UCI as the Relying IRB (External sIRB)

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.

External sIRB Eligibility

External sIRB Eligibility

The UCI IRB complies with the single IRB (sIRB) requirement under 45 CFR 46.114.

When not otherwise federally mandated, UCI will consider relying on an external (non-UCI) IRB for review. The decision to cede is based on many factors, such as: 

  • is the UCI investigator the prime recipient of the funding award,
  • does the research primarily take place at UCI sites/facilities,
  • do the investigator(s) have a disclosable conflict of interest,
  • does the research involve an investigational drug or device,
  • is the research first in human, etc.

For more information, refer to HRP Policy # 4 and the External sIRB Consideration Checklist.


The chart below reflects which studies are eligible to cede to a non-UCI (external) IRB review, and which ones are not eligible.

IMPORTANT! To maintain efficiencies and provide consistency for the IRB, the HRP, our Research Faculty, and Research Coordinators, no exceptions will be made. If the study sponsor has questions, please cite this webpage and provide our most recent sponsor letter.

UCI Serves as HIPAA Privacy Board

UCI IRB Does Not Cede HIPAA Privacy Board Review

When the UCI is the Relying IRB, it does not cede HIPAA review. Rather, the UCI IRB contnues to serve as the HIPAA Privacy Board. Exceptions may be considered.

The UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. Each institution will retain their own privacy reporting responsibilities should a breach of privacy occur.

External sIRB Agreements

External sIRB Agreements

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.
Institutional Authorization Agreement (IAA)An IAA is a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying Institution.

When a non-UCI entity is an institution that does not have their own IRB and they do not participate with SMART IRB, an IAA may be utilized.
National Cancer Institute (NCI) Central IRB (CIRB)NCI CIRB serves as the IRB of record for eligible NCI cooperative group trials.

The Adult NCI CIRB reviews Cooperative Group trials from the ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC, NSABP, RTOG, and SWOG, as well as any other studies opened in the Cancer Trials Support Unit (CTSU).
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) - UCI IRB
• NEALS - Northeast ALS Consortium
• NeuroNEXT
• StrokeNet
• UC IRB Reliance
• Other Single Institutional Agreements (e.g., Fountain Valley, Kaiser)
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.

Submit an External sIRB Request

Submitting an sIRB Request to the UCI IRB

 

  1. Section 1. Enter Title of Study as it appears on the IRB Approval Letter from the IRB of Record.

 

  1. Section 2. Enter Level of Review as determined by Reviewing IRB

 

  1. Section 6. IRB of Record – Select the following:
  1. Upload a copy of all Reviewing IRB’s study documents, if applicable:
    1. IRB Approval Letter, with active approval dates
    2. Protocol Narrative
  • Consent form
  1. Recruitment materials
  2. Questionnaires/surveys/measures, etc
  3. Data Abstraction Sheet (for Records Review)
  4. HIPAA Research Authorization Form, if applicable

UCI prefers that requests for sIRB be submitted via a formal amendment to the UCI IRB approved study, not during the initial review of the study. Requesting an sIRB process during initial review often protracts the initial IRB approval timeframe for the UCI site. Exceptions may be considered.

The following revisions and documentation requirements will need to be addressed during the amendment, as applicable.

  1. Provide a sIRB agreement signed by each non-UCI entity.
  2. Revise the protocol to account for the research activities of the non-UCI entity as applicable:
    • Subject Population: Revise to account for the subject enrollments at the non-UCI entity.
    • Recruitment: Revise to account for any recruitment methods that are specific to the non-UCI entity.
    • Consent Process: Revise to account for any consent methods that are specific to the non-UCI  entity.
    • Procedures: Revised to account for the non-UCI entity's role in the research and for any alterations in the research procedures that are specific to the non-UCI entity.
    • Compensation: Revised to account for any compensation that is specific to the non-UCI entity.
    • Confidentiality of Research Data: Revised to account for any data storage methods that are specific to the non-UCI entity.
  3. If consenting at a non-UCI site, a revised UCI Consent / Assent Form that includes any non-UCI entity specific information in context of the research. UCI prefers that only the Lead Collaborating Researchers (LCRs) from each non-UCI entity be listed at the top of the UCI consent form. Do not list other non-UCI researchers from the non-UCI entity on the consent form.
  4. Provide the non-UCI entity’s conflict of interest management plan.
  5. Provide the non-UCI entity’s RSC approval.
  6. Provide the non-UCI entity’s IBC approval.

Post-Cede Responsibilities

Post-Cede Responsibilities

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 or translated version of an approved consent form

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

3. Any change in research site

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

5. Any change in Protected Health Information (PHI)

6. Adding new or revised recruitment materials

7. Change in Lead Researcher

8. 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