Ohio State conducts non-exempt human subjects research in cooperation with external institutions and investigators. These collaborations must be documented through reliance agreements. In certain situations, Ohio State may serve as the IRB of record for the collaborating site and/or external investigator, or Ohio State may rely on an external IRB.
An IRB Authorization Agreement (IAA) is a document signed by two or more institutions engaged in human subject research that permits one or more institutions to cede review to or rely on another IRB. Ohio State executes a variety of master IAAs for sharing IRB reviews between collaborating institutions, sponsors, and independent IRBs. These IAAs describe each organization’s responsibilities for IRB review, reporting, and research oversight. In addition, study-specific IAAs with organizations can be developed, depending on the nature of the research.
An external individual investigator (also known as a consultant) is someone who is not an employee or agent of Ohio State, who is conducting research activities on behalf of Ohio State on an IRB-approved research study, and who is not acting as an employee of any other institution with respect to his/her involvement in the research being conducted by Ohio State. For researchers meeting this criteria, Ohio State requires the individual to sign an Individual Investigator Agreement (IIA).
For assistance in completing application materials for external collaborators or multi-site research (non-Ohio State locations) utilize the collaborative research tools packet.
IRB Authorization Agreements
National Cancer Institutional (NCI) Central Institutional Review Board (NCI CIRB) – For select NCI-sponsored clinical trials (determined by NCI)
Nationwide Children’s IRB (NCH IRB) – For Ohio State studies performed at NCH or involving an NCH investigator
Western-Copernicus Group (WCG) IRB (WCG IRB) – For proposed industry-sponsored and industry-initiated research
Ohio Clinical and Translational Science Award (CTSA) Consortium – For biomedical and cancer studies involving any of the following Ohio institutions:
- Nationwide Children’s Hospital
- University of Cincinnati
- Cincinnati Children’s Hospital Medical Center
- The MetroHealth System (Cleveland)
- The Cleveland Clinic Foundation
- University Hospitals Case Medical Center
- Case Western Reserve University
Single IRB Agreements
As part of the Revised Common Rule Regulations and the NIH single IRB (sIRB) mandate, all domestic, federally funded, multi-site research studies are required to use a single IRB.
SMART IRB Participating Institution
Ohio State is a participating institution in SMART IRB, a platform designed to ease common challenges and burdens associated with initiating multi-site research. SMART IRB allows institutions to minimize duplicative IRB reviews while maintaining appropriate oversight and navigating the National Institutes of Health (NIH) Policy on the Use of Single Institutional Review Board for Multi-Site Research and the 2018 Common Rule Cooperative Research Single IRB Mandate.
Request for Ceded Review
A ceded review request is an administrative review performed by the Office of Responsible Research Practices (ORRP) when an Ohio State principal investigator (PI) requests that an external IRB review their human subjects study. If Ohio State relies on an external IRB to review and approve research occurring at Ohio State, a reliance agreement is required. ORRP staff will facilitate this agreement once a submission requesting ceded review is received in Buck-IRB.
Buck-IRB is used to make requests for review of Ohio State research by an external IRB (i.e., “ceding review” to a non-Ohio State IRB). The applicable review board is selected after basic study information is entered into the system. Selecting an external IRB will direct the user to questions and requests for document uploads (e.g., protocol and consent form) that will provide the information necessary to determine if the research meets the requirements for ceding review.