Should you count your mice before they're weaned? the variable used to evaluate the number of animals in the power calculation). Date: January 28, 2016 Animal numbers may be justified based on the probability of observing the desired effect of the experimental procedure or the numbers needed to test a new paradigm. the holding protocol. Excerpts from both the PHS and NIH Grants Policy Statements can be found below. Protocol Structure and Planning. All animalsmust be counted and justified, including experimental animals, donor animalsand live-born offspring of pregnant animals and animals that are produced inbreeding colonies … AAALAC Accredited. See below for examples of acceptable number justifications involving replicates. Animal numbers cannot be justified on the basis of how many experiments the laboratory personnel can perform in a week or month, and the cost cannot be used as a determining factor for the use of a particular species or model. C. Exploratory or Pilot Studies: Animals may be needed for a pilot or proof-of-concept study. IMPORTANT INFORMATION. The title or titles (multiple titles are allowed) iii. Animal numbers. Need Help? ; 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. The IACUC considers the purpose/intent of the protocol in their evaluation and can approve protocols using small numbers of animals. Additionally, most data publication requires replicate experiments, either as journal policy or due to data analysis by reviewers who appreciate the issues discussed above. Many of the animals covered in IACUC review are used in research, including agricultural research (such as the study of food and fiber production or diet manipulation) as well as medical, biological, and behavioral research.Animals in this category are typically acquired and housed by the University, but may also include free-ranging wildlife. At UMKC, the IACUC conducts a side by side direct comparison of the proposal and IACUC protocol. Lab Animal. Justification of animal numbers begins with aclearly-stated, hypothesis-driven outline of the experimental design. As a rough estimate, we would anticipate that approximately 50% of our experiments require a direct replicate and 25% require a second replicate. a. Animal Research Protections. Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. 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. This is true for the rationale, animal numbers, etc., and not solely for the procedures that will be performed. 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. Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. List each experimental group separately, briefly summarize the procedures, and include the number of animals for each group. 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. NIH Grants Policy Statement (10/12) 4.1.1.2 Verification of IACUC Approval. approximate numbers of animals to be used, the rationale for involving animals, and the appropriateness of the species and numbers to be used (PHS Policy IVD1a; IVD1b). Per federal regulations, once an IACUC protocol has received approval, any subsequent changes to the study must be reviewed and approved by the IACUC prior to implementation. These may include; change in technician, seasonal variation, differences in reagents or other consumables used in the subsequent experiments. 6. 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. 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. Supersedes: February 7, 2013. Methods such as mathematical models, computer simulation, and in vitro biological systems should also be considered. When Power Calculations Won’t Do: Fermi Approximation of Animal Numbers To protect the welfare of animals used in research, keeping the integrity of our enterprise, and providing exceptional and professional customer service. 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. Online protocol tech support, contact IT support, (858) 822-2760. Contact ORIS Help Desk for any problems logging in with a verified university username (lastname.#) and password. To this end, the IACUC reviews all animal use protocols, ensures compliance with federal regulations, inspects animal facilities and … For information on the InfoEd implementation for animal care and use, please go to the Protocol Page of this website.. COVID-19. 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. University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. 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 … FAQ. Alternatively, appropriate numbers of animals may be determined based on comparable studies for which the desired effect sizes were shown to be statistically significant. Please contact the Office of the IACUC at iacuc@uiowa.edu to schedule training, and/or with any questions regarding use of the system. Exempt Protocols. If circumstances require a change in this number, please submit an amendment to change this number. 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. 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. EFFECTIVE 04/10/2020 GUIDANCE FOR IACUC PROTOCOL REVIEW AND APPROVAL In order to reduce regulatory burden, the requirement to allocate animal numbers to individual funding sources within an IACUC protocol has been removed effective Friday April 10th, 2020. IACUC AUF Numbering System . IACUC AUF Numbering System . Lab Animal. Submit comments, questions and feedback to our team. Continuing Review: Each protocol must be reviewed by the IACUC at a minimum of once a year. During Regulatory and Accreditation visits the visitors will expect the numbers housed under the exemption to match the number stated in the 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. Animal reuse. The system is web-based and can be accessible by internet. All rights reserved. a. Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes. 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. The IACUC is required to report significant noncompliance with animal use protocols to OLAW, as well as IACUC actio… This report can be tallied against the numbers in the approved protocol 1.” This passage makes it very clear that the census of the number of animals used in the IACUC-approved protocol must include the neonatal mice. Protocol assistance ClickTM IACUC: Animal Numbers Page 1 of 13. The new protocol should … C. Principle : According to federal regulations, all vertebrate animals used in teaching, testing, exhibition, and research are to be accounted for by the institution. 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 2010; 39(2). Protocol issues, contact the IACUC office, (858) 534-6069. 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. The statistical power you are aiming to achieve. ; Submit a new IACUC Protocol (or be added to an Approved Protocol). Adding personnel to a protocol; ... IACUC Committee Members Sign In (University of Minnesota login and committee membership required) Subscribe to OVPR's Inquiry Newsletter. 2. the holding protocol. A unique numbers b. Copyright © 2021 Regents of the University of California. 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. Searching is based off of the criteria entered into the various search fields and will provide a … There are several things that you need to do: Read the Cornell Animal Care and Use Policy 1.4, and understand your responsibilities. 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. Search It's Your Yale . A. At the end of three years, a new protocol must be submitted to the IACUC and a new protocol number assigned to the project. This session will: Provide IACUC members with a basic understanding as to what constitutes a significant change to an IACUC-approved protocol. 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. Once revisions is received and protocol added on the agenda for IACUC review, feedback from the meeting is sent back to the investigator (usually takes 5-7 business days following a meeting). Protocol Submission . Breeding pairs covered under the expired protocol must be separated. Standard Error from Mean values) and the difference the investigator expects between groups. Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes. 4. ... Change in animal numbers. 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. Institutional Animal Care & Use Committee (IACUC) Yale Link: 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. Does the eIACUC system monitor animal numbers? Institutional Animal Care & Use Committee (IACUC) Yale Link: • IACUC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. The 2 valid methods of protocol review are either full committee review (FCR) or designated member review (DMR). 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 … However, it is impossible to predict ahead of time which of these experiments will show effects that require replication and which do not. It is a good resource for individuals who must write animal care and use protocols. Amendment Submission and Review: Changes in the original IACUC approved protocol CANNOT be implemented without IACUC … New PIs: Please contact Lisa Magnusson to schedule a training session on use of the electronic protocol system, eIACUC. Lab Animal. 15.2.1: Personnel Protocol Related Activities: Select the activities the individual will be involved in pertaining to the protocol. University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. Animal Research Online. 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. Investigators must show that they are using the appropriate species and the minimum number of animals necessary to obtain scientifically valid data. 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. All work on that protocol must cease and no more animals may be ordered. Single Sign On help, contact your departmental DSA or MSO . 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. 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. 2008; 37(2). The IACUC Protocol Search function in CoeusLite provides a User with the capability of quickly locating both historic protocols and protocols which are currently being developed. 6. NIH Grants Policy Statement Effective June 19, 2018: All IACUC submissions must be made via Click at http://iacuc.bu.edu. 3 Year Re-write. Online protocol tech support, contact IT support , (858) 822-2760. When a completed IRB or IACUC application is received in the Office of Research Administration Office, it is assigned an identification number (e.g., HS#, IACUC#) that will be referenced on all subsequent committee correspondence. 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. 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. Justification should include potential variability that may be anticipated and how it could impact the study. 6. This number is provided to the Lead Researcher and Administrative Contact, when applicable in a memo confirming committee receipt of the application. S pecific Help Materials for the eIACUC Animal Protocol Management System can be found at the following links: 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. Note that in general, the grant proposal descriptions will be broad and the IACUC protocol more specific. Current IACUC standards are to count all animals ordered and received as though they are being used for the project. This table must account for all animals proposed for use under the submitted protocol. 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. It should be noted what variables will be altered that could warrant repeated study. A unique numbers b. Animal usage is not tracked by the IACUC office and the eIACUC system will not track animal use numbers. Protocol issues, contact the IACUC office, (858) 534-6069. An “Annual Renewal” is required at the end of years one and two. 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. Provide IACUC members with a basic understanding as to what constitutes a significant change to an IACUC-approved protocol. If a number of studies of different design are planned as part of your protocol, provide a justification of numbers of animals for each study type. 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. 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. 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. 2006; 35(1). 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. 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. Protocol Submission . What the IACUC expects: (50 to 1,000 words depending on complexity) In all cases, a rational basis for the number of animals requested must be provided. An exempt protocol involves only the use of dead animals, animal tissues or fluids, invertebrate animals, or non-intrusive field research. Animal Research Online. This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. The IACUC sends Research Animal Resources (RAR) a daily protocol file to provide information about new and invalid protocol numbers. 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 … Also can use a reference to a publication that performed similar experiments to provide an estimate of animal number. The IACUC recognizes that the basis for an appropriate justification of animal numbers depends largely on the nature of the study. Once the annual review is submitted and approved by the IACUC, it may be reactivated. Please send a copy of the approved protocol and approval letter from the performance site’s IACUC to IACUC@bu.edu to begin the MOU process. IACUC approved protocol regardless of location of species. The method by which the number of animals was determined must be clearly stated. 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 If justification is based on journal requirements or similar rationale provided by a funding agency, please provide those references in the IACUC protocol. Please ensure before submitting initial IACUC protocol or amendment submissions that the scope of work, species, numbers, agents and methods for them, procedures, and euthanasia methods are congruent between the grant proposal and submission. Moreover, the record keeping and reporting are the responsibility of the investigator. The variation between animals treated the same way. Thus, three independent experiments are anticipated and animal numbers adjusted accordingly. UC San Diego 9500 Gilman Dr. La Jolla, CA 92093 (858) 534-2230 Search It's Your Yale . Please contact the IACUC at IACUC@bu.eduwith any questions or to sign up … Consultation with a statistician or use of statistical software during the design phase of the experiment is important to identify the animal numbers required. “To obtain statistically significant results, 15 animals will be needed per treatment and control group. 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). 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. A protocol submitted to the IACUC should demonstrate a clear hypothesis driven thought process and a thorough understanding of the number, species, housing and transport requirements of animals proposed for use in research studies All protocols require a new submission approximately every 33 months if the work continues. 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. Each IACUC AUF is identified by: i. If research will extend past the end of the third year, researchers need to submit a new protocol for approval. It is the IACUC's responsibility to clearly define and communicate its policy for determining significance to investigators. Investigators must demonstrate that they are using the fewest number of animals allowed to achieve their scientific objectives. (PDF - 149 KB) Breeding without research. This report can be tallied against the numbers in the approved protocol 1.” This passage makes it very clear that the census of the number of animals used in the IACUC-approved protocol must include the neonatal mice. This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. 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)”. (PDF - 510 KB) When reducing numbers might increase pain. The purpose of this guide is to give researchers step-by-step guidance from the Institutional Animal Care and Use Committee (IACUC) on how to fill out the IACUC Protocol Application Form, and … Background Having trouble finding something? Examples are listed below, including guidelines for justification of animal numbers. Teaching Protocols: Animal numbers are determined by a specified student-to-animal ratio, which must be fully explained in the justification narrative. 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. Additional animal numbers will be added via the Amendment Form and the PI will be notified that the increase has been added to the approved protocol. InfoEd . Note that any IACUC member may elect to review the protocol and submit questions or AAALAC Accreditation Number 000503. 1. 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. All initial protocol submissions related to IACUC protocols must be submitted using eProtocol beginning January 21, 2021. 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. Sample IACUC protocol forms. 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. Policy 39 IACUC Protocol Review Process (PDF) List of AAALAC-accredited custom antibody vendors (PDF) Search for Alternatives Brochure (PDF) How to do a Literature Search (Question 9) Helpful Tips (PDF) PI Record Keeping Requirements (PDF) Minor Amendments - Federal Guidelines And received as though they are using the fewest number of animals for group... The basis for an appropriate justification of animal number could impact the.... 90 % power to detect a 2-fold change in technician, seasonal variation differences. 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