Single IRB (sIRB) Process

A Single IRB means one IRB of record (or Reviewing IRB), selected on a study-by-study basis, provides the regulatory and ethical review for all sites participating in a specific multisite study.

For questions about collaborative research, please note the following:

  • When UCI will serve as the IRB of record contact the HRP Teams at IRB@research.uci.edu
  • When UCI will rely on another IRB, including a commercial IRB, contact the HRP Reliance Team: IRBReliance@uci.edu
  • To review IRB Committee considerations for when the UCI IRB can cede review to Advarra / WCG IRB please click below:
Click Here

sIRB Requirement

At UCI, a single IRB will be required for the following types of non-exempt cooperative (multisite) research carried out within the United States:

  1. Research supported by an agency that has signed on to the 2018 Common Rule. For a full list of HHS Departments and Agencies that follow the Common Rule, please click here.
  2. Research supported by NIH; there are some exceptions.  For more information, see: NOT-OD-16-094. 

Important: For all other types of research, the UCI IRB will decide, on a case-by-case basis, whether to proceed with a sIRB review process.

 

sIRB Models

Typically, a sIRB reliance model can fall into the following two categories:

Central IRB Model (or Ceded Model)

One IRB serves as the IRB of record for all participating sites involved in a multi-site protocol. The IRB of record assumes all responsibilities associated with an ethical review, including initial review, continuing review, and review of all documents.

Shared Model

One IRB serves as the IRB of record for all participating sites involved in a multi-site protocol. The IRB of record approves the study but the local IRB shares in some responsibilities, including conducting local context review.

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Definitions

Reviewing IRB is the “IRB of record” to which authority for IRB review and oversight has been ceded by another institution for an instance of research under a sIRB reliance agreement. The Reviewing IRB is responsible for reviewing all IRB transactions for the Relying Institution. This includes, initial/continuing reviews, amendments to approved protocol, and unanticipated problems that may arise.

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

sIRB Reliance Agreements

A sIRB reliance agreement is a formal, written document that provides a mechanism for an institution or individual engaged in research to delegate IRB review to an IRB of another institution. Institutions may use different descriptive terms, (e.g., reliance agreement, cooperative agreement, letter of agreement). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).

Examples of reliance agreements are explained in the table below, although individual campuses may have other arrangements including agreements with private IRBs:
Individual Investigator Agreement (IIA) This agreement used when one institution agrees to serve as the IRB of record for external investigator engaged in non-exempt human-subjects research who is not affiliated with an institution with its own IRB. Reviewing IRB
Institutional Authorization Agreement (IAA) 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. An IAA is a formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying Institution. Agreements are generally used to cover a single research study, categories of research studies, or all human subjects research under an organization’s Federalwide Assurance (FWA). Relying IRB or Reviewing IRB
SMART IRB Agreement SMART IRB supports and encourages collaboration and harmonization across the nation through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS). Relying IRB or Reviewing IRB

UCI Prefers to use SMART IRB

SMART IRB is not an actual IRB that provides regulatory approval. SMART IRB is a platform designed to ease common challenges associated with initiating multisite research. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS). For more information, visit SMART IRB.

In an effort to promote a more streamlined process, 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 Reliance
  • NEALS - Northeast ALS Consortium 
  • NeuroNEXT
  • StrokeNet
  • Single Institutional Agreements (e.g., Fountain Valley, Kaiser)
  • UC IRB Reliance