Initial Review: Review Types & Timing
This page describes how an ED/SBS IRB Initial Review 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. Delays in the review process typically take place when the Initial Review application is waiting for action by the study team: completing the application, submitting the application, revising the application, etc.
We strongly encourage all study teams to submit and address any issues in a timely manner. For studies 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 Initial Review 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.
See ARROW FAQ: Questions During Review to identify the assigned 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 Initial Review 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.
Exemption determinations are still a type of IRB review and are made by the assigned Staff Reviewer, after IRB Pre-Review is complete. Once an ED/SBS Initial Review application has been through IRB Pre-Review and determined to be exempt per the federal regulations, the application will be assigned to In Exempt Review. This determination will be visible in the application workspace. Exempt determinations are made on a rolling basis, typically within 7-10 days.
Initial Review applications can be 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 Initial Review 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 Initial Review 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. Not many Initial Review applications require Full Review, but may include studies involving subject populations that are considered vulnerable (prisoners, minors, participants with diminished capacity to consent, etc.), some research taking place at international locations, or complex studies with multiple arms, sites, or phases.
Once an ED/SBS IRB Initial Review 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.