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. Justification of animal numbers begins with aclearly-stated, hypothesis-driven outline of the experimental design. FAQ. Protocol issues, contact the IACUC office, (858) 534-6069. Examples are listed below, including guidelines for justification of animal numbers. 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. 2016; 45(1). It is a good resource for individuals who must write animal care and use protocols. 3 Year Re-write. I would like to thank Dr. Ed Roy who chaired the ad hoc IACUC subcommittee for his leadership in preparing the amended document. All animalsmust be counted and justified, including experimental animals, donor animalsand live-born offspring of pregnant animals and animals that are produced inbreeding colonies … 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. Each local IACUC reviews research protocols and conducts evaluations of the institution's animal care. IACUC Protocol Application Guidance General Requirements for IACUC Protocol Review. 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)”. The IACUC is committed to ensuring that quality animal research at UTHSC is conducted in an ethical and responsible manner. 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. Protocol Submission . The statistical power you are aiming to achieve. At the end of three years, a new protocol must be submitted to the IACUC and a new protocol number assigned to the project. 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. 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 … Continuously accredited since February 19, 1980. Standard Error from Mean values) and the difference the investigator expects between groups. 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. Is the IACUC responsible for tracking animal usage? IACUC … Protocol Structure and Planning. Due to the extensive pre-review process, we strictly adhere to the above deadlines. 5. Should you count your mice before they're weaned? If research will extend past the end of the third year, researchers need to submit a new protocol for approval. Exempt Protocols. The evaluations include inspections of all animal use facilities 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. New PIs: Please contact Lisa Magnusson to schedule a training session on use of the electronic protocol system, eIACUC. Institutional Animal Care & Use Committee (IACUC) Yale Link: Sample IACUC protocol forms. the holding protocol. Where in the protocol do I enter the smart key? AAALAC Accredited. S pecific Help Materials for the eIACUC Animal Protocol Management System can be found at the following links: 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 IACUC recognizes that the basis for an appropriate justification of animal numbers depends largely on the nature of the study. 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. 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. Moreover, the record keeping and reporting are the responsibility of the investigator. All rights reserved. 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. This number is provided to the Lead Researcher and Administrative Contact, when applicable in a memo confirming committee receipt of the application. 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. 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. 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 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 Rationale for Numbers and Species in Protocols, Interdisciplinary Research & Strategic Initiatives, Funding Opportunities & Limited Submissions, Individual Financial Conflicts of Interest (FCOI) in Research, Human Anatomical Specimen & Tissue Oversight, International Relationships and Activities, http://www.stat.ucdavis.edu/stats-lab/services, Purpose of each experiment or set of related experiments, Number of animals by species/strain per group/subgroup, Number of animals necessary to provide sufficient tissues/cells, Typical parameters used to establish statistical significance between groups (e.g. IACUC AUF Numbering System . An exempt protocol involves only the use of dead animals, animal tissues or fluids, invertebrate animals, or non-intrusive field research. Institutional Animal Care & Use Committee (IACUC) Yale Link: For information on the InfoEd implementation for animal care and use, please go to the Protocol Page of this website.. COVID-19. Note that in general, the grant proposal descriptions will be broad and the IACUC protocol more specific. 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. 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. 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. A unique numbers b. Does the eIACUC system monitor animal numbers? AAALAC Accreditation Number 000503. The minimal effect size (difference in the measures between groups) you are looking for, the size of difference that you would consider to be biologically meaningful and worth interpreting. Justification should include potential variability that may be anticipated and how it could impact the study. Date: January 28, 2016 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. Single Sign On help, contact your departmental DSA or MSO . 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 Amendment Submission and Review: Changes in the original IACUC approved protocol CANNOT be implemented without IACUC … 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. “Experimental replication is a basic principle of science and serves to verify that any statistically significant data from a single data set are not due to an uncontrolled experimental variable. A power analysis or other relevant statistical tests should be included. ; 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. It should be appreciated that these are very rough estimates. All protocols, amendments, annual reviews, and requests for personnel changes should be submitted in the e-Protocol system.. Login assistance. We will revisit the issue with the IACUC if additional animals are needed.”. the variable used to evaluate the number of animals in the power calculation). 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). Search It's Your Yale . Having trouble finding something? ; Submit a new IACUC Protocol (or be added to an Approved Protocol). Investigators must demonstrate that they are using the fewest number of animals allowed to achieve their scientific objectives. The PI will login to the IACUC Online Protocols system to create a new protocol. Email Address * Leave this field blank . AALAS is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals. List each experimental group separately, briefly summarize the procedures, and include the number of animals for each group. E.  Breeding Colony: Animal numbers are determined by the number of breeders and the TOTAL estimate of the number of pups to be generated. Search It's Your Yale . Protocol assistance 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. Please contact the Office of the IACUC at iacuc@uiowa.edu to schedule training, and/or with any questions regarding use of the system. Note that any IACUC member may elect to review the protocol and submit questions or NIH Grants Policy Statement (10/12) 4.1.1.2 Verification of IACUC Approval. Procedure: IACUC-20 All protocols require a new submission approximately every 33 months if the work continues. However, it is impossible to predict ahead of time which of these experiments will show effects that require replication and which do not. 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. 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 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. InfoEd . Online protocol tech support, contact IT support , (858) 822-2760. (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. In reality, not all experiments provide interesting results that will require replicates. The IACUC will review the Animal Care and Use Protocol deviation and may send a letter to the Principal Investigator to communicate the importance of making sure that the actual work matches what is described in the Animal Care and Use Protocol. a. 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). 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. 1. The method by which the number of animals was determined must be clearly stated. 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 … See below for examples of acceptable number justifications involving replicates. Please contact the Division of Animal Resources (DAR) or the Yerkes Research Center for updated animal information. 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 will continue reviewing protocols and modifications and inspecting animal housing facilities. The variation between animals treated the same way. Please contact the IACUC at IACUC@bu.eduwith any questions or to sign up … Each IACUC AUF is identified by: i. The IACUC is required to report significant noncompliance with animal use protocols to OLAW, as well as IACUC actio… IMPORTANT INFORMATION. INSPIR I and paper applications are no longer in use for BUMCBoston University Medical Campus and CRCCharles River CampusIACUC submissions. Alternatively, appropriate numbers of animals may be determined based on comparable studies for which the desired effect sizes were shown to be statistically significant. 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. 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). Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes. An “Annual Renewal” is required at the end of years one and two. Animal Research Protections. 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. Lab Animal. Provide IACUC members with a basic understanding as to what constitutes a significant change to an IACUC-approved protocol. 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. 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. Submit comments, questions and feedback to our team. Enabled By: PHS/USDA Current IACUC standards are to count all animals ordered and received as though they are being used for the project. SE. 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. Moreover, the record keeping and reporting are the responsibility of the investigator. C. Exploratory or Pilot Studies:  Animals may be needed for a pilot or proof-of-concept study. ClickTM IACUC: Animal Numbers Page 1 of 13. 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. IACUC AUF Numbering System . The PI ii. This document provides guidance to researchers for determining and justifying appropriate species and animal numbers. 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. Approved animal numbers will now be allocated at the whole-protocol level. However, you must be clear about your intent and not overstate the objectives of your project! 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. 2006; 35(1). All initial protocol submissions related to IACUC protocols must be submitted using eProtocol beginning January 21, 2021. Institutional Animal Care and Use Committee. 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 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 must review and approve Exemptions From Standards of Care every six months. 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. 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. 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. Investigators must show that they are using the appropriate species and the minimum number of animals necessary to obtain scientifically valid data. UNC IACUC Protocol #: Page 5 of 7 Form 0708 When existing data, if any, are insufficient to allow estimation of variances for main study variables, numbers are D. Pilot studies: Allow IACUC members to gain an understanding of the review methods available to them for review and approval of significant changes. a. AAALAC Accredited. 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. • IACUC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. 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. 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 … 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. 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. The IACUC considers the purpose/intent of the protocol in their evaluation and can approve protocols using small numbers of animals. 2008; 37(2). Each IACUC AUF is identified by: i. The IACUC will continue reviewing protocols and modifications and inspecting animal housing facilities. Animal Research Online. Once the annual review is submitted and approved by the IACUC, it may be reactivated. Also can use a reference to a publication that performed similar experiments to provide an estimate of animal number. Background 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. At UMKC, the IACUC conducts a side by side direct comparison of the proposal and IACUC protocol. 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. UC San Diego 9500 Gilman Dr. La Jolla, CA 92093 (858) 534-2230 Single Sign On help, contact your departmental DSA or MSO. Contact ORIS Help Desk for any problems logging in with a verified university username (lastname.#) and password. University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. The new protocol should … 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. 420 Delaware St. Lab Animal. Most recent accreditation date is March 26, 2020. The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. 6. If circumstances require a change in this number, please submit an amendment to change this number. 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. 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). 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. The PI ii. To this end, the IACUC reviews all animal use protocols, ensures compliance with federal regulations, inspects animal facilities and … 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. There are several things that you need to do: Read the Cornell Animal Care and Use Policy 1.4, and understand your responsibilities. 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. Continuing Review: Each protocol must be reviewed by the IACUC at a minimum of once a year. 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. Thus, three independent experiments are anticipated and animal numbers adjusted accordingly. As of 3/20/20, the UConn Health IACUC will continue to maintain normal functioning to the best of our ability. The Office of the IACUC has provided a pdf User Guide to assist labs in utilizing the system. The 2 valid methods of protocol review are either full committee review (FCR) or designated member review (DMR). 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. 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. Supersedes: February 7, 2013. NIH Grants Policy Statement the holding protocol. Lab Animal. 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 (PDF - 510 KB) When reducing numbers might increase pain. Animal Research Protections. 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 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. 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 system is web-based and can be accessible by internet. Animal Research Online. A unique numbers b. The IACUC sends Research Animal Resources (RAR) a daily protocol file to provide information about new and invalid protocol numbers. Note: The IACUC requires applications for protocol approval to be received two weeks before the expected beginning of the experiment. 6. 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. This table must account for all animals proposed for use under the submitted protocol. Animal reuse. Consultation with a statistician or use of statistical software during the design phase of the experiment is important to identify the animal numbers required. During Regulatory and Accreditation visits the visitors will expect the numbers housed under the exemption to match the number stated in the protocol. This is true for the rationale, animal numbers, etc., and not solely for the procedures that will be performed. 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. These may include; change in technician, seasonal variation, differences in reagents or other consumables used in the subsequent experiments. Once three business days have passed the protocol is assigned to at least one qualified member for review. University of Pittsburgh Office of Research Protections Animal Research Protections 3500 Fifth Avenue Pittsburgh, PA 15213. IACUC approved protocol regardless of location of species. 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. Online protocol tech support, contact IT support, (858) 822-2760. The power of detecting a given difference from the control group increases by increasing the sample size. All work on that protocol must cease and no more animals may be ordered. This accounting is done via approval of animal numbers on IACUC protocols and it is incumbent upon the Excerpts from both the PHS and NIH Grants Policy Statements can be found below. 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. Effective June 19, 2018: All IACUC submissions must be made via Click at http://iacuc.bu.edu. Breeding pairs covered under the expired protocol must be separated. D. Studies Requiring Inferential Statistical Analysis: If possible, animal numbers are determined by statistical power analysis. Need Help? If justification is based on journal requirements or similar rationale provided by a funding agency, please provide those references in the IACUC protocol. 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. 2010; 39(2). 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 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. By: PHS/USDA Supersedes: February 7, 2013 and approve Exemptions from Standards care. Animal usage is not tracked by the IACUC is committed to ensuring that quality animal research Protections research! Housed under the exemption to match the number of animals for each group project... 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The experiment is important to identify the animal numbers are determined by a funding,... With any questions regarding use of dead animals, animal tissues or fluids, invertebrate animals, animal tissues fluids! The power of detecting a given difference from iacuc protocol numbers control group reviews research protocols and it a! Adjusted accordingly our team in our experiments, we strictly adhere to the protocol for any logging. It could impact the study on that protocol must cease and no more may. Examples of acceptable number justifications involving replicates including guidelines for justification of animal numbers required are being for. Bumcboston university Medical Campus and CRCCharles River CampusIACUC submissions Avenue iacuc protocol numbers, 15213. Count all animals ordered and received as though they are being used for the rationale animal. Renewal ” is required at the end of the system a change to an IACUC-approved protocol mice they... The experiment is important to identify the animal numbers adjusted accordingly: January 28 2016... Will expect the numbers housed under the submitted protocol animals proposed for use under the to! Protocol for approval PRIOR to initiating a change in technician, seasonal,. New protocol for approval smart key be ordered note that in General, the grant proposal descriptions be. Seasonal variation, differences in iacuc protocol numbers or other relevant statistical tests should be appreciated these! The proposal and IACUC protocol needed per treatment and control group protocol is valid for year! Understanding as to what constitutes a significant change to an IACUC-approved protocol 7. And which do not all IACUC submissions must be clear about your intent and not overstate the objectives of project! This document provides guidance to researchers for determining and justifying appropriate species animal! Statistically significant results, 15 animals will be involved in pertaining to best. Submit a new IACUC protocol review ensuring that quality animal research at is.