Reliant review is the process of engaging reliance agreements when clinical investigators are collaborating on multisite research with other institutions. A reliance agreement is an agreement between two Institutional Review Boards (IRBs). Reliant review aims to reduce duplicative IRB reviews and promote greater efficiency and consistency among IRB determinations for multisite research by defining the reliant relationship between the two IRBs.
There are many avenues for reliance and the University Hospitals IRB administration office continues to consider new opportunities for reliance and new ways to streamline the reliance process. Historically, the UH IRB has entered into reliance agreements with various institutions for specific research protocols, a series of related protocols (i.e. a registry), for all research conducted at the other site, as well as with independent, central IRBs.
With each avenue for reliance, it is important for investigators to consider:
Institutional oversight of the protocol is still applicable and institutional requirements must be met. Refer to Investigator Manual for IRB Submissions, Chapter 21 – Reliant Review
- Submission of the study to the UH IRB office in the IRB electronic system, SpartaIRB, is required.
- Communication over the life of the study, between research teams and IRBs is absolutely essential to the success of reliant studies.
Investigators interested in engaging in any of the below pathways for reliance should contact the UH IRB administration office for more information prior to engaging in research.
- IRB Authorization Agreements
IRB authorization agreements (IAAs) are the written agreements between two institutions identifying which IRB will serve as the IRB of record and delineating the roles and responsibilities of each institution. The scope of the agreement may be for one specific protocol, a series of protocols or for all research studies at an institution (often referred to as a master agreement).
An individual investigator agreement (IIA) is another type of agreement allowing the UH IRB to extend its FWA to non-UH personnel not otherwise covered by an FWA.
- Reliance Platforms
In response to a recent national effort to encourage reliance relationships, multiple reliance platforms have been developed. Web-based systems, such as SMART IRB and IREx, engage master institutional agreements to facilitate reliance relationships and streamline the execution of protocols using reliant review.
- The Ohio CTSC
The Ohio Clinical and Translational Science Collaborative (CTSC) is a statewide collaboration between three Ohio CTSAs and encompasses eight institutions: University Hospitals, Case Western Reserve University, The MetroHealth Medical Center, The Cleveland Clinic, The Ohio State University, Nationwide Children’s Hospital, Cincinnati Children’s Hospital and The University of Cincinnati.
Find additional information on the Ohio CTSC.
- Advarra IRB
Advarra is an independent IRB. For interested investigators, the UH Clinical Research Center has engaged Advarra to serve as the IRB of record for University Hospitals industry sponsored Phase I-IV protocols. University Hospitals Cleveland Medical Center IRB and Advarra IRB have executed an IRB Authorization Agreement. Investigators must receive approval from the industry sponsor to use and pay all additional associated fees for the use of Advarra IRB.
The National Cancer Institute’s Central Institutional Review Board (CIRB) is an initiative based in the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Institutes of Health, Department of Health and Human Services to reduce the administrative burden on local IRBs and investigators by partnering with local institutions to provide a high level of protection for study participants in NCI-sponsored clinical trials.
Get additional information on using the National Cancer Institute’s Central Institutional Review Board (CIRB).
- Case Comprehensive Cancer Center (Joint Studies)
Case Comprehensive Cancer Center is a National Cancer Institute (NCI)-designated Comprehensive Cancer Center located at Case Western Reserve University. It is a partnership organization supporting cancer-related research efforts at Case Western Reserve University, UH Cleveland Medical Center, and Cleveland Clinic. The Cancer Center advocates for cancer research support across the institutions; provides funding for promising pilot grants, shared resource development, training programs, and recruitments; and catalyzes multidisciplinary and transdisciplinary cancer research across institutions, emphasizing innovative discovery that will have an impact on cancer patients.
Please note that information regarding institutional policies and what is required to be reviewed by the UH IRB after approval can be found in the UH Investigator Manual.
For questions, contact Kristen Ulmann at Kristen.Ulmann@UHhospitals.org or 216-844-7812.