It is fairly common to observe experimental variability in mouse experiments that could be a consequence of batch changes in reagents, intermittent animal vendor issues, or infectious agents or microbiota alterations in the animal housing room. 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. “To obtain statistically significant results, 15 animals will be needed per treatment and control group. If you will be requesting that group numbers exceed the minimum number statistically determined from a power analysis you will need to provide a rationale for this increase or for the complete replication of a study. If an IACUC member steps outside during a vote of their protocol, this does not reduce the quorum nor change the number of votes required – this member’s vote is an automatic abstention. (PDF - 149 KB) Breeding without research. The Office of the IACUC has provided a pdf User Guide to assist labs in utilizing the system. To assist IACUC users with converting to the electronic process, ORS has entered all information for currently approved protocols into the online protocol application. 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. This table must account for all animals proposed for use under the submitted protocol. The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. At UMKC, the IACUC conducts a side by side direct comparison of the proposal and IACUC protocol. Standard Error from Mean values) and the difference the investigator expects between groups. UC San Diego 9500 Gilman Dr. La Jolla, CA 92093 (858) 534-2230 Investigators are encouraged to consult a statistician (http://www.stat.ucdavis.edu/stats-lab/services) and bioinformatics specialists to determine the number of animals necessary for a project. The IACUC is required to report significant noncompliance with animal use protocols to OLAW, as well as IACUC actio… Clickwill be available 24/7 except for standard change windows, which occur on the 3rd Saturday of every month from 6:30PM until 12:30AM EST and weekly on Sundays from 2:00AM until 3:00AM EST. An updated protocol should be submitted with changes requested highlighted. The power of detecting a given difference from the control group increases by increasing the sample size. The variance is often expressed as sigma, the sample standard deviation (statistical way of expressing the precision of the observed measures within a group of animals treated the same way). 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 Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. The Guide states: The following topics should be considered in the preparation of the protocol by the researcher and its review by the IACUC: rationale and purpose of the NIH Grants Policy Statement Examples are listed below, including guidelines for justification of animal numbers. Investigators must demonstrate that they are using the fewest number of animals allowed to achieve their scientific objectives. Please contact IACUC if this new policy applies to your research and you would like assistance in, or have questions about, revising your current protocol. The statistical power you are aiming to achieve. For information on the InfoEd implementation for animal care and use, please go to the Protocol Page of this website.. COVID-19. Please contact the IACUC at IACUC@bu.eduwith any questions or to sign up … the holding 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. 2006; 35(1). Date: January 28, 2016 Protocol issues, contact the IACUC office, (858) 534-6069. The title or titles (multiple titles are allowed) iii. 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. E.  Breeding Colony: Animal numbers are determined by the number of breeders and the TOTAL estimate of the number of pups to be generated. IACUC Protocol Application Guidance General Requirements for IACUC Protocol Review. Most recent accreditation date is March 26, 2020. 6. Sample IACUC protocol forms. Animal Research Protections. 4. 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. Exempt Protocols. Policy Justifying Animal Numbers The proposed number of animals to be used must be clearly stated in the justification section of the protocol along with the method of determining those numbers, such as I would like to thank Dr. Ed Roy who chaired the ad hoc IACUC subcommittee for his leadership in preparing the amended document. 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. C. Principle : According to federal regulations, all vertebrate animals used in teaching, testing, exhibition, and research are to be accounted for by the institution. A second replicate is often important, either because of conflicting data from two experiments, an experimental failure (tissues inadvertently destroyed in processing for example), or a particularly surprising result that challenges current dogma and therefore requires additional verification before publication. For new users that will edit existing protocols in established PI Labs, please contact Paul Mireles in the IACUC Office to schedule a one hour training session on use of the electronic protocol … Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. Procedures must include methods to ensure animal use is covered by an active IACUC-approved protocol and that the numbers of animals used do not substantially exceed those approved in the protocol. An “Annual Renewal” is required at the end of years one and two. Animal Research Protections. Institutional Animal Care and Use Committee. This session will: Provide IACUC members with a basic understanding as to what constitutes a significant change to an IACUC-approved protocol. SE. This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. In order to reduce regulatory burden, and to better serve the research community, the requirement to allocate animal numbers to individual funding sources within an IACUC protocol has been removed effective Friday April 10 th, 2020.. Approved animal numbers will now be allocated at the whole-protocol … Lab Animal. The PI ii. 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. UC Davis statistical consultation includes the Center for Statistical Consulting for assistance in estimating animal numbers in research proposals http://www.stat.ucdavis.edu/stats-lab/services or 530-752-2361. This accounting is done via approval of animal numbers on IACUC protocols and it is incumbent upon the The title or titles (multiple titles are allowed) iii. All animalsmust be counted and justified, including experimental animals, donor animalsand live-born offspring of pregnant animals and animals that are produced inbreeding colonies … Protocol Structure and Planning. NIH Grants Policy Statement (10/12) 4.1.1.2 Verification of IACUC Approval. Protocol Submission . Approved animal numbers will now be allocated at the whole-protocol level. Searching is based off of the criteria entered into the various search fields and will provide a … Note that any IACUC member may elect to review the protocol and submit questions or 3 Year Re-write. S pecific Help Materials for the eIACUC Animal Protocol Management System can be found at the following links: The objective of this quick guide is to help principal investigators and research teams get st arted in the Click IACUC module with the structure and organization of animal numbers. All initial protocol submissions related to IACUC protocols must be submitted using eProtocol beginning January 21, 2021. The IACUC reports to the NIH Office of Laboratory Animal Welfare (OLAW) annually, and is issued an animal welfare assurance number by OLAW without which no federally funded use of animals in research may occur. The IACUC office has a workbook entitled “Working with the IACUC: Writing an Animal Protocol” which was written by the American Association for Laboratory Animal Science (AAALAS). List each experimental group separately, briefly summarize the procedures, and include the number of animals for each group. Email Address * Leave this field blank . As of 3/20/20, the UConn Health IACUC will continue to maintain normal functioning to the best of our ability. Contact IACUC@bu.edu with any questions. Please contact the Office of the IACUC at iacuc@uiowa.edu to schedule training, and/or with any questions regarding use of the system. ... Change in animal numbers. 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. 2016; 45(1). Institutional Animal Care & Use Committee (IACUC) Yale Link: Alternatively, appropriate numbers of animals may be determined based on comparable studies for which the desired effect sizes were shown to be statistically significant. Consultation with a statistician or use of statistical software during the design phase of the experiment is important to identify the animal numbers required. The evaluations include inspections of all animal use facilities every six months. 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 The animal numbers section of the IACUC protocol application will ask you to categorize your animals as C, D, or E. These categories help the IACUC determine whether the benefit of the study outweighs the costs of potential pain or distress to experimental animals. InfoEd . Animal reuse. Thus, three independent experiments are anticipated and animal numbers adjusted accordingly. Investigators must show that they are using the appropriate species and the minimum number of animals necessary to obtain scientifically valid data. An IACUC charge under the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals is to review the investigator’s rationale for the species and the number of animals selected. Note that in general, the grant proposal descriptions will be broad and the IACUC protocol more specific. It should be noted what variables will be altered that could warrant repeated study. INSPIR I and paper applications are no longer in use for BUMCBoston University Medical Campus and CRCCharles River CampusIACUC submissions. the holding protocol. 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. 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. The IACUC has some discretion to define what it considers a significant change, or to establish a mechanism for determining significant on a case-by-case basis according to PHS Policy IV.C.1.a.-g. We will revisit the issue with the IACUC if additional animals are needed.”. Contact ORIS Help Desk for any problems logging in with a verified university username (lastname.#) and password. A unique numbers b. Animal Research Online. The timetable for approval is dependent upon a numbers of factors including the reponsiveness of the PI to questions by the IACUC, the schedule of monthly meetings, and whether the protocol requires full committee review. This justification must include information about the proposed experiment such as: All animals involved in the study must be addressed in the protocol table as required. AAALAC Accredited. Search It's Your Yale . ; Submit a new IACUC Protocol (or be added to an Approved Protocol). If research will extend past the end of the third year, researchers need to submit a new protocol for approval. Each IACUC AUF is identified by: i. At the time of an Initial or Amendment Review, the IACUC will determine an appropriate certification period (no greater than one year) based on the parameters of the protocol. 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. 2008; 37(2). University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. The new protocol should … Each IACUC AUF is identified by: i. All work on that protocol must cease and no more animals may be ordered. The IACUC will continue reviewing protocols and modifications and inspecting animal housing facilities. “In our experiments, we have assumed that every experiment will be repeated twice for a total of 3 experiments. the variable used to evaluate the number of animals in the power calculation). Power is one minus beta (the probability of failing to reject the null hypothesis when it is actually false), and most researchers rather arbitrarily accept powers of 0.8. Copyright © 2021 Regents of the University of California. Last Updated: December 14, 2020 7:14:20 AM PST, The Institutional Animal Care and Use Committee (IACUC) Office is one of the four core offices of the, 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, UC San Diego 9500 Gilman Dr. La Jolla, CA 92093 (858) 534-2230, Research Compliance and Integrity Program, Video: How to Log in to the Animal Use Protocol System (AUPS) (MP4), Top 10 things you must know to use animals at UCSD, PHS Assurance Number A3033-1 or D16-00020. In general, for most experiments, the number of animals can be determined by a power analysis (sample size estimation), which is identified by the variability in the data (e.g. AAALAC Accreditation Number 000503. Given the intermittent nature of these variables and the potential for them to affect interpretation of an entire experiment, these issues are best controlled for by performing replicate experiments. Once the annual review is submitted and approved by the IACUC, it may be reactivated. 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. Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes. Note: No personnel are allowed to work with animals on a protocol, unless the amendment is approved by the IACUC, and the protocol reflects the addition of the personnel. 1. The 2 valid methods of protocol review are either full committee review (FCR) or designated member review (DMR). Once three business days have passed the protocol is assigned to at least one qualified member for review. 2. New PIs: Please contact Lisa Magnusson to schedule a training session on use of the electronic protocol system, eIACUC. Search It's Your Yale . Should you count your mice before they're weaned? A unique numbers b. During Regulatory and Accreditation visits the visitors will expect the numbers housed under the exemption to match the number stated in 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. D. Studies Requiring Inferential Statistical Analysis: If possible, animal numbers are determined by statistical power analysis. 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