Since E-IRB has been put into production, ORI has received feedback indicating preparation of the application by study support-staff is cumbersome due to the multiple points at which the Principal Investigator (PI) is required to log-in to E-IRB and perform a PI-only task. 

The solution agreed to by the IRB leadership, involves an addition to the PI’s Assurance Statement indicating the PI attests to his/her awareness of and full responsibility for the accuracy of all materials submitted to the IRB for review.  The PI will still be required to log-in to E-IRB and verify his/her identity with Link Blue ID and password in order to complete the PI Assurance Statement task.  Other actions involving submission of an IR, MR, or CR will no longer be restricted to the PI role.  Study personnel who have been delegated edit authorization of the E-IRB application will be permitted to:

• send the E-IRB application to other assurance statement signees like the Department Authorization (e.g., Dept. Chair or equivalent), Faculty Advisor, “Review by Other”, and,
• send the E-IRB IR, MR, or CR application to ORI for processing.

The E-IRB system was originally designed with measures in place to enforce the IRB’s policy dictating that the PI hold primary responsibility for actions involving submission of an application for Initial Review (IR), Modification Request (MR), or Continuation Review (CR).  ORI responded to the feedback by brainstorming for compromises acceptable to all involved. 

ORI believes this solution more closely mimics what researchers were able to do with the paper and email submission process, while still reassuring the IRB that the PI is aware of the research activities proposed and submitted to the IRB for approval/acknowledgement.

With the cooperation of Research Information Services (RIS), who will re-program the E-IRB system to operate under the revised IRB policy, ORI anticipates this change to be put into production by mid-May.  Another announcement will be issued to notify researchers of the exact date when these changes to the E-IRB system have been installed.  Subsequently, ORI will work on updating the affected E-IRB video tutorials to reflect this change in policy and procedure in E-IRB.