Institutional Review Board Process
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.
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.