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About Reliance Agreements

NIH identifies a reliance agreement as 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 may use different descriptive terms, e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA). MOUs are generally used when covering an entire research program; reliance agreements are generally used to cover a designated protocol or protocols.

The type of agreement may be based on the nature of established financial, legal, or collaborative relationships between the entities. The HHS Office for Human Research Protections (OHRP) sample template uses the term “authorization agreement”; the Food and Drug Administration (FDA) uses the term “agreement.”

Regardless of the term used, the agreement should clearly identify the IRB of record for a protocol or program and the delineation of responsibilities for the designated IRB/reviewing institution, as well as the deferring institution, e.g., who is responsible for reporting non-compliance, serious adverse events, or unanticipated problems, and to whom. Also, who is responsible for providing emergency medical care, if needed, and who will be named as contact in the consent document. Additional resources include:

NIH list of Reliance (Authorization) Frequesntly Asked Questions

FDA Guidance for Industry Using a Centralized IRB Review Process in Multicenter Clinical Trials

CTTI Considerations to Support Communication Between Institutions and Outside IRBs

OHRP has published a sample template IRB Institutional Authorization Agreement

For more information about reliance agreements, or about having us help you with the review of your NIH funded research please contact E&I. We offer the streamlined efficiency of a central IRB, with the years of experience offered by a long-standing independent board, without the burdensome cost often associated with other corporate IRBs.

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