Reliance Agreements
Effective January 20, 2020, the revised Common Rule requires US institutions engaged in federally supported cooperative research to rely on a single IRB (sIRB) to oversee the portion of the research conducted at US sites. Cooperative research refers to research projects involving more than one institution (45 CFR 46.114(a)).
A Reliance Agreement (also called an IRB Authorization Agreement or IAA) is a document signed by two or more FWA holding institutions engaged in human subjects research that allows one or more institutions to cede review to (or rely on) another IRB (single IRB)
The reliance agreement documents the respective authorities and responsibilities of collaborating institutions. Such responsibilities include conducting local ancillary reviews, and compliant implementation of a study at a site. Therefore, even when Columbia University relies on an external IRB to review a study, a (truncated) submission to Columbia HRPO (HRPP) is required so that Columbia HRPO can ensure that institutional responsibilities under the agreement are met.
Columbia University is a signatory of version 3 of SMART IRB Authorization Agreement (SMART IAA), along with multiple reliance agreements with commercial IRBs, and other institutions.