How long is the processing time?

How long is the IRB review process?

The length of the review process is dependent upon the type of review, the time of year submitted (peak times are at the beginning of the semester – August-September and February-March), and the thoroughness of the application.  Be sure to submit all application materials (e.g., surveys, letters of permission) with your application to accelerate the review process.  We review applications in the order they are received. 

Average times from a complete submission to approval are as follows:

Exempt = 1-2 weeks
Expedited = 3-4 weeks
Full = 2 months

NOTE:  Review of applications will not begin until ALL documents are submitted and the necessary conditions have all been met.

Once a protocol is approved, there are specific deadlines for post-approval actions and reporting.  Refer to the Dates and Deadlines page for more information. 

Steps in the Review Process

The following steps are generally followed for all types of protocols.  But there may be slight changes depending on the specific study and the review mechanism. 

Submission: The receipt of a protocol application will be confirmed and acknowledged within 5 business days.  Send all IRB documents to [email protected].  Please avoid copying multiple email addresses as they invoke multiple ghost actions leading to confusion and delays.  The study will be assigned an IRB ID if the request is for a new protocol.  A reference ID will be issued if the request is for a post-approval action.  

Prescreen & Validation: The IRB request will be screened for completeness.  Missing information and inadequate document will be notified and the PI will be asked to resubmit.  Most frequent road block is training deficiencies.  

Review: Once the application is complete, an IRB reviewer will be assigned.  The reviewer may directly contact the investigators or will make indirect interactions through the Office of Compliance.  Moreover, the review and approval of most post-approval action requests, such as minor amendments and continuing reviews will be handled by the Office of Compliance.  The reviewer comments will be written within the application forms and IRB templates (informed consent, recruitment email, and etc.)

Review response: The PI will be given a chance to respond to any review concerns and comments raised by the IRB.  The investigator is expected to provide a clear response to the review comments.  The response must also include a clear description of any alternatives to the reviewer’s suggestions.  

Additional Review: Inadequate responses that lack clarity and completeness would lead to follow up questions resulting in longer review process.  

Full member convened meeting: The primary and secondary reviewers assigned to a full member protocol would submit their comments and thoughts to the IRB along with any review discussions they had with the investigator. The IRB will deleberate and vote on any recommendations by the primary/secondary reviewers and/or a motion made by a member from the floor.  

Additional Review:  Depending on the outcome of the IRB’s deliberation, further review may be needed before a final decision can be made.  In most cases, the additional review would just require modification of a protocol application or supporting documents.  

IRB Decision: Decision to approve would be made by a single member for exempt and expedited protocols.  The member will not disapprove any protocols but would have the authority only to elevate the review to the next level.  For instance, an exempt protocol will be sent to a different IRB member for an expedited review.  Additional paperwork/documentation will be sought from the investigator if needed.  Decision to defer a protocol will be made by a full committee and their decision is final.  There is very little latitude for an appeal.