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IRB Application Guidance for Multisite and Collaborative Research Studies
Version Date: July 2017
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. NOTE: The guidance below will generally not apply to fully industry-sponsored or cooperative group studies.
Study Team Page
Key personnel for a study or project are entered on the Study Team Page of
the IRB application. Whether to list personnel or collaborators not affiliated with UW-Madison/UW Health/Madison VA depends on if the HS-IRBs are serving as IRB of record for these personnel as well as whether the study or project may qualify for exemption.
- List external personnel on this page ONLY if UW-Madison will serve as their IRB of record. For instructions on how to do this, see NetID and Training Requirements for External Personnel When the Health Sciences IRBs Are IRB of Record .
- Do NOT list external personnel on this page who will receive IRB approval from their own IRB. These personnel should instead be listed in the study protocol.
- Do NOT list external personnel on this page who are not engaged in human subjects research. These personnel should instead be listed in the study protocol.
- For studies or
projects that may qualify for exemption, do NOT list any external
personnel on this page UNLESS the study will be reviewed via an existing IRB reliance agreements that allows for review of exemptions.
- NOTE: Any external personnel for whom UW-Madison will serve as IRB of record must complete human subjects training.
Study Location Section
The Study Location section of the IRB application asks study teams to describe where a study is taking place as well as to provide any IRB of record requests.
- For question 1.1 in the study location section, answer “Yes” if the study involves any sites or personnel/collaborators external to the UW-Madison, UW Health, or Madison VA.
- For question 2.1 in the study location section, list all the non-UW-Madison sites that will be involved in the study.
- For question 2.2 in the study location section, answer "Yes" if you are requesting that UW-Madison serve as IRB of record for any sites or collaborators external to the UW-Madison, UW Health, or Madison VA.
- If you are requesting that UW-Madison serve as IRB of record for any sites or collaborators external to the UW-Madison, UW Health, or Madison VA, select all the appropriate options in response to question 2.2.1. After you click Continue on this page, you will be branched to other pages that will more specific questions about the IRB of record request(s).
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. For guidance on what information should be included in a multisite protocol, please see the Checklist for Investigator-Initiated Multisite Studies.
Informed Consent Section
If the study will use consent documents, these should be
uploaded in the Informed Consent section (page 6). If separate consent
documents will be used to enroll subjects at different sites for which the
HS-IRBs will serve as IRB of record, be sure to clearly label each
one. Please note that the Meriter-UW-Madison IRB Partnership has a consent template that must be used for studies that qualify for review under this arrangement.
Supplemental Information Page
For investigator-initiated multisite or collaborative research studies with a large number of external personnel, the study team may find it helpful to complete and upload an External Personnel List on the supplemental information page unless it is already included in the study protocol.
All Other Sections of the IRB Application
Throughout all other sections of the IRB application, study teams must address the involvement of each site and/or personnel not affiliated with UW-Madison, UW Health, or the Madison VA. This is especially critical in the subject recruitment section as well as in the special procedures sections applicable to the study (e.g., collection of biological specimens, interviews/focus groups/surveys, etc.). Study teams should take care to describe who is doing what at each site as well what activities are happening at each site and how these are being implemented at each site.
- 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 not all IRBs will agree to rely on another IRB.
- Study teams new to multisite research are encouraged to consult with the HS IRBs' Reliance Team to obtain more detailed guidance.