What research can be reviewed under the Agreement?

Applies to: Agreement V3.0

The Agreement covers any human subjects research for which one Participating Institution relies on another's IRB, at every level of review:

• exempt determinations (including limited IRB review where the Common Rule requires it),
• expedited review, and
• full (convened) board review,

regardless of funding source, and including social, behavioral, and educational research as well as biomedical research. Research is defined in the Agreement to include human subjects research under the Common Rule, clinical investigations under FDA regulations, research under other federal human subjects protection regulations, and any other research for which a Participating Institution chooses or is required to rely on a Reviewing IRB.

Research not subject to federal regulations. When research falls outside the Common Rule, FDA regulations, and other federal human subjects requirements, Version 3.0 has the Reviewing IRB apply Common Rule standards unless the parties agree otherwise. The Agreement does not require external reporting for such research.

Institutions and research outside the U.S. The Agreement is written to meet U.S. federal requirements. An institution outside the U.S. that meets the eligibility criteria may join for purposes of its U.S. obligations, but the Agreement makes no representation that it satisfies any foreign law, so institutions with international requirements must judge for themselves whether it meets them.

See also - Exempt research, limited IRB review, and the Common Rule - How reliance works under the Agreement