Wisconsin IRB Consortium (WIC) Reliance Fact Sheet
Version date: March 2015
What is the Wisconsin IRB Consortium (WIC)?
The WIC is an agreement among the IRBs at four institutions in Wisconsin that allows eligible studies to be reviewed by a single IRB of record. The agreement has been in place since 2008 and over 170 studies have qualified for review by a single IRB under WIC process.
Which institutions are WIC partners?
- Aurora Health Care
- Marshfield Clinic
- Medical College of Wisconsin
- University of Wisconsin-Madison
Who may qualify to use WIC?
Researchers affiliated with a WIC institution who are collaborating with investigators at another WIC institution may use WIC. All investigators using WIC must comply with WIC Responsibilities for Conduct of the Study.
What types of studies may qualify for review under the WIC agreement?
Studies most likely to qualify for review by a single IRB of record under WIC are those that are minimal risk and/or those for which the involvement of a WIC institution may be limited (e.g., data analysis is occurring at UW-Madison and subjects are being enrolled at Marshfield Clinic). Some clinical trials and other more than minimal risk studies have qualified for single IRB review under WIC in the past and may be submitted for consideration. For all requests, the IRB administrators at each involved WIC institution will determine whether the study can be reviewed by a single IRB of record.
What is the first step in requesting review under WIC?
Researchers interested in using WIC must first submit a WIC request and supporting materials (e.g., study protocol, consent/authorization forms) to the designated WIC point of contact at their institution. Only one WIC request needs to be submitted for a study. No IRB application should be submitted until after the WIC request and supporting materials have been reviewed unless otherwise advised by an IRB administrator at a WIC institution. For instructions on how to submit a WIC request to the HS-IRBs as well as what supporting materials should be provided, see Submitting a WIC Request.
What happens after WIC request is submitted?
After the WIC request and supporting materials have been submitted, they are reviewed by IRB administrators from each of the WIC institutions involved in the proposed study. Based on its review of the materials, each WIC institution decides whether ceding IRB oversight to a single IRB of record is appropriate. Decisions regarding the outcome of a review of a WIC request will be communicated to the study team by the appropriate IRB administrator.
How long does it take for WIC partners to determine whether a study qualifies for review by a single IRB?
WIC requests and supporting materials are typically reviewed within 2 weeks of receipt. How long it may take for a WIC institution to decide whether deferral of IRB review is appropriate depends on several factors including the complexity of the study and that site's role in the study, the quality of the completed WIC request form and supporting materials, and the study team's responsiveness to questions from IRB administrators at each involved WIC site. As with all other IRB submissions, well-prepared applications help ensure that the review process goes as quickly as possible.
What happens after a study has been determined to qualify for review by a single WIC member IRB?
After a study has been determined to qualify for review by a single IRB, the study team will be advised to submit IRB application materials to that IRB in accordance with the IRB of record's procedures. WIC institutions ceding IRB review may provide comments during the review process to the WIC institution serving as IRB of record.
After a study has been approved by a WIC member IRB of record, where does the study team submit changes of protocol, continuing reviews, and reportable events?
After a study has been approve, all further actions for that study should be submitted to the IRB of record. As needed, the IRB of record will consult with relying WIC institutions, especially if significant changes of protocol or reportable events arise.
- All studies using WIC must have a protocol that is followed by all study sites. Study activities can vary by site, but all sites must follow the same overall protocol.
- WIC does not permit IRB shopping: After single IRB of record has been identified for a study, only IRB administrators can reverse that decision.
- In addition to following the requirements of the IRB of record, collaborating investigators must comply with any additional requirements at each involved WIC site (e.g., securing administrative approvals).
- If you have questions about the WIC process, please consult with the WIC point of contact at your institution: