UC IRVINE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE DETERMINATION OF NEED FOR IACUC REVIEW Version: December 2011 Federal regulations and UC/UCI policies require IACUC review and approval for the use of “any live vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes. In some situations, the need for IACUC review may not be entirely clear: Tissues obtained from a collaborator, originating from animals covered by another IACUC approved protocol; Purchase of monoclonal or polyclonal antibodies; Animals maintained for purposes other than research, training or testing or related purposes. Please complete and submit this form to the Institutional Animal Care and Use Committee for a determination of whether the proposed activities require committee review. Submission to the UCI IACUC: Complete and sign this form. Send by campus mail to the UCI IACUC, Office of Research, 5171 California, Suite 150, Zot Code 7600 or scan the completed form and send it by e-mail to IACUC@uci.edu. SECTION 1: CONTACT INFORMATION 1. UCI LEAD RESEARCHER (LR): 2. LR DEPARTMENT: 3. LR PHONE NUMBER: 4. LR E-MAIL ADDRESS: 5. UCI FACULTY SPONSOR (FS – if required): 6. FS PHONE NUMBER: 7. FS E-MAIL ADDRESS: 8. ADMINISTRATIVE CONTACT (AC – if applicable): 9. AC PHONE NUMBER: 10. AC E-MAIL ADDRESS: 11. PROJECT TITLE (if applicable): December 2011 version UCI Institutional Animal Care and Use Committee Page 1 of 3 12. FUNDING SOURCE*: Grant/Subaward (provide details below) Contract/Subcontract (provide details below) Department or campus funds (includes department support, unrestricted funds, startup funds, personal funds, campus program awards, etc.) Non-cash support from manufacturer/sponsor (e.g., free drug, device, research materials) Other (describe): 13. List all extramural proposals or awards that will support these activities. Sponsor Name(s): Award #(s): SPA Proposal #(s): SECTION 2: NATURE OF THE ACTIVITY 1. Do the proposed activities involve a systematic approach? A “systematic” approach involves a predetermined method or a plan for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory. A systematic approach incorporates collection of data, either quantitative or qualitative, or specimens; and analysis. YES* NO** 2. Is the intent of the proposed activities to develop or contribute to generalizable (scholarly) knowledge? Activities ‘designed to develop or contribute to generalizable knowledge’ are those that may have potential relevance to human or animal health, advancement of knowledge or the good of society). YES* NO** 3. Is the proposed activity associated with scientific or medical training or higher education? YES* NO** If you have answered NO to any of the above questions, please describe the nature of the animal activity: SECTION 3: DETERMINATION OF “LIVE VERTEBRATE ANIMAL” 1. Indicate the Species to be studied: 2. Do the activities involve analysis of existing data/specimens (i.e., data/specimens have been collected and are available for analysis)? YES NO If YES, provide the following information regarding the collaborator from whom the specimens will be obtained: Name: Email address: December 2011 version UCI Institutional Animal Care and Use Committee Page 2 of 3 3. Do you need to purchase live animals yourself in order to gather the required tissue, fluids, or other materials? Does your collaborator need to purchase, breed or otherwise obtain additional animals in order to accommodate this collaboration? YES* NO 4. Will any procedures be conducted on animals that are still alive (i.e. breathing and/or with a beating heart)? YES* NO SECTION 5: STUDY INFORMATION 1. Describe the purpose of the proposed activities. State the overall objectives and specific aims. Provide a brief description of the procedures. 2. Describe the type of data and/or specimens to be studied. 3. Describe how the data and/or specimens will be harvested/obtained. 4. REQUIRED: Submit a list of the variables and/or information to be analyzed. SECTION 6: LEAD RESEARCHER & FACULTY SPONSOR SIGNATURE(S) Lead Researcher’s Signature Date UCI DETERMINATION OF NEED FOR IACUC REVIEW Researchers do not complete this section. For IACUC staff only The activities as described DO NOT require review of the Institutional Animal Care and Use Committee because The activities as described DO require review of the Institutional Animal Care and Use Committee. Submission of an IACUC Application IS REQUIRED. IACUC Approval must be obtained before the research can begin. IACUC Staff or Chairperson December 2011 version Date UCI Institutional Animal Care and Use Committee Page 3 of 3