IMPORTANT NOTE: The United States Department of ...



IMPORTANT NOTE: The Office of Laboratory Animal Welfare, Public Health Service (PHS) requires full continuing review of previously approved, ongoing animal research every 3 years. This requirement is in addition to the annual reviews required by the United States Department of Agriculture (USDA) Animal Welfare Regulations and UT Arlington’s Animal Welfare Assurance.Failure to conduct continuing review of approved animal research in a timely manner will result in automatic expiration of the protocol. The federal regulations do not allow a grace period. When a protocol expires, all activities involving animals must immediately cease and a new protocol must be submitted for IACUC review and approval. Use of animals without an IACUC-approved protocol in place is considered a violation of federal regulations that govern the use of animals in research. Such violations must be reported to the federal government and to University officials. Termination of research and research funding by the government and/or the University may occur.INSTRUCTIONS: Please complete and submit this form (typed) to the Office of Research Administration by the IACUC-requested due date:? E-mail to iacuc@uta.edu ? Drop off at 202 E. Border St., Suite 300 (Center for Innovation Building)? Mail to Box 19188? Fax to 817-272-4732General Information Principal Investigator FORMTEXT ?????Dept FORMTEXT ?????E-Mail FORMTEXT ?????Phone FORMTEXT ?????Box # FORMTEXT ?????IACUC Protocol # FORMTEXT ?????Original Approval Date FORMTEXT ?????Project Title FORMTEXT ?????Funding Source(s) FORMTEXT ?????Section A: Protocol StatusDuring the past year (check one option): FORMCHECKBOX The study was not active and no animals were used. FORMCHECKBOX The study was active.Future plans (check one option): FORMCHECKBOX The research will continue without change. I seek IACUC approval to continue this project. [Complete all sections of this form except Section F.] FORMCHECKBOX The research will continue with change (procedures, animals, PI, co-PI, etc.). I seek approval to continue this project, with modification. [Complete all sections of this form.] FORMCHECKBOX The research will not continue. Please close the protocol upon completion of this Triennial Review. [Complete Sections B, E, and G only.]Section B: Progress ReportPlease provide a progress report of the project to date (avoiding jargon and specialized terminology), including your progress toward specific aims and objectives outlined in your original protocol. FORMTEXT ????? Throughout the course of the project, describe any unanticipated adverse events, morbidity, or mortality; please also explain the cause(s), if known, and how these problems were resolved. (If none, please write “N/A.”) FORMTEXT ?????Section C: Objective and Significance of ResearchPlease provide justification for continuation of this research by describing the objective and significance, including the probable benefits of this work to human and/or animal health, the advancement of knowledge, or the good of society. FORMTEXT ?????Section D: The Three R’s: Reduction, Refinement, and ReplacementAlternatives to the use of animals should be considered and used when possible. Since the original IACUC approval of this research study, have alternatives to the use of animals become available that could be substituted to achieve your specific project aims? FORMTEXT ?????(Address the following if your project involves animals in USDA Category D or Category E; see Category descriptions in Section E.) Procedures that cause the least amount of pain or distress to the animals should be considered and used when possible. Since the original IACUC approval of this research study, have alternatives which are potentially less painful or distressful become available that could be used to achieve your specific project aims? FORMTEXT ?????Activities involving animals must not unnecessarily duplicate previous experiments. Provide written assurance that the activities of this project remain in compliance with the requirement that there must be no unnecessary duplication. If you choose to include details of a literature search, please provide: source, dates covered, keywords used, and number of hits. FORMTEXT ?????Section E. Part 1Species: FORMTEXT ?????Species: FORMTEXT ?????Species: FORMTEXT ?????Number of Animals Used, Previous 12 Months(Refer to the original approved protocol to determine Category C, D, or E, or review the descriptions provided below this box)# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????Number of Animals Used, Total Project to Date (Please refer to the original approved protocol and your records/previous annual reports.)# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????INSTRUCTIONS: Number of Animals Planned for Use in Project Continuation – The number of animals starts over at the time of the Triennial Report. Please do not include any animals left over at the end of your last project period. Include #’s for total anticipated period of project funding and animal use. If you are adding new species that were not included in your original approved protocol, please describe below in Section F, “Modification.”Number of Animals Planned for Use in Project Continuation# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????# in Category C: FORMTEXT ?????# in Category D: FORMTEXT ?????# in Category E: FORMTEXT ?????Section E: Animal Use Information (Attach additional copies of this table as necessary.)Section E. Part 2For continuation of this study with the same species as originally approved, please describe your reason for selecting the species and provide justification for the number of animals requested for continuation. Are other animals, especially a lower species, suitable for these studies? FORMTEXT ?????Category C: Animals used for teaching, research, experiments or tests involving no pain, distress, or use of pain-relieving drugs.Category D: Animals used for experiments, teaching, research, surgery, or tests involving accompanying pain or distress and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used.Category E: Animals used for teaching, experiments, research, surgery, or tests involving accompanying pain or distress and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, research, or interpretation of the teaching, research, experiments, surgery, or tests.Section F: Modifications (Skip this section if there are no changes currently planned for continuation of this study.)Please check the nature of your requested change (check all that apply): FORMCHECKBOX Change of project title FORMCHECKBOX Change of funding agency FORMCHECKBOX Change/addition of animal species or strain FORMCHECKBOX Change and/or addition of procedures FORMCHECKBOX Change of PI or co-PI For each item selected above, please fully describe the change: FORMTEXT ?????If requesting a new species/strain, please provide information for the following 4 items (if N/A, proceed to Section G):Number of animals requested. Specify USDA Category C, D, or E: FORMTEXT ?????A detailed description of the procedures to which the animals will be subjected: FORMTEXT ?????Justification for the type and number of animals to be used. Are other animals, especially lower species, suitable for these studies? FORMTEXT ?????Describe your experience with the proposed animal model and manipulation: FORMTEXT ????? Section G: Assurance and SignatureFor active and/or continuing protocols, I certify that the use of animals has been and/or will be in accord with U.S. Department of Agriculture Animal Welfare regulations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the National Research Council Guide for the Care and Use of Laboratory Animals, and the policies established by the University of Texas at Arlington. I further certify that no significant change in this protocol will be implemented without prior IACUC approval.**As principal investigator of this study, I understand that I am responsible for maintaining appropriate and accurate recordkeeping pertaining to the use of animals during the course of this study, and for reporting animal use numbers on an annual basis, or as requested by the IACUC. FORMTEXT ????? FORMTEXT ?????Signature of Principal InvestigatorDate ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download