There is a new submission status in IRBIS called “Pending COI Review.” This new status will be used when OHRE has completed the submission review, yet the COI disclosure is still pending review by the COI Office. The COI disclosure may be awaiting review by COI Staff, COI Chair, or the COI Committee.
IRBIS automatically performs a check on the disclosure review status each hour between 6am and 10pm. Once the COI determination is recorded, the submission will automatically return to the OHRE analyst, and the OHRE analyst will receive an email notification that the COI review is complete. At this point, the final approval will be issued, or the assignment to a Full Board agenda may proceed.
Please note the OHRE/IRB review process is NOT changing, but this new status will provide more transparency for research teams pertaining to the submission. In addition, OHRE analysts will not have to send stipulations regarding pending COI reviews, and the research teams will not have to repeatedly check if COI review is complete. It is infrequent that COI review is not completed by the time the IRB submission is ready to proceed, but if the COI review is pending, the status will be evident to research teams and OHRE staff.
Expedited, Both Initial Submissions and CR
“COI Pending Review” is used when pre-review is complete, but the COI review is still pending. Once the COI determination is final, the OHRE analyst will ensure that any requirements of the COI management plan are met, if any, and the final approval will be issued.
Full Board, Initial Submissions
The “COI Pending Review” is used for initial reviews when the study pre-review has been completed but the COI review is still pending. Once the COI determination is final, the analyst will proceed appropriately, including placing the study on an agenda, as appropriate. If the COI management plan requires a change of PI or other requirements, the submission will be returned to the study team for updating.
Full Board, Continuing Review Submissions
The study will be reviewed by the full board prior to the COI review being completed but if the review is still pending after the full board review AND there are not any pending stipulations, the study will be placed in “COI Pending Review” status until the COI review is complete and the study can be issued final approval by the IRB.
How can research teams help?
All researchers on a study team should submit their COI disclosures immediately following an initial study submission to IRBIS. This will ensure that the COI office has sufficient time during the OHRE pre-review process to review the COI disclosure and COI review will not delay the finalization of the IRB application. Please note that the COI Office will not complete a COI review until all team members have submitted their disclosures, so it is essential that all team members submit promptly.