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 firstname.lastname@example.org(link sends e-mail). 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:
- The study involves human subjects and is designed to prospectively evaluate the safety and/or effectiveness of new drugs, devices, or behavioral interventions.
- The protocol was designed and written by the sponsor.
- The sponsor holds all Investigational New Drug (IND) applications for the protocol.
- The only sponsor is a for-profit entity/company.
- The UI investigator has not previously submitted the study to a UI IRB.
- The project does NOT involve any of the following:
- Embryonic stem cells
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.
- Federally-Funded Studies: Although this falls outside of our Master Service Agreement with WCG, the UI allows studies with federal funding to seek oversight by WCG. Therefore, a separate reliance agreement must be sought between UI and WCG on a case-by-case basis when studies seeking oversight with WCG have federal funding. The Commercial IRB Coordinator is responsible for initiating this reliance agreement. To submit a federally funded study to WCG, see the WCG as Central IRB link
- Unique situations: The UI IRB may direct studies to submit to WCG if the IRB has concerns whether it possesses the appropriate expertise or resources to provide proper oversight of a study. Please consult with the Commercial Coordinator for additional guidance in these unique situations.
- VA Health Care System (VAHCS) Studies: The VAHCS does not currently accept commercial IRB review unless special approval is received from the VA Office of Research and Development (ORD). Therefore, projects conducted at the Iowa City VAHCS may not be reviewed by WCG. They must be reviewed by IRB-03. This includes projects which propose the use of Veteran's Administration facilities, equipment, or patients. Full-time VA employees may not be involved as PI, Co-I, or Sub-I in any project submitted to WCG without prior VA approval.
WCG Policies & Procedures
The information provided below is to assist UI investigators with the UI/WCG process for submission of applications. Follow the links for more information regarding each category.
- WCG Submission Process
- WCG Consent Document Templates & Instructions
- Record of Consent FAQ
- WCG Review Process & Approval Notification
- WCG-UI FAQ Quick Reference Sheet
Contact WCG with any questions regarding WCG procedures or forms:
Email: email@example.com(link sends e-mail)
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:
Email: firstname.lastname@example.org(link sends e-mail)
Mail: 105 HLHS, Human Subjects Office, University of Iowa, 600 Newton Rd, Iowa City, IA 52242