Reliance Agreements

As required under the 2018 revisions to the Common Rule (45 CFR 46.114) and the NIH Single IRB (sIRB) Policy, cooperative human subjects research that is funded or supported by federal agencies generally must rely on a single IRB for Expedited and Full Board research. The purpose of this requirement is to streamline IRB review, reduce duplicative regulatory oversight, and improve the efficiency of multisite research.

A reliance agreement allows one institution (the IRB of Record or Reviewing IRB) to provide IRB oversight for one or more participating institutions (Relying Institutions). To facilitate this process, Montclair State University may enter into reliance agreements with collaborating institutions. Reliance agreements may be established through the SMART IRB platform or executed directly by the Montclair State University IRB Office.

Montclair State University may serve either as the Reviewing IRB when the lead Principal Investigator is affiliated with the University, or as a Relying Institution when another institution serves as the Reviewing IRB.

If your study involves collaborating institutions and you believe a reliance agreement may be required, or you are aware that a sponsor or funding agency requires a single IRB, indicate this in your Cayuse IRB application and notify the IRB Office by emailing reviewboard@montclair.edu so the appropriate reliance process can be initiated.

Please note that research determined to be exempt under the Common Rule is not subject to the federal single IRB requirement. Each participating institution should obtain its own exempt determination in accordance with its institutional policies and procedures unless the collaborating institutions have agreed to an alternative reliance arrangement.