IRB Submission

IRB Submission Support we provide: 

• Addressing general IRB questions
• Regulatory and ethical guidance for how to address or IRB modifications, for initial submissions, amendments, continuing reviews and event reports
• Regulatory Training and Guidance for Regulatory Compliance Officers outside of the CCRM and CTO

Request support for Essential Documents by contacting the CTSI-Regulatory Team. 

How do I utilize the Multicenter IRB Review?

The Ohio State University is committed to accelerating the IRB approval process for clinical research. This is illustrated through the establishment of:

• IRB Authorization Agreements
• IRB Reciprocity Agreements
• Individual Investigator Agreements (IIAs)
• Institutional Authorization Agreements (IAAs)

Ohio State has established IRB Authorization agreements to cede IRB review to the following external IRBs:

• Advarra IRB - for review of some industry sponsored clinical trials
• National Marrow Donor Program (NMDP IRB) - for review of studies sponsored by the Bone Marrow Transplant Clinical Trials Network (BMT CNT)
• NCI CIRB – for review of select NCI-sponsored clinical trials
• WIRB Copernicus Group IRB (WCG IRB) - for review of most industry initiated and sponsored clinical trials

Ohio State has an established IRB Reciprocity Agreement with Nationwide Children’s Hospital that permits Ohio State and Nationwide Children's Hospital to collaborate in the review and oversight of human subjects research that would otherwise require review by both organizations. This agreement applies when an:

• Ohio State Investigator performs or is engaged in a study at Nationwide Children's Hospital
• Nationwide Children's Hospital investigator performs or is engaged in a study at Ohio State

The CTSI has an established agreement between Ohio State’s Office of Responsible Research Practices and the eight institutions that compose the three CTSA sites in Ohio, to allow for one IRB to serve as the IRB of record for multi-center clinical research studies involving these CTSA-affiliated institutions which include:

• The Ohio State University
• Nationwide Children’s Hospital
• University of Cincinnati
• Cincinnati Children’s Hospital Medical Center
• Case Western Reserve University
• University Hospitals – Cleveland
• MetroHealth
• Cleveland Clinic Foundation

Read Ohio State’s IRB Guide to Establish Ohio State as Your Central IRB

Ohio State has also joined SMART IRB in support of the NIH Single IRB Review policy. SMART IRB is a platform designed to streamline and harmonize the IRB review process for multisite research. This effort was led by our CTSA consortium partner Harvard Catalyst, in collaboration with Dartmouth Synergy and University of Wisconsin-Madison. SMART IRB is intended to serve as a roadmap for institutions to implement the NIH policy on the Use of Single Institutional Review Board for Multisite Research.

SMART IRB

SMART IRB is a platform designed to ease common challenges and burdens associated with initiating multisite research and provide a roadmap for institutions to implement the NIH Single IRB Review policy. Through a flexible master IRB reliance agreement, standard operating procedures and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

The CTSI aims to apply this “Reliant IRB” model to other collaborative research networks, with a goal to improve efficiencies in the IRB review and study implementation processes without compromising the regulatory and ethical environments that exist within any institution.