HawkIRB forms are automatically withdrawn if there is no response to workflow in 60 days.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In addition to the two-week reminders, a new 55-day HawkIRB email notice states that the form will be withdrawn in five days.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: 

The 106 withdrawn forms represent a considerable timesaving for HSO staff reviewers. Most withdrawn forms have not been recreated and very few recreated forms have been submitted to the IRB. 

NOTE: For a withdrawn form, the PI can only use the “recreate” link once.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. 

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. 

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.  

NOTE: There were several limiting factors for evaluation of this change. IRB meeting agendas were full through April 22 when this change took effect on April 1. The first New Project form included in this evaluation was submitted on April 2 and scheduled to a meeting on May 9. This evaluation is based on data from early May through mid-June. 

Also, when this change took effect the hold for three Human Research Protection Program (HRPP) committees prevented scheduling forms to an IRB meeting. The IRB Efficiency Initiative rollout on June 14, 2024, lifted this hold by separating the IRB and HRPP Committee approvals. Future data will provide a more in-depth evaluation. 

HSO staff can now provide required actions to the PI shortly after the IRB meeting, which gives the PI/research team a head start to address required actions before receiving the full set of IRB meeting minutes.  

Before April 1, 2024, the average time to provide required actions to the PI in the full meeting minutes was 9 days. The goal is to provide required actions within 24 hours and the full set of meeting minutes within four business days.  

Of 167 sets of meeting minutes completed between April 1 and mid-June, HSO staff effectively decreased the average time to provide required actions to the PI to less than 24 hours. The research community has provided positive feedback about this change.   

Seventeen sets of minutes (10%) did not meet the goal due to the complexity of the issues the board discussed. Approximately half of these minutes were from a monthly IRB-01 Executive Committee meeting. The Executive Committee reviews more complex study design and compliance-related issues.