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:
At UCI, a single IRB will be required for the following types of non-exempt cooperative (multisite) research carried out within the United States:
- 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.
- 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.
Typically, a sIRB reliance model can fall into the following two categories:
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.
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.
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.
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)
|An 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.
|Institutional Authorization Agreement (IAA)
|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 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).
|Relying IRB or Reviewing IRB
|UC IRB Reliance
|All UC campuses and Lawrence Berkeley National Laboratory have signed a Memorandum of Understanding (MOU) that allows one UC IRB to rely on another UC IRB for review and approval of human subjects research. In an effort to promote a more streamlined process, effective in 2020, where UCI serves as the IRB of record, UCI will utilize the SMART IRB agreement instead of the UC IRB Reliance.
|Children's Hospital of Orange County (CHOC) - MemorialCare Health System (MHS) - UCI IRB Reliance
|CHOC, MHS and UCI, established an IRB Reliance agreement that allowed for human subjects research to be reviewed by a single IRB rather than submitting for IRB approval at each institution where the research would take place. In an effort to promote a more streamlined process, effective in 2020, CMU has agreed to utilize the SMART IRB agreement instead of the prior CMU IRB Reliance process.