What is a Continuing Review?
KUMC 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 being minimized and are still reasonable in relation to any anticipated benefits to the subjects and the knowledge that is expected to result.
How do I know when the continuing review for my study is due?
Via email from our electronic IRB system (eCompliance), you will receive a 90 day, 60 day, and a 30 day notice before the date your study is set to expire.
What is the process for submitting my Continuing Review?
For continuing review, please ensure that your request for continuation is received at least 21 days before the project expires. If studies are not submitted before that date, there may not be sufficient time to review before your approval lapses. Investigators must take the following steps to request continuation of their current studies, listed below (OR in the Quick Start Guide - Create a Contintuing Review in eCompliance):
Step 1: Prepare the form entitled Continuing Review Supplement 07/12/2016
Step 2: Access the study in the electronic system under the Active tab by the current HSC#.
Step 3: Select the Create Modification / CR button under My Current Actions in the left panel.
Step 4: Select the Continuing Review option if you are
OR Select the Modification and Continuing Review option if you are planning on making any changes to the study at this time (i.e., personnel changes, adding new documents for approval, flyers, DSMB reports, and changes in wording to the informed consent, protocol etc.).
Step 5: Complete the online questions and upload the Continuing Review Supplement to the Supporting Documents section.
Step 6: If you have chosen the Modification and Continuing Review option, complete the corresponding modification at this point. Refer to our Modification to Your Study screen for details.
Step 7: Submit or Notify PI to submit for review.
Step 8: For studies that involve written consent and have enrolled subjects in the last year, scan and send the required signed consent copies to the HRPP Quality Assurance Program at ResearchQA@kumc.edu. The required signed informed consents are needed in their entirety, with no names blacked out. Please refer to the instructions in the Continuing Review Supplement.