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Submitting a WIC Request

Version date: March 2015

Below are instructions for submitting a WIC request both for ceding IRB review to another WIC institution and asking UW-Madison to serve as IRB of record for another WIC institution. Please follow these instructions carefully to help avoid delays during the review process.

How do I submit a request for UW-Madison to serve as IRB of record for another WIC institution?

Step 1:
Review Wisconsin IRB Consortium (WIC) Reliance Fact Sheet  regarding the WIC review process.
Step 2:
Ensure the study protocol and consent/authorization forms (if any) used for the study meet WIC requirements, as described below.
Step 3: Complete the WICRequestFormRevisedMay2015.pdf.
Step 3: Submit the WIC request form, study protocol, and draft consent/authorization documents (if any) to the HS IRBs Reliance Team at Do NOT submit an IRB application in ARROW until the WIC request and supporting materials have been reviewed. Creating an IRB application in ARROW first may result in unnecessary effort if it turns out that another IRB will serve as IRB of record for the study.
Step 4: The Reliance Team may request additional information about the request, including questions raised about the study by other involved WIC sites.
Step 5: When you are notified via email that the HS-IRBs will serve as IRB of record for a study involving another WIC institution(s), you can then submit an IRB application via ARROW.
Step 6: Please note that when completing the study team page, you will need to list external personnel as well. For additional information how to add external personnel, see the Accessing ARROW for External Personnel Engaged in Research: UW-Madison is Serving as IRB of Record
Step 7: After you complete the application, click finish and then submit. The remainder of the review process will generally continue as with any other initial review application. If additional input from the relying  WIC sites is required during the review process, the Reliance Team will facilitate that communication.

How do I submit a WIC request to cede IRB oversight to another WIC institution?

Generally, the study team at the institution that will serve as IRB of record for UW-Madison will submit a WIC request to its own IRB. Since only one (1) WIC request needs to be submitted for each study, the UW study team will typically NOT need to submit a WIC request to the HS-IRBs. If you are unsure whether a request has been submitted, please contact the HS IRBs Reliance Team for assistance.

What information needs to be included in the study protocol?

All studies using WIC should have a study protocol. The same protocol must be used by all study sites, even if study activities differ at each site. Any protocol submitted must address all the points described on the WICProtocolChecklist.pdf. The following elements are especially important:

  • Study Coordination: The protocol must identify the lead site of the study.  The lead site is responsible for coordinating study activities at all study sites, receiving and analyzing study data, and developing and updating the study protocol as needed. These responsibilities and any others assumed by the lead site must be described in the protocol.
  • Distribution of Responsibility: The protocol must describe what research activities will take place at each site, who will be responsible for each activity at the specific sites, which site and individual will lead the project, and the responsibilities of the lead site and individual.
  • Timeline: The protocol should include a timeline in chart or graph format that reflects the project activities and anticipated time frame of completion (e.g., enrollment, chart abstraction, data analysis, etc.).
  • Monitoring: If the study involves interaction with human subjects, the protocol must describe your institution’s standard and, if applicable, study specific plans for monitoring at each site involved in the research.
Protocols that do not adequately address all points in the WIC protocol format will be returned to the study team for revision and without further review.

What information needs to be included in the consent and authorization forms?

WIC has a combined consent/authorization form template Consentauthtemplatefinal.doc that should be used for all studies being submitted through WIC.  Study teams should not alter the template without prior consultation with the appropriate IRB administrator at their institution.

See Also:

Keywords:irb of record, defer, deferral, WIC, protocol format, template consent, authorization   Doc ID:17741
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-03-29 19:00 CDTUpdated:2016-12-14 16:55 CDT
Sites:Health Sciences IRBs
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