Stanford as Relying IRB

Overview

Stanford may enter into a reliance agreement to rely on an external IRB for Single IRB review. This is sometimes referred to as "ceding" IRB review.

When will Stanford Agree to Rely on an External IRB?

When not required by the federal regulations, reliance on an external IRB is considered on a case-by-case basis.

• Stanford will generally rely on an external IRB for review when required per NIH Single IRB policy and the Common Rule Cooperative Research provision.
• Stanford will consider reliance when the lead PI or the research consortium requires the use of single IRB to participate in the research.
• Stanford will not rely on an external IRB when Stanford is the only participating site.

Examples of when reliance may not be appropriate include:

• first-in-human drug or device studies,
• certain studies using biological agents or recombinant DNA vectors, and
• studies involving stem cells. 

If you are unsure whether your study meets the general criteria for the Stanford IRB to rely on an external IRB, please contact the Single IRB team.

What Does it Mean for Stanford to Rely on an External IRB?

The Reviewing IRB is responsible for ensuring federal and state regulations (including the Common Rule and FDA requirements) for IRB review are met. The Reviewing IRB is responsible for conducting initial and continuing reviews, and reviewing modifications and reportable events (including reports of serious and/or continuing noncompliance and unanticipated problems).

The Stanford IRB maintains responsibility for local review requirements including:

• confirming review of reportable events
• confirming investigator training
• study monitoring
• ensuring local ancillary and institutional reviews

The reliance terms are outlined in a reliance agreement.

What is Needed for Stanford to Rely on an External IRB?

The Stanford Investigator will need to submit a 'Stanford Relying' application in eProtocol to request reliance on an external IRB. The eProtocol application should include:

• Reviewing IRB approved study protocol;
• Reviewing IRB approved consent form (with Stanford required elements included);
• IRB Reliance document (check with Reviewing IRB; not needed if using a Master Reliance Agreement);
• Investigator Brochure and/or FDA documentation (if applicable);
• Reviewing IRB initial approval letter for the overall study (this typically does not include approval to add Stanford as a site); and
• Local Context document if requested by Reviewing IRB.

How Do I Know When the Study Can Begin?

The Stanford IRB will issue a Reliance Letter to the study team once the following items have been completed: 

1. the Reliance Agreement has been executed,
2. the Reviewing IRB approval is in place, and
3. the Stanford IRB local review is complete. 

This letter may need to be provided to the contracts office to finalize any pending contracts. The Stanford Protocol Director is responsible for ensuring any required local ancillary and institutional reviews are completed (as applicable) before initiating the research.

What are the Protocol Director’s Responsibilities when Relying on an External IRB?

The Protocol Director’s additional responsibilities are outlined in the SMART IRB’s Relying PI Checklist.

Where Should Modifications, Continuing Reviews, and Reportable Events be Submitted?

All activities should be submitted to the Reviewing IRB, i.e. modifications, continuing reviews, adverse events, protocol deviations, other reportable events, and any other information as required by the Reviewing IRB.

The following modifications should also be submitted to the Stanford IRB when relying on an External IRB for review:

• Change in Protocol Director or other study personnel
• Change in Stanford required consent language
• Addition of MRI procedures (when using the Lucas Center and/or CNI, Jordan Hall)
• Updating Protected Health Information (PHI) to be accessed or collected
• Any change that requires additional Stanford institutional and ancillary review

The following events should also be reported to the Stanford IRB when relying on an External IRB for review:

• When the study is closed, terminated or suspended
• Any local protocol event that requires prompt reporting, including:
  • Possible Unanticipated Problem posing risks to subjects or others
  • Possible serious and/or continuing noncompliance

Continuing Reviews are not required with the Stanford IRB when relying on an External IRB for review, however researchers will receive an annual check-in notice to confirm the status of the study.

Are there Fees when Stanford Relies on an External IRB?

The Stanford IRB charges initial and continuing review fees for industry-sponsored clinical trials. See Industry Fees for IRB Review for fee schedule.

Resources for Stanford as Relying IRB

• Stanford Required Consent Elements
• Stanford HIPAA Authorization Template
• SMART IRB Resources for Investigators and Study Teams

Page updated October, 2025