Guidance for Researchers on Using the Wisconsin IRB Consortium (WIC) February 2014

WIC Background Consortium began in 2007 WIC partner institutions –Aurora Health Care –Marshfield Clinic –Medical College of Wisconsin –University of Wisconsin-Madison Over 140 studies reviewed under the WIC process WIC website:

WIC Goals Provide more effective and efficient oversight of multi-site human subjects research in Wisconsin Reduce administrative burden and costs for study teams and IRBs alike by identifying a single IRB of record for eligible studies Facilitate collaborative research among partner institutions

WIC Basics WIC is not a separate IRB. It is a process by which a single IRB at a WIC institution may be designated to review a multisite study Investigators affiliated with a WIC institution who are collaborating with investigators at another WIC institution can request review under the WIC process IRB administrators from the institutions involved will determine whether a study is eligible for review by a single IRB

Using WIC: Step 1 Identify which WIC sites and personnel will be involved in your study Before preparing any study materials, confirm that your collaborators at each site are aware of the study and committed to participate in a multisite study

Using WIC: Step 2 Prepare a project summary or protocol that includes the elements in the WIC protocol checklist available on the WIC website Summaries or protocols that are incomplete will be returned to the study team for revision and without additional review

Using WIC: Step 3 Ensure that local institutional requirements for each site have been met Such requirements may include human subjects research training, conflict of interest disclosures, and administrative approval external to the IRB office Information about each institution’s requirements are posted on the WIC website

Using WIC: Step 4 After steps 1-3 have been completed, submit a WIC request, project summary or protocol, and any supporting documents to the WIC point of contact (POC) at your institution Only one WIC request should be submitted for each study, typically to the WIC POC at the proposed IRB of record Do not submit an IRB application until the WIC review process is complete

WIC Review Process After a WIC point of contact receives a WIC request, she will notify the points of contact at the other WIC sites that materials are ready for their review The WIC points of contact will then determine whether the study qualifies for review by a single IRB of record The WIC point of contact will notify the study team when the WIC review process is complete and whether a single IRB of record has been identified

WIC Tips WIC does not allow IRB shopping. After a single IRB of record has been identified for a study, only IRB administrators can reverse that decision. Protocols must be clear and followed by all study sites. Study interventions can differ by site, but all sites must follow the same overall protocol. Make sure that your WIC request and protocol include a complete description what study activities will occur at each site, including how subjects will be identified and recruited at each site

WIC Tips Securing all required local approvals at each site involved in the study before submitting a WIC request is helpful Consult with the WIC point of contact at your IRB office if you have questions about the process

Who to Contact with Questions Aurora Health Care –Michelle Maternowski Marshfield Clinic –Linda Jaros Medical College of Wisconsin –Connie Byrne University of Wisconsin-Madison –Carol Pech