UCI is the Relying IRB

Relying IRB will rely on the review of the Reviewing (external) IRB. The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB.

Single IRB (sIRB) Review Process Overview

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Step 1

Review the UCI HRP Policy #4 & this Website

  • UCI Investigator confirms Relying IRB eligibility criteria 

Step 2

UCI Investigator Pre-Submission

  • Initiate process to obtain other UCI regulatory committee/ institutional approvals (i.e., Radiation Safety Committee (RSC), Conflict of Interest Oversight Committee (COIOC)), as needed
  • Industry Sponsored Clinical Trials:
    • Confirm that the Sponsor/CRO has contracted with the External IRB to provide services for the study
    • Confirm that the Sponsor/CRO will include the UCI IRB fees in the clinical trial budget

Step 3

UCI Investigator Submits a New sIRB Application

Step 4

UCI IRB Agrees to Rely 

  • UCI local context and consent form language confirmed
  • Clearance Notice Issued 

Step 5

UCI Investigator/Sponsor Submits to External IRB 

  • External IRB reviews UCI documentation

Step 6

External IRB Agrees to serve as Reviewing IRB

  • sIRB Agreement signed by Reviewing IRB or Approval Letter documenting UCI as a Relying Site
  • Release of UCI specific approved documents

Step 7

UCI Releases the Initial Reliance Approval & Study Documents

Eligibility Criteria: UCI is the Relying IRB

Eligibility Criteria: UCI is the Relying IRB

Review the following tables and flowchart to determine whether the UCI IRB may rely on an external (non-UCI) IRB.

IMPORTANT! When the UCI is the Relying IRB, it does NOT rely on the External HIPAA Privacy Board. Rather, the UCI IRB continues to serve as the HIPAA Privacy Board.

 

Table: Exceptions for when UCI IRB will Rely on an External IRB

EntityRegulations or PolicyExceptions
Human Health Services (HHS) & Signatories of the 2018 Common Rule45 CFR 46.114 Cooperative Research

Any institution located in the United States that is engaged in cooperative (non-Exempt) research must rely upon approval by a single IRB (sIRB) for that portion of the research that is conducted in the United States.

The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.		HHS Exceptions - § 46.114(b)(2)

(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or

(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
Food and Drug Administration (FDA)21 CFR 56.114(b)(1) Cooperative Research

FDA has proposed new regulations to require that any institution located in the United States participating in FDA-regulated cooperative research rely on approval by a single IRB for that portion of the research that is conducted in the United States.		FDA Exceptions - § 56.114(b)(2)

(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an AI/AN tribe).

(ii) Research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required. *Rare*

(iii) Research on drugs that is exempt from the requirements for an IND application under § 312.2(b).

(iv) Research on medical devices that meets the abbreviated requirements under § 812.2(b) or
that meets the requirements for exempted investigations under § 812.2(c), to the extent the exempted investigation would be subject to part 56.
UC Irvine (UCI)Human Research Protections (HRP) Policy #4 Cooperative Research

When not otherwise federally mandated, UCI will consider relying on an external (non-UCI) IRB for non-exempt human subjects research conducted at more than one U.S. site when all of the following is true:

*the external IRB is AAHRPP accredited or CARE-Q Certified, or the organization is actively seeking accreditation / certification, and

*UCI has a master service agreement with the external IRB or the SMART IRB agreement v3.0 is used.		UCI Exceptions - Policy 4

1. Research does not involve any HHS or FDA exceptions to cooperative research

2. Investigator initiated/authored clinical investigation (includes both UCI or non-UCI investigator authored)

3. Expanded access, compassionate use, right to try

4. Exempt research

Table: sIRB Agreements for when UCI is the Relying IRB

External Entity/IRBsIRB Agreement Description
Advarra Institutional Review Board (IRB)Advarra is an independent IRB that provides services for academic and non-academic institutions.

UC has a Master Service Agreement with Advarra to serve as the IRB of record for eligible clinical trials. For these trials, the industry sponsor’s protocol has already received IRB approval from Advarra.
SMART IRBSMART IRB provides a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, supporting and encouraging collaboration and harmonization across the nation.

The following reliance agreements will be processed utilizing the SMART IRB agreement:

    • Children's Hospital of Orange County (CHOC)
    • MemorialCare Health System (MHS)
    • NEALS - Northeast ALS Consortium
    • NeuroNEXT
    • StrokeNet
    • UC IRB Reliance
    • Other Single Institutional Agreements

IMPORTANT! External (non-UCI) IRBs must have joined SMART IRB Agreement v3.0 for ANY NEW reliance arrangements with UCI.

While previously documented arrangements under agreements v1.0/v2.0 remain valid, as of March 17, 2025, these agreements may not be used for any new arrangements.
WIRB Copernicus Group (WCG) IRBWCG is an independent IRB located in Olympia, Washington that provides services for academic and non-academic institutions.

UC has a Master Service Agreement with WCG IRB to serve as the IRB of record for eligible clinical trials. For these trials, the industry sponsor’s protocol has already received approval from WCG IRB.

Flowchart: When UCI IRB will Rely on an External IRB

Submission Requirements: UCI is the Relying IRB

Submission Requirements: UCI is the Relying IRB

Step STEP 1: Review the External IRB's policy and touch base with their sIRB contact

Step STEP 2: Review 'Eligibility: UCI an the Relying IRB' and verify the study's eligibility criteria

Eligibility Uci Relying

Step STEP 3: Log into Kuali Research Protocols (KRP), select 'Register a Reliance on an External IRB'

KRP User Guide

Register Reliance

Step STEP 4: Complete the entire KRP form and attach the following documents (as applicable):

Attach

    • IRB Approval Letter, with active approval date
    • Protocol (when a Master Protocol is not available)
    • Questionnaires/surveys/measures, etc.
    • Sponsor Study Documents:
      • Master Protocol
      • Investigator’s Brochure
      • Documentation from the Sponsor/CRO confirming that:
        • the External IRB is providing IRB services for the study and
        • the Sponsor/CRO will cover IRB review fees
    • UCI Specific Documents:
      • UCI Site Recruitment Materials
      • Draft of External IRB Consent that Includes UCI Template Language
      • UCI HIPAA Research Authorization Form
      • FDA Documentation
    • Evidence of UCI Ancillary Review:
      • Conflict of Interest (COI) Management Plan
      • Radiation Safety Committee (RSC)
      • Institutional Biosafety Committee (IBC)
    • For SMART IRB, attach the Letter of Agreement (LOA)

Post-Rely Responsibilities: UCI is the Relying IRB

Post-Rely Responsibilities: UCI is the Relying IRB

 

TransactionSubmit to External IRB of RecordSubmit to UCI IRB
AmendmentsAccording to External IRB PolicyUCI Specific Changes: once approved by the External IRB, submit a UCI amendment request for the following local context revisions:

1. Adding new version of an approved consent form

2. Any change in the informed consent process (e.g., adding short form consent)

3. Adding translated HIPAA Forms or non-English speaking subjects as a new study population Note: Do not submit translated consent forms

4. Any change in Protected Health Information (PHI)

5. Any change in research site

6. Any change in a research team member’s disclosable financial interests

7. Adding new or revised recruitment materials

8. Change in Lead Researcher

9. Adding or removing Co-Researchers or Research Personnel (when adding individuals UCI IRB approval must be provided prior to the individual engaging in research activities)
RenewalsProgress Report of Research Activities at UCI1. Renewal Letter Approval from the External IRB of Record

2. Routine monitoring reports, as applicable
Reportable EventsAccording to External IRB Policy1. External IRB’s Potential Unanticipated Problem or Noncompliance Form

2. Serious and/or Continuing Noncompliance that occurred at the UCI site

3. Unanticipated Problem that occurred at the UCI site

4. Notification of a hold or a suspension by the FDA, a sponsor, or a DSMB possibly related to risk to human subjects
Advarra: Reporting Requirements
Advarra: SAE Reporting Guidelines
WCG: Reporting Requirements
WCG: Reportable Info Form
Audits By External EntitiesAccording to External IRB Policy1. Notify UCI IRB and Internal Audit Services in advance of any audit or non-routine monitoring of study records to be conducted by an external entity (e.g., FDA, OHRP, study sponsor, CRO). The IRB and/or Internal Audit Services may wish to send a representative to observe proceedings including the "exit interview."

2. Any audit or non-routine monitoring written reports must be submitted to UCI, Routine monitoring findings by study sponsor or CRO must also be submitted to UCI IRB for their review and records.

3. Reports that include significant findings (potential Unanticipated Problem, Serious or Continuing Noncompliance) must be reported.
Study ClosureAccording to External IRB PolicyExternal IRB’s study closure report

FAQs: UCI is the Relying IRB

FAQs: UCI is the Relying IRB

 

Informed Consent Process

HIPAA Authorization