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 was held on January 24, 2024, from 12:00-1:00.  IRB EI Information sessions will be held on the fourth Wednesday of every month from 12:00-1:00 pm. See the web page for recordings of each information session and brief demonstrations of the changes.

We are excited to announce all Human Research Protection Program (HRPP) Committee approvals will no longer be required before either IRB (Institutional Review Board) review or approval. This transition represents a continued commitment for all committees to focus on achieving approval within the institutional goal of 45 median days.  This IRB EI change is now live.

Prior to June, IRB-01/02 process requires the following HRPP approvals to occur before IRB review:

  • Holden Comprehensive Cancer Center (HCCC) Protocol Review and Monitoring Committee (PRMC) (IRB-01 only)
  • UI Health Care Research Billing Committee (RBC) (IRB-01 only)
  • Conflict of Interest in Research Committee (CIRC)

Prior to June, IRB-01/02 process requires the following HRPP approvals to occur before IRB approval:

  • Pharmacy & Therapeutics (P&T) (IRB-01 only)
  • Medical Radiation & Protection Committee (MRPC) (IRB-01 only)
  • Nursing Research Committee (NRC)

Submissions to WCG (Western Copernicus Group – formerly known as WIRB) will apply these same changes as the terms of the WCG master service agreement allow for an institutional hold similar to the IRB-01/02 process. This HRPP transition will not apply to IRB-03 Iowa City VA or any other external or commercial IRB submission(s). This change will allow all HRPP committees, including the IRB, to continue to work together concurrently to address outstanding questions and grant our respective approvals. It also allows the Human Subjects Office (HSO)/IRB to pull accurate reporting data solely on HSO/IRB review metrics.  

All HRPP approvals will now be allowed after IRB approval.  All applicable HRPP approvals are required prior to release of the project to the Principal Investigator (PI) and research team. HRPP flowcharts and other information found on the Other Research Review page of the HSO website as well as the University of Iowa IRB Standard Operating Procedures and Researcher Guide have also been updated to reflect these changes.

IRB-01/02 and WCG submissions in HawkIRB will be allowed to submit one modification after IRB approval to address any HRPP requested changes that could impact the IRB approved contents of the HawkIRB application, informed consent, or other IRB approved materials.  The modification will be allowed after all HRPP committee(s) have either indicated changes are required or issued their approval. If changes are required, the HawkIRB application will document necessary changes to support the Principal Investigator(PI)/study team to complete the modification to the IRB application and/or associated materials. HawkIRB system notifications will also be sent to the PI to keep them informed. When a modification is submitted to the IRB as a result of any HRPP requested changes, it will follow all standard IRB modification review processes.

The last IRB Efficiency Initiative Information Session was held this past Wednesday, March 27, 12:00pm – 1:00pm.  It covered programming updates that will be implemented on April 1, 2024.  The information session will also cover a number of other new initiatives and activities that will be introduced in June, July, and August/September. Watch the session here.

The April 1, 2024 programming updates will impact IRB-01, IRB-02, and IRB-03 full board meeting processes. The primary change is:

  • Identifying an IRB Meeting Date Goal for new project applications at the point the submission has passed the prescreen process and begins full staff review. The intent of identifying a meeting date goal well in advance is to: 
    • promote transparency
    • foster teamwork
    • allow additional concurrent reviews to occur
    • increase time for IRB primary reviewers to review assigned materials and submit all required documentation prior to the IRB meeting
    • increase time for PI to address any outstanding questions or concerns from the primary reviewer

The HSO also gave a sneak peak of the new HSO Website! The HSO is transitioning to the newest Drupal platform.  This transition has allowed the HSO an opportunity to update the HSO website to be more user-friendly and accessible.   

HSO/IRB policy changes discussed at this information session are posted on the UI Investigator’s Guide\IRB SOPs page of the HSO website.

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:

January 2024 updates

  • Answers to common questions asked by the research community
  • Two additional enhancements 
    • IRB-03 VA Section III funding updates: Funding routed through the VA Research Foundation is not linked in the HawkIRB system. The IRB-03 funding section has a number of funding sources not applicable at the VA so they have been removed from all IRB-03 submissions. 
    • An additional indicator in the HawkIRB inbox has been added to remind the PI the 60 day withdraw deadline is nearing. When a project has been in the PI’s inbox for 55 days, the project form will now be highlighted as a visual indicator that the 60 day deadline is nearing.
  • Preliminary data on the impact of 1/29/24 changes This preliminary data will include counts of impacted studies, require action count and timelines, and number of forms returned or withdrawn since the 1/29/24 rollout.

Preview April 2024 changes:  The next set of changes include:

  • Setting IRB Meeting Target Date Goal for New Project Forms 
    • An IRB full meeting date goal will be identified shortly after a full board staff member receives a new project form requiring full board review.
    • This meeting date goal will be communicated to all involved in the preparation of the new project submission. This communication will be sent to the PI, delegates, study contacts, IRB Chair, and IRB Primary Reviewers. The Human Research Protection Committees required to review the new project form will also be informed of the meeting goal.
    • The communication and goal is to ensure the new project has sufficiently addressed the criteria for IRB approval, standard expectations by the IRB, HRPP changes that may impact the IRB review, or any other institutional issues that could impact the IRB Review.
    • If the meeting goal is not met, the project will be scheduled to a meeting once all outstanding requests have been addressed.
  • Primary Reviewer Review Deadline 
    • The Primary Reviewer Checklist deadline will be moved to two days prior to an IRB meeting to allow adequate time for a Principal Investigator to address any outstanding questions or concerns raised by the reviewer.
    • The HSO full board staff will work with the Primary Reviewer to ensure the Principal Investigator is notified prior to the meeting of any outstanding questions or concerns are raised. The intent of this change is to allow more time for the PI or study team to address these items prior to the IRB meeting. 

Educational Tools:

  • NEW! Recruitment Letter Template available for use
  • Revised: Short Form Consent Educational Tool

New HSO Website coming soon!

IRB EI Website updates

The next IRB EI related programming 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.

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: