Western Institutional Review Board (WIRB)
The University of Iowa has contracted with the Western Institutional Review Board (WIRB) to all for the option of review and oversight of new protocols that meet the following 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 they meet the below condition:
- The study has funding from DOD (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 conditions below:
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 may be 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 or devices or behavioral interventions.
- The protocol for the project was designed and written by the sponsor.
- The sponsor holds all INDs/IDEs for the protocol.
- 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
VAMC Studies: The VAMC does not currently accept commercial IRB review. Therefore, projects reviewed by WIRB may not be conducted at the VAMC. 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.
January 2013 UI IRB fees for WIRB submissions and WIRB processing fees have changed. Please see WIRB Fees for detailed information.
Dec 2012: UI researchers will have the option to elect to submit to the UI IRB or WIRB. If the UI IRB is assigned as the IRB of record, a one time IRB review fee of $2000 will be assessed for any Industry sponsored studies that meet the definition of a clinical trial.
6/1/12 WIRB Fee Schedule has changed. Please review the WIRB Fees link below for additional information. Further clarification or an explanation of WIRB Fee Charges can also be found on the WIRB website and by calling WIRB Client Services.
12/5/11: WIRB responsibilities are transitioning to a new HSO staff member. During this transition a 24 hr turn around time can not be guaranteed. Thank you for your patience and understanding during this transition.
4/12/11: Beginning June 1, 2011 any new WIRB Form A received in the Human Subjects Office that involves an investigational device (IDE or Non-Significant Risk), or carotid stent, and any new Form A received in the HSO if the PI is from either the Department of Internal Medicine or the Department of Pediatrics must obtain JOC Research Billing approval.
1/25/11: A WIRB specific Record of Consent Frequently Asked Questions document has been created by the Human Subjects Office. This FAQ includes a link to the UIHC policy, contact information, guidance on implementing the policy, and information on the Record of Consent in EPIC. Suggestions on the content of this FAQ document can be sent to email@example.com.
10/22/10: WIRB's initial review forms have been revised and will be available for use November 1, 2010. WIRB encourages researchers to begin using the new format; however, use of the updated forms will not be required until January 1, 2011. Older versions of the submission form will not be accepted after this date. Copies of the new forms can be downloaded from the Download Forms page of the WIRB website.
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
- Consent Document Templates & Instructions
- Record of Consent FAQ
- Review by Other University of Iowa Entities
- 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