Page 1 of 10 UNIVERSITY OF SOUTHERN MAINE Office of Research Integrity & Outreach Procedure #: Date Adopted: Last Updated: Prepared By: Reviewed By: Procedure Title: 01-012 6/29/2007 8/2/2011 Sarah Gilliam, Animal Facilities Manager USM IACUC Committee Animal Census Tracking Policy 1.0 Purpose: To ensure that the use of animals within any given protocol does not exceed the number that has been approved by the USM IACUC Committee. 2.0 Responsibility: It is the responsibility of the investigator, manager, technician, analyst or student performing the task to follow the procedures established in this document. 3.0 Applicable Documents: 3.1 USM Animal Facility Standard Operating Procedures. 3.2 Guide for the Care and Use of Laboratory Animals 3.3 Public Health Service Policy on Humane Care and Use of Laboratory Animals 3.4 Appendix A-Daily Census Sheet 3.5 Appendix B-Census Tracking Log 3.6 Appendix C- Approaching Animal Limit Letter 3.7 Appendix D- At or Exceeding Animal Limit Letter 3.8 Appendix E- Animal Increase/Amendment/Revision Form 3.9 Appendix F- Field Study Animal Usage Form 3.10 SOP 01-011 Satellite Animal Facility Policy 3.11 SOP 02-012 Missing Animal Policy 3.12 SOP 02-013 Animals of Unknown Origin 4.0 Main Animal Facility Procedure: 4.1 For each protocol, the IACUC Committee shall approve a given number of animals for a three year period. 4.2 Animals that are purchased, weaned, transferred, euthanized or found dead must be recorded in the daily census sheet (Appendix A) accordingly. 4.3 Each week a facility staff member will do a physical count of the animals and cages within a protocol and record the results. 4.3.1 If there is an inconsistency with the physical count and what the daily census sheet reflects, then the staff shall follow the steps outlined in SOP 02-012 Missing Animal Policy or SOP 02-013 Animals of Unknown Origin dependent on the situation. 4.4 From the beginning of the approval period for each protocol, the animal facilities manager shall utilize information from the daily census sheets and record the number of animals used during each week on the census tracking log (Appendix B). 4.4.1 The census tracking log will be kept on record to provide a manual backup of census counts. 01-012 Page 2 of 10 4.5 The census tracking log will be used by the Office of Research Integrity & Outreach to enter animal counts into the database and to compare with approved animal usage numbers for each protocol. 4.6 If an investigator is within 50 animals or 25% of his approved animal use number, then the Office of Research Integrity & Outreach will issue a letter (Appendix C) notifying the investigator of this. 4.7 If an investigator is shown to be at their limit or over their limit, then the Office of Research Integrity & Outreach will issue a different letter (Appendix D) warning that their protocol in danger of suspension and requiring that the investigator cease all breeding, procurement, and transfer of all animals into their protocol. Furthermore the letter will ask that the investigator file an Animal Increase/Amendment/Revision form (Appendix E) to the IACUC if they need to increase their animal number. 4.8 If the investigator fails to comply with their animal usage limit, and does not file an Animal Increase/Amendment/Revision form, then it will be referred to the IACUC and the protocol will be suspended until the situation can be resolved. 5.0 USM Satellite Animal Facility Procedure: 5.1 Each satellite facility within the University of Southern Maine campuses will be provided with a daily census sheet. 5.2 Each investigator or designee shall perform steps 4.2 through 4.3 outlined in this document. 5.3 At the end of each week, the investigator will be required email or otherwise inform the animal facilities manager the number of animals used for the week. Steps 4.4 through 4.8 will then be followed by the appropriate individuals. 6.0 Field Study Procedure: 6.1 Each field study investigator is responsible for tracking their census numbers for each protocol. 6.2 Every six months each field study investigator is required to submit a Field Study Animal Usage Form (Appendix F) for each protocol to the Office of Research Integrity & Outreach for comparison to their approved animal usage number(s). 6.3 The Office of Research Integrity & Outreach will then follow steps 4.6 through 4.8 accordingly. 01-012 Page 3 of 10 Appendix A Daily Census Sheet P.I.: Dr. _____________________ Protocol #_____________ Month_____________ Room #:___________________ date sent + Animals - total + cages - total Room checks/comments Temp* o F* Humd* %* sentinels # 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 *Normal temperature range should be 64o-73oF and 40%-60% humidity. Deviations from this should be reported to the Animal Facilities Manager. 01-012 Page 4 of 10 Appendix B Animal Census Tracking Log IACUC Protocol # _____________________ Principal Investigator: __________________ Species: ___________________ Approved Number of Animals (per year): ___________ Approval Period (1 year): ______________________ Week 1: Week 16: Page #: _____ Week 31: Week 46: + + + + Week 2: Week 17: Week 32: Week 47: + + + + Week 3: Week 18: Week 33: Week 48: + + + + Week 4: Week 19: Week 34: Week 49: + + + + Week 5: Week 20: Week 35: Week 50: + + + + Week 6: Week 21: Week 36: Week 51: + + + + Week 7: Week 22: Week 37: Week 52: + + + + Week 8: Week 23: Week 38: Week 53: + + + + Week 9: Week 24: Week 39: + + + Week 10: Week 25: Week 40: + + + Week 11: Week 6: Week 41: + + + Week 12: Week 27: Week 42: + + + Week 13: Week 28: Week 43: + + + Week 14: Week 29: Week 44: + + + Week 15: Week 30: Week 45: + + + 01-012 Page 5 of 10 Appendix C Approaching Animal Limit Letter Date: TO: FROM: RE: Office of Research Compliance IACUC Animal Census Total Protocol IACUC # NOTICE OF APPROVED ANIMAL LIMIT For IACUC # , you were approved for the usage of animals during the period from to . Currently, your animal total is 50 animals or less away from this approved number. Please make sure that you do not go over your approved animal number-if you do your protocol will be in danger of suspension. If you need to increase the number of animals for your protocol, you will need to file an Animal Increase/Amendment/Revision form. This form may be found on the Office of Research Compliance (ORC) website at http://www.usm.maine.edu/orc/iacuc/forms.htm. If you have any questions or concerns, please do not hesitate to call the ORC at 7804268. cc: 01-012 Page 6 of 10 Appendix D At or Exceeding Animal Limit Letter DATE: TO: FROM: Office of Research Compliance RE: IACUC Animal Census Total Protocol IACUC # NOTICE OF EXCEEDED ANIMAL LIMIT For IACUC # , you were approved for the usage of animals during the approval period from to . You have now reached or exceeded the total IACUC approved number of animals. Your protocol has been referred to the IACUC and is in danger of suspension. You must cease all breeding, animal procurement, and transfers immediately. If you wish to increase the number of animals for this protocol, you will need to file an Animal Increase/Amendment/Revision form. This form may be found n the Office of Research Compliance (ORC) website at http://www.usm.maine.edu/orc/iacuc/forms.htm. If you have any questions or concerns, please do not hesitate to call the ORC at 7804268. cc: 01-012 Page 7 of 10 Appendix E Request for IACUC Revision/Amendment Request for Increase in Animal Usage/ Study Completion Notification Instructions: Please check all applicable boxes below. Fill out the section(s) of this form that is applicable, then return completed form to the Office of Research Compliance, 178 Science Wing, Portland. Study Completion Notification Request for Increase in Animal Usage Request for IACUC Revision/Amendment MANDATORY SECTION 1. Study Title: (cell will expand) 2. IACUC Study Number (Assigned at time of initial review.): 3. Principal Investigator Information: All Information Below is Required Name of Principal Investigator: Mailing Address: Are You? (Please check) Faculty Staff Undergraduate Student Graduate Student Postdoctoral fellow Department: E-mail address: Other Phone Number: Fax : Section I: Study Completion Notification Check one of the following. This study is: Active Not Active 01-012 Completed or Discontinued Page 8 of 10 Appendix D (cont.) Please go to Section IV and complete the Signatures section. Section II: Request for Increase in Animal Usage Are you using transgenic animals: □ Yes □ No 1. Number of animals approved for use this year: 2. Additional number of animals needed for remainder of this study year: 3. Total number of animals needed for year. (#1 + #2 = #3). This should include any previously approved increase request(s): 4. Justification for Increased Number of Animals. Please go to Section IV and complete Signatures section. Section III: Request for IACUC Revision/Amendment Instructions: For any changes/revisions to your study, complete this section, attach changed research documents, and fill out Signatures section below. Are you changing, adding, and/or deleting any of the following from your study? Check those that apply: Transgenic animals Controlled Substances Radioactive Materials Hazardous Materials Use of Risk Group 2, 3, or 4 agents Change requiring occupational health review/assessment Did the original study submission require IBC or RSC review? Yes No 1. Briefly describe, and explain the reason for the revision/amendment. Include a copy of the affected study pages, with specific changes highlighted, including any changes in the use of controlled substances, transgenic animals, and biohazards. (If any new substances (previously noted) have been added to your study, you must request IBC approval prior to making any changes.) 01-012 Page 9 of 10 Appendix D (cont.) (cell will expand) Section IV: SIGNATURES Original signatures are required. The application will not be processed until all signatures are obtained. SIGNATURE OF PRINCIPAL INVESTIGATOR: The undersigned accept(s) responsibility for the study, including adherence to any federal or state regulation; IACUC policies and procedures; requirements of the granting agency (if applicable); and all USM policies regarding research conduct, safety and security. In the case of student studies, the faculty supervisor and the student share responsibility for adherence to policies. Print Name of Signature of Date: Principal Principal Investigator : Investigator : SIGNATURE OF FACULTY RESEARCH SUPERVISOR- REQUIRED FOR STUDENT RESEARCH **By signing this form, the faculty research supervisor attests that (s)he has read the attached study submitted for IACUC review, and agrees to provide appropriate education and supervision of the student investigator, above.** Print Name of Faculty Research Supervisor: Signature of Faculty Research Supervisor : Date: Submit form to the Office of Research Compliance, 178 Science Building, Portland Campus. A drop off box is located outside Science Room 178. For questions call: (207) 780-4268. 01-012 Page 10 of 10 Appendix F Please type in the gray field below: Field Study Animal Usage Form PI Name(s): IACUC #: Date: Current Approval Period Dates: (Write in Total Below) 6 Month Animal Usage Total Return this form to: Deborah Briskey, Operations Specialist: U.S. Mail Address: - OR - Office of Research Compliance University of Southern Maine P.O. Box 9300 Portland, ME 04104-9300 Inter-Campus Address: 178 New Science Wing Portland Campus Thank You! 01-012