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.
Key personnel for a study or project are entered on the Study Team Page (page 3) 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.
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.
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 both the Meriter-UW-Madison IRB Partnership and WIC have their own consent templates that must be used for studies that qualify for review under these arrangements.
For investigator-initiated multisite or collaborative research studies, the study team should complete and upload an External Personnel List on the supplemental information page unless it is already included in the study protocol.
Throughout all other sections of the IRB application, study team must be sure to 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 each site as well what activities are happening at each site and how these are being implemented at each site.
|Keywords:||IRB of record,collaborative, external personnel, sites, study location, community-based research, Meriter, WIC, study team page,||Doc ID:||17919|
|Owner:||Molly L.||Group:||Health Sciences IRBs|
|Created:||2011-04-07 18:00 CST||Updated:||2012-05-30 09:13 CST|
|Sites:||Health Sciences IRBs|
|Feedback:||2 0 Comment Suggest a new document|