Key Terms

IRB Authorization Agreement: A written agreement between the institutions that spells out the responsibilities of the institution providing IRB review as well as the institution relying on the external IRB (also called IRB Reliance Agreement, IRB Reciprocity Agreement)

Lead PI: The PI of the institution where the reviewing IRB is located. Usually, but not always, the lead PI is also the main PI of the multi-site research and is ultimately responsible for the research.  (also called overall PI)

Relying Institution: An institution that cedes IRB review to a Reviewing IRB for a particular research study. (also called relying site, relying institution)

Reviewing IRB: The IRB of record to which authority for IRB review and oversight has been ceded by another institution for particular research study. (also called IRB of record, single IRB, sIRB)

sIRB: Effective January 25, 2018, NIH-funded multi-site studies, where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program must use a single Institutional Review Board (sIRB). This requirement applies to all competing NIH grant applications (new, renewal, revision or re-submission) with submission date on or after Jan 25, 2018.

Site PI: The PIs at the various relying institutions. (also called local PIs).