Modifications to Your Study
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 may request IRB approval for a planned, non-emergent deviation from the protocol. . Examples include: exceptions to eligibility criteria, exceptions to the form or manner of obtaining informed consent, use of out-of-window test results, and exceptions to the administration or use of an investigational product.
Use this form to request a one-time exception. If a permanent change is being requested, submit a protocol modification for your study.
- Exception request form 07/2018
Step 1: Choose the Scope of the Modification: Study Personnel Changes OR Other Parts of the Study.
- The Study Personnel Changes scope only allows additions or deletions to the study team members list.
- All other changes would be requested through the scope Other Parts of the Study.
- You can choose both scopes if you don't already have a Modification open for that study.
Step 2: Choose the corresponding Quick Start Guide on Modifications:
- Modification: Changing Study Personnel ONLY
- Modification: Amending Other Parts of the Study, NOT Personnel
- Modification: Changing Study Personnel AND Amending Other Parts of the Study
- Please include the following information under "Summarize the Modification" within in the eIRB modification application:
- In lay terms, summarize the key changes being 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 3: Check to see if re-consent is necessary
- Re-consenting/ Informing research subjects about new information - Form - 08/2016
- Notification letter template - 08/2016
- Guidance on Informing Subjects of New Information - 05/2016
Step 4: Submit the study or Notify the PI to submit
- PI Proxy Policy 06/2018
- For PIs: Reviewing a Modification Created by Study Staff or Regulatory Staff (Screen Shot Guide)
Step 5: Respond to Provisos / Modifications Required for Approval
- Answering Provisos (Quick Start Guide)
- 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 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.