Project updates

The IRB Efficiency Initiative rollout in June 2024 separated IRB review and approval from the other Human Research Protection Program (HRPP) committee approvals. This article provides an overview of that change and a summary of other initiatives in progress, updated documents, policies and procedures and information session/demonstration recordings. 

Separate IRB and HRPP Committee Approvals - June 2024 Rollout 

HawkIRB programming changes rolled out June 14, 2024, separated IRB review and approval from other HRPP Committee approvals. Prior to this change, the IRB could not begin the convened board review process until the issuance of approval from three committees/entities: Conflict of Interest in Research (CIRC), Protocol Review and Monitoring Committee (PRMC, in Holden Comprehensive Cancer Center), and Research Billing Compliance (RBC). The HSO can now schedule a New Project or Modification form to a convened IRB meeting before the completion of these HRPP committee reviews/approvals.  

The second programming change allows the IRB to grant full IRB approval before the issuance of all HRPP approvals. Prior to this efficiency initiative, the IRB would hold approval pending approval from these additional HRPP committees: Pharmacy & Therapeutics (P&T), Medical Radiation and Protection Committee (MRPC), Institutional Biosafety Committee and Nursing Research Committee (NRC). Additionally, the IRB can now grant approval before the Division of Sponsored Programs (DSP) signs off on the grant or contract. 

The Principal Investigator (PI) can now submit a Modification form in HawkIRB to address requests from HRPP Committees that complete their review after the IRB approves the New Project form. The New Project form is released when the Modification form is approved and released in HawkIRB. 

Several documents, policies and procedures were updated or added in June. See a detailed list at the end of this article. 

What’s Next for the IRB Efficiency Initiative? 

The following initiatives are in progress or have already been implemented since the June IRB Efficiency Initiative Information Session: 

  1. New IRB review and approval structure for IRB-02 (social/behavioral research) – Effective at the start of Fiscal Year 2025, we added an IRB Chair Designee to assist with approval of post approval forms (e.g., Modification, Continuing Review, or Modification/Continuing Review) meeting an expedited or exempt criteria for approval. This enhancement is consistent with a long-standing IRB-01 review structure and is consistent with IRB practices across the nation. The new IRB-02 Chair Designee is an experienced IRB member who is already serving as an IRB-01 Chair Designee. 

  1. New IRB-02 Chair – The new IRB-02 Chair, an experienced IRB member, will begin onboarding and training in August as part of succession planning for IRB-02 Chairs. 

  1. Primary Reviewer process enhancements for full board review – HawkIRB programming is underway to update the Primary Reviewer Checklist used at convened board meetings and enhance the training process for Primary Reviewers. 

  1. HawkIRB Application Redesign – This initiative to streamline the HawkIRB application began with the rollout of Section III updates on January 29, 2024. The goal is to make forms easier for researchers to complete and more efficient for the IRB review. This is a continuation of the 2022-2023 initiative to update the HawkIRB form for projects that qualify for Exempt Status. The next HawkIRB application redesign rollout will focus on updates to the single IRB review process. This is in preparation for the anticipated FDA adoption of the revised Common Rule regulations regarding the use of a single IRB for multi-site projects. 

  1. New HSO website – The new HSO website is now live! HSO staff are still making final tweaks and corrections to URLs. It will take time for search engines to only identify pages of the new website. Use the gold buttons on the home page and the menu options to find what you need. We welcome your feedback. For assistance with finding anything on the new website or to provide feedback, please contact us at irb@uiowa.edu.  

  1. AAHRPP Accreditation Site Visit – 2024-2025 is our HRPP reaccreditation period and will involve a significant amount of HSO time and resources. There are two steps in the reaccreditation process. The UI is currently at Step I; the initial application was submitted in March, and we are currently responding to AAHRPP review of submission materials. Step II is the site visit which will occur this fall. The site visit includes interviews with select PIs and research staff. See February through July IRB Connection Newsletter articles for additional information about accreditation and preparing for the site visit. 

Announcements and Updated Resources 

The following documents were updated or added during the June IRB Efficiency Initiative rollout:  

  • New Resources: 

  • Other HRPP Committee Tool – Includes an organizational chart, information about each committee and when their review is required, and regulatory references for these reviews. [Link at end of first paragraph] 

  • Updated Policies and Procedures: 

  • Trainings and Demos: 

The next IRB Efficiency Initiative Information session will be held on Wednesday, May 22, from 12:00-1:00pm.  We are excited to announce that, beginning in mid-June, all Human Research Protection Program (HRPP) Committee approvals will no longer be required before either IRB (Institutional Review Board) review or approval. 

The current IRB-01/02 process requires the following HRPP approvals to occur before IRB review:

The current IRB-01/02 process requires the following HRPP approvals to occur before IRB approval:

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. 

This transition represents a continued commitment for all committees to focus on achieving approval within the institutional goal of 45 median days. It also allows the Human Subjects Office (HSO)/IRB to pull accurate reporting data solely on HSO/IRB review metrics.

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. A brief summary of the WCG process will be reviewed as part of the information session. This HRPP transition will not apply to IRB-03 Iowa City VA or any other external or commercial IRB submission(s). 

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 May 22 information session will cover: 

  • an explanation of how the current process will be changed
  • a demonstration of what is different in HawkIRB 
  • review revised HRPP flowcharts of the HRPP/IRB review process and  
  • revisions to HSO/IRB policies and procedures   

Please register to attend the session the May 22 info session from 12:00-1:00pm.     

The IRB Efficiency Initiative Information Session scheduled for Wednesday, March 27, 12:00pm – 1:00pm, covered programming updates that will be implemented on April 1, 2024. The information session also covered a number of other new initiatives and activities that will be introduced in June, July, and August/September. 

Watch the session here.

The programming updates will primarily 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 Human Subjects Office (HSO) also provided a sneak peak of the new HSO Website.

We hope you will join us for the next info session.  Register here to attend.   

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)….

Powerpoint slides (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