The IRB Efficiency Initiative updates specific to Human Subjects Office\IRB policies and procedures will be housed here.
The first IRB Efficiency Initiative (IRB EI) information session will be held the fourth Wednesday of every month from 12-1.
IRB Efficiency Initiative: February 2024 |
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This Wednesday, February 28, from 12-1 IRB Efficiency Initiative (IRB EI) Informational Session. We do have a number of topics to cover during this session. Those items include:
Preview April 2024 changes: The next set of changes include:
New HSO Website coming soon! IRB EI Website updates The next IRB EI related programing and policy changes will occur on April 1, 2024. Please register here for February 28th Information Session. Recording of the session will be available for 24/7 access. |
IRB Efficiency Initiative – January 29th changes
On January 29, 2024, the Human Subjects Office (HSO) and IRB will be rolling out the first changes associated with the IRB Efficiency Initiative, which was formally launched in November 2023. The first set of efficiency initiative changes involve process optimization and application of regulatory flexibility that will include:
- Withdrawing a project from further HSO\IRB consideration at 60 days of inactivity
- Returning required actions from an IRB meeting to the study team to address prior to completion of the full IRB meeting minutes
- Section III updates to human subjects research funding and sources of support
Withdrawing a project from further HSO\IRB consideration at 60 days of inactivity
Once a pending project has reached 60 consecutive days of inactivity in HawkIRB, it will be withdrawn from the workflow system. This change will allow the HSO\IRB to focus review on submissions that are ready to move forward. The projected impact of this change to the IRB approval metrics shows a significant improvement in overall processing time. In preparation for these changes, the HSO\IRB will notify all Principal Investigators who have had an inactive project form in their inbox for 30 days or longer. This will allow the study team to take action to address any outstanding HSO\IRB requests before 1/29/24. If action is not taken by this date, the project form will automatically be withdrawn. However, the form will be saved in HawkIRB and the study team may resubmit the form to the HSO\IRB for review.
Returning required actions from an IRB meeting to the study team to address prior to completion of the full IRB meeting minutes
Human subjects research determined to be greater than minimal risk requires convened board review. IRB meeting minutes are sent to the Principal Investigator after the IRB meeting. IRB meeting minutes capture required changes requested by the IRB, regulatory determinations, IRB motions and vote, and a summary of any controverted issues. The changes, or required actions, requested by the IRB will now generally be sent within 24 hours after the conclusion of the IRB meeting. Researchers can work on addressing outstanding IRB requests while the HSO staff document the remainder of the contents of the IRB meeting minutes. The Principal Investigator will receive notification once the minutes have been completed. The PI remains responsible for ensuring all regulatory determinations are applied to the conduct of the research.
Section III updates to human subjects research funding and sources of support
The Human Subjects Office and the Division of Sponsored Programs have identified several areas where delays have occurred in processing human subjects research as a result of inconsistencies in sources of monetary funding or sources of support. In an effort to reduce these delays, changes to section III have been made to reduce those common inconsistencies. Section III will capture both financial and non-financial sources of support with this update.
Learn more about the Initiative
The Human Subjects Office is offering a month informational session the fourth Wednesday of every month from 12-1 related to the IRB efficiency initiative. The first info session is on January 24, 2024, from 12-1 via Zoom. Registration for this event can be found here.
Read more about the initiative, including a project roadmap and timeline, on the IRB efficiency initiative website. Policy specific information for these changes can be found on the Human Subjects Office website under UI Investigator’s Guide\IRB Standard Operating Procedures.
Previous IRB Efficiency Initiative updates:
- Executive Summary and Initiative Timeline
- Project Launch (November 2023)
- Presentation: Where we started, where we are, and where we are going (December 2023)….