A. Application and Approval Procedures 1. Steps to Obtain IACUC Approval of Research Study <ol> <li style="list-style-type: none;"> <ol style="list-style-type: upper-roman;"> <li>Step 1: <ol style="list-style-type: lower-alpha;"> <li> The investigator(s) (PIs/staff/students) should establish the need for an IACUC protocol by reviewing relevant <a href="https://grants.nih.gov/policy-and-compliance/policy-topics/animal-welfare/laws-regulations/phs-policy" title="NIH Policies">National Institute of Health policies</a> and <a href="https://www.ecfr.gov/current/title-9/chapter-I/subchapter-A" title="federal regulations">federal regulations</a>. </li> <li> PIs using animals on campus must consult with the Institutional Research Compliance Officer regarding available facilities and procedures before submitting an application. </li> <li> Animals cannot be used or procured for a project until the protocol has been approved by the IACUC. </li> <li> PIs who are proposing animal work that also involves potential biohazards or zoonotic diseases, controlled substances, radiation, or radioactive isotopes should consult with the Institutional Research Compliance Officer before completing their application. </li> </ol> </li> <li>Step 2: <ol style="list-style-type: lower-alpha;"> <li> Screening for potential health risks: <ol style="list-style-type: lower-roman;"> <li> All individuals (PIs/staff/students) who handle or directly assist with the care of vertebrate animals must be screened for potential health risks associated with working with animals. </li> <li> Each investigator must complete the first page of the Animal Handler’s Health Questionnaire form, and the PI must attach a copy of the form in the online application and email a copy to all individuals who handle animals or be exposed to these risks. </li> </ol> </li> <li>Collaborative Institutional Training Initiative (CITI) Training <ol style="list-style-type: lower-roman;"> <li> Investigator(s) must complete CITI training before you submit your protocol to the IACUC. Log in to  CITI by registering or login under their current login information. </li> <li> All researchers, students and staff participating in the project must complete an online CITI training course on using animals in research. I </li> <li> f Investigator(s) have been awarded a federal grant, additional modules or one-on-one training may be required.  Please review the grant requirements or contact ORSP to help determine the educational requirements for grant compliance. The first course for “Working with the IACUC” is available on the CITI Program site at any time. </li> <li> After completing the training investigator(s) must upload the certificate in the online application and save a copy for your records. Notification of completion will automatically be sent by CITI to the ORSP Office.  Note: All members of the research team must complete training, including co-investigators, research assistants, and/or faculty advisors.  </li> </ol> </li> </ol> </li> <li>Step 3: Submitting an Application <ol style="list-style-type: lower-alpha;"> <li> All protocol applications must be submitted online. </li> <li> Please consult the ORSP webpage for meeting dates of the IACUC meetings and when protocol packages must be submitted for consideration at those meetings. </li> <li> All investigators (faculty, staff, and students) involved in a project must be listed in the Personnel section. </li> <li> Please make sure that you upload CITI Certificate and the completed Animal Handlers Health questionnaire. </li> <li> Please make sure that all sections are completed and that, for all literature reviews, the database(s) searched, key words used, the date the search was done and dates covered by the search are all provided. </li> <li> Submit your Application when you complete all sections of the application. </li> <li> Investigator(s) will receive a “receipt” via email once your protocol package is received.  </li> </ol> </li> <li>Step 4: Review of Protocols <ol style="list-style-type: lower-alpha;"> <li> First, ORSP will verify whether the application is complete. Applicants may be requested for additional information or to upload CITI training certificate and/or the Animal Handlers Health questionnaire. </li> <li> Second, the IACUC review is initiated by a preliminary review by the veterinarian followed by a decision by IACUC for review by the Full Committee or the Designated Member(s). </li> <li> The Full Committee or the Designated Member(s) review the application and make a determination of: “APPROVED,” “NEED REVISION” or "DISAPPROVED." </li> <li> The decision is recorded in the IACUC meeting minutes. </li> </ol> </li> <li>Step 5: Communication</li> </ol> </li> </ol> Written notice of decisions shall be provided to investigators, including reasons for disapproval and required changes when applicable. Based on the decision recorded in the minutes, the Institutional Research Compliance Officer, on behalf of the IACUC, will send a letter signed by the IACUC chair informing applicants of the decision: “Approved,” “Revisions Needed,” or “Disapproved.” 2. Protocol Validity, Amendment, Revewal and Closeout <ol> <li style="list-style-type: none;"> <ol style="list-style-type: upper-roman;"> <li>Protocol Validity <ol style="list-style-type: lower-alpha;"> <li> IACUC approvals are valid for three years. </li> <li> Approved protocols must be reviewed annually by the PI submitting a Continuing Review request.  </li> </ol> </li> <li>Amendment <ol style="list-style-type: lower-alpha;"> <li> If a protocol needs to be modified, the PI must submit the proposed changes as an Amendment request. </li> <li> Amendment requests must be reviewed and approved by the IACUC prior to beginning work. </li> <li> The PI (Investigator(s)) must describe the Reason(s) for the Change in detail in the online application. </li> <li> Minor changes, i.e., that are not considered significant as defined by NIH-OLAW and USDA, such as personnel changes, may be approved solely by the IACUC Chair. </li> </ol> </li> <li>Renewal and Closeout <ol style="list-style-type: lower-alpha;"> <li> After three years, work that is ongoing must be renewed by submitting a new protocol application. </li> <li> When all work on a project is completed, PIs (Investigator(s)) must close the protocol by reaching out to the Institutional Research Compliance Officer. </li> </ol> </li> </ol> </li> </ol> 3. Continuous Review and Noncompliance <ol> <li style="list-style-type: none;"> <ol style="list-style-type: upper-roman;"> <li>Continuous Review <ol style="list-style-type: lower-alpha;"> <li> The IACUC conducts semiannual inspections of all areas where animals are housed or undergo procedures. </li> <li> The IACUC collaborates with investigators to resolve any deficiencies found during reviews and inspections. </li> <li> The IACUC is charged with reviewing and, when necessary, investigating animal-related matters such as welfare concerns, adverse events, facility incidents, and unexpected animal losses. </li> <li> The IACUC ensure that investigators comply with federal, state, or local laws or regulations or campus policies. </li> <li> The IACUC must investigate such events and ensure the implementation of suitable corrective measures and disciplinary actions to prevent their recurrence. </li> <li> The PI holds the ultimate responsibility for all animal use activities described in an approved IACUC protocol. This accountability extends to any actions executed or neglected by personnel listed on an approved IACUC protocol, irrespective of the PI’s awareness of these actions. </li> </ol> </li> </ol> </li> </ol> 4. Procedures for Noncompliance <ol> <li style="list-style-type: none;"> <ol style="list-style-type: upper-roman;"> <li>General <ol style="list-style-type: lower-alpha;"> <li> If it is determined that an urgent safety or welfare concern exists, the Vice Chancellor for Academic Affairs, or their designee, may expeditiously intervene to ensure animal welfare standards are maintained. </li> <li> The Vice Chancellor for Academic Affairs has the authority to assess and treat the animal, remove it from an experiment, institute appropriate measures to relieve pain or distress, or perform euthanasia, if necessary. </li> <li> The Vice Chancellor for Academic Affairs has the authority to halt an experiment until it can be determined that the activity may be safely resumed. </li> </ol> </li> <li>Preliminary Assessment <ol style="list-style-type: lower-alpha;"> <li>  Upon receiving a report of potential noncompliance, ORSP and the IACUC chair, in collaboration with the veterinarian(s), will perform a preliminary assessment. This assessment may include: <ol style="list-style-type: lower-roman;"> <li> Correspondence with the principal investigator (PI) of the applicable IACUC protocol(s) to verify the report and obtain in writing the PI’s plan for preventing future noncompliance; </li> <li> Ad hoc inspections of animal use areas; </li> <li> Interviews with the PI, students, and/or lab and facility staff to gather pertinent information and context; </li> </ol> </li> <li> The IACUC and ORSP will also verify funding source(s) of the relevant protocol to determine the external reporting obligations. </li> <li> The findings of the preliminary assessment will be discussed with the PI and their response will be considered in making an initial IACUC determination, which may lead to the following: <ol style="list-style-type: lower-roman;"> <li> Dismissal of the allegation (i.e., an unsubstantiated claim); </li> <li> IACUC recommended actions being implemented by the PI; </li> <li> Immediate corrective action as implemented by the Vice Chancellor for Academic Affairs, IACUC Chair, or Institutional Officer (required in cases of urgent safety or welfare concerns); </li> <li> Further inquiry by the IACUC and ORSP. </li> </ol> </li> <li> Regardless of the initial assessment, all issues related to potential noncompliance will be reviewed during a convened meeting of the IACUC and will be documented in the meeting minutes. </li> </ol> </li> <li>Determination of Noncompliance <ol style="list-style-type: lower-alpha;"> <li>  Following deliberation of the preliminary assessment and PI response at a convened meeting, the IACUC will determine whether a full investigation is necessary. If warranted, the IACUC Chair or Vice-Chair will charge a subcommittee to ensure thoroughness in the investigative phase. </li> <li> The ad hoc investigative subcommittee will comprise IACUC members, possibly supplemented by IACUC Specialists, independent domain experts, and consultants to ensure diverse and unbiased viewpoints. The IACUC subcommittee will compile a formal report to be shared with the full committee and discussed at a convened IACUC meeting. Importantly, all information and documents generated during the review and investigation of potential noncompliance will remain confidential. </li> <li> Upon concluding an IACUC investigation, a convened quorum of the IACUC will deliberate and vote on the following questions: <ol style="list-style-type: lower-roman;"> <li>Incident Classification: Is this incident noncompliance? (Yes, No, Tabled) <ul> <li> Yes: Noncompliance is substantiated, and a subsequent vote will determine the degree of noncompliance (minor, serious, repeated). </li> <li> No: Noncompliance was not substantiated, and the incident is closed. However, any animal welfare issues unrelated to noncompliance may still be addressed by the IACUC. </li> <li> Tabled: Discussion on the matter will pause but must resume by the end of the next convened meeting for appropriate resolution. </li> </ul> </li> <li>Incident Resolution: Is the issue satisfactorily resolved (Yes, No, Tabled)? <ul> <li> Yes: The matter will be closed without a corrective action plan. </li> <li> No: A corrective action plan must be developed and implemented by the PI, in consultation with the IACUC. </li> <li> No: An investigation is warranted, and a subcommittee will be formed. </li> <li> Tabled: Additional information is needed before official IACUC action can be taken, but the matter must be addressed by the end of the next convened meeting. </li> </ul> </li> <li>Preventative Measures: Are programmatic changes needed to prevent further occurrences (Yes, No, Tabled)? <ul> <li> Yes: An IACUC subcommittee will be charged by the IACUC Chair to address the matter for future consideration by the IACUC. </li> <li> No: No further actions are necessary. </li> <li> Tabled: Additional information is needed before official IACUC action can be taken, but the matter must be addressed by the end of the next convened meeting. </li> </ul> </li> </ol> </li> <li> Following the IACUC meeting(s) where these questions are resolved, the IACUC Chair or Vice-Chair will relay committee findings in writing to the PI. Responsibilities to communicate with a PI may be delegated to ORSP, as appropriate. Such communication will occur regardless of whether noncompliance was substantiated to ensure every report is followed through. </li> <li> The communication will include a summary of findings, corrective actions recommended/required by IACUC, disciplinary actions imposed by the IACUC, and applicable PI response deadlines. </li> <li> If serious or repeated noncompliance is substantiated, an IACUC action letter will be emailed to the PI from the IACUC Chair. The action letter will detail the noncompliance determination, disciplinary actions imposed by the IACUC, and applicable PI response deadlines. </li> <li> Depending on the circumstances, the PI’s unit head/chair/director, Dean, Academic Vice Chancellor, and IO may also receive the IACUC action letter. </li> </ol> </li> <li>Disciplinary Actions <ol style="list-style-type: lower-alpha;"> <li> The IACUC may impose disciplinary actions that align with the severity of the incident and the PI’s responsiveness and cooperation. </li> <li> For actions that include the suspension of an activity (i.e., any action or procedure that involves animals used in research and teaching), a majority vote of a quorum of the IACUC is required at a convened meeting. The goal of disciplinary actions is to bring the PI and the institution back into compliance with all applicable standards for the care and use of animals in research and teaching.  </li> <li> Depending on the circumstances, approved by the full committee, the IACUC may impose one or more of the following disciplinary actions: <ol style="list-style-type: lower-roman;"> <li> Actions managed by the IACUC or /ORSP – Formal Notification, Enhanced Monitoring, Increased Review Frequency, Reporting Noncompliance to Federal and/or accrediting entities, Protocol Suspension/Termination, or Revocation of Privileges. </li> <li> Actions requiring PI effort – Mandatory Training, Written Response by PI, Direct Engagement of PI with the IACUC, Protocol Knowledge Assessment via written or verbal formats, Protocol Amendment, or Professional Development Training. </li> </ol> </li> <li> Inherent in the IACUC determination of whether an animal-related issue constitutes noncompliance is the committee's acknowledgment that the situation may require reporting to external regulatory entities, as specified in the <a href="https://animalcare.illinois.edu/policies/reporting-adverse-events" title="Reporting Adverse Events Policy - non UWW">Reporting Adverse Events policy</a>. If the IACUC determines that noncompliance should be reported to federal or accrediting agencies (i.e., OLAW, USDA, and/or AAALAC) or funding sources, a report detailing the determination and correction of the noncompliance will be written by the IACUC Chair or the campus Attending Veterinarian. Written reports to federal/accrediting agencies and/or funding sources will be sent by the Institutional Officer and co-signed by the IACUC Chair. </li> </ol> </li> <li>Appeal of IACUC Decisions <ol style="list-style-type: lower-alpha;"> <li> While the AWAR, PHS Policy, and relevant compliance guidance documents do not explicitly describe or require an appeal process, the right to appeal is a fundamental principle of fairness.  </li> <li> An individual may officially appeal to rectify perceived prejudicial errors in the IACUC investigation process, challenge the application of pertinent regulations or guidelines, and/or dispute disciplinary actions deemed to be unjustly imposed. </li> <li> Any resolution reached by the IACUC during an officially convened meeting, in accordance with parliamentary procedure, can only be reversed by the IACUC itself; there is no further appeal process. This includes disciplinary actions imposed because of noncompliance determination and decisions made during the IACUC appeal process. Any disciplinary actions imposed by the IACUC will remain in place during the appeal process. </li> <li> A written appeal must be provided by the appellant to the IACUC Chair within three weeks of receiving the official IACUC notification, and the written appeal must identify specific IACUC actions being appealed and provide a clear explanation as to why these should be altered or expunged from the record. In addition to the written appeal, an appellant may request to make a direct appeal to the IACUC.  </li> <li> If requested by the appellant, they will be invited to attend a convened IACUC meeting as a guest to present their appeal, after which they will be excused. </li> <li> Appeals will be deliberated at a convened monthly IACUC meeting following the receipt of a written appeal, and after the appellant has been excused following their in-person appeal (if they choose to give one).  </li> <li> The IACUC will evaluate the information put forth by the appellant and decide whether to amend any aspect of the original decision. An appeal decision will be made at a meeting convened after the one in which the appeal was initially discussed, and the IACUC will notify the appellant in writing within 2 weeks of that decision. </li> </ol> </li> </ol> </li> </ol>