Review Process
How to Apply
a-tune tick@lab
The Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC) have transitioned to an electronic software system for submission, review, and maintenance of IACUC and IBC applications. The system will also integrate research, teaching and testing protocols, animal procurement and management, as well as veterinary medical records.
- Request User Access for the a-tune electronic submission system: Use this Excel file to enter the PI and any personnel you will want to be included in a-tune for your protocols. Please submit this to our office. This email request must be from the PI or the PI must be copied on it. Only personnel requested by the PI will be entered into the Production environment. The system administrators must add users to the a-tune software before personnel, including the PI, are allowed access to the system. Please send these requests to the IACUC office (iacuc@iastate.edu).
- Submit Protocol: Any new IACUC protocol will be required to be submitted electronically via a-tune tick@lab.
If this project also involves Biohazards, the PI must have an IBC application approved, as well. The application will be reviewed by the IACUC for animal use issues and by the IBC for biosafety issues.
Timelines
A designated member review committee meets weekly to review proposed uses of live vertebrate animals, and special meetings may be called by the chairperson at any time. Regular meetings of the full committee are held monthly.
In order to be included in the agenda for the following week’s designated member review committee meeting, a well-written new application, renewal, or major amendment must be received by noon on Wednesday. NOTE: This deadline may be affected by holidays. The IACUC Administrator then forwards these submissions to the IACUC for review at the following week’s designated member review committee meeting. This procedure satisfies the federal requirement that all committee members have the opportunity to review all protocols and call for full committee review.
Each designated member review committee is composed of members of the IACUC. The designated member review committee may approve a project, request additional information or amendments, or refer the entire protocol to the full committee for review.
The IACUC receives more than 15-20 applications and amendments to existing protocols each week. Additionally, federal regulations require that IACUC review of applications and amendments be meaningful and that the committee must ensure compliance with the animal welfare regulations, Public Health Service Policy, and the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.
For these reasons, please allow at least 4-6 weeks for review of new applications and 2-4 weeks for review of amendments and renewals of approved studies.
Approval
Following IACUC approval, protocols can be accessed via a-tune tick@lab. The PI should retain a copy of the approved application and any communication from the IACUC, including the emailed approval letter. All documents of Review will be maintained in a-tune.
A decision not to approve a protocol must be made at a meeting of the full committee. A majority of the quorum present is necessary to deny approval. Written notification of denial and the justification for this action will be sent to the PI, with a copy going to the Vice President for Research.
Because of the number of disciplines in which proposals are submitted, it is not possible for a committee such as the IACUC to have expertise in all areas. Thus, both the Animal Welfare Act and the Public Health Service Policy recognize the need for the committee to refer certain questions to consultants occasionally. When this situation arises, the IACUC will contact the PI and give the PI the option of agreeing that a consultant may be contacted or withdrawing the proposal from IACUC consideration. The PI may suggest individuals who may serve as consultants. The IACUC may or may not utilize these suggestions. In cases involving a consultant, the person chosen is generally asked questions regarding a specific aspect of the protocol (e.g., the species chosen as a model, a specific proposed procedure, a drug dosage, or route of administration). The PI will be notified before copies of the protocol are shared with a consultant.
Amendments to Approved Protocols
The Principal Investigator must notify the IACUC of any changes to their project and must obtain approval prior to implementation of amendments.
- Amendments for new applications approved through a-tune tick@lab must also be submitted through a-tune tick@lab.
Course of Action for Amendments: In an attempt to help Iowa State University investigators determine what course of action is necessary when making modifications to an existing animal protocol, we have generated the following lists of examples. These lists are in no way complete and are shown here only as a guide to help investigators make informed decisions when modifying existing protocols.
Major, Minor, or VVC Protocol Amendments
Note: Per the Research Compliance Advisory Committee, a change in Principal Investigator (PI) is not a modification, but rather requires submission of a new protocol for review and approval by the IACUC through a-tune.
Note: For annual review, please submit in advance of the protocol expiration date to allow adequate time for the review process. If the submitted amendment is too complex and/or changes the original objective(s) of the study, the committee may require a new protocol be submitted for review. Approval of an amendment does not alter the date by which annual (continuing) review must occur.
Annual Review of Protocols
All approved, ongoing research, breeding colony, and teaching protocols must be reviewed and approved annually. Approximately 45 days prior to a project’s expiration date, an annual review notice will be sent via email from a-tune as a courtesy to the PI. The investigator is responsible for ensuring that the Annual Review application is submitted with adequate time for IACUC review and approval before the annual review date.
- All Annual Reviews must be submitted through a-tune tick@lab.
Special event activities will now be submitted to the Office of Risk Management for review. Special event activities are activities in which animals will only be used for handling and restraint; this does not apply to teaching protocols. If the animals will be used for a scheduled class or for more than handling or restraint, a teaching protocol is required. This Flow Chart is designed to help individuals determine if future activities require a form be submitted to the IACUC for review, or if individuals need to contact the Office of Risk Management (orm@iastate.edu). This does not change the review of research and testing activities
If an Annual Review and/or Amendment Form or new protocol application has not been submitted, reviewed, and approved by the expiration date, the project will be considered expired, and the PI will be notified in writing that no animals (including any currently being housed) can be used on the project until a new protocol application has been reviewed and approved by the IACUC.