Abstract Description
With increasing national focus on IRB reliance to reduce duplicative reviews for multisite studies, a regional consortium of five universities has developed an innovative Reliance Services Program to expedite industry-sponsored clinical trials. In many current reliance models, a “lead principal investigator (PI)” oversees multi-site studies and takes on additional responsibilities as subsequent sites are added. The unique element of our approach is “PI Independence,” whereby each site has its own PI acting independently of one another while benefiting from central administrative support.
In our model, any one of the five IRBs can serve as the Reviewing IRB, which is typically the institution that first approves a multi-site study. If no initial approval has taken place, member institutions choose the Reviewing IRB based on factors such as IRB expertise and capacity, and input from PIs and sponsors.
The Reliance Services Program provides administrative support to the relying investigators throughout the life of a study and serves as a conduit to the Reviewing IRB, facilitating post-approval reporting, continuing reviews, and study closures. Ancillary reviews (e.g., biosafety, radiation) take place at the local level.
To enable identification of reliance opportunities, the consortium built a searchable database of approved clinical trials populated by IRB data. When investigators submit a new application to an IRB, intake analysts search the database to see if the trial is underway at one of the other institutions. If so, the IRB contacts Reliance Services to initiate a reliance.
The Reliance Services team tracks actionable metrics throughout the studies. Average reliance approval time is 11.6 calendar days (n=13) versus weeks or months for a full IRB review, with some reliance approvals taking less than 24 hours. Approval times continue to improve as IRBs become more experienced with this reliance model and Reliance Services streamlines processes.
Next Steps:
Future development includes:
Other consortia looking to implement this IRB reliance model should:
- Expanding Reliance Services capacity sustainably, which includes billing industry sponsors for reliances
- Broadening Reliance Services eligibility beyond industry-sponsored trials
- Engaging researchers to use the clinical trials database, enabling them to pursue a reliance before assembling a full IRB application
- Evaluating technology solutions supporting reliances, including tracking, workflow, notifications, and document management
Other consortia looking to implement this IRB reliance model should:
- Establish an advisory committee including members from all participating institutions
- Share IRB data on approved studies through a searchable database to identify reliance opportunities
- Develop shared standard operating procedures to harmonize processes and ensure regulatory compliance