TEXAS TECH UNIVERSITY Office of the Vice President for Research Institutional Animal Care and Use Committee™ IACUC Policy 12: Animal Protocol Control Policy Purpose: The intent of this policy is to describe the protocol approval process by the IACUC committee. Table of Contents 1. 2. 3. 4. 5. 6. Purpose General Sequence of Events After the DMR has sent in the review Protocol Approval IACUC AUF Numbering System Revision No: 04 Authors: Amber Matthews Replaces: Date in effect: 03 9/10/2014 Responsible faculty: (Signature/Date) Phil Smith 9/10/2014 1. Purpose The goal of this policy is to establish a process on how protocols are approved by the IACUC committee. 2. General One important function of the IACUC is to receive, review, approve (or not), and oversee animal care and use activities as described in the Animal Use Form (AUF) which is also called the ACUC Protocol. AUFs originate with investigators, teachers, veterinarians or others. This SOP describes the document control system for AUFs. 3. Sequence of Events a. A faculty member submits an AUF electronically to the IACUC Coordinator to the address: iacuc@ttu.edu (Only faculty members can submit an AUF). b. The IACUC Coordinator logs in the AUF in the review folder. Logging in entails: i) Assigning the new AUF a unique number (see numbering system protocol below) ii) Creating a folder in the Reviews file iii) The protocol is sent electronically to the committee with a due date for comments. c. The Coordinator will collect comments for the protocol and put them in the checklist to be sent to the DMR for the review. 4. After the DMR has sent in the review the Coordinator sends those comments to the PI to make revisions a. When the revisions are made, the revised version will be sent to the DMR and chair for approval. Their approval emails will be printed and put with the physical file. 5. Protocol Approval a. Once a protocol is approved the T is removed and it is assigned the permanent approval number and logged on the Database Spreadsheet. Effective Date: September 10, 2014 IACUC Chair: Phil Smith Page 1 of 3 TEXAS TECH UNIVERSITY Office of the Vice President for Research Institutional Animal Care and Use Committee™ b. A physical file is established for the AUF. The physical file contains printed copies of the following: i. The AUF ii. Any and all emails regarding that AUF iii. Any amendments iv. All approval memos v. Each annual review vi. A termination documentation (the last annual review that indicates progress made and requesting termination) c. Terminated protocols are moved to an archive file. They are kept for 3 years. Terminated AUFs older than 3 years can be destroyed about once every quarter. d. A duplicate copy (by email) of the AUF fill will be given to and maintained by Animal Care Services for projects conducted in their facilities. This group conducts rounds of the animal facilities and requires up-to-date information on protocols. e. Each AUF file will be maintained by number in the physical file. f. An IACUC Main Data Set (Excel Spreadsheet) can be sorted in a number of ways, electronically and on paper, and kept up to date daily. The sorted data sets include: i. A sort by PI ii. A sort by approval date and number iii. A sort by pain category (B-E) iv. A sort by USDA covered species (yes or no) v. A list of non-compliant AUFs will be kept (these protocols can not use animals until the compliance issues are resolved), or animals are placed on the holding protocol. 6. IACUC AUF Numbering System a. Each IACUC AUF is identified by: i. The PI ii. The title or titles (multiple titles are allowed) iii. A unique numbers b. The unique number will contain the year submitted or approved (which ever is later), the AUF sequential number for that year, and the month in which its annual review will be performed (same month as its original approval). For example: 07-054-May represents: Year Number within the year 07 054 (54th AUF for that year) Approval Month Month (Jan-Dec) c. AUFs that have an anniversary date in a given month must have their annual review completed and approved by the IACUC no later than the last day of their anniversary month. AUFs must undergo annual review each year. After 3 years, the number is terminated. If the work continues, a new AUF must be approved. The new AUF will Effective Date: September 10, 2014 IACUC Chair: Phil Smith Page 2 of 3 TEXAS TECH UNIVERSITY Office of the Vice President for Research Institutional Animal Care and Use Committee™ be assigned a unique number which will be linked, on the AUF and in the Main Database, to the old AUF to avoid unnecessary duplication of animal work. d. An AUF can never be more than 3 years old because the life of an AUF is 3 years or less by law and regulation. Effective Date: September 10, 2014 IACUC Chair: Phil Smith Page 3 of 3