The KU Medical Center IRB is available to serve as the lead IRB (Reviewing IRB) for multi-site studies when required by the funding source or when single IRB review will enhance the efficiency and effectiveness of the review process. Decisions about whether to serve in this capacity are made on a case-by-case basis. The graphic below summarizes the study start-up process. Each step is detailed in the text that follows.

Study Start-Up Process for Multi-Site Studies

The Grant Proposal Stage Involves:

1. An initial consultation meeting with the principal investigator and project manager
2. Development of the budget estimate for single IRB services
3. Provision of a letter of support and suggested grant language about the IRB oversight plan

Investigators are asked to schedule a consultation meeting well in advance of the grant proposal deadline. Please contact the IRB at IRBreliance@kumc.edu. The documents below explain the grant proposal stage. They can be accessed on the Reliance Forms and Templates webpage: 

• Consultation Meeting Agenda
• Lead IRB Timeline Summary
• Cost Considerations

The Funding Confirmed Stage involves:

1. A pre-submission meeting with the principal investigator and project manager
2. Planning the IRB submission timeline
3. Discussing aspects of the IRB's review specific to the role of Reviewing IRB

Once funding is confirmed, the IRB office meets with the study team to specifically plan out the IRB submission and adjust the single IRB budget if needed. The meeting also covers protocol details and IRB documents that are specific to leading a multi-center study. IRB staff members are available to pre-review study documents before the formal submission. The documents below explain the funding confirmed stage. They can be accessed on the Reliance Forms and Templates webpage:

• Pre-submission Meeting Agenda
• Single IRB Process Overview
• Lead Investigator Supplemental Application form

Working With Rural Sites & Rural Communities:

Some study teams want to work with rural clinics, schools, or other organizations throughout the state of Kansas and Missouri. These communities bring unique perspectives and opportunities to help KU Medical Center conduct research across the state. The KU Medical Center IRB has developed guidance on who to interact with these groups.

• Guidance on Identifying Rural Researchers and Their Training and Disclosures
• Guidance on Recruiting and HIPAA when Rural Sites who are not Engaged (Coming Soon)
• Guidance on Completing Reliance Agreements
• Guidance on how to file an FWA
• Checklist on Rural Studies

These guidance documents should help you start the process of working in the rural community. The IRB has also developed a check list to help KU Medical Center research track this process.

The Initial IRB Review Stage involves:

1. Study team's submission in the myIRB system
2. Study team's response to conditions of IRB approval
3. IRB team's initial outreach to planned collaborating sites

The study team will submit the project in the myIRB system and respond to the IRB review as typical for all studies. During this time, the IRB Reliance Manager will begin reaching out to IRB colleagues at the relying sites to discuss the collaboration and to inquire about state laws, site-specific policies or other local requirements.

The Onboarding Relying Sites Stage involves:

1. An onboarding strategy meeting with the principal investigator and project manager
2. Development of materials for the relying sites
3. Site investigators' processes to obtain permission to rely on the KUMC IRB
4. KU Medical Center IRB's review of site-specific documentation
5. Protocol training for relying on site study teams that covers oversight by the KU Medical Center IRB

After the overall study has IRB approval, we begin the process to onboarding sites. The IRB Reliance Manager develops the packet of materials that site investigators will submit to their home institutions. The reliance packet solicits local requirements so they can be appropriately reviewed by the KU Medical Center IRB.

IRB approval for relying sites occurs on a rolling basis as individual sites complete their documentation. Once the relying sites have been approved, the IRB Reliance Manager or other Human Research Protection Program representatives will join a protocol training webinar or conference call to discuss KU Medical Center IRB requirements and answer any questions from relying study teams.

The documents below are used during the onboarding stage. They can be accessed at the Reliance Forms and Templates webpage:

• Onboarding Meeting Agenda
• Single IRB Process Overview
• Submission Checklist to Add Relying Sites

The All Sites Enrolling Stage involves:

1. Ongoing IRB review of global protocol amendments and new information
2. IRB submission of any site-specific changes during the study
3. Submission of reportable adverse events or reportable non-compliance that occurs at any study site
4. Continuing IRB review, at least annually, of study conduct at all sites.

Once the study is initiated, the KU Medical Center IRB is the IRB for all study sites. The KU Medical Center IRB will review any changes, updates or problems that occur. At the time of continuing review, the KU Medical Center IRB will solicit an overall continuing review submission from the lead PI and also site-specific updates from each relying investigator.

The documents below are used after all sites are enrolling. They can be accessed at the Reliance Forms and Templates webpage:

• Tips for Reportable Events for Lead Study Teams
• KU Medical Center IRB Guidance for Relying Study Teams
• Continuing Review Supplement for Relying Sites

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