IRB Timelines

IRB Target Turnaround Times

The information provided here should be used for general information, as there are several factors that may delay a submission, which may be outside the IRB staff control. 

Tips for efficient IRB review:

  1. Timelines are mainly affected by the quality of the submissions. Submissions that are incomplete or do not adhere to IRB submission guidelines (for example, not using current ICF/HIPAA templates) may require additional time.  Make sure you review - and use - our helpful guidance information and latest protocol templates (for investigator-designed studies)
  2. Please submit early and in parallel with grant/CTA routing and other required reviews.
  3. Approval is dependent on meeting the regulatory criteria, and the investigator(s) responding to the IRB's requests in a timely manner (you'll get email alerts and can also check your study in eIRB to see if we've requested information).
  4. Departmental review (or faculty advisor review) is required in eIRB before the study is assigned to an analyst, and a frequent mistake is to choose a dormant department in eIRB, or too many departments. Please review the "Departmental Review Help" section here - it could save you weeks! Study Submission Guidance
  5. eIRB guides you through the forms, but for more information about the submission process, please review this instructional video.
  6. Timelines may also be affected by other negotiations and reviews, e.g. contractual terms for injury compensation, ancillary committee review, FDA IND issues...

What If I Need Faster-than-average Review? This is a relatively frequent request. However, in general, studies are reviewed in the order in which they are received, due to our very high volume. Taking items out of queue must be for a truly urgent matter that may adversely affect study subject; that is because reviewing studies out of order means that other investigators' submissions will not receive timely review. Investigators who believe that their submission requires urgent processing should contact the IRB Director or Team Leads and provide their justification for such review along with any suggested deadlines.

Please note that the time to when the IRB review is complete is not the same as time to approval

General IRB Timelines

Our staff has timelines to screen studies, and to respond to requests from study teams. Note: Repeated calls or emails about the same issue may delay the initial screening as our staff will need to respond to several requests about the same topic.

We ask you to review the following chart to know what to expect, and when you may wish to email/call for a status check because your study is not proceding according to our target timelines (all in business days):

Type of Submission

Study Staff submission

IRB Staff Screening

Follow up/Letter after review

Approximate review time

Full Board new studies and amendments[1]

As soon as possible – Study team should prioritize amendments involving new risks for subjects

Intro comment for new studies within 2 days.  Pre-screening feedback within 5-7 days.

Max 2 days after review at IRB meeting

3-5 weeks from submission

Expedited new studies  and amendments

As soon as possible

Intro comment for new studies within 2 days.  Pre-screening feedback within 5-7 days

Max 2 days after review by designated reviewer (reviewers have a 5 day turnaround expectation)

3 weeks from submission

Continuing Review (CR)

For full board review: 45 days before expiration to allow for full board placement

For expedited review: Within 30 days of expiration

Pre-screen 3-4 weeks prior to expiration (if submitted in time)

2 days after full board meeting or review by designated reviewer

Review complete 2 weeks in advance of expiration (if timely submission) - earlier if Grady ROC required

“Does my study need IRB review?” Determination

As soon as possible using our online tool.

Once assigned, you will receive an email within two business days letting you know who will process your request. Inintial review ASAP, but within a week

If no clarification needed, you will be notified via email about the decision within about 7 days from submission (usually clarification is needed, however)

ASAP, but no more than 2 weeks from submission if investigator responds promptly (less if no clarification needed)

Exempt New Studies

As soon as possible

Intro comment for new studies within 2 days.  Pre-screening feedback within 5-7 days

Max 2 days after exemption review (reviewed by IRB staff members)

2 weeks from IRB receipt if clear submission

More Information

  • The IRB full board meets 6 times a month, and there are up to 6 new studies on each agenda. The interval between submission and meeting date depends on the timing of the submission relative to the next scheduled meeting that has space available.
  • Studies eligible for expedited review make up approximately 75% of the IRB's new volume (excluding exempt determinations).
  • The expedited studies are reviewed by one of the IRB meeting chairs, or (less frequently) by another designated member.
  • The IRB sets a turnaround goal of 5 business days for our reviewers.
  • Continuing reviews submitted earlier than 45 days prior to expiration will not be screened until the study is within 45 days (Full Board) or 30 days (Expedited) of expiration, unless specially requested (this is to preserve more of the prior approval period)

[1] Studies involving procedures that may involve risk to subjects, or when drug or devices are used, generally required full board review.  Amendments are reviewed at full board if they involve a new risk for participants, if the protocol is adding new procedures, drugs or devices that may pose new risks for subjects.