How reliance works under the Agreement

Applies to: Agreement V3.0

Joining SMART IRB commits your institution to the terms of the Agreement — not to ceding or providing review for any particular study. Four principles shape every arrangement:

Study by study, by choice. Each Participating Institution decides, for each study, whether to cede review, provide review, or do neither. No institution is required to cede or to serve as a Reviewing IRB unless a funder, sponsor, or consortium it has joined requires it. If one institution declines to join a ceded review, the others can still proceed.

One IRB of record per institution per study. SMART IRB is a "non-share" model. The Reviewing IRB handles all IRB review for the institutions relying on it — initial review, continuing review, amendments (study-wide and site-specific), and reportable events. For any given institution and study there is a single IRB of record.

One-way or reciprocal. An institution may only ever rely, may only ever review, or may rely on one study and review another. Institutions without an IRB can join to rely.

Any scale. The Agreement can document reliance for a single study, a category of studies, or an entire consortium or network.

The Agreement itself cannot be modified — changing its language voids it — but many of its provisions can be implemented flexibly by mutual agreement, documented study by study. See Default vs. flexible implementation.

See also - What research can be reviewed under the Agreement? - Selecting the Reviewing IRB - Default vs. flexible implementation