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.

Pre-Review

Submitted studies go through a pre-review to check for the completeness of the 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.  Once a pre-review is completed, a study is either assigned to a designated reviewer or assigned to a full board.

Designated or Fullboard Review

Studies that can be assigned to a Designated review:

  • are no greater than minimal risk research, and
  • meet any of the criteria for “exempt” status, or
  • can receive “expedited” review if they do not meet any of the criteria for exempt status.

Studies that can go to a Fullboard review:

  • do not qualify for Exempt or Expedited Review as defined above,
  • are greater than minimal risk,
  • include sensitive subject matter (e.g., substance abuse),
  • include vulnerable populations (e.g., children, prisoners), or
  • include research areas that are new to the IRB (i.e., not a survey/focus group/secondary data use, etc.)

If the study is assigned to a Designated Reviewer, the reviewer may request additional information before making a final determination. During the study review, required training must be completed in order to receive a determination on your study.

Fullboard Meetings

Because the ORSIRB meets as needed for full board reviews, there is no set meeting schedule. The IRB requires 21 days to review the materials before the board meeting. During this time, the Board may request additional information before making a final determination. Required training must be completed in order to receive a determination on your study.

IRB Determination

Once a determination has been made and all required training completed, a letter from the IRB is sent through the electronic IRB system. It is posted in the study workspace. The electronic IRB system will send an email alerting the PI of the determination. The letter will state if a continuing review or annual review is required.

Continuing Reviews

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

For studies that do not  require a continuing review, including exempt studies, an annual check-in is required by DOE Order 443.1C, Chg. 1 (or current version).