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Animal Use Protocol Process

Animal Use Protocol Process

All research, teaching, and outreach activities involving vertebrate animals at the University of Illinois must receive approval from the Institutional Animal Care and Use Committee (IACUC) before initiation of the activity.

Initiating a New Animal Use Protocol

A resident faculty member acting as the responsible principal investigator (PI) must prepare and submit a protocol once the need to use animal subjects is determined. The PI will login to the IACUC Online Protocols system to create a new protocol. 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. Once created, the PI can assign "Senior Personnel" who will have access to edit and complete the remainder of the protocol. The PI has sole responsibilty for the content of the protocol and is the only person that may submit the completed protocol. 

Information required for completing a protocol:

  • Project Overview
  • List of Species, Sources and Numbers (View Approved Sources)
  • Rationale for the Species
  • Rationale for the Number of Animals (View the Regulation)
  • Description of Use
  • Exceptions to Policies, Standards, or Procedures
  • Regulated Agents
  • Surgical Procedures
  • Clinical Outcomes
  • Minimization of Pain
  • Veterinary Care
  • Care and Use Facilities
  • Field Studies
  • Disposition of Animals
  • Ag Animal Usage
  • Funding Sources
  • Personnel Participation and Experience

All individuals listed in the protocol will need to complete mandatory training. See the training requirements for Animal Care and Use
 

IACUC Review Process

The protocol review process is a sequence of specific tasks and approvals. The PI submitting a protocol may be engaged throughout the process to provide additional information and clarification. The status of a protocol is indicated on the PI's Protocol Dashbard in the Online Protocols System. The review process includes:

  • Pre-Review for Completeness
  • Primary Review by an IACUC Committee Member
  • Primary Review by a Veterinarian
  • Verification of Research Personnel Training 
  • Confirmation of DRS Requirements
  • PI Submission of Requested Changes, Corrections, or Clarifications
  • Review by an IACUC Quorum
  • Decision Notification 
  • PI Signature Agreement
  • PI Notification of Approvals

For more details about the submital and approval process:

View the Policy

Timetable for Approval

Approval of a new protocol usually takes between two and six weeks. 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. 

Type of Review Approx. Time
Pre-review by IACUC staff 2 days
New protocol review 28 days
Renewal protocol review 28 days
Significant amendments 26 days
Minor amendments 2 days
Full committee review Monthly Meetings
Facility Inspections Every 6 months
PI requested Grant verification 3 days

Protocal Instructions and Procedures

The instructions below outline the processes for completing and revising animal protocols. Additional standards and procedures for researchers using animals should be followed when they pertain to the specific studies. Exceptions to standards and procedures must be scientifically justified and may be made by special request to the IACUC.

Instructions for Making Amendments to a Protocol
Instructions for Adding Project Personnel to a Protocol
Instructions for Searches to Alternatives for Animal Use
Instructions for Review of Chemicals Used in Animal Research Protocols
Instructions for Rendering Carcasses
Rationale for Numbers of Animals
Breeding Colony Calculator

Amendments to a Protocol

Any change in a project involving animals requires additional review by the Institutional Animal Care and Use Committee (IACUC) and may not be undertaken until approval has been granted. Changes may include, but are not limited to, any of the following:

  • Personnel
  • Species
  • Numbers of animals
  • Procedures
  • Anesthetics or other drugs
  • Disposition (including method of euthanasia) of animals at the end of the study.

All amendments must be made in the Online Protocols System. Approved protocols are accessible by the PI and senior staff for editing and additional separate amendment forms are not necessary. Amendments are considered either "minor" or "significant" depending on requested change. When submitting the amendment, the PI or senior staff will not need to make a distinction between minor and significant changes. Changes will be assessed and categorized by the IACUC Staff. If changes are considered significant, the PI will be notified that a review by the committee is required. 

To make an amendment, follow the steps outlined below:

  1. Find the protocol in the dashboard of the Online Protocols System.
  2. Make changes to each section as needed. Any changes made to text boxes will be highlighted automatically.
    1. If adding personnel, remember to complete their procedures and experience information in Section 17, in addition to adding their names to the title page. Personnel will not be approved until training is complete. Incomplete/expired training will be immediately obvious as each person is added.
  3. Click “Submit” after completing your changes and a text box will pop up. Summarize the requested changes and their rationale in the text box.
  4. If any additional information is needed, the PI will be notified via email from the messaging system internal to the system. Please follow instructions in the notification and respond within the system.

Reviews of significant amendments by the IACUC are similar to reviews of full protocols and may take 3 - 4 weeks to complete. Some amendments may require review at a convened meeting of the IACUC. Meetings are scheduled for the first Tuesday of every month (second Tuesday if a holiday occurs in the first week).

Examples of Minor Ammendments include:

  • Changes to the title of a protocol or a funding source;
  • Adding a new strain or genetic background of animal;
  • An addition of animals to your protocol that does not exceed 10% of the originally approved number of animals for that species;
  • Change in animal care facility, housing unit or field site;
  • Change in administration of experiment/treatment as it relates to the timing, dose, route of administration and/or specific chemical composition, if no increase in invasiveness or risk to the animal for pain or distress;
  • Addition or removal of personnel other than the PI.

Significant Ammendments to a Protocol:

If a significant change to an approved protocol is required, a new protocol MUST be submited. Such protocols will be reviewed as new (early renewal) protocols and should be written with these in mind:

  • All procedures and experiments that have been completed should be removed.
  • Animal numbers requested should reflect ongoing work transferred to the new protocol as well as work planned for the next 3 years.
  • There is no need to indicate what procedures or experiments would have constituted your significant amendment.
  • The current protocol will remain in effect only until the renewal is approved.

IACUC Specialists can assist with the completion of protocols and answer questions. Contact the IACUC Office at 333-7789 or IACUC@illinois.edu.

Access the Online Protocols System

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