Modifications / amendments are expected to occur through the life of your study. These modifications could include protocol changes, personnel updates, new recruitment materials, and updated consent forms as a result of protocol changes.
For expedited and full-committee studies, modifications will be submitted in the electronic system. Once your currently-approved study is registered in the system, you'll be able to make further changes. Steps to submitting a modification follow.
Note: Beginning January 1, 2017, protocol modifications of multi-center studies must be submitted to the IRB within 45 days of receipt at the institution. Investigators are expected to be responsive to any requests for additional information from the IRB so that final approval or disapproval of the modification can be accomplished within 90 days of receipt.
Exceptions: A research team or Sponsor may want to enroll a subject who does not meet the criteria outlined by the research protocol. A deviation report is needed if a ineligible subject is enrolled without IRB permission. However, a modification can be submitted to the IRB requesting an exception to the eligibility requirements. For exception requests please submit a modification with the following exception request form.
Step 1: Choose the Scope of the Modification: Study Personnel Changes OR Other Parts of the Study.
Step 2: Choose the corresponding Quick Start Guide on Modifications:
Step 3: Check to see if re-consent is necessary
Step 4: Submit the study or Notify the PI to submit
Step 5: Respond to Provisos / Modifications Required for Approval
My study was an exempt review. How do I request modifications?
For exempt studies that were approved before eIRB implementation (approximately August 2013), please contact the HSC office for further guidance.
Can I submit a modification and continuing review at the same time?
Yes, a Modification can be submitted with a Continuing Review. HOWEVER, during these first few months while you are uploading your currently approved documents, we are requesting that you focus on getting those documents uploaded first and wait for processing by the IRB before you attempt to make any changes.
Select the Modification/Continuing review item and complete the continuing review portion to extend your project for an additional year. When prompted to summarize your modifications, describe this information in detail. Make applicable changes to your study and upload new materials and consent forms. Finally, click the submit button to send the project to IRB Pre-review.
I've tried to submit two or three modifications, but the system will not accept them all. What's happening with those requests?
After you've submitted one modification, you can't submit a second modification until the first one has been approved by the IRB. It would be advisable to list all the known changes before submitting the initial modification.