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. In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail. However the Principal Investigator will also be required to continue to follow all University of Iowa institutional policies as well as state and local laws governing human subjects research. The HawkIRB application is designed to capture the majority of the information necessary to identify the Human Research Protection Program review requirements and various institutional policies.
If you are interested in pursuing human subjects research 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 . We will help you determine which model may work best for your proposal (Lead IRB of record, relying IRB, commercial IRB models, etc.)
On December 8th, 2021 at 3pm Central, the Human Subjects Office will facilitate a virtual online training to help research teams become familiar with WCG's new system. In this one-hour training, a representative from WCG will provide an overview of the new WCG Connexus online portal, as well as insight and guidance for what to expect from this system.
Pre-registration is required. After your registration, the Human Subjects Office will send a separate email with the specific Zoom training link and calendar invite. If you have questions, please feel free to reach out. Thank you,
Mayzie M Tucker
Commercial IRB Application Analyst
Human Subjects Office
General Submission Information
The University of Iowa has contracted with the Western IRB / WIRB-Copernicus Group (WIRB / WCG) for the option of review and oversight of new industry initiated and industry sponsored protocols that meet certain criteria.
The UI researchers will have the option to elect to allow the study to remain with the University of Iowa IRB. If this option is selected, one time UI IRB fees of $2000 will apply for Industry sponsored studies.
Studies must be submitted to WIRB/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 WIRB/WCG if they meet the following conditions:
Note: The UI reserves the right to withhold any new research protocol, regardless of industry sponsorship, from being sent to WIRB for review. For those studies that are retained by the UI IRB, there are associated IRB fees.
- The project is a study that involves human subjects and is designed to evaluate prospectively the safety and/or effectiveness of new drugs, devices, or behavioral interventions.
- The protocol for the project was designed and written by the sponsor.
- The sponsor holds all INDs for the protocol. (Please Note: Sponsor held IND studies will temporarily be required to submit to the UI IRB for review.)
- The only sponsor of the research is a for-profit entity/company.
- The UI investigator has not previously submitted the study to another UI IRB.
- The project does NOT involve any of the following:
- Embryonic stem cells
- Any research funds from a federal or other not-for-profit funding source
- This option may be allowed under a Central IRB Model that uses WIRB; see the WIRB as Central IRB link
VAMC Studies: The VAMC does not currently accept commercial IRB review. Therefore, projects reviewed by WIRB/WCG may not be conducted at the Iowa City VAHCS. 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 WIRB.
WIRB/WCG Policies & Procedures
The information provided below is to assist UI investigators with the UI/WIRB process for submission of applications. Follow the links for more information regarding each category.
- WIRB Submission Process
- WIRB Consent Document Templates & Instructions
- Record of Consent FAQ
- WIRB Review Process & Approval Notification
- Modifications & Other Post-Approval Submissions to WIRB
- WIRB-UI FAQ Quick Reference Sheet
- WIRB Fees Please Note: At the point an investigator submits a WIRB application, any WIRB or University of Iowa coordination fees not paid by the sponsor are the responsibility of the investigator and his/her department.
Contact WIRB with any questions regarding WIRB/WCG procedures or forms:
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:
Mail: 105 HLHS, Human Subjects Office, University of Iowa, 600 Newton Rd Iowa City, IA 52242