Collaborative Research and IRB Reliance 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.
- Overview of IRB Requirements for Collaborative Research
- Tips for Preparing IRB Applications Involving Collaborative Research
- 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
- IRB Requirements Flowchart for Multisite Research
- Frequently Asked Questions about Exemptions, Not Human Subjects Research Projects, and Collaborative Research Requirements
- UW-Madison HRPP Policy on IRB of Record
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.
- IRB Application Guidance for Multisite and Collaborative Research Studies
- Checklist for Investigator-Initiated Multisite Studies
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
- How to Submit an IRB of Record Request
- Working with Community Partners
- International Research Guidance
Relying on Another IRB
In some cases, the UW-Madison may cede IRB oversight to a non-UW IRB, particularly when the involvement of UW-Madison personnel is limited (e.g., data analysis). Studies eligible for review through an existing IRB reliance partnership also may qualify for review by a non-UW IRB. Please see the guidelines and FAQ below for additional information on when the HS-IRBs will consider ceding IRB review as well as how to request review by a non-UW IRB. NOTE: The HS-IRBs have the contracted with the Western IRB (WIRB) to serve as the IRB of record for most industry-sponsored trials. Please see the WIRB Gateway for more information.
- HS-IRBs Guidelines for Ceding IRB Review
- How to Submit a Request to Cede or Defer IRB Review to Another IRB
- IRB Reliance Partners
- Study Team Responsibilities When IRB Oversight Is Ceded to a Non-UW-Madison IRB
- Research and Sponsored Programs (RSP) Release of Grant Funds When Studies Are Ceded to Another Institution's IRB for Review and Approval