SMART IRB: Supporting single IRB review
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PCORnet-Designated Flu Dosing Study Pilots SMART IRB Approach

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Advancing research together.

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.

singlesource icon Single IRB Authorization Agreement
Institutions can use the SMART IRB Agreement to streamline IRB review for multi-site studies, eliminating the time and effort typically required to negotiate an IRB authorization agreement for each new study. View the SMART IRB Agreement [PDF].

guidance icon Guidance
Standard operating procedures (SOPs) provide clarity during the review and conduct of research using the SMART IRB Agreement. The SOPs and additional educational materials, tools, and checklists are available on our Resources page.

expertise icon Access to Expertise across the Nation
A team of SMART IRB ambassadors who are knowledgeable in the processes and practicalities of IRB reliance are available to assist institutions in joining and implementing the SMART IRB Agreement and SOPs. IRBs can also request expert advice or guidance through our consultation service.

online sharing icon Online Sharing
An open-source, web-based platform allows institutions to join SMART IRB and create an institution profile. A reliance determination system (in development) will centrally facilitate decision making on a study-by-study basis.

How to join.

Institutions that meet the eligibility requirements and agree to the terms of the SMART IRB Agreement may join through the SMART IRB Joinder platform. This platform allows an institutional representative to register the institution, then generate and submit an institution-specific Joinder Agreement for review and activation.

At this time, any U.S. institution may begin the process by reviewing the SMART IRB Agreement and eligibility requirements. The institutional official or other institution representative may then contact a SMART IRB ambassador with any questions or to discuss next steps.

When an institution is ready to proceed, an authorized institution representative (e.g. IRB administrator or research compliance personnel) may initiate the process by following the link below:

Next steps.

Once your institution has joined SMART IRB, you will be added to our list of participating institutions. You can then use the SMART IRB Agreement and SOPs to support collaborative research projects with other participating institutions. Joining SMART IRB does not obligate institutions to participate in any given research study or agree to a reliance arrangement.