• 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.

New Projects

• Obtain the WCG-approved template consent for the "protocol level" (overall study approval).
• Track in University of Iowa required language into the WCG-approved template consent ensuring "tracked changes" are turned on. Ensure the site/sponsor does not turn off tracked changes or "accept" changes during review. All changes to the template must be shown as "tracked changes" when submitting to WCG.
  • University of Iowa language could include the following. Most language is included in the downloadable informed consent template during creation of your HawkIRB application, with exception of committee-specific language:
    • Add HawkIRB number within the title page (Ex: Institutional Number: 202512345)
    • HIPAA section (Authorization to use and disclose information for research purposes) (Institutional policy)
    • Compensation for Injury (Institutional policy)
    • SSN collection: for compensation purposes (if compensation if greater than $100 per payment or $600 or more in a calendar year) (IRS regulations/Grant Accounting Policy)
    • SSN collection for any other reason is required by the University to be disclosed in the consent
    • Legally Authorized Representative (LAR) order of authority list (Iowa law/Institutional policy)
    • Pregnancy testing for females under the age of 18 (UIHC policy)
    • HIV/Hepatitis reporting requirements (Iowa law)
    • Medical Radiation Protection Committee required changes outlined in the eMRPC form (Institutional policy)
    • Note: Institutional committees and the Human Subjects Office reserve the right to require changes outside of the items listed above
• Once this is complete, upload this version to the "Tracked Change" Consent Document category within the HawkIRB application for HSO review
  • Note: It is preferred the HSO reviews your consent documents in HawkIRB PRIOR to sending to the sponsor so the HSO reviewer can verify all required changes are incorporated when to sending on to the sponsor. This reduces confusion and unnecessary back and forth with the sponsor.
• Once all workflow is addressed within the HawkIRB application, an "external IRB exception memo" will be issued for the study approving it to be submitted to the external IRB. When submitting consent forms, please submit the most recent tracked change versions that have been negotiated in HawkIRB. 

Modifications

Sponsored-initiated changes

• Sponsors typically submit consent form changes on the "protocol level" when the changes affect all sites. Once approved at this level, modifications are typically automatically created for sites. WCG will send an email to the PI and all team contacts with the tracked changes version of the protocol level template stating:

  "Due to the policies established between the Institution and WCG IRB, please note that the request to review the information for this investigator has been withdrawn, but will resume processing once the site has sent to WCG IRB a request for review of the information outlined above. "

  The University of Iowa has an agreement with WCG IRB that new consent documents must have site approval to continue processing. When this notice is received you can do one of two things:

• Review the tracked changes version of the protocol level template, verify that none of the changes affect UI language or HRPP committee reviews. If this is true, you can reply to this email from WCG stating the modification can resume processing. WCG will then apply the tracked changes to the site-level consent and contact the HSO if any of the language deviates from the University of Iowa template language on file. This is typically the better option when the tracked changes do not affect any local requirements and the research team does not require any additional changes outside of what is outlined in the tracked changes.
• Download the most recent clean approved version of the consent from WCG Connexus, make the tracked changes shown in the version of the protocol level template WCG sent in their email, and respond to their email attaching the version created. This is typically the better option when the team needs to make changes outside of the changes outlined in the protocol level template. Examples below:
  • Local contact information updates
  • Changes prompt UI-required template language
    • New changes add an LAR signature line, therefore prompting UI and state law LAR language
    • Sponsor adds an entity to the consent they will be sharing PHI with therefore prompting changes to the second paragraph of the UI HIPAA section

OR

• Once WCG has fully approved the consent modification, submit this as a modification to HawkIRB.

Site-initiated changes

• Download the most recent approved version of the consent from WCG Connexus.
• Make any tracked changes necessary.
• Initiate a modification in WCG Connexus for the study and submit for approval
• Once WCG has fully approved the modification, create a HawkIRB modification for the study implementing the changes and submit the modification to the HSO

Additional Considerations:

• This process could differ between sponsors. Please communicate with the sponsor of your research project how they will handle sponsor-initiated changes.
• The research team is responsible for understanding when UI required language and UI HRPP reviews may apply to their research. For example, changes like adding a new consent form, study arm/cohort additions or new risks may require approval from one or more UI HRPP committees. A modification can be submitted in HawkIRB for these items to be reviewed prior to submitting to the commercial IRB. This reduces the number of back-and-forth submissions that can occur either between the site and sponsor, or the site and the commercial IRB. To do this, answer "No" to EXT.2 to indicate the changes are not yet approved by the commercial IRB
  • Upload the tracked changes versions of the consents and any other necessary updates that apply to the changes
  • Properly answer the questions in XIV to trigger committee reviews. Once committee reviews are completed and the committees have approved the consent with or without changes, follow the instructions above to continue processing the modification with the commercial IRB.
• Once the commercial IRB approves new consent documents or materials, those materials should be used immediately. Do not wait until HawkIRB has approved new materials to use new IRB-approved materials, this could lead to non-compliance.
• Please submit modifications in HawkIRB for required Post-Approval Submissions as soon as possible to notify the HSO and HRPP of any changes to the research. There are institutional requirements to update the institution’s research system in a timely manner when using an External IRB of Record. Not submitting required updates in HawkIRB could affect the funding and clinical trial status if not updated in a timely manner. 

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.