Reliance Agreements

What is a Reliance Agreement?
A reliance agreement is a written agreement that must be established when an institution engaged in research delegates institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions may use different terms, e.g., reliance agreement or IRB authorization agreement (IAA). Reliance agreements may cover individual studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).

What is sIRB or single Institutional Review Board (sIRB) review?
The sIRB is the single IRB of record that conducts the ethical review for participating sites of a multi-site or collaborative study. A sIRB may also be called a central IRB or CIRB.

When is single IRB review required?

• Non-exempt human subjects research that is funded or supported by a federal agency and conducted in the US requires single IRB review (unless more than single IRB review is required by law, e.g., tribal law passed by the official governing body of an American Indian or Alaska Native tribe).
• When single IRB review is required, the Federal department or agency supporting or conducting the research may determine and document that the use of a single IRB is not appropriate for the particular context. (https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/index.html)
• Contact the UMass Chan IRB before submitting a grant that involves a single IRB plan. A discussion is necessary to determine whether UMass Chan is able to serve as the single IRB or rely on an external IRB.
• The UMass Chan IRB will consider reliance agreements when sIRB is required and when sIRB is optional.

What if my research is Exempt?
UMass Chan typically restricts reliance agreements to non-exempt human subjects research. If you are joining research that has already been deemed exempt elsewhere, email IRBreliance@umassmed.edu to inquire about ways to streamline the eIRB application.
 
Does single IRB eliminate local institutional review at the relying site?
No, institutions remain responsible for all research they conduct, and UMass Chan has implemented corresponding sIRB procedures within its HRPP.
See below for instructions related to the NCI CIRB, NEALS, NMDP, and StrokeNet CIRBs, WCG IRB, SMART IRBs, and other reliances.