When relying on an external or centralized IRB of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of record.  However, the Principal Investigator must also follow all University of Iowa (UI) institutional policies, as well as state and local laws governing human subjects research. The HawkIRB application captures information needed for UI HRPP Committee review and to ensure compliance with institutional policies.

If you are interested in utilizing an External IRB model, please review the "Final SOP for General External IRB" for specific information on the process and contact the Human Subjects Office at uirb-external@uiowa.edu. We will help you determine which model may work best for your proposal (Lead IRB of record, Relying IRB, commercial IRB models, etc.)

General Submission Information

The UI has contracted with the WIRB-Copernicus Group (WCG) for the option of review and oversight of new industry-initiated and industry-sponsored protocols that meet certain criteria. UI researchers have the option to submit the study to the UI IRB. 

Studies must be submitted to ​WCG automatically if the following condition(s):

  • The study has funding from DOD Navy (Department of Defense) and requires the institution to sign a DOD addendum to the UI FWA.

Studies may be submitted to WCG if they meet the following conditions:

Note: The UI reserves the right to retain IRB oversight of any new research protocol, regardless of industry sponsorship, and prevent it from being sent to WCG for review.  For those studies that are retained by the UI IRB, there are associated IRB fees.

WCG Policies & Procedures

The information provided below is to assist UI investigators with the UI/WCG process for submission of applications.

  • UI HawkIRB application for New Protocol Submissions to WCG
    • 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. 
    • Enter Study Team members (Section II) of the application.
      • A current eCOI disclosure is required.
    • 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.  
    • 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.  
    • Other Committee Review (Section V). Effective June 2024, 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)
    • Subject information, including the recruitment of prisoners (Section VI)
    • 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
    • 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.")
    • 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
    • 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.)
    • Log into Connexus to complete the new smartform application. Any questions during the WCG submission process should be directed to WCG at clientservices@wirb.com or 1-800-562-4789.

Informed Consent Document(s)

The following sections of the UI/WCG consent template include required UI language which cannot be modified in any way:

  • Authorization to Use and Disclose Information for Research Purposes
  • Compensation for Injury

Be sure to always download the consent template from the Attachments Page in HawkIRB to ensure you are using the most current version. 

Record of Consent

Please review the Record of Consent FAQs or the UI Investigator’s Guide for more information on when the documentation of research participation in a research subject’s medical record, via the EPIC Research tab, must be used.

A contact person(s) from the research team must be listed in the ROC section in the HawkIRB application. This should be someone who can be contacted any time. The project information must be detailed in this section of the HawkIRB application, including details about the study drug, potential complications, and/or any other important information. The UIHC no longer requires the use of G-12s for studies including drugs not approved by the FDA (or not being used for the approved indication, age range, etc.). Please ensure the ROC section in the application is detailed to include all common and severe complications of the study drug.

The Record of Consent (ROC) section in HawkIRB is only reviewed by the Human Subjects Office; it should not be sent to WCG.  If the 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” conditions apply to the conduct of the research, the study team should select either “does meet” or “do not meet.”  If selecting either of these options, include required template language in the HIPAA section of the Informed Consent Document.

  1. Submission to WCG: The study team will submit their application to WCG after receiving the “Approval to Submit” memo in HawkIRB. The team will ensure the most updated consents, “Approval to Submit” memo, and any other updated documents are submitted with the application to WCG.
  2. Approval from WCG: WCG will notify the Human Subjects Office (HSO) and the study team when the new project application is approved via email.  WCG is now the IRB of record for the protocol.
  3. Institutional Hold Pending Committee Reviews: Studies cannot begin until all UI committees complete their review, therefore WCG places an institutional hold on approved documents until the HSO confirms all approvals are in place at UI. 
  4. Return Project in HawkIRB Upon Notification of WCG Approval: Once WCG approves the study at a site level, the team is responsible for returning the application in HawkIRB to the HSO.
  5. HSO Final Review: The WCG Coordinator verifies that the UI template language in the Informed Consent Document is correct, confirms a Partial HIPAA is granted by WCG if applicable, and verifies all approval documents are correct.
  6. Institution Hold Release: After a final review of the documents approved by WCG, the WCG Coordinator will then notify WCG to release the institutional hold on the approval documents.  WCG typically releases the approval documents to the research team within two business days from the UI notification.
  7. WCG Notification to PI of Institutional Hold Release: The PI will receive copies of all regulatory documents and approved consent forms from WCG.
  8. HawkIRB Approval and Release: The WCG Coordinator will attach the WCG Approval Memo documentation in HawkIRB and release the project to the PI. 
  9. Full Approval: Research may begin once the WCG approved materials have been received by the Principal Investigator.  

Please note: The UI IRB Compliance Program may monitor any WCG-approved protocols.

Contact Information

Contact WCG with any questions regarding WCG procedures or forms:

Phone: 800-562-4789
Fax: 360-252-2498
Email: clientservices@wirb.com
Mail: 1019 39th Avenue SE, Suite 120 Payallup, WA 98374-2115

Contact the University of Iowa's Commercial Coordinator in the Human Subjects Office with questions regarding the application process or UI requirements:

Mayzie Tucker
Phone: 319-467-4182
Fax: 319-335-7310
Email: uiwirb@uiowa.edu
Mail: 105A HLHS, Human Subjects Office, University of Iowa, 600 Newton Rd Iowa City, IA 52242