The SMART IRB SOPs: what they are and when they apply

Applies to: Agreement V3.0

The SMART IRB Standard Operating Procedures (version date March 17, 2025) describe how institutions carry out their responsibilities under the Agreement: who communicates what to whom, how the Reviewing IRB is established, how sites are added, how consent documents are customized, how reportable events flow, and so on. They are written for the reliance relationship and are not meant to replace your institution's own HRPP SOPs.

Under Version 3.0 the SOPs apply by default (§3.4). Unless the institutions involved in a study document that a different set of policies and procedures applies (or federal Mandated Policies apply), the SMART IRB SOPs govern the arrangement. You do not need to document that you are using the default — though you may, by noting "Default implementation applies" in the Letter of Acknowledgment or the Implementation Checklist.

When something else applies

• Mandated Policies (§3.4.1). If a federal department or agency mandates policies and procedures for the reliance relationship (for example, as a condition of funding), those apply, and where a Mandated Policy conflicts with a term of the Agreement, the Mandated Policy governs.
• Other Policies you choose (§3.4.2). Institutions may agree to use a Reviewing IRB's own reliance SOPs, a network's SOPs, or another set. Where an Other Policy conflicts with the Agreement, the Agreement governs — for example, a policy against sharing IRB minutes cannot override the Agreement's provision on access to minutes. (Under Versions 1.0 and 2.0, policies required by a funder or network overrode the Agreement; Version 3.0 reserves that only for federal Mandated Policies.)

How to document the choice (§3.4.3). Any of these works: complete the Implementation Checklist together; state the SOPs in the Letter of Acknowledgment; or keep a note to file in your electronic IRB system. Whatever the method, communicate the decision to the other institutions in writing.

Can institutions modify the SOPs? Yes. Unlike the Agreement, the SOPs may be adapted, and SMART IRB updates them over time (changes are approved by the SMART IRB Executive Committee, posted at smartirb.org, and announced to Participating Institutions). Study-team-facing checklists derived from the SOPs are in Checklists for study teams.

See also

• Default vs. flexible implementation
• The Implementation Checklist
• Overall PI and Lead Study Team checklist