Multisite studies involve communication among many stakeholders and, as a relying site study team, you will be responsible for developing clear lines of communication with the lead study team. The study protocol should include a communication plan that clearly describes the roles and responsibilities of the four main groups involved in multisite studies:

• Lead study team (including the lead PI)
• Relying site study team (UW study team and UW PI)
• Reviewing IRB
• Relying site IRB/HRPP (UW-Madison)

Some of the elements of a communication plan include:

• Who provides IRB documentation to relying sites as well as how and when
• How changes to the overall study and/or sites will be prepared and submitted
• Management of continuing review information
• Plan for handling reportable events

If the study protocol does not include a communication plan, you will need to work with the lead study team to understand the arrangements for communication across study sites (e.g., remote meetings, regular updates) and dissemination of study documents. We recommend that you consult with the lead study team as early as possible to discuss these arrangements. This will help reduce confusion about who is responsible for what and allow your study to run more smoothly.

Please keep in mind that while RELIANT provides support to UW-Madison study teams navigating reliance and institutional requirements for human research, we cannot answer questions from the lead study team about their own institutional requirements or IRB submission processes, including how to request that the lead study team’s IRB serve as the reviewing IRB for UW-Madison. We encourage you to work closely with your collaborators to ensure they are in contact with their own IRB early in the reliance process; this will help make the review process move more efficiently.