Collaborative Research and Single IRB Review Basics
Version date: March 2015
If your project or study involves collaboration with any sites and/or personnel outside the UW-Madison/UW Health/Madison VA then it is considered to be multisite research and IRB reliance issues will need to be addressed. Study teams conducting multisite or collaborative research should become familiar with IRB requirements for such studies, including what information needs to be included in the IRB application and protocol as well as how to address IRB reliance issues.
The IRB issues raised by collaborative research and IRB reliance requirements are often complex. To assist study teams in addressing these issues, the HS-IRBs office has a Reliance Team consisting of staff members with expertise in collaborative research and IRB reliance agreements. Please contact the Reliance Team if you have any questions regarding IRB requirements for collaborative research or IRB reliance agreements. NOTE: As of February 2018, this page is regularly being updated to reflect changes to ARROW as well as the NIH single IRB review policy.
- Overview of IRB Requirements for Collaborative Research
- Tips for Preparing IRB Applications Involving Collaborative Research
- NIH Single IRB Review Policy Resources
- IRB of Record Issues and Collaborating with Non-UW Researchers
- Relying on Another IRB
- Other Reliance Issues
Overview of IRB Requirements Collaborative Research
Whether additional IRB requirements apply to multisite /collaborative research often depends on whether an external site or personnel are engaged in human subjects research. UW-Madison relies on the federal guidance on engagement in research to determine whether IRB oversight for external sites or personnel is required and, if so, what IRB reliance mechanism to use to ensure oversight is in place. Study teams are encouraged to review the resources below to help determine what additional requirements may apply to their study and to contact the Reliance Team with any questions.
- Overview of IRB Requirements for Multisite and Collaborative Research
- IRB Reliance Terms and Definitions
- Engagement in Research
- Understanding Engagement in Research
- Frequently Asked Questions about Exemptions, Not Human Subjects Research Projects, and Collaborative Research Requirements
- UW-Madison HRPP Policy on IRB Reliance
Tips for Completing IRB Applications for Multisite/Collaborative Research Studies
Study teams conducting multisite/collaborative research need to ensure that both the study protocol and the IRB application address the roles and activities of all external sites and/or personnel. The HS IRBs require that all multisite/collaborative research studies have a protocol, which must include information about how the study activities will be coordinated. Study teams are strongly encouraged to review all of the documents below when preparing their application materials to help ensure the review process goes smoothly.
NIH Single IRB Review Policy ResourcesThe NIH policy on single IRB review went into effect January 25, 2018. Please see the resources below for more information about this requirement and how to address this in grant proposals.
- How the Reliance Team Can Help with the NIH Single IRB Review Policy
- Single IRB Review FAQS
- RSP Single IRB Guidance
IRB of Record Issues and Collaborating with Non-UW Researchers
In some cases, UW-Madison may agree to serve as the IRB of record for an external site or individual engaged in human subjects research as part of a study reviewed by a UW-Madison IRB. Please review the guidance below for information on when the HS or MR IRB may agree to serve as the IRB of record. For instructions on how to submit an IRB of record request, please see the FAQ below.
- HS-IRBs Guidelines for Serving as IRB of Record
- Study Team Responsibilities When UW-Madison Serves as the Reviewing IRB
- How to Submit an IRB of Record Request
- How to Draft Consent and Authorization Documents for Relying Sites
- Training Requirements for External Personnel When the HS IRBs Serve as IRB of Record
- Working with Community Partners
- Letters of Support for External Sites
- International Research Guidance
Relying on an External IRB
UW-Madison may cede IRB oversight for eligible studies to an external - IRB. Please see the guidelines below for additional information on when the HS-IRBs will consider ceding IRB review, how to request review by an external IRB, and other resources. NOTE: The HS-IRBs have the contracted with independent or commercial IRBs to serve as the IRB of record for most industry-sponsored trials. Please see the Central IRB Gateway for more information.
- Guidelines for Ceding IRB Review to an External IRB
- Interim Guidelines for Use of Commercial IRBs Participating in SMART IRB
- How to Submit a Request to Cede IRB Review to an External IRB
- Single IRB Review Partners
- Study Team Responsibilities When IRB Oversight Is Ceded to an External IRB
- Research and Sponsored Programs (RSP) Release of Grant Funds When Studies Are Ceded to Another Institution's IRB for Review and Approval
- Preparing Consent and Authorization Documents When Relying on an External IRB Review
- Improved Ceded Review Process FAQ