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

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. New studies approved on or after January 20, 2020 supported by an agency that has signed on to the Common Rule. For a full list of HHS Departments and Agencies that follow the Common Rule, please click here.
  2. Research supported by NIH.  Click here for the official notice from NIH: NOT-OD-16-094. There are some exceptions.  For more about the NIH exceptions and additional information on the single IRB requirement for NIH supported research (in effect since January 25, 2018) click here.
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Definitions

Reliance agreement is a formal, written document that provides a mechanism for an institution 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, IRB authorization agreement (IAA), or memorandum of understanding (MOU)). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).

Reviewing IRB is the IRB that conducts initial and continuing reviews, and will review modification to approved protocol and unanticipated problems or adverse events that may arise. The Reviewing IRB will have the authority to suspend the research for failure to comply with conditions of approval or regulatory requirements.

The Reviewing IRB will notify the federal or funding agencies of these events consistent with their policies and procedures and copy the Relying IRB on any such correspondence. The Reviewing IRB will serve as the IRB of record. The IRB may refuse, on a case-by-case basis, to serve as the IRB of record for another location.

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.

When UCI Requests to Rely on Non-UCI IRB?

Background

Current UCI policy requires that all faculty, staff, and students must have UCI IRB approval before they begin research with human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, regardless of the site of the study activities.

UCI will consider relying on another institution for IRB review on a protocol by protocol basis when a UCI investigator is engaged in human subjects research with a non-UC investigator and:

  • The non-UCI investigator is the prime recipient of the funding award, or
  • The PI of the study is affiliated with the Reviewing IRB’s institution, or
  • The research will primarily take place at the Reviewing IRB’s institution, or
  • The other institution’s reviewing IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context, and
  • The UCI investigators will conduct human research activities that involve no more than minimal risk to subjects, and
  • The other institution is located within the United States.

To facilitate human research and in response to requests by investigators for a more streamlined IRB review process UCI allows for researchers to request that UCI rely on a non-UCI IRB.  This may be indicated through the UCI IRB Application process. Include a copy of the approved study documents from the Reviewing IRB. The UCI IRB will then make a determination as to whether it is appropriate to defer to another IRB, and will notify the investigator of the decision. Note: accepting the review of another IRB does not eliminate the UCI investigator’s responsibility to seek approval from other applicable UCI regulatory entities (e.g., Institutional Biosafety Committee, Radiation Safety Committee, and Human Stem Cell Research Oversight Committee). Please contact the HRP staff for more information.

When Can the UCI Serve as the Reviewing IRB (i.e. IRB of Record) for non-UC entity?

UCI will consider serving as the Reviewing IRB for a non-UC entity on a protocol by protocol basis when the research meets the criteria and the flow chart listed below:

  • The UCI investigator is the prime recipient of the funding award, or
  • The research will primarily take place at UCI sites/facilities, or
  • The UCI IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context, and
    • The UCI investigators will conduct human research activities that involve no more than minimal risk to subjects, and
    • The other institution is located within the United States.

Sirbflowchart

sIRB Reliance Agreements

Review the flow chart below to determine which sIRB agreement applies.

Sirbflowchart2

UCI requires the appropriate sIRB agreement, signed by the relying entity, with the request for UCI to serve as the Reviewing IRB. All templates for sIRB agreements can be found on IRB Forms.

 

  • SMART IRB: UCI prefers to use the SMART IRB whenever the non-UCI entity has their own IRB or if the participate with SMART IRB.  The SMART IRB is free resource that enables IRB reliance for multisite studies across the nation, regardless of funding status. When UCI is the IRB of Record, it does not utilize the SMART IRB Online Reliance System, but requires the execution of a SMART Letter of Agreement (LOA).

 

  • Non-Affiliated Institutions: When a non-UCI entity is an institution that does not have their own IRB and they do not participate with SMART IRB, an IRB Authorization Agreement (IAA) may be utilized.

 

  • Non-Affiliated Individual Investigators: In situations where the non-UCI entity is an independent researcher who is not affiliated with an institution, an Individual Investigator Agreement (IIA) may be utilized.

 

Submitting an sIRB Request to the UCI IRB

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.

  • Provide a sIRB agreement signed by each non-UCI entity.
  • 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.
  • 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.
  • Provide the non-UCI entity’s conflict of interest management plan.
  • Provide the non-UCI entity’s RSC approval.
  • Provide the non-UCI entity’s IBC approval.

When Can the UCI IRB Serve as the HIPAA Privacy Board for a non-UCI Entity?

The UCI IRB will consider serving as the HIPAA Privacy Board only when the non-UCI entity is within California and it does not have a privacy board. Exceptions may be considered.

During the review process, the UCI IRB determines whether participants should sign an "Authorization" or if a Waiver of HIPAA Authorization may be granted. The non-UCI entity may use the Relying Site HIPAA Research Authorization template. Each institution will retain their own Privacy reporting responsibilities should a breach of privacy occur.

UCI requires the version of the SMART LOA or IAA that includes language acknowledging the request for UCI IRB to serve as the HIPAA Board,  signed by the relying entity, with the request for UCI to serve as the IRB of record. All templates for sIRB agreements can be found on IRB Forms.

Guidance on Single IRB:

  • NOT-OD-20-058: Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-18-004Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-18-003Guidance on Exceptions to the NIH Single IRB Policy
  • NOT-OD-17-076: Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
  • NOT-OD-16-109: Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
  • NOT-OD-16-094: Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

Guidance on International Research: