Institutional Review Board Process
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).