IRB Application Guidance for Multisite and Collaborative Research Studies

January 2012

Please 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 (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.

  • 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 Accessing ARROW for External Personnel Engaged in Research: UW-Madison is Serving as 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 the Wisconsin IRB Consortium (WIC) process.
  • 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 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.

Supplemental Information Page

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. 

All Other Sections of the IRB Application

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. 

Tips

  • 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 defer IRB review to another IRB as not all IRBs will agree to defer IRB oversight to another IRB.
  • Study teams new to multisite research are encouraged to consult with IRB staff before submitting an application to the IRB to obtain more detailed guidance.




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 19:00 CDTUpdated: 2012-05-30 10:13 CDT
Sites: Health Sciences IRBs