The University of Iowa
Human Subjects Office

WIRB Submission Process

  1. Complete Form A (UI Pre Project Checklist for WIRB Review Eligibility)

    1. Complete Pre Project Data Checklist (formerly Form A) in Hawk IRB to confirm the project meets the criteria for WIRB submission.
    2. If the study meets the conditions to submit to WIRB, proceed to the next portion of the Hawk IRB application by selecting the radio button next to WIRB as the reviewing IRB.     
                                                                                                                             

  2. UI HawkIRB application for New Protocol Submissions to WIRB (formerly Form B)

    1. Select WIRB as the reviewing IRB in question I.1.
    2. Enter Study Team members (Section II) of the application.
      • A current eCOI disclosure is required.
    3. Enter the funding source (Section III), if any.
      • Answer the question about financial conflicts of interest.
      • Project Materials Check. This page allows the user to submit the application without attaching required documentation in order to generate an IRB number. Please Note:  Users will still need to return the application to the HSO with all required attachments (protocol, consent document, other HRPP-related committee review materials, etc.) in order to obtain institutional signoff for the WIRB submission.  Other Committee review also will not begin until the project form has been routed back to the HSO.  
    4. Project Type (Section IV). Indicate whether or not the study will follow full ICH-GCP standards.  This selection is required only if the sponsor has indicated they are not willing to agree to ICH-GCP as per the FDA regulations.  
    5. Other Committee Review(Section V). Please note: Except where noted below (*) Other UI Committee review is required prior to WIRB submission:
      • Pharmacy and Therapeutics Committee (P&T)
      • Medical Radiation Protection Committee (MRPC)
      • Institutional Biosafety Committee (IBC)
      • Clinical Research Unit (CRU)
      • Holden Comprehensive Cancer Center (PRMC)
      • *UIHC Research Billing Compliance (JOC)
      • *Nursing Research Committee (NRC)
    6. Subject information, including the recruitment of prisoners (Section VI)
    7. Project Description (Section VII), including:
      • Location of research activities
      • Use of registries, repositories, type of study, etc.
      • Protocol details
      • Compensation
    8. The final section is for Attachments. Attachments should include
      • Consent Document (created from the template generated in Hawk IRB in the Application section)
      • Record of Consent Document (created from the template generated in Hawk IRB in the Application section)
      • A copy of the protocol
      • A copy of your draft WIRB application
      • Additional documents submitted to WIRB (not listed above) should be attached in a zip folder, labeled "Submitted_To_WIRB_Month.Date.Year" in the Copy of External IRB Application Section on the Attachments page.
    9. Once a Hawk IRB application has been submitted to the HSO for review, all required other UI Committees will receive a notification that its review is required. After the HSO has reviewed the Hawk IRB Application in its entirety and determined all UI requirements are being met, the Institutional Approval Memo will be attached to the application. The application will then be routed back to the PI in Hawk IRB Workflow.

  3. Submit the application to WIRB.  You must include the HSO Institutional Approval Memo in your submission in order for WIRB to review your application.

    1. Click on Begin Online Submission to use the online submission process. Click on Download Forms to access the WIRB “Initial Review Submission Form.”
      or
    2. Log into Connexus to complete the new smartform application. (When completing this form, select "No" for the question that asks, "Does a local IRB have jurisdiction over this research site?" The University of Iowa has a Master Agreement with WIRB, so a "Yes" response to this question is not required.)

Any questions during the WIRB submission process should be directed to WIRB at clientservices or 1-800-562-4789.