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 are made on a case-by-case basis.
How do I make a request for the KUMC IRB to oversee my multisite study?
Investigators should consult with the IRB office as soon as plans are being made to propose the multi-site study. Single IRB review may impact study design, budget, legal arrangements and compliance review. Consultations can be requested by contacting the IRB reliance specialist at IRBreliance@kumc.edu
What are the additional responsibilities for the Lead Investigator and the Lead Study Team?
Additional responsibilities include:
- Designing an oversight plan to effectively manage scientific, regulatory and compliance for all sites. The oversight plan will be described in the Lead Investigator Supplement and included in the IRB submission.
- Collaborating with the IRB office to develop the Communication Plan that outlines responsibilities for protocol training, regulatory submissions, document management and overall study coordination.
- Monitoring protocol compliance at all study sites
- Gathering status reports from all sites at the time of continuing review
- Obtaining prompt reports from all sites on serious adverse events or protocol deviations that could impact safety or data integrity
- Informing the KUMC IRB of any problems at external sites, changes to external sites or collaborating investigators/study personnel, any change in the nature of the study activities being performed at the external sites; or closure of a site
How do I pay for the additional costs when KUMC is the Reviewing IRB?
Initial conversations with the reliance specialist will include planning for the additional costs. The costs will be covered by the study contract (for studies funded by industry or foundations) or by the grant budget (for grants from NIH and other federal funding sources.)
The additional IRB fees for multi-site studies will cover the secondary activities that are specifically related to overseeing the non-KUMC sites. Secondary activities may include negotiating reliance agreements, communicating with the sites about IRB oversight processes, reviewing site and investigator qualifications, collecting site-specific information such as state laws and institutional policies, revising and issuing site-specific consent forms, evaluating adverse events and other site-specific updates, and reviewing site-specific information at the time of continuing review.
The budget for secondary activities will depend on whether reliance agreements exist, the number of sites, the type of IRB review required, length of the grant and other study-specific coordination efforts.
These IRB costs should be negotiated with the study contract or submitted as part of the initial grant application. For grants, NIH considers these secondary activities related to single IRB to be direct costs that are charged to the grant.
How does the KUMC IRB obtain the information it needs to conduct review on behalf of other institutions?
The IRB office will communicate with IRB representatives at the relying sites to learn about their local requirements and institutional policies. Relying site investigators will be required to complete a Local Context Questionnaire that documents this information.
What support does the IRB office provide to lead investigators?
The KUMC IRB office guides the lead study team throughout the life-cycle of the study. Our services include:
- Advising the KUMC study team on the oversight strategies and communication/coordination plans
- Developing the budget related to additional costs for single IRB review
- Coordinating with relying sites to negotiate IRB reliance agreements
- Educating relying site study teams about the IRB process and about KUMC IRB requirements that apply to their conduct of the study
- Developing and issuing site-specific consent forms
- Consulting during the study about ongoing regulatory management
What is the IRB submission process if KUMC has agreed to serve as the Reviewing IRB?
IRB submissions should follow standard procedures for full-board or expedited review as described on the main IRB website. Investigators should include the Lead Investigator Supplement with the study documents. The protocol should outline any additional safety monitoring, compliance monitoring, or data coordination that is relevant to managing all the sites.
When the single IRB plan is known at the time of submission, the initial IRB review will include both the standard federal requirements as well as the investigator’s oversight plans. As part of its review, the IRB will approve a master consent template. This master consent template will be customized for each site, according to their institutional requirements and state laws. The customization process is overseen by the IRB reliance specialist.