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Modification Requests
Any changes made to your protocol after you receive approval/exemption must be reported to and reviewed by the IRB-SBS. If you are updating the protocol’s information, please see the procedure below. All other modifications must be submitted and reviewed via the Modification Form.
Updating Protocol information:
If you are only modifying the following items, do not fill out the Modification Form. Instead, send an email to irbsbs@virginia.edu and describe the change. These items include:
Please make the subject for the email “Update Protocol Information” and include the protocol number and Principal Investigator in the email.
Submitting the Modification Form:
Any modification that is not listed above needs to be reported via the Modification Form. To submit a modification, please do the following:
- Submit one electronic copy of the Modification Form as a cover sheet to the proposed changes.
- Submit one signed copy of the Modification Form. (Signed materials can be submitted by mail, fax (924-1992), or email (scanned document to irbsbs@virginia.edu). Please click here for submission directions.)
- Submit electronic copies of any materials affected by the modification, such as the Protocol Form, Consent Form(s), instrument(s), advertisement(s), etc. Modify the documents so that they reflect the changed procedures. To highlight the changes in the document(s), use the “Track Changes” feature in Microsoft Word (please use where possible).
- To enable the Track Changes feature, go to Tools: Track Changes
- Please note that to show the changes made in the document, enable the Track Changes feature first before you make any changes to the document.
- If your protocol was created after 10/01/05, you will need to unprotect the document before you can use the Track Changes feature. To unprotect the document, go to Tools: Unprotect Document. If you are unable to navigate to the text in the gray boxes, try using the cursor instead of clicking on the box with the mouse.
Modification Review Procedures
- Modifications may be submitted for IRB-SBS review at any time.
- After the IRB-SBS receives your materials, a member of our staff will pre-review your materials to verify that everything is submitted properly.
- Within two business days you will receive a response from an IRB-SBS staff member outlining suggested revisions for the modification.
- When the modification has completed the pre-review process, the IRB-SBS staff member will recommend your modification for either full board review or expedited review.
- The modification will then be reviewed by an IRB-SBS member in an expedited review, or it will be assigned to the next available full board meeting. Please note that the IRB-SBS committee member conducting the expedited review could require that the modification be reviewed at the full board meeting. Modifications requiring full board review will automatically be reviewed at the next IRB-SBS meeting.
- After the modification is reviewed by the committee member or the full board, you will receive an email confirmation regarding the IRB-SBS decision and further directions for revisions or resubmission, if necessary. If/when the modification is approved or exempt, you will receive an email confirmation followed by a hard copy letter which will include stamped consent forms (where applicable). Do not apply your modification to your research until you have received confirmation of your approval or exemption.
- If you are making extensive modifications to the protocol, it may be necessary to submit a new protocol.
Continuation and modification requests:
- Continuation requests do not include a section to describe modifications. All modifications must be reported on a separate modification form. Please see Continuations for more information.
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