Highlights from May IRB Insights  

The May IRB Insights session outlined a number of upcoming system enhancements, process changes, and new research support tools aimed at improving efficiency, compliance, and data integration.

• ClinicalTrials.gov Integration and Reporting Enhancements

The HSO is strengthening integration between HawkIRB, OnCore, and ClinicalTrials.gov to improve data alignment, compliance,  and reporting accuracy. New reporting capabilities will track study milestones (e.g., accrual status, completion dates) and support timely results reporting and compliance with federal requirements. Beginning Summer 2026, research determined to be an Applicable Clinical Trial (ACT) under the Food and Drug Administration Amendments Act (FDAAA), where a UI PI is the sponsor or responsible party, will be required to use OnCore as a clinical trial management system. Approximately 100 new studies annually are expected to be impacted.

• Community Connect Data Expansion for Research

A new initiative allows researchers to access Community Connect electronic health record data from partner hospitals. The current use is limited to retrospective record reviews, feasibility assessments and study development. There are some key constraints: the data must remain within UI Health Care systems, the study will require IRB (IRB-01) oversight and HIPAA compliance, and no prospective recruitment or FDA-regulated studies will be allowed at this stage.

• External IRB HRPP Review Process Standardization

The HSO is expanding a centralized “approval-to-submit” workflow for  all external IRBs. This process already allows IRB-01,IRB-02, and WCG to grant IRB approval before all required HRPP committee reviews are completed. In such cases, the study is placed in an “IRB approved, pending HRPP review” status until all remaining committee approvals are finalized. This expansion will include commercial, academic, and nonprofit IRBs similar to how WCG reviews occur now.

We are currently testing the application of this parallel review model across all external IRBs. Pending the resolution of any issues identified during testing, the tentative go-live date for this broader implementation will be in June 2026. 

• Cash Handling Form Integration

A new integration will allow the Grant Accounting Office’s cash handling form to be populated with HawkIRB application information. The form can be initiated within HawkIRB and this will allow PIs to submit IRB applications before final cash handling approval (with approval required prior to release). 

• Automated Approval for Research Team Changes

A new automation feature in HawkIRB will enable faster approval of certain research team member additions or removals. This automatic approval applies only to non-key personnel without conflicts of interest when added as research team members in Section II of HawkIRB. This feature can be used when adding certain types of employees with specific University of Iowa HR employment appointments and University of Iowa students. 

Watch the Recording: May 27 IRB Insights Presentation