Tuesday, August 27, 2024

In 2023, the University of Iowa’s Office of the Vice President for Research and the Human Subjects Office embarked on a new organizational efficiency initiative to streamline processes for IRB review while at the same time maintaining regulatory compliance. 

Over the course of the first year of the initiative, the project team gathered input from a specialized consultant and created a road map for moving forward. Starting in January 2024, the team implemented a range of organizational changes that seek to enhance communication and transparency with the research community, streamline their process, and reduce bottlenecks.  A summary of their work, and a plan for moving forward, are below.

Highlights

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  • Reduction in rework (effective January 2024): Automatic withdrawal of any New Project or Modification forms after 60 days of inactivity in the PI’s workflow, which saves a considerable amount of time for HSO staff reviewers
  • Streamlined DSP approval (effective February 2024): The Division of Sponsored Programs will now approve industry-initiated clinical trials when contract negotiations are complete, instead of when the contract is fully executed. The IRB can approve and release the research application to the study team much more quickly.
  • Quicker communication (effective April 2024): HSO staff can now provide required actions to the PI shortly after the IRB meeting, instead of waiting for the full meeting minutes to be finalized. 
  • Enhanced transparency about timeline (effective April 2024): HSO staff can now set a goal date for the IRB meeting at the beginning of the IRB review process, giving the PI and HRPP committees a transparent timeline for addressing questions and concerns.
  • Reduced bottlenecks for multiple committees (effective June 2024): The IRB can now review and approve projects without waiting on approvals from other HRPP committees, allowing these groups to complete their reviews at the same time. 
  • New IRB review and approval structure for social/behavioral research (effective July 2024): A new IRB-02 chair was added and a new chair designee can now assist with sign off on post-approval forms. 

48

days earlier

DSP released industry-sponsored clinical trials an average of 48 days earlier

< 24 hrs

average time for PI actions

Average time to provide the PI with required actions from IRB meeting minutes has been reduced from 9 days to less than 24 hours since April 1

71 %

meeting date goal

Since implementation, 71% of studies met the meeting date goal

Process

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Evaluation

Hired a consultant in the field of human subjects research to conduct a thorough external evaluation of the UI IRB full board process (January – July 2023)

  • Determined opportunities for process improvements to increase efficiencies, decrease processing times, increase faculty satisfaction, increase competitiveness for acquiring clinical trials, and assure the highest quality of protections for human subjects
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Organizational Changes

Implemented operational changes in the following areas: IRB Meetings, Human Research Protection Program (HRPP) processes, and organizational design.

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Communication

Launched new communications tools to support changes and keep the research community informed across the institution

  • A new website to facilitate access to information, monthly email updates, monthly Zoom calls with the research community to share updates, answer questions, and demo operational changes
Checklist

Next Steps

  • Pause and collect additional data about the impact of the changes over time. Quarterly data will be presented to campus leadership starting in October 2024.
  • Assess next steps based on data results.
  • HawkIRB Application Redesign – The goal is to make forms easier for researchers to complete and more efficient for the IRB review.
  • AAHRPP Accreditation Site Visit: AAHRPP accreditation enhances the effectiveness and efficiency of HRPPs by ensuring that they adhere to both rigorous standards for quality and protections in human subjects research and the best practices of the industry.

Major Initiatives and Data Collected to Date

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: 

Categories 

New Project Forms 

Modification Forms 

Submissions (Feb 1-mid June) 

594 

465 

Forms withdrawn due to PI inactivity 

95 (16%) 

11 (2%) 

Forms recreated 

16 

1 

Recreated forms submitted 

8 

1 

 

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.  

Category 

Totals 

Notes 

Met Meeting Date Goal 

10 (71%) 

Two of these were assigned to an earlier meeting than the original goal. 

Not assigned  

3 (21%) 

This can happen if we do not have the necessary IRB expertise scheduled for meetings around the time of the typical goal date.  

Missed Deadline 

1 (7%) 

The form was not returned in time to keep the original meeting date goal. Scheduled to a later meeting. 

Total 

14 

 

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.