Project updates

IRB Efficiency Initiative – February 29, 2024 Update

 

The next programing and policy set of changes will occur on April 1, 2024

On Wednesday, February 28, the Human Subjects Office hosted the second IRB Efficiency Initiative Informational Session campus. Watch the session here

 

The February Informational session covered the following topics: 

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data will include counts of impacted studies, require action count and timelines, and number of forms returned or withdrawn since the 1/29/24 rollout.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 of April 2024 changes

The next set of changes will 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

 

Register here for the next informational session on March 27, Noon – 1:00pm.    

A recording of all sessions will be posted on the IRB Efficiency Initiative website

To: Human subjects researchers and staff
Subject: January 29, 2024 changes
Date: January 22, 2024

IRB Efficiency Initiative – January 29th changes

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:

Presentation: Where we started, where we are, and where we are going (December 2023)….

To: Human Subjects researchers and research staff
Subject: New IRB Efficiency Initiative
Date: 11/30/23

At the University of Iowa, we are committed to supporting the incredible faculty, staff, and students who are engaged in research and creative discovery across our campus. It’s at the heart of what we do in research administration.

In the Human Subjects Office, our work involves protecting research subjects, the institution and individual researchers by navigating the complex federal regulations and policies that are in place to minimize risk to people and assure adequate protections of their rights and welfare. We process more than 12,500 forms per year and maintain full accreditation from the AAHRPP, an independent, non-profit accrediting body that ensures that institutional programs like ours meet federal standards for quality and protection. Our team is dedicated to upholding integrity, ensuring quality, and providing excellent customer service to our campus community.

Today, we are reaching out to let you know that we are launching a new IRB Efficiency Initiative, sponsored by the Office of the Vice President for Research and the Human Subjects Office.

This new initiative will focus on streamlining processes for IRB review in an effort to remain competitive with our peer institutions’ average processing times for your research applications, while at the same time maintaining research subject safety and regulatory compliance.

We have already engaged an independent consultant to conduct a thorough external evaluation of the IRB process, with the following goals in mind:

  • Determine opportunities for process improvements to address the goals of increasing efficiency and decreasing processing time from submission of the application to release of approval
  • Identify meaningful opportunities for change that could address the following goals:
    • provide long-range planning for shifts in the research landscape
    • increase researcher satisfaction
    • increase competitiveness for acquiring research funding
    • assure the highest-quality  protections for human subjects

We will be in touch over the coming months to share updates on our progress towards implementing changes in key areas, including IRB meetings. In some cases, these changes will require us to work together closely with the campus community to achieve our goals for decreasing processing times for applications.

Starting in January, the Human Subjects Office will begin hosting monthly information sessions for the research community about recent changes and upgrades. The first training session will be held on January 24, 12:00-1:00pm. Future sessions will be scheduled on the fourth Wednesday of each month.

Additional details about the plan and timeline are available on our website. Please reach out to our office at vpr-office@uiowa.edu with questions at any time.

Sincerely,

 

Jennifer Lassner, Associate Vice President for Research

Michele Countryman, Director, Human Subjects Office and IRB