I would like to learn more about IRB reliance
I am requesting KUMC to be the lead IRB for my multi-site study
The KUMC 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:
- An initial consultation meeting with the principal investigator and project manager
- Development of the budget estimate for single IRB services
- 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 at the KUMC Reliance Forms and Templates webpage:
- Consultation Meeting Agenda
- Lead IRB Timeline Summary
- Cost Considerations
The Funding Confirmed Stage involves:
- A pre-submission meeting with the principal investigator and project manager
- Planning the IRB submission timeline
- 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 at the KUMC Reliance Forms and Templates webpage:
- Pre-submission Meeting Agenda
- Single IRB Process Overview
- Lead Investigator Supplemental Application form
The Initial IRB Review Stage involves:
- Study team's submission in the eIRB system
- Study team's response to conditions of IRB approval
- IRB team's initial outreach to planned collaborating sites
The study team will submit the project in the eIRB 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:
- An onboarding strategy meeting with the principal investigator and project manager
- Development of materials for the relying sites
- Site investigators' processes to obtain permission to rely on the KUMC IRB
- KUMC IRB's review of site-specific documentation
- Protocol training for relying site study teams that covers oversight by the KUMC 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 KUMC 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 HRPP representatives will join a protocol training webinar or conference call to discuss KUMC 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 KUMC Reliance Forms and Templates webpage:
- Onboarding Meeting Agenda
- Single IRB Process Overview
- Submission Checklist to Add Relying Sites
The All Sites Enrolling Stage involves:
- Ongoing IRB review of global protocol amendments and new information
- IRB submission of any site-specific changes during the study
- Submission of reportable adverse events or reportable non-compliance that occurs at any study site
- Continuing IRB review, at least annually, of study conduct at all sites.
Once the study is initiated, the KUMC IRB is the IRB for all study sites. The KUMC IRB will review any changes, updates or problems that occur. At the time of continuing review, the KUMC 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 KUMC Reliance Forms and Templates webpage:
- Tips for Reportable Events for Lead Study Teams
- KUMC IRB Guidance for Relying Study Teams
- Continuing Review Supplement for Relying Sites