Changes: Review Types & Timing
This page describes how an ED/SBS IRB Change application may be reviewed and typical timelines
The IRB office is confident that turnaround time - from date of submission to final approval - is equivalent or superior to the national average. It is important to note that the review and approval process involves both the IRB and the study team. We strongly encourage all study teams to submit and address any issues in a timely manner. For Changes involving external deadlines - such as departure dates for international research, funding deadlines, etc. - study teams must allow adequate time for IRB review within the standards outlined below and be prepared to take any necessary action quickly to keep the review process moving.
After IRB Pre-Review
After an ED/SBS IRB Change application has gone through IRB Pre-Review, completed by an assigned Staff Reviewer, the application will be assigned to a review type as determined by the Staff Reviewer.
The ED/SBS IRB does not use a deadline-based scheduling system. The review type and date/timing of an ED/SBS IRB Change application can only be determined after pre-review is complete and all issues have been addressed. The best way to ensure the IRB review process goes as smoothly as possible is to submit a very well prepared IRB application and to respond quickly and thoroughly to issues raised throughout the review process.
If your study was initially determined to be Exempt, you still can submit changes to the Exempt application. The staff reviewer will review the change in relation to the original
application and determine whether the change affects its exemption
it looks like your change may require a new application, please email
the staff reviewer about the change first. Once an Exempt change application has been through
IRB Pre-Review and it has been determined that the study still qualifies as Exempt, with the proposed changes,
the application will be assigned to In Exempt Review. This
determination will be visible in the application workspace. Acknowledgement of Exempt changes are made on a rolling basis, typically within 7-10 days.
ED/SBS IRB Change applications are reviewed via expedited procedures,
as defined in the federal regulations. Expedited reviews can be
completed by an assigned Staff Reviewer that is also a voting member of
the IRB, or by an IRB subcommittee. Similar to above, once an ED/SBS
Change application has been through IRB Pre-Review and determined to
meet the criteria for expedited review, the application will be assigned
to In Expedited Review. This determination will be visible in the
application workspace. Expedited reviews are completed on a rolling
basis, typically within 7-10 days.
The ED/SBS IRB meets monthly to review ED/SBS IRB Change applications that either require review by the full committee per federal regulations, or have been assigned to a Full Review agenda by the assigned Staff Reviewer. Change applications that may require Full Review include those adding/changing subject populations that are considered vulnerable (prisoners, minors, participants with diminished capacity to consent, etc.), adding/changing international locations, or adding/changing complex studies with multiple arms, sites, or phases.
Once an ED/SBS IRB Change application has been through IRB Pre-Review and determined to require review by the full committee, the application will be assigned to the next available Full Review agenda. The assigned meeting date will appear in the application workspace. The next available Full Review meeting date may be several weeks out, depending on when pre-review is complete, to allow adequate time for IRB Members to receive and review applications prior to Full Review meetings.