Single IRB Reliance

When Institutions Rely on Other Institutions for IRB Approvals

To help reduce the administrative burden and complexity of multi-site research, institutions and sponsors have been exploring models of multiple institutions relying on a single IRB. A single IRB is an arrangement where one IRB provides review services for multiple sites participating in a study. In contrast, a local IRB is an IRB that provides review services for only the researchers of its own institution, even if a study has collaborators from multiple sites. A single IRB avoids duplicate IRB initial review and continued oversight when a research involves multiple site.

A single IRB arrangement is typically achieved by the establishment of a reliance agreement. A reliance agreement is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to another IRB. The signed agreement permits a single IRB to review human subject research activities for more than one site.

Single IRB Reliance Agreements

Single IRBs may also utilize different reliance agreements. Examples of reliance agreements are explained in the table below, although individual campuses may have other arrangements including agreements with private IRBs:

Agreement Type	Explanation
Individual Investigator Agreement (IIA)	An agreement used when one institution agrees to serve as the IRB of record for external institutions engaged in human subjects research who are not affiliated with an institution with its own IRB.
IRB Authorization Agreement (IAA)	A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying Institution. Agreements are generally used to cover a single research study, categories of research studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).
UC Memorandum of Understanding (MOU)	The UC MOU allows an IRB at any UC campus to rely upon the review and approval, or determination of exemption, of human subject research by an IRB at another of the UC campuses.
SMART IRB Agreement	SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is a national master reliance agreements funded by the National Center for Advancing Translational Sciences (NCATS). It is intended to serve help institutions facilitate the implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multisite Research.
CTSA Consortium	A reciprocal IRB agreement that allows an IRB at one of the signatory institutions to rely on one of the other institution’s IRB for review and approval of human subjects research for collaborative research under certain specified conditions.