Getting Started with Single IRB (sIRB)

Single IRB review is the process by which an institution formally relies on an external Reviewing IRB (or IRB of record) to provide human subjects regulatory and ethical review for all sites participating in a multi-site or collaborative study. The Reviewing IRB is selected on a study-by-study basis and should be determined during the study design/grant writing phase.

When is Single IRB Review Required?

Single IRB review is required for federally-supported research involving two or more sites that are conducting human subjects research activities. See When Do External Organizations Need IRB Approval for activities conducted at other sites that may require single IRB review. The Stanford Single IRB team should be consulted when writing the federal grant proposal to discuss which IRB will serve as the Reviewing IRB.

When Stanford is the Prime Awardee (or the lead site) for a federally supported, multi-site or cooperative study requiring the use of sIRB, researchers will need to consider including one of the following reviewing IRBs in their grant proposal:

Independent IRB (e.g., Advarra IRB, WCG IRB, North Star IRB)
Trial Innovation Network Central IRB
Another academic IRB (i.e., one of the other participating institutions)
Stanford IRB in certain limited cases. See information on Stanford as Reviewing IRB for when this may be appropriate.

See the SMART IRB’s Overall PI Checklist for additional responsibilities when the Stanford Investigator is the lead PI.

Single IRB Review Fees

Single IRB review fees should be included as a direct line item in the grant budget prior to submission.

See additional information on Stanford Single IRB Review Fees.

Single IRB Reliance Pathways

Review the Single IRB reliance pathways to determine if one of these options would be appropriate for your study.

Stanford as Relying IRB

View Information Here

Contact the Single IRB Team

For questions about Single IRB please contact the Stanford sIRB team at singleirb@stanford.edu or 650-736-9024.

The Single IRB team holds weekly Office Hours to assist with questions or inquiries related to Single IRB reliance. No registration is needed.

Reliance Agreements

A reliance agreement, also called an IRB Authorization Agreement (IAA), is a document signed by two or more institutions engaged in human subjects research that permit one or more institutions to cede review to an external IRB. There are multiple types of reliance agreements and generally the Reviewing IRB selects the agreement type.

Stanford IRB has designated a signatory official that works with the IRB office on signing the reliance agreement. The Single IRB team facilitates obtaining the Stanford signatory official’s signature on behalf of the study team. The reliance agreement is signed after Stanford receives and completes its review of the 'Stanford Relying' application in eProtocol.

The SMART (Streamlined, Multi-site, Accelerated Resources for Trials) IRB Agreement is a Master IRB Reliance Agreement designed to harmonize and streamline the IRB review process for multi-site and cooperative studies. The SMART IRB Agreement is not an IRB that reviews and approves research. Stanford has signed on to SMART IRB Agreement, which supports IRB reliance agreements nationwide.

The SMART IRB agreement can be implemented in two different ways, typically determined by the reviewing IRB:

The use of a SMART Letter of Acknowledgement (LOA) that signatory officials affiliated with both the Reviewing IRB and the Relying IRB sign.
The use of an online portal to document reliance using the SMART Agreement (i.e., SMART Online Reliance System (ORS) or the IRB Reliance Exchange (IREx)). When a portal is used, the Stanford Single IRB team executes reliance digitally in the portal without the need for the signatory official to be involved.

Single IRB Mandates

The NIH policy on the Use of a Single Institutional Review Board for Multi-Site Research (effective January 25, 2018), applies to all NIH funded multi-site studies conducting the same non-exempt research at each site. Applicants must include a plan for the use of a Single IRB in their application/proposal submissions. The proposed Reviewing IRB will not be evaluated as part of the peer review process and will not affect the overall assigned score of an application/proposal.

Single IRB review costs may be included as direct costs in the application budget. Work with your Research Process Manager prior to submitting your proposal to NIH.