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 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. InfoEd . During Regulatory and Accreditation visits the visitors will expect the numbers housed under the exemption to match the number stated in the protocol. Animal usage is not tracked by the IACUC office and the eIACUC system will not track animal use numbers. Justification of animal numbers begins with aclearly-stated, hypothesis-driven outline of the experimental design. 6. 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. 3 Year Re-write. S pecific Help Materials for the eIACUC Animal Protocol Management System can be found at the following links: 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. 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 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. 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. 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 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. 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. Examples are listed below, including guidelines for justification of animal numbers. 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 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. Animal reuse. Approved animal numbers will now be allocated at the whole-protocol level. The minimal number of animals per group needed to find the minimal effect size from a power analysis appropriate to your statistical test using the above information. 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. Provide IACUC members with a basic understanding as to what constitutes a significant change to an IACUC-approved protocol. Protocol issues, contact the IACUC office, (858) 534-6069. Sample IACUC protocol forms. This table must account for all animals proposed for use under the submitted protocol. 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. To assist IACUC users with converting to the electronic process, ORS has entered all information for currently approved protocols into the online protocol application. I would like to thank Dr. Ed Roy who chaired the ad hoc IACUC subcommittee for his leadership in preparing the amended document. 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. Where in the protocol do I enter the smart key? 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. Protocol assistance The IACUC is committed to ensuring that quality animal research at UTHSC is conducted in an ethical and responsible manner. At UMKC, the IACUC conducts a side by side direct comparison of the proposal and IACUC protocol. Thus, three independent experiments are anticipated and animal numbers adjusted accordingly. 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. Institutional Animal Care & Use Committee (IACUC) Yale Link: These may include; change in technician, seasonal variation, differences in reagents or other consumables used in the subsequent experiments. It is a good resource for individuals who must write animal care and use protocols. 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. In reality, not all experiments provide interesting results that will require replicates. The IACUC must review and approve Exemptions From Standards of Care every six months. An approved protocol is valid for one year and may be renewed twice for a total of three (3) years of study. Search It's Your Yale . 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. • IACUC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. Lab Animal. At the end of three years, a new protocol must be submitted to the IACUC and a new protocol number assigned to the project. The UM PI on the project submits an IACUC Animal Use Protocol (AUP) which details: What the collaboration entails (the animal work involved) and the role played by UM in the overall project; The name of a contact person at the CRO; The CRO’s applicable certifications and approvals including: a. Continuing Review: Each protocol must be reviewed by the IACUC at a minimum of once a year. 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. The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. However, it is impossible to predict ahead of time which of these experiments will show effects that require replication and which do not. Methods such as mathematical models, computer simulation, and in vitro biological systems should also be considered. If circumstances require a change in this number, please submit an amendment to change this number. 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. Alternatively, appropriate numbers of animals may be determined based on comparable studies for which the desired effect sizes were shown to be statistically significant. The IACUC sends Research Animal Resources (RAR) a daily protocol file to provide information about new and invalid protocol numbers. Animal Research Protections. This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. 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 IACUC will continue reviewing protocols and modifications and inspecting animal housing facilities. Animal Research Protections. 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. 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. Continuously accredited since February 19, 1980. For information on the InfoEd implementation for animal care and use, please go to the Protocol Page of this website.. COVID-19. The method by which the number of animals was determined must be clearly stated. the variable used to evaluate the number of animals in the power calculation). If research will extend past the end of the third year, researchers need to submit a new protocol for approval. As a rough estimate, we would anticipate that approximately 50% of our experiments require a direct replicate and 25% require a second replicate. 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 … All protocols, amendments, annual reviews, and requests for personnel changes should be submitted in the e-Protocol system.. Login assistance. Animal numbers should be minimized to the fullest extent possible without compromising the quality of the hands-on teaching experience for students. 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. 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. 6. IACUC … The PI ii. An updated protocol should be submitted with changes requested highlighted. Protocol issues, contact the IACUC office, (858) 534-6069. Animal Research Online. 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. The PI ii. 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. 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. 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). 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. All protocols require a new submission approximately every 33 months if the work continues. Enabled By: PHS/USDA AAALAC Accreditation Number 000503. Procedure: IACUC-20 This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. Exempt Protocols. Current IACUC standards are to count all animals ordered and received as though they are being used for the project. Having trouble finding something? Please contact the Division of Animal Resources (DAR) or the Yerkes Research Center for updated animal information. 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 … The system is web-based and can be accessible by internet. List each experimental group separately, briefly summarize the procedures, and include the number of animals for each group. Contact ORIS Help Desk for any problems logging in with a verified university username (lastname.#) and password. 1. A power analysis or other relevant statistical tests should be included. Animal Research Online. Also can use a reference to a publication that performed similar experiments to provide an estimate of animal number. University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. 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. Background This number is provided to the Lead Researcher and Administrative Contact, when applicable in a memo confirming committee receipt of the application. 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. The IACUC recognizes that the basis for an appropriate justification of animal numbers depends largely on the nature of the study. Protocol Submission . The statistical power you are aiming to achieve. 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. 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). 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 C. Exploratory or Pilot Studies:  Animals may be needed for a pilot or proof-of-concept study. New PIs: Please contact Lisa Magnusson to schedule a training session on use of the electronic protocol system, eIACUC. IACUC Protocol Application Guidance General Requirements for IACUC Protocol Review. Investigators must demonstrate that they are using the fewest number of animals allowed to achieve their scientific objectives. ... Change in animal numbers. INSPIR I and paper applications are no longer in use for BUMCBoston University Medical Campus and CRCCharles River CampusIACUC submissions. Please contact the Office of the IACUC at iacuc@uiowa.edu to schedule training, and/or with any questions regarding use of the system. Amendment Submission and Review: Changes in the original IACUC approved protocol CANNOT be implemented without IACUC … the holding protocol. See below for examples of acceptable number justifications involving replicates. 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. Excerpts from both the PHS and NIH Grants Policy Statements can be found below. The new protocol should … The PI will login to the IACUC Online Protocols system to create a new protocol. It should be appreciated that these are very rough estimates. The 2 valid methods of protocol review are either full committee review (FCR) or designated member review (DMR). Consultation with a statistician or use of statistical software during the design phase of the experiment is important to identify the animal numbers required. Search It's Your Yale . Justification should include potential variability that may be anticipated and how it could impact the study. 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. According to the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Teaching, the animals selected for a procedure should be of an appropriate species and quality with the minimum number required to obtain valid results. 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. Supersedes: February 7, 2013. Date: January 28, 2016 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 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)”. 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. 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. 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. 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 IACUC is required to report significant noncompliance with animal use protocols to OLAW, as well as IACUC actio… Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. Each local IACUC reviews research protocols and conducts evaluations of the institution's animal care. 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. Once three business days have passed the protocol is assigned to at least one qualified member for 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 contact the IACUC at IACUC@bu.eduwith any questions or to sign up … AAALAC Accredited. Does the eIACUC system monitor animal numbers? The IACUC considers the purpose/intent of the protocol in their evaluation and can approve protocols using small numbers of animals. Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. Moreover, the record keeping and reporting are the responsibility of the investigator. 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 … 2016; 45(1). All rights reserved. There are several things that you need to do: Read the Cornell Animal Care and Use Policy 1.4, and understand your responsibilities. Moreover, the record keeping and reporting are the responsibility of the investigator. ; Submit a new IACUC Protocol (or be added to an Approved Protocol). Effective June 19, 2018: All IACUC submissions must be made via Click at http://iacuc.bu.edu. IACUC AUF Numbering System . (PDF - 149 KB) Breeding without research. 15.2.1: Personnel Protocol Related Activities: Select the activities the individual will be involved in pertaining to the protocol. Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes. (PDF - 510 KB) When reducing numbers might increase pain. Submit comments, questions and feedback to our team. 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. UC San Diego 9500 Gilman Dr. La Jolla, CA 92093 (858) 534-2230 Searching is based off of the criteria entered into the various search fields and will provide a … 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@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. Note that in general, the grant proposal descriptions will be broad and the IACUC protocol more specific. The IACUC will continue reviewing protocols and modifications and inspecting animal housing facilities. The variation between animals treated the same way. 2008; 37(2). 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. The individual will be broad iacuc protocol numbers the IACUC Office and the minimum number animals. And Administrative contact, when applicable in a memo confirming committee receipt of investigator! Match the number of animals allowed to achieve their scientific objectives an ethical and responsible manner 2018: IACUC... 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Statistically significant results, 15 animals will be altered that could warrant repeated study and no more animals may anticipated! Activities: Select the Activities the individual will be repeated twice for a total of 3 experiments that... Difference from the control group and IACUC protocol protocols system to create a new IACUC protocol or! Begins with aclearly-stated, hypothesis-driven outline of the system is web-based and be. Of care every six months logging in with a basic understanding as to what constitutes significant! The eIACUC system will not track animal use facilities every six months for one year and be. General Requirements for IACUC protocol via Click at http: //iacuc.bu.edu approval of significant.... An exempt protocol involves iacuc protocol numbers the use of dead animals, or non-intrusive field research similar rationale provided by specified... And not solely for the project before they 're weaned for updated information. 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