Institutional Review Board Process

Institutional Review Board ProcessPre-Submissionto SubmissionPre-ReviewDesignatedReviewFullboardReviewInvestigator and study staff • Complete required IRB training in CITI for initial or refresher training. (Must be completed before IRB determination.)• Gather and complete required submission documents (protocol, consent form, recruitment materials, surveys, TOS, DUA, etc..). Contact IRB Administrator if you have questions.• Upload all materials into the electronic IRB system. Note: Only Investigator and PI proxies can submit.IRB Administrative staff• Send clarification requests to the Investigator as needed. Requests often result from using the wrong template, missing materials, or incomplete information.• Assign to Designated OR Fullboard review.Protocols are assigned to the Fullboard agenda 21 days before the meeting date.Account for Pre-Review time as well.Designated Reviewer• Send clarification requests to the Investigator as needed. Inconsistencies among materials and need for additional information are common reasons for requests.Occasionally another IRB member does a secondary review.This may impact the timeline for review.Determination is sent to Investigator through the electronic IRB system.Submissions are assigned to an agenda 21 days before the meeting date. Investigator is notified in electronic IRB system. Submissions are usually assigned to a primary reviewer before the meeting to provide comments to the committee members during the Board meeting.Determination is sent to Investigator through the electronic IRB system. Timeline impacted if studies require modifications or deferred.


Studies submitted go through a pre-review to check for completion of a submission. During a pre-review, the submission is reviewed to confirm the correct protocol template was used, the protocol is completed with all applicable question answered, and all applicable documents included. The IRB will request additional information from the principal investigator if something is missing or not completed.

Designated or Full Board Review

Once a pre-review is completed, a study is either assigned to a designated reviewer or assigned to a full board. During this time, the Designated Reviewer or the Board may request additional information before making a final determination. During the study review, training must be completed in order to receive a determination on your study.

There are several elements that affect the overall IRB timeline. Those elements include, but are not limited to:  

  • Completion of training for principal investigator and study staff (Study staff are members of the research team who are involved in the design, conduct, or reporting of the research or who participate in those aspects of the research that involve contact with human subjects or their data or biospecimens)
  • Submission quality
  • Responsiveness of the study team to requests for clarification or changes
  • Time required for IRB members to complete a comprehensive review of all submitted materials
  • Increased volume of submissions to the IRB

If you have an urgent need about a submission, please contact the IRB Administrator as soon as possible.

Full Board Meetings

Because the Oak Ridge Sitewide Institutional Review Board meets as needed for full board reviews, there is no set meeting schedule. Full board meetings are determined by study content and member availability. The IRB requires 21 days to review the materials before the board meeting.

Note: Repeated calls or emails to the IRB may delay your study’s review.

Continuing Reviews

A continuing review should be submitted two weeks before the expiration date to allow time for review.

For studies that do not need a continuing review, even for exempt studies, an annual check-in is required by DOE Order 443.1C.