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.