Overview of IRB Requirements for Multisite and Collaborative Research
Version date: March 2015
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).
- An investigator with a VA appointment is conducting a study involving other VA locations.
- UW-Madison investigator conducting a study at a community-based site with a 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 a IRB reliance agreement such as an IRB authorization agreement or independent investigator agreement. In addition, the HS-IRBs require that all collaborative research studies have a protocol, regardless of the study's risk level. For guidance on developing a protocol for multisite/collaborative research, see the Checklist for Investigator-Initiated Multisite Studies.
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. Anyone for whom the HS-IRBs serves as IRB of record must be listed as a study team member and must complete human subjects research training. 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 serving as one of the sites for a multisite study, will the HS-IRBs consider ceding IRB oversight to another IRB?
Yes, although it depends on the
nature of the study and the study activities to be conducted at the
UW-Madison/UWHC. 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. For additional information on each of these partnerships, please see the IRB Reliance Partners .
Does the IRB review process take longer for collaborative research studies?
Depending on the complexity of the study, the need for IRB reliance agreements, and the quality of the study materials, 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. The HS IRBs Reliance Team also is available to assist study teams with addressing IRB requirements for collaborative research projects.