternative/index.html Yes *  FORMTEXT      No FORMTEXT      *If YES, attach copy of results. I certify that the MAP/RAP tested materials to be used have not been passed through rodent species outside of the animal facility in question and/or the material is derived from the original MAP tested sample. To the best of my knowledge the material remains uncontaminated with rodent pathogens: Signed Initials of Principal Investigator: F. REQUIRED ATTACHMENTS (Only if requesting to change/modify/add a new procedure) Most recent letter of approval. Current Full Protocol- CHECKLIST OF ATTACHEMENTS To assist the IACUC members, please apply a label to all attachments. Please list below the label and title of each attachment: Label Title  G. PRINCIPAL INVESTIGATOR(S) SIGNATURE & CERTIFICATIONS 1. I certify that I have completed the institutionally required (CITI) investigator training course or attended the institutionally conducted animal use refresher course (required every 3 years). Please list the completion date for ALL Faculty/Staff/Students listed on the protocol: PI/Staff/ Student Name(s):Year of Course Attendance:CITI/Institutional Refresher2. I certify that I have determined that the research proposed herein is not unnecessarily duplicative of previously reported research. 3. I certify that the individuals listed in Section A. are authorized to conduct procedures involving animals under this proposal, have attended the institutionally required training course, and received training in: the biology, handling, and care of this species; aseptic surgical methods and techniques (if necessary); the concept, availability, and use of research or testing methods that limit the use of animals or minimize distress; the proper use of anesthetics, analgesics, and tranquilizers (if necessary); and procedures for reporting animal welfare concerns. 4. For all USDA Classification D and E proposals: I certify that I have reviewed the pertinent scientific literature and the sources and/or databases as noted in Section E and have found no valid alternative to any procedures described herein which may cause more than momentary pain or distress, whether it is relieved or not. 5. I certify that I will obtain approval from the IACUC before initiating any changes in this study. 6. I certify that I will notify the IACUC regarding any unexpected study results that impact the animals or personnel. Any unanticipated pain or distress, morbidity or mortality will be reported to the attending veterinarian and the IACUC. 7. I certify that I am familiar with and will comply with all pertinent institutional, state, and federal rules and policies. 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