WCG Review and Approval Process
- 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.
- 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.
- Institutional Hold Pending Committee Reviews: Studies cannot begin until all UI committees are completed with their review, therefore WCG will place a hold on all approval documents until the HSO confirms all approvals are in place at UI. The following committees can review concurrently with WCG’s review:
- Division of Sponsored Programs (DSP)
- UIHC Research Billing Compliance (RBC)
- Nursing Research Committee (NRC)
- Return Project in HawkIRB Upon Approval of Committee Reviews: Upon verification of the finalized contract (DSP), NRC approval, billing plan execution (RBC), and verification of approval from WCG, the team is responsible for returning the application in HawkIRB to the HSO.
- 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.
- 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.
- WCG Notification to PI of Institutional Hold Release: The PI will receive copies of all regulatory documents and approved consent forms from WCG.
- HawkIRB Approval and Release: The WCG Coordinator will attach the WCG Approval Memo documentation in HawkIRB and release the project to the PI.
- 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.