Version: March 2019
What is single IRB review?Single IRB review means that a single IRB of record (aka Reviewing IRB) conducts the ethical review for sites participating in a multi-site study. To use a single IRB, institutions must enter into formal arrangements called reliance agreements to document which institution will serve as the Reviewing IRB and which will cede IRB review to that institution. How could single IRB review affect my federal funding proposal? Single IRB review requirements can affect:
The Reliance Team can also advise study teams selected as a site, or are considering acting as a site, for a federally funded multi-site protocol, regarding:
To request assistance with any of these items, please email the Reliance Team at email@example.com with as much of the following information as possible:
When working with a community partner (e.g., an individual or group employed or volunteering at a community organization and/or that is self-employed, in private practice), first determine whether IRB oversight is required for those community partners depending on whether they are engaged in human subjects research, as defined by federal guidance. A community partner may be engaged in research if they are involved in research activities such as data collection, recruiting participants, consenting participants, or analyzing identifiable data. A community partner may not be engaged in research if, for example, it is simply serving as a location for study activities or providing recruitment flyers to potential participants. Determining whether an external site or individual is engaged in human subjects research can be difficult, especially for community-engaged research. Study teams are encouraged to consult with the HS IRBs’ Reliance Team for assistance in making this determination when preparing an IRB application.
If a community partner is engaged in human subjects research, then all personnel involved in the research must have their study activities covered by an IRB. NOTE: If the study likely qualifies for exemption, IRB requirements are more flexible and study teams are encouraged to consult with the Reliance Team before submitting an application. Typically, UW-Madison will provide IRB oversight in these situations and study teams should plan to include an IRB of record request in their application, if the study likely does not qualify for exemption. If the HS IRBs will serve as IRB of record for a community partner, community partner personnel must complete human subjects training and be listed on the IRB protocol application. In addition, a formal agreement between UW-Madison and the community partner may be required pursuant to federal regulations.
Regardless of engagement status, a letter of cooperation for external sites may be required from the community partner site.
See Also: Training Options for External Personnel