Efficiency Updates: Single IRB (sIRB)

On Monday, April 14, 2025, the UCI HRP will simplify the current sIRB process.  The UCI HRP will more closely align with the FDA’s Proposed Rule for Cooperative Research<> when determining which studies may rely on a non-UCI IRB.

Efficiency impact on the sIRB review process when UCI is the Relying IRB:

• Streamlined sIRB eligibility criteria for FDA-regulated research 
• A streamlined sIRB review process, as the IRB Chair no longer reviews each reliance request

Please visit our UPDATED webpage UCI is the Relying IRB for more information.

As of March 17, 2025, institutions must join SMART IRB Agreement v3.0 for any NEW reliance arrangements. 

Efficiency Impact on the sIRB review process:

• Aligns both the reviewing and relying institution with the same set of expectations and standards as specified in the SMART IRB Agreement.  This includes full incorporation of the 2018 Common Rule at 45 CFR 46.

Impact on the sIRB review process:

• UCI Investigators should verify that the Participating Institution has joined v3.0
• If the Participating Institution does not join v3.0, UCI cannot be the Relying IRB and UCI IRB review is required. 
• When UCI is the IRB of Record, letter of authorization (LOA) templates for v3.0 must be used and are available on IRB Forms under Single IRB Review. This documents the reliance arrangement or “handshake” between the two institutions.
• SMART IRB Letter of Acknowledgement – Research Does Not Involve Access to Medical Records
• SMART IRB Letter of Acknowledgement – Research Involves Access to Medical Records
• Existing reliance arrangements utilizing agreement v1.0/2.0 (Legacy Agreements) remain valid.

Please visit SMART IRB for more information on the SMART IRB Agreement. 

 Questions?Visit HRP Office Hours or send an email to irbreliance@uci.edu

Stay informed! Sign up for our HRP Newsletter: send a blank email to or-irb-hrp+subscribe@uci.edu