Overview of IRB Requirements for Multisite and Collaborative Research
Version date: December 2017
What is a multisite study?
From an IRB perspective, multisite research includes projects or studies that involve collaboration with sites or individuals external to the UW-Madison, UW Health, or the Madison VA. Some examples of multisite and collaborative research include:
- UWHC participating as one site in a multisite clinical trial (including cooperative oncology group studies)
- UW-Madison investigator conducting a study at a community-based site with community partners
- UW-Madison investigator sharing identifiable or coded data/images/specimens collected for a study with researchers at another university or institution
Are any IRB requirements different for multisite or collaborative research studies?
Yes. Although multisite studies undergo the same type of IRB review as single site studies, the IRB also must determine whether external sites or personnel need IRB approval in order to participate in study activities. This may include requiring an IRB reliance agreement in order for the UW-Madison to serve as IRB of record for other sites or to cede review to another IRB. In addition, the HS-IRBs require that all collaborative research studies have a formal protocol, regardless of the study's risk level.
When is IRB approval required for an external site or personnel?
Whether IRB approval is required depends on whether the external site or personnel are engaged in human subjects research as defined by federal guidance. It also can depend on whether a study qualifies for exemption. Determining whether an external site or external personnel are engaged in research can be difficult and study teams are encouraged to consult with the HS-IRBs Reliance Team for guidance.
Will the HS-IRBs consider serving as the IRB for an external site or personnel?
Yes. Depending on the nature of the study and the activities that will be conducted by the external sites or personnel, the HS-IRBs may consider serving as their IRB of record (aka Reviewing IRB). For more information about when the HS-IRBs may consider serving as IRB of record, see HS-IRBs Guidelines for Serving as IRB of Record.
If the UW-Madison/UWHC is a participating site for a multisite study, will the HS-IRBs consider ceding IRB oversight to another IRB?
Yes, although it may depend on the nature of the study activities to be conducted at the UW-Madison/UWHC as well as the study sponsor. Please see HS-IRBs Guidelines for Ceding IRB Review for details.
Do the HS-IRBs have any IRB reliance agreements with other IRBs regarding oversight of multisite studies?
Yes, the HS-IRBs participate in a variety of IRB reliance agreements, including SMART IRB. For additional information on each of these partnerships, please see the Single IRB Review Partners.
Does the IRB review process take longer for multisite and collaborative research studies?
Depending on the complexity of the study, and whether any IRB reliance arrangements are needed, the IRB review process may take additional time. A well-prepared application and study protocol can help ensure that the IRB review process goes as smoothly as possible. We also encourage study teams to contact the HS IRBs Reliance Team as early in the application preparation process as possible to get assistance with addressing IRB requirements.
How can the HS-IRBs Reliance Team assist study teams with multisite research projects?
Our Reliance Team consists of IRB staff members with special expertise in navigating multisite research issues, such as:
The Reliance Team encourages study teams to reach out to them whenever they have any questions related to multisite research.
- Assisting with engagement in human subjects research determinations
- Determining whether reliance agreements are needed and making those arrangements on the study team’s behalf
- Providing letters of support about single IRB review for inclusion with grant applications as well as assistance with identification of IRB review costs
- Consulting with study teams to determine when best to seek IRB approval for external sites or personnel, including identifying a reviewing IRB