IRB Target Turnaround Times
The IRB sets target turnaround times for initial screening, screening of changes, expedited review, and producing correspondence after review. We hope that this information will help you know what to reasonably expect, and when it's reasonable to start checking in.
The other main element in the overall IRB timeline is the study team's turnaround time when the IRB requests changes. In addition, the following can have an impact.
Factors Impacting the Overall Timeline
The quality of the submission:
- Use our (ICF/HIPAA templates)
- See our guidance information for new studies, and...
- Our Protocol templates for investigator-designed studies
- Instructional video for eIRB submission
Whether grant/contract negotiations and any ancillary reviews are still outstanding:
- Submit to other departments in parallel whenever possible
- How quickly the study team replies to requests for clarification or changes
- Departmental review (or faculty advisor review) issues
- Please review the "Departmental Approval - What should I select in the smartform?" section on our FAQ page - it could save you weeks!
Requests for Accelerated Handling
We get these requests frequently so must evaluate them carefully. Taking items out of the queue must be for a truly urgent matter that may adversely affect study subjects. Contact the IRB Director or Team Leads to provide justification.
Type of Submission | IRB Staff Screening | Time until review after receipt of complete submission | Follow up/Letter after review |
---|---|---|---|
Full Board new studies and amendments[1] | Pre-screening within 5-7 days; screening of responsive changes 1-7 days depending on complexity | 1-3 weeks (i.e. next available meeting) | 2 days after IRB meeting |
Expedited new studies and amendments | Pre-screening within 5-7 days Screening of responsive changes 1-7 days depending on complexity | 5 days | 2 days after review |
Continuing Review (when submitted at least 45 days before expiration) | Pre-screen 3-4 weeks prior to expiration (if submitted in time); sooner if Grady site | 2 weeks before expiration Earlier if Grady site | 2 days after meeting or expedited review |
"Does my study need IRB review?" inquiries (aka NHSR determination) | Acknowledgment within 2 days Initial review within 5 days | 2 days | N/A (handled by IRB staff) |
Exempt New Studies | Pre-screening within 5-7 days Screening of responsive changes 1-7 days depending on complexity | 5 days | 2 days after review |
More Information
- The IRB meets 6 times a month, and there are up to 6 new studies on each agenda.
- Expedited review means review by one designated reviewer, instead of review at a convened meeting.
- Most IRB reviewers are full-time faculty/clinicians, and while they have target turnarounds, delays sometimes occur.
- Continuing reviews will generally be held until the study is within 45 days (Full Board) or 30 days (Expedited) of expiration, to preserve more of your approval period. Studies requiring Grady ROC review are processed earlier.
[1] Studies involving procedures that may involve risk to subjects, or when drug or devices are used, generally require full board review. Amendments are reviewed at full board if they indicate a potential increase in risk to participants, or if they involve more than a "minor change" to a more-than-minimal-risk study.