Launch in Hawk IRB on October 22, 2015!
The Humans Subjects Office is pleased to announce that effective Thursday, October 22, 2015, WIRB submissions will now be processed in Hawk IRB. This will replace the former paper and email process of the Forms A and B. When users log into Hawk IRB, they will initiate an application by selecting the New Project link found in the upper left corner of the HawkIRB application. Under section I.1, the user will first click on the WIRB link next to the WIRB radio button. This will begin the Pre Project data checklist process to answer questions which were formerly included on Form A. Once those questions have been completed, and the project meets the conditions for submission to WIRB, users will then be redirected back to the Project Introduction page(Section I) where they can now choose WIRB as the IRB.
After selecting WIRB as the IRB for the project, users will then add study team members, funding source(s), and answer additional questions about the project, including Other Committee Review requirements. After the application is submitted, users will then upload attachments and submit the application for review by the WIRB Coordinator. When the WIRB Coordinator has completed the required review, a UI-WIRB-APPROVAL-MEMO will be generated and sent to the research team. At this point, the project is ready for submission to WIRB.
Please note: Current, ongoing WIRB studies will not be "grandfathered in" for the Hawk IRB electronic process. These studies will retain the current paper process until they are closed.
General Submission Information
The University of Iowa has contracted with the Western Institutional Review Board (WIRB) 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 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 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
- Review and approval by the UI Institutional Biosafety Committee (e.g. studies that involve recombinant DNA)
- 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 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 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 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 procedures or forms:
Mail: PO Box 12029
Olympia, WA, USA 98508-2029
Contact the University of Iowa's WIRB Coordinator in the Human Subjects Office with questions regarding the application process or UI requirements:
Mail: 105 HLHS, Human Subjects Office
600 Newton Rd, University of Iowa, Iowa City, IA 52242