WCG Submission Process

UI HawkIRB application for New Protocol Submissions to WCG

  1. Select the WIRB-Copernicus Group, Inc. (WCG) (formerly known as WIRB) in question I.1.  Any non-industry funding source will require a separate reliance agreement. 
  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 WCG 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). The WCG Coordinator can grant permission to submit to WCG even if all HRPP committees are still pending.  HRPP committee approvals must be finalized before the institutional hold with WCG is lifted and the study is released in HawkIRB:
    • Pharmacy and Therapeutics Committee (P&T)
      • Pharmacy and Therapeutics (P&T) Investigational Drug Device (IDS) - studies involving approved or investigational drugs with a focus on drug disbursement, storage, preparation and inventory control.
    • Medical Radiation Protection Committee (MRPC)
    • Institutional Biosafety Committee (IBC)
    • Clinical Research Unit (CRU)
    • Holden Comprehensive Cancer Center (PRMC)
    • *UIHC Research Billing Compliance (RBC)
    • *Nursing Research Committee (NRC)
    • *Division of Sponsored Programs (DSP)
  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
    • Recruitment requiring local context review, i.e., mass email
    • Compensation
  8. ROC- Record of Consent (University of Iowa Health Care policy IM-MR-06.21 titled, "Documentation of patient participation as a subject in a research protocol or use of an investigational medication, study medication, investigational device, or biologic.")
  9. The final section is for Attachments. Attachments should include
    • Consent Document (created from the template generated in Hawk IRB in the Application section)
    •  A copy of the protocol
    • A copy of your draft WCG IRB application
  10. 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.

Submit the application to WCG.  (You must include the HSO Institutional Approval Memo in your submission in order for WCG to review your application.)

  1. Log into Connexus to complete the new smartform application.
  2. Any questions during the WCG submission process should be directed to WCG at clientservices or 1-800-562-4789.