When to Submit?

Please be mindful of the timeline for submission and review activities described below. No exceptions will be made to the application submission deadline and only complete and accurate submission materials will be assigned to a meeting agenda for review. Protocols submitted after the last Monday of the month will be reviewed in the following monthly cycle.

 

Possible Outcomes of a Full Committee Review (FCR)

There are several possible determinations that may be made for proposed research that is reviewed by the IACUC:

• The IACUC may vote to approve the proposed research when all criteria for approval are met.
   
• The IACUC may determine that modifications are required to secure approval (MRSA) of the proposed research protocol and will outline those specific modifications for the investigators. Individual IACUC members are designated to review the modifications, when received, to determine whether the researchers have made all the required changes and if the revised protocol meets the criteria for approval.
   
• The IACUC may make a determination of MRSA with FCR (previously deferred) for proposed research that would not qualify for approval with minor modifications. Such studies are typically unreviewable because of insufficient or ambiguous information in the application. Once additional information and/or revised research materials are received from the researchers, the study is assigned to the next available IACUC meeting for further review.
   
• The IACUC may vote to disapprove proposed research and will provide the Principal Investigator with their reasoning for this decision.  If a study is disapproved, the investigators may appeal this decision or substantially modify their protocol and submit for a new IACUC review.  Please be aware that no one at the institution, including the administration, deans, or department chairs, can override an IACUC decision to disapprove a proposed study.

IACUC Office staff will help facilitate the review process and send appropriate correspondence to the Principal Investigator via Kuali of any determination made by the IACUC.
 

Post-Approval Requirements

Protocols are approved by the IACUC for a total of three years and require continuing review on an annual basis. Continuation of a project beyond the three year approval period requires de novo submission of a new protocol. No modifications can be made to an approved protocol without prior review and approval by the IACUC. Please consult the Kuali Quickguide Creating & Submitting IACUC Protocols in Kuali for instructions about submitting the following post-approval applications.

• Amendments
• Annual Renewals
• Closure Requests
• Reportable Event

Resources

• Kuali QuickGuide Accessing Kuali Research
   
• Kuali Quickguide Creating & Submitting IACUC Protocols in Kuali