July 2024 IRB Connection Newsletter

Beginning in January 2024, the Human Subjects Office (HSO) rolled out six major initiatives to improve Institutional Review Board (IRB) and Human Research Protection Program (HRPP) review processes. This article provides an evaluation of previous programming changes that were presented at the May IRB Efficiency Initiative Information Session .

Here’s a brief overview of the initiatives and results to date:

• 60-Day Withdrawal Due to PI Inactivity (effective 1/29/24): 1,059 New Project and Modification Forms submitted since implementation. Of these, 106 forms were withdrawn (10%), 17 were recreated, and 9 were resubmitted.

• DSP Approval Timing (effective mid-February 2024): The new process for faster signoffs from the Division of Sponsored Programs allowed the release of HRPP approvals an average of 48 days earlier ( 36 days median).

• Required Actions After the IRB Meeting (effective 4/1/24): the average time to provide the PI with required actions from IRB meeting minutes has gone from 9 days to less than 24 hours since April 1.

• Assign a Meeting Date Goal (effective 4/1/24): Limited data is available, but 71% of studies met the date goal. More in-depth information will be available after the June rollout that separated IRB review from HRPP Committee Approvals.

60-Day Withdrawal Due to PI Inactivity (effective 1/29/24)

HawkIRB forms are automatically withdrawn if there is no response to workflow in 60 days . This change will allow for more accurate metrics for IRB review time.

In addition to the two-week reminders, a new 55-day HawkIRB email notice states that the form will be withdrawn in five days. The form in the PI’s inbox shows the number of days in Workflow over the total days since submission. At 55 days , the form is highlighted in red in the PIs inbox.

Evaluation data for New Project forms and Modification forms:

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New Project Forms

Modification Forms

Submissions (Feb 1-mid June)

Forms withdrawn due to PI inactivity

Recreated forms submitted

The 106 withdrawn forms represent a considerable timesaving for HSO staff reviewers. Most withdrawn forms have not been recreated and very few recreated forms have been submitted to the IRB.

NOTE: For a withdrawn form, the PI can only use the “recreate” link once. It is best to hold off on recreating the form until all issues that were holding up the response to the workflow questions in the original form have been resolved.

DSP Approval Timing (effective mid-February 2024)

Division of Sponsored Programs (DSP) approval is required in HawkIRB for industry-initiated, industry-funded clinical trials where a research contract is required to document institution and sponsor expectations. The research application can be approved by the IRB, but not released to the study team until DSP approval is documented. In February, DSP updated their “contract approval” process for these industry-sponsored clinical trials. DSP approval used to be documented when the contract was fully executed; contract negotiations were complete, all signatures in place (institution, PI, and sponsor), and budget approved. Now DSP issues approval in HawkIRB when contract negotiations are complete, even if signatures and/or budget remain pending. This removed a significant delay in the HRPP approval process. Note: The PI must continue to work with the sponsor to obtain signatures and finalize the budget prior to initiating the research.

This change affected 38 studies from mid-February to early June. Faster DSP sign off allowed the release of HRPP approvals 48 days earlier than the previous average. For these studies, the median turnaround for IRB approval was 36 days , which is considerably below the goal of a 45-day median from submission to approval for full board review.

Assign a Meeting Date Goal (effective 4/1/24)

Application Analysts can now set an IRB meeting date goal, and a due date for meeting this goal, at the beginning of the IRB review process.

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