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December 6, 2016


Supporting single IRB review on a National Scale, Advancing collaborative research

Over 57 institutions have joined SMART IRB, a platform designed to streamline and harmonize the IRB review process for multisite research. 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 National Institute of Health (NIH) policy on the Use of Single Institutional Review Board for Multi-Site Research.

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.

Enabling Single IRB Review

As part of SMART IRB, institutions may choose to rely on another IRB to review, approve, and oversee a research study.

The Reviewing IRB takes on IRB oversight responsibilities associated with that study throughout its duration. Relying Institutions provide key local context information about state law, study team member training and qualifications, and any applicable conflict of interests. Investigators and institutions retain their respective responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms of the institution's FWA.

How it works

The Overall Principal Investigator (PI) of a multi-site study works with the Points of Contact (POCs-listed on SMART IRB website) for each participating institution involved in the study to determine an appropriate reliance arrangement. Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research. Additional details on these processes are available in the SMART IRB SOPs on "Establishing Reviewing IRBs and Relying Institutions" and "Initial Review Submission and Review Process." See the Resources page.

SMART IRB helps streamline human subjects research, while ensuring robust protections for study participants. SMART IRB can be used for a range of research, from large, complex clinical trials to two-site collaborations. Clinical investigators can obtain trial results faster and, ultimately, speed development of new diagnostics, treatments, and preventative measures for patients.

By opting for IRB reliance with SMART IRB, institutions minimize duplicative IRB reviews while maintaining appropriate oversight. Click on the link to SMART IRB for more information. Contact OSU’s SMART IRB point of contact at: IRBAgreements@osu.edu.

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Acknowledging CTSA grant support in publications

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