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IRB Application Guidance for Multisite and Collaborative Research Studies
Version Date: September 2018
follow the guidance below when preparing an IRB application for a multisite or collaborative research
study (i.e., a study involving sites or personnel external to UW-Madison, UW Health,
or the Madison VA). This includes community-based research.
Study Team Member Pages
Effective October 1, 2018, external personnel -- whether affiliated with a site or not -- no longer need to be listed on the study team member page of the application. Only UW-Madison, UW-Health, or Madison VA personnel should be listed in the study team member pages. External personnel will be listed in the study location section (see below for details).
Study Location Section
The Study Location section of the IRB application is where study teams will indicate whether they are asking UW-Madison to serve as the reviewing IRB for external sites or individuals. It is also the section of the application where study teams should list external personnel as described below.
- For question 1.2, answer Yes if you are requesting the HS IRBs serve as the reviewing IRB for any external sites or individual personnel. If you are unsure whether you need to request this, please contact the HS IRBs' Reliance Team for assistance (email@example.com).
- For question 1.2.1, indicate whether you are asking the HS IRBs to serve as the reviewing IRB for sites and/or individuals. Depending on the nature of the collaborations, you may need to select both options.
- To list external personnel, please do the following:
- For sites, upload a delegation log for each site in response to question 1.3 on the Reviewing IRB: Sites page.
- For individuals, enter each person's name for whom the HS IRBs will serve as the reviewing IRB in response to question 1.1 on the Reviewing IRB: Individuals page.
Study Summary Page
The HS-IRBs require all multisite studies to have a study protocol. The study protocol should be uploaded in response to question 1.1 in the Study Summary section of the IRB application. The protocol should include a list of all sites and their roles, and a communication plan for sIRB.
Informed Consent Section
If the study will use consent documents, upload these in the Informed Consent section (page 6). If subjects will be enrolled at one or more site for which the HS IRBs will serve as the reviewing IRB, please do the following:
- Create and upload a consent form template. This template will serve as the basis from which all other site consent documents will be made. Clearly label this document as a template to avoid confusion.
- If subjects will be enrolled at UW-Madison, UW Health, or Madison VA, upload a consent document to be used at these sites and clearly label it for use at UW-affiliated sites.
- For each other site, use the template consent documents to create a consent document specific for that site following its requirements. All changes from the template must be tracked.
- The Meriter-UW-Madison IRB Partnership has a consent template that must be used for studies that qualify for review under this arrangement.
- If you plan on requesting that
UW-Madison serve as IRB of record for external personnel who are
affiliated with an organization with its own IRB, check with that external
IRB first to see if it is willing to cede IRB review to another IRB as well as what requirements it has for submitting a request to cede IRB review to an external IRB.
- Study teams new to multisite research are encouraged to consult with the HS IRBs' Reliance Team to obtain more detailed guidance.