All work on that protocol must cease and no more animals may be ordered. The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. We will revisit the issue with the IACUC if additional animals are needed.”. See below for examples of acceptable number justifications involving replicates. Lab Animal. Potential animal loss due to morbidity, mortality, or other challenges with the experimental procedures must be described in order to justify the need for additional animals above the minimum required by the power analysis. It is the IACUC's responsibility to clearly define and communicate its policy for determining significance to investigators. C. Principle : According to federal regulations, all vertebrate animals used in teaching, testing, exhibition, and research are to be accounted for by the institution. Based on a two-sided t-test, 7 animals would provide 90% power to detect a 2-fold change in expression at a significance of. All animalsmust be counted and justified, including experimental animals, donor animalsand live-born offspring of pregnant animals and animals that are produced inbreeding colonies … ; Complete Training – both Module I and facility-specific Module 2.; Get access to the protocol management system, eSirius, by sending an email to the IACUC office requesting access to e-sirius. Animal Research Online. Note that in general, the grant proposal descriptions will be broad and the IACUC protocol more specific. The total number of animals listed in this section must correspond to the total number listed in section 4 “Species” and the justification provided in section 13c “Reduction (Animal numbers justification)”. Adjusting the alpha to a more conservative level in a power analysis or simply increasing the “n” of every experiment does not deal effectively with these issues and will lead to unnecessary animal use. Methods such as mathematical models, computer simulation, and in vitro biological systems should also be considered. The method by which the number of animals was determined must be clearly stated. The IACUC oversees the university's animal care and use program and is responsible for reviewing all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories, and overseeing training and educational programs. AAALAC Accredited. Thus, three independent experiments are anticipated and animal numbers adjusted accordingly. Background When justifying animal numbers based on a statistical test the IACUC will expect a description of the test used and the following information in the IACUC protocol: Replication: As part of the protocol review process the IACUC is charged with ensuring there in not unnecessary duplication of experiments and that the minimum number of animals needed to obtain valid data is being requested. Protocol Submission . If research will extend past the end of the third year, researchers need to submit a new protocol for approval. Moreover, the record keeping and reporting are the responsibility of the investigator. 2. Continuing Review: Each protocol must be reviewed by the IACUC at a minimum of once a year. 420 Delaware St. Please contact the Office of the IACUC at iacuc@uiowa.edu to schedule training, and/or with any questions regarding use of the system. Does the eIACUC system monitor animal numbers? Justification for the species must include the rationale for why the species selected is most appropriate for the study and why non-animal models will not meet the study objectives. Each IACUC AUF is identified by: i. All protocols require a new submission approximately every 33 months if the work continues. It is a good resource for individuals who must write animal care and use protocols. Justification of animal numbers begins with aclearly-stated, hypothesis-driven outline of the experimental design. Procedure: IACUC-20 If there are differences in the grant application and what is described in your approval IACUC, then you are not (yet) IACUC approved, and you should state "approval pending" if that is an acceptable option for the granting agency. Investigators must demonstrate that they are using the fewest number of animals allowed to achieve their scientific objectives. Where in the protocol do I enter the smart key? B. Tissue Harvest Required for In vitro Studies (including antibody production): Animal numbers are typically determined by the amount of tissue/cells required based on experimental conditions, statistical consideration, and the number of individual animals needed to provide the appropriate amount of tissue/cells or antibodies. IACUC AUF Numbering System . IACUC@yale.edu and regulatory.services@yale.edu will be monitored daily, so please use email to contact the office, as attending to phone calls will likely be interrupted. An exempt protocol involves only the use of dead animals, animal tissues or fluids, invertebrate animals, or non-intrusive field research. Breeding pairs covered under the expired protocol must be separated. A unique numbers b. 2006; 35(1). Last Reviewed: 8-14-2019 Numbers for Protocols Office for Responsible Research Page 1 of 3 Iowa State University Institutional Animal Care and Use Committee (IACUC) Policy ALLOCATING AND COUNTING ANIMAL NUMBERS FOR PROTOCOLS 1. Protocol issues, contact the IACUC office, (858) 534-6069. Investigators must show that they are using the appropriate species and the minimum number of animals necessary to obtain scientifically valid data. However, if the IACUC permits an estimate for 50% of animals in a first replicate and an additional 25% for second replicates, this should be sufficient. This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. Please contact the IACUC at IACUC@bu.eduwith any questions or to sign up … Institutional Animal Care & Use Committee (IACUC) Yale Link: If justification is based on journal requirements or similar rationale provided by a funding agency, please provide those references in the IACUC protocol. An “Annual Renewal” is required at the end of years one and two. Due to the extensive pre-review process, we strictly adhere to the above deadlines. Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. Protocol Structure and Planning. SE. Examples are listed below, including guidelines for justification of animal numbers. If the conditions are not met or are ambiguous, IACUC staff have the authority to refer the amendment to the IACUC for FCR or DMR. IACUC Protocol Instructions and Checklist (DOC) Instructions and checklist for submitting an IACUC Protocol Application: Observation Only Study Checklist (DOC) If your study only involves observational procedures, use this checklist to see if your study requires IACUC review. At UMKC, the IACUC conducts a side by side direct comparison of the proposal and IACUC protocol. The Institutional Animal Care and Use Committee (IACUC) Office is one of the four core offices of the Research Compliance and Integrity Program in Research Affairs, along with Export Control, Conflict of Interest and Research Misconduct. If circumstances require a change in this number, please submit an amendment to change this number. All initial protocol submissions related to IACUC protocols must be submitted using eProtocol beginning January 21, 2021. 15.2.1: Personnel Protocol Related Activities: Select the activities the individual will be involved in pertaining to the protocol. This number is based on data from our previous studies, in which the standard deviations of the fold-change protein expression levels measured by western analysis were around 0.8. a. 6. 2016; 45(1). AAALAC Accreditation Number 000503. The IACUC reserves the right to request additional information and may withhold approval from protocols that do not meet criteria for humane use of animals. However, it is impossible to predict ahead of time which of these experiments will show effects that require replication and which do not. the variable used to evaluate the number of animals in the power calculation). Protocol assistance IACUC protocol applications with other proposed sources of funding need not be accompanied by a grant proposal, but Comparative Medicine will not fill requests for animals or service under a specific IACUC-approved protocol until an association between fiscal support, an IACUC protocol, and an account or purchase order number is assured in writing. To this end, the IACUC reviews all animal use protocols, ensures compliance with federal regulations, inspects animal facilities and … The IACUC will continue reviewing protocols and modifications and inspecting animal housing facilities. Institutional Animal Care & Use Committee (IACUC) Yale Link: Search It's Your Yale . Each local IACUC reviews research protocols and conducts evaluations of the institution's animal care. D. Studies Requiring Inferential Statistical Analysis: If possible, animal numbers are determined by statistical power analysis. The IACUC reserves the right to request additional information and may withhold approval from protocols that do not meet criteria for humane use of animals. “In our experiments, we have assumed that every experiment will be repeated twice for a total of 3 experiments. 2008; 37(2). Search It's Your Yale . Current IACUC standards are to count all animals ordered and received as though they are being used for the project. List each experimental group separately, briefly summarize the procedures, and include the number of animals for each group. Justification of animal numbers begins with a clearly stated summary of the experimental objectives, including experimental animals, donor animals, and live-born offspring of pregnant animals, and animals that are produced in breeding colonies but will not be used in research. The evaluations include inspections of all animal use facilities every six months. IACUC AUF Numbering System . The lead faculty member on the project must be the person that starts the process becuase the system will automatically assign the role of PI to the creator of the protocol. Failure to do so, resulting in exceeding approved animal numbers, will result in sanctions and, potentially, reporting to the Public Health Service/National Institutes of Health. Copyright © 2021 Regents of the University of California. The IACUC may administratively handle the following, less substantial, changes that do not fall under the above categories: Increase in animals < 50% the number approved in the original protocol, given: The original rationale for the number of animals supports the requested increase. University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. An approved protocol is valid for one year and may be renewed twice for a total of three (3) years of study. C. Exploratory or Pilot Studies:  Animals may be needed for a pilot or proof-of-concept study. Animal Research Protections. The IACUC recognizes that the basis for an appropriate justification of animal numbers depends largely on the nature of the study. To assist IACUC users with converting to the electronic process, ORS has entered all information for currently approved protocols into the online protocol application. If only a percentage of the pups can be used for the project (e.g., only male pups or a specific genotype), that estimate should be included in the calculation of the final number required for the study. Protocol Submission . Is the IACUC responsible for tracking animal usage? Allexperiments involving live animals or animal tissue must be outlined in theprotocol, and the number of animals required must be directly relevant to theexperimental design in order to achieve the goals of the project. The IACUC is committed to ensuring that quality animal research at UTHSC is conducted in an ethical and responsible manner. protocol to go to FCR, then that protocol is moved to the FCR process and is scheduled for discussion at the next available meeting of the committee. Teaching Protocols: Animal numbers are determined by a specified student-to-animal ratio, which must be fully explained in the justification narrative. Additionally, most data publication requires replicate experiments, either as journal policy or due to data analysis by reviewers who appreciate the issues discussed above. The new protocol should … 2010; 39(2). • IACUC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. IACUC Tissue Form is required for animal tissue or materials that will be shared between approved IACUC protocols or for the use of animal tissue or materials that will be taken from an euthanized animal incidental to the original use of the animal. 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