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Process for Just-In-Time NIH Funding and IRB Review

March 18, 2009

This memo is directed to those DUHS researchers who have a high likelihood of receiving Just-In-Time funding from the NIH.  As you know, the NIH will be releasing additional funding over the next few months. The notice of funding will come with a 5 day turnaround for institutional approvals, including IRB approval.  In order to comply with this requirement, the IRB has devised the following review process that requires the cooperation of the research team, investigators, and departmental officials.

For all studies with a high likelihood of receiving this funding:

1. The PI should complete the submission form and upload all study documents in the eIRB, leaving the study in the "Presubmission" state. Once the notice of funding is received, hit the "Submit" button. Please do not submit the study until the notice of funding has been received. Please confirm beforehand that your study team's ethics credentials are up to date, and please remember that all co-PIs must electronically sign before the submission is considered complete. In addition, once you submit, you can go to the Modifications tab in the eIRB to see the list of study staff personnel whose ethics credentials are incomplete. Please check this list so that you are not in the position of having approval withheld at the end of the review process so that ethics credentials can be obtained.

2. Immediately after hitting the "Submit" button, please send an e-mail to your departmental IRB Board Specialist, Department Chairperson, Department Business Manager, Departmental Reviewer (or administrator), and me (power008). Notification to your Board Specialist and me will allow the IRB to monitor the progress of your submission and notify you if the submission is delayed at any step.

3. Departmental Reviewers and other departmental officials or administrators must be prepared to turn around reviews/signatures within 24 hours of receipt. The IRB is prepared to forego departmental review, so, for this specific process, it is acceptable for the Departmental Reviewer/Administrator to simply sign-off on the review. A complete review will be conducted once the study is in the possession of the IRB.

4. New studies arriving in the IRB will be immediately assigned to either an expedited reviewer or one of that week's convened IRBs (Wednesday and Thursday afternoons). Study staff should be on standby to receive and process modifications requests.

5. Modifications will be sent to the study staff immediately after review. For those studies reviewed by a convened IRB, modifications will be sent during the meeting, immediately after the discussion and vote. Completed modifications must be returned to the IRB immediately, in less than 24 hours of receipt. Modifications will be promptly reviewed and, if satisfactory, approval issued. Please make a point to address all required modifications. Please do not submit additional modifications or alter IRB-approved wording; otherwise, approval may be delayed.

It will require cooperation from all parties involved to meet the 5 day turn around time. Please let your study teams and departmental officials/administrators know about this process. Thank you.

Jody Power
Executive Director
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