Examples
Worked examples
- Is an instance
A 15-site NIH-funded behavioral trial's coordinating center is a SMART IRB participating institution, and so is each of the other 14 sites; every relying site invokes the existing master agreement through SMART IRB's online reliance system to rely on the coordinating center's IRB for that specific study, instead of negotiating a new IRB Authorization Agreement.
- Is an instance
A university joins SMART IRB for the first time by having its Signatory Official execute the master agreement once. From that point on, any qualifying multi-site study between it and another SMART IRB institution can use the reliance system to document that study's reliance arrangement, with no new bespoke contract review required for each study.
Counter-examples
Looks similar, but isn't
- Not an instance
Two institutions, neither of which has signed the SMART IRB master agreement, negotiate an IRB Authorization Agreement from scratch for a single two-site study, with each institution's legal counsel reviewing bespoke contract language -- this is exactly the per-study negotiation process SMART IRB exists to replace, not an instance of using it.
- Not an instance
A single-site study with no other participating institutions has no reliance question to resolve at all; there is nothing for a reliance agreement, SMART IRB or otherwise, to apply to.
Editorial commentary
The SMART IRB Reliance Agreement is the master common reliance agreement at the center of SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials IRB) — the national IRB reliance platform used by U.S. institutions to avoid negotiating a bespoke IRB Authorization Agreement for every individual multi-site study. Participating institutions execute the master agreement once, through their Signatory Official; from that point forward, any qualifying study between two or more participating institutions can rely on the existing agreement, documenting that specific study’s reliance arrangement through SMART IRB’s online tools rather than drafting new contract terms from scratch each time.
SMART IRB is not itself an IRB and does not review protocols. It is reliance infrastructure — the agreement, standard operating procedures, and an online system for documenting which institution’s IRB serves as the reviewing IRB for a given study and which institutions are relying on that review.
Origin and scale
The National Center for Advancing Translational Sciences (NCATS) funded the initial collaborative effort to develop a common reliance agreement and shared SOPs beginning in September 2014, and the SMART IRB Agreement launched officially in July 2016. Harvard Catalyst now coordinates ongoing operations. A revised Version 3.0 of the agreement, with expanded participation criteria, launched in March 2025. As of the platform’s own reporting, more than 1,400 institutions participate — including universities, academic medical centers, community hospitals, cancer centers, independent IRBs, federal agencies, and Clinical and Translational Science Awards (CTSA) hubs. This scale is the point of a master agreement: reliance terms that once required a separate negotiation for every study pair now exist as a single standing agreement across the entire participating network.
How the master agreement works operationally
- One signature, many studies. An institution executes the master agreement a single time. It then covers reliance for any qualifying study between that institution and any other participating institution, not just one specific project.
- Per-study reliance is still documented, just not renegotiated. Each study still needs its reliance arrangement recorded — which institution’s IRB is the IRB of record, which institutions are relying sites — but that documentation happens through SMART IRB’s online reliance system rather than through fresh legal drafting.
- Local responsibilities are unchanged. As with any single-IRB (sIRB) arrangement, relying sites retain informed consent administration, local context considerations, and local reportable-event tracking; only the substantive ethical review is centralized in the IRB of record.
- Either institutional or commercial IRBs can serve as the reviewing IRB. The IRB of record for a given study under the agreement can be an institution’s own IRB or a commercial IRB — the master agreement governs the reliance relationship, not which type of board is doing the reviewing.
What it replaces
Before shared reliance infrastructure like SMART IRB existed, a multi-site study’s sponsor or coordinating center typically had to negotiate a separate IRB Authorization Agreement with every relying institution, each time a new multi-site study needed reliance — a process that could take weeks to months per agreement and was a frequently cited source of delay in getting a multi-site protocol activated. A pre-executed master agreement removes that per-study negotiation step for any two institutions that have already joined the platform, though it does not eliminate the need to document reliance for each individual study.
SMART IRB vs. the general reliance-agreement concept
An IRB Authorization Agreement (IAA) is the general mechanism by which one institution formally relies on another institution’s IRB for a given study; SMART IRB is one specific, widely adopted implementation of that mechanism, built as a shared master agreement rather than a one-off contract. Institutions can still execute standalone, bespoke IAAs outside SMART IRB for studies or partners not covered by the platform — SMART IRB is the dominant shared infrastructure for this in the U.S., not the only route to establishing reliance.
Related terms
- Central IRB / Single IRB (sIRB)
- Commercial IRB
- IRB (Institutional Review Board)
- IRB/REC Approval Process
References
- SMART IRB, About Us (smartirb.org/about-us)
- NIH, Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NOT-OD-16-094)
- 45 CFR 46 (Common Rule), Subpart A
Machine-readable encodings
Use in your systems
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