Useful Definitions

A formal, written document that provides a mechanism for an institution engaged in research to delegate Institutional Review Board (IRB) review to an independent IRB or an IRB of another institution. Institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement and receive approval from the reviewing IRB before the research can begin.

An Institutional Review Board that oversees all sites participating in a multi-site study. A Single IRB (sIRB) is the IRB-of-Record, selected on a study-by-study basis, which provides the ethical review for all sites participating in a multi-site, collaborative human subjects study. Common Rule agencies/funding sponsors (for example, NIH) require a sIRB for domestic multi-site, collaborative studies.

The reviewing IRB is the “IRB of Record” to which authority for IRB review and oversight has been ceded by another Participating Institution for an instance of research under the reliance agreement.

A Participating Institution that cedes IRB review to a Reviewing IRB for an instance of research under a reliance agreement.

“Multi-site” is defined as two or more sites under the NIH Single IRB Review policy.  “Multi-site” means that the same research protocol is being conducted at two or more domestic sites and that each site is under the control of a local participating investigator.

SMART IRB is not an IRB.  SMART IRB is a master reliance agreement to streamline the IRB review process for multi-site studies.  It enables reliance on a study-by-study basis and clearly defines roles and responsibilities of relying institutions and reviewing IRBs.  More than 900 institutions have already signed onto this master agreement and are actively using it as the basis of reliance for multi-site projects.

It is the preference of the DUHS IRB that the SMART IRB reliance agreement be used as the basis for all studies when either relying on an external IRB or when serving as the sIRB, when possible.

*The only exception is when using a commercial IRB such as WCG or Advarra, since the DUHS IRB already has a master agreement on file with both entities and can use their applicable IAA template.

It is a type of reliance agreement. A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of Record for a relying Institution. The DUHS IRB has a template IAA when acting as the reviewing IRB. Please contact Minna Pak ( if you need this template.

When the DUHS IRB is the reviewing IRB, the DUHS IAA is to be used in cases in which an institution has not signed onto the SMART IRB master reliance agreement.

This is another type of reliance agreement.  However, this is a formal written agreement between an institution who is conducting research and an individual investigator who is collaborating on the research, by which the institution agrees to extend its Federalwide Assurance (FWA) for human subjects research to the individual, and by which the individual investigator agrees to fulfill specified expectations and responsibilities.

The DUHS IRB has a template IIA when acting as the reviewing IRB for the non-DUHS individual investigator. Please contact Minna Pak ( if you need this template. Please note: IIAs are used only when the investigator is not connected to another institution (for example, a consultant). If connected to another institution, the IAA or SMART IRB Cede letter should be used.