The first phase of the redesign went live on 8/16/25 as part of the IRB Efficiency Initiative and included 

• one new section (Single IRB (sIRB) of record multi site research) and
• changes to five existing sections  (II, III.5, VII.A, X, and XII).

Information on these changes are outlined as part of the, now retired, IRB Efficiency Initiative.

Section VII changes to the HawkIRB application are live as of 2/15/26.  At a high level, section VII changes include:

• VII.A.1 - Revised to include additional checkboxes to select UI Health Care primary physical locations where human subjects research may occur.
• VII.B - VII.E - The changes were primarily to eliminate free text fields, where possible, by adding options to select identified as the most common responses addressing study specific research activities. 

All IRB applications will be required to provide responses to the redesigned questions. Where possible, existing responses, have been carried over to the newly redesigned structure.  However, it was not possible for all free text field responses to be carried over to the new redesign of section VII.  

• A one time change to provide details for all redesigned questions in section VII will be required the next time a modification is submitted to the IRB.  
• All draft IRB applications will automatically be updated to the newly redesigned structure.
• All pending forms will not undergo redesign changes until after IRB approval at the time a modification is submitted. 

VII.A.1 - Revised to include the UI Health Care primary physical locations where human subjects research may occur. This change identifies

• 200 Hawkins Drive locations such as the Clinical Cancer Center, the Medical Center University (non oncology locations), and the Stead Family Children's Hospital.  
• Iowa River Landing (both locations) and the North Liberty Hospital
• Mission Cancer + Blood and the Quad Cities Oncology locations can now also be selected and
• An option for all other UIHC physical locations not identified.
• The CRU will remain a stand alone selection and is automatically checked if V.21 is Yes.

These changes are to support ongoing enhancement of location details pushed over from HawkIRB to the UIHC Clinical Research and Trials website.  The last stage of this development is to update this linkage.  Expected completion March 2026.

The last option in this question about conducting research activities virtually has been expanded with additional examples of virtual activities.

Section VII.B captures the following study related activities and includes a small number of changes:

• Renumbering of VII.B after moving two study series sections from VII.B to section I. (Now I.6-I.13)
• Estimated date of the last subject to undergo study procedures supporting compliance for posting of informed consent (federally funded clinical trials only)
  • No changes to this section
• Drug washout
  • No changes to this section
• Use of placebo
  • Separation of one question into two questions to attempt to avoid confusion.  This question series has caused additional work for researchers and the IRB when completed incorrectly.  
  • The revisions clarifies wording on whether or not there are FDA approved treatments a subject may or may not have available if they were not participating in the research.
  • Clarification of management plan expectations during placebo phase of the research.
• Use of an investigational medical device
  • Wording in one question added to reference to device selection as identified in I.6
  • Move attachment categories directly after question requiring attachment.

A recording is available from the 2/4/26 IRB Insights presentation for additional details on changes in section VII.B & VII.C.  You can access this recording by using your UI HawkID and password to log into the HSO\IRB ICON platform under 2.4.26 IRB Insights Information Session-Recording (37:59) 

VII.C removes several free text field questions collecting research related details about genetic testing.  After analysis of genetic research responses in all open IRB applications during 2024, several questions were changed to a "check all that apply" structure offering selections based on  

• the most common types of genetic testing submitted to the IRB and
• the most common types of blood, fluid, or tissues, etc. collected from subjects to complete genetic testing and
• the most common data points associated with the specimens.

A requirement for the use of a CLIA certified lab for dissemination of genetic testing results has been added for all new submissions.  Current IRB approved submissions will not be grandfathered into this specific change.

Finally clarification has been added to what the IRB expects to have included in a genetic counseling plan if results are shared with subjects.

A recording is available from the 2/4/26 IRB Insights presentation for additional details on changes in section VII.B & VII.C.  You can access this recording by using your UI HawkID and password to log into the HSO\IRB ICON platform under 2.4.26 IRB Insights Information Session-Recording (37:59) 

VII.D includes all research related activities associated with research subject recruitment and the informed consent process.  A number of changes have been made to this section that include:

• Option to attach required attachments immediately following a number of questions in this section that require an attachment.
• VII.D.1. changes to the recruitment related selections
  • New commonly IRB approved recruitment activities added to VII.D.1
  • Moved research recruitment plan outline required in VII.D.29 directly under VII.D.1 to clearly link options to the recruitment plan used by the study team.
  • Expansion of new recruitment activities that require a partial HIPAA waiver of authorization for recruitment purposes in VII.D.
    • The option of MyChart and the EPIC Our Practice Advisory (OPA) have been added.  These services are not currently available at this time, as they remain under pilot in the UIHC.  These opts will appear but will remain grayed out until the expected release later in 2026.
  • New question added to select method(s) the study team will use to obtain informed consent.  This question will now include an electronic consent (eConsent) option.  
    • An FDA regulated eConsent solution available in the eReg system (part of ICTMS Oncore) is expected to be released by the beginning of March
  • The waiver of documentation of informed consent criteria have been updated from two to three options.  
  • The free text field questions (Formerly VII.D.29 & 30) to gather details on the full recruitment plan and the plan to obtain informed consent has been revised to an acknowledgement to define and reinforce the regulatory expectations when obtaining informed consent. 

No changes were made to the series of questions requesting study related details when deception is used in the study.

A recording is available from the 2/4/26 IRB Insights presentation for additional details on changes in section VII.D & VII.E.  You can access this recording by using your UI HawkID and password to log into the HSO\IRB ICON platform under 1.28.26 IRB Insights Information Session (53:35) 

VII.E includes questions designed to collect study related procedures that will occur during the course of the study as well as research subject compensation. The following changes have been made to VII.E:

• Move attachment categories directly after question requiring attachment.
• A question has been moved from VII.D to VII.E as it gathers details that occur after informed consent has been obtained.  
• Research subject compensation methods have been expanded to include a method frequently used in industry sponsored research. (e.g. use of 3rd party payor platforms such as Clincard, Greenphire, MTurk, Prolific, etc.)
• Improved structure identifying when a cash handling plan is required to be attached.
• Direct linkage to initiate a cash handling form when one is required.
  • Collaboration will continue with Grant Accounting Office this spring to further integrate information found in HawkIRB to the Cash Handling submission to reduce the amount of duplication of effort from the study team.
• A new question has been added to capture scenarios where subjects may be reimbursed for costs incurred to participate in the research.  More information regarding what is, and is not, considered reimbursement can be found on the Research Subject Reimbursement page of the HSO website.

A recording is available from the 2/4/26 IRB Insights presentation for additional details on changes in section VII.D & VII.E.  You can access this recording by using your UI HawkID and password to log into the HSO\IRB ICON platform under 1.28.26 IRB Insights Information Session (53:35)