Reliant Review Process for Joint Studies with Institutions Participating in the Ohio CTSC
The University Hospitals Institutional Review Board (IRB) participates in a statewide collaboration between three Ohio Clinical and Translational Science Awards (CTSA) encompassing eight institutions. Participating institutions utilize the Reliant Review model to streamline the IRB review process. The Reliant Review model relies on a simplified agreement that focuses on 45 CFR 46 and 21 CFR 50 and 56 (human subjects protections). One Consortium institution serves as the Reviewing IRB for a given protocol; also referred to as the IRB of record (IRBR). Collaborating institutions, designated as Relying IRBs (RIRB), agree to accept the research review and oversight of the IRBR for the life of the protocol. Currently, the model serves biomedical and social behavioral research, industry sponsored and investigator initiated protocols, any phase of clinical trials, and any risk determination.
The Consortium utilizes an online submission portal referred to as the HUB. The HUB allows communication between the eight Clinical and Translational Science Collaborative (CTSC) institutions and is housed on the MetroHealth Medical Center IRB platform. Users of the HUB must register with the Metro IRB.
The Reviewing IRB focuses on regulations regarding human subject protections, but does not review for local requirements. Local requirements, such as Key Personnel/ HSP Certification, Department Review, Conflict of Interest, Coverage Analysis, Radiation Safety, Recombinant DNA, etc. must be met and are the responsibility of the local study team.
At University Hospitals, a Shell Submission is submitted via iRIS to inform the UH IRB of the plan to rely on another institution and to address local requirements. Submit the shell early in the process to encourage timely acceptance of a Reliant Review study.
Ongoing and regular communication during the initial Reliant Review process, and for the duration of the study, between the lead principal investigator (PI) and the Relying PI’s is crucial for the review process and to ensure that all sites are conducting the research according to the most currently approved protocol.
Glossary of terms
Reliant Review checklist
Reliant Review process flow diagram
HUB registration instructions
For questions, contact Michelle Jacobs at 216-844-0383 or Sarah Pfeiffer at 216-844-7812.