What is a Continuing Review?

KU Medical Center IRB is required to conduct continuing review of each human subjects study at least annually, which provides an opportunity to reassess the totality of the project. This review assures that risks to subjects are minimized and are still reasonable in relation to any anticipated benefits to subjects and knowledge expected as a result of study findings.

How do I know when the continuing review for my study is due?

You will receive a 90-day, 60-day, and 30-day notice before your study is set to expire via email from the myIRB system.

What is the process for submitting my Continuing Review?

Submit the continuing review at least 21 days before the project expiration date to allow adequate time for IRB review. If a study is submitted less than 21 days before the project expiration date, study approval may lapse and no study activities can occur during this time.

Detailed guidance for submitting continuing review can be found in the myIRB Guidance Document and on the myIRB intranet page.

A video tutorial on submitting a continuing review can be found here. 

Step 1: Prepare the Continuing Review Supplement form, available on the Forms and Templates page.

Step 2: Access the study in the myIRB system and complete the steps for submitting a Continuing Review, as outlined in the myIRB Guidance Document. 

Select Continuing Review option if you are 1) NOT changing anything, 2) NOT uploading any documents other than the Continuing Review Supplement, OR 3) if you are closing the study (see Closing Study sectio in myIRB Guidance Document).

OR

Select Modification and Continuing Review option if you plan to make changes to the study personnel at this time. Please submit a separate modification if you plan to add new documents for approval or modify existing documents. Examples include, but are not limited to, flyers, informed consent, protocol, etc. More information about submitting modifications can be found in the Modification Section of the myIRB Guidance Document.

Step 3: Complete the online questions and upload the Continuing Review Supplement. Please ensure the milestones entered for Item #2 are current, as this item dictates the type of IRB review that will occur. The Continuing Review IRB Milestones Guide (03/2019) has examples for your reference.

Step 4: Submit or Notify PI to submit for IRB review.