Modifications to Your Study
If you plan to revise your protocol/study for COVID-19, please consult the research FAQ for different scenarios about how to proceed with modifications and what needs to be submitted to the IRB.
Modifications / amendments are expected to occur throughout the life of your study. Modifications may 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 will be able to make further changes.
Note: Protocol modifications for multi-center studies must be submitted to the IRB within 45 days of receipt at the institution. Investigators are expected to respond 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.
- A video tutorial on submitting a personnel modification can be found here.
Step 1: Choose Modification Type and prepare documents
- Review eCompliance/eIRB Guidance to select the appropriate modification process
- Study Personnel Changes only allow additions or deletions to the study team members list.
- All other changes would be requested through the Other Parts of the Study.
- You can choose both types if you don't already have a Modification open for that study.
- Please include the following information under "Summarize the Modification" within in the eIRB modification application:
- In lay terms, summarize the key changes proposed.
- Summarize the reason for the changes.
- List the documents included in the submission.
- Please ensure that any revised documents are in track-changes mode or otherwise highlighted so that changes are clear. If a tracked document is not available, please include a Summary of Changes or reference where it can be found in the document.
Step 2: Check to see if re-consent is necessary
- Informing subjects of new information - Guidance 12/2020
- Informing subjects of new information - Form 12/2020
- Notification letter template
Step 3: Submit the study or Notify the PI to submit
Step 4: Respond to Provisos / Modifications Required for Approval
- Supplement for Answering Provisos (optional form for guidance in submitting provisos)
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 IRB office for further guidance.
Can I submit a modification and continuing review at the same time?
Yes, a Modification can be submitted at the same time as a Continuing Review. HOWEVER, if the modification is for other parts of the study outside of study team updates, these should be separate actions in the system.
You can submit a combined continuing review and study team modification. This type of action should only be for modifying the study team. 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 to clarify the study team personnel updates. 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 submit one modification, you cannot submit a second modification until the first one receives IRB approval. We recommend you list all known changes before submitting the initial modification.