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

Requirements for Approval of Offsite Research

All research activities performed by or under the direction of UCI personnel in the course and scope of University duties, or which use University resources, must comply with applicable UCI policies and procedures, regardless of funding and whether performed in UCI facilities or at offsite locations.

Any human subjects research conducted in whole or in part offsite, including research at UCI affiliated institutions, must be reviewed and approved/registered by all applicable UCI entities prior to initiation if it satisfies any of the following criteria.

  1. It is conducted by or under the direction of UCI personnel in connection with his or her UCI responsibilities.
  2. It uses UCI property, facilities, or resources to support or carry out the research.
  3. The name of the University of California, Irvine is used in applying for funds (intra or extramural).
  4. The name of the University of California, Irvine is used in explanations and/or representations to subjects.
  5. The investigator plans to use his/her University of California, Irvine association in any publication or public presentation resulting from the research.
  6. UCI's non-public information will be used to identify or contact human research subjects or prospective subjects.

The UCI IRB may approve/register human subjects research that is proposed to occur at or in collaboration with offsite locations when appropriate documentation demonstrating the support and collaboration of the offsite location(s) and compliance with federal requirements is provided.

The documentation necessary for UCI approval/registration of offsite human subjects research is dependent upon several factors, including but not limited to the degree of risk to subjects, UCI's relationship with the site, the source of funding for the research, and the degree of responsibility UCI personnel will assume. See the campus Offsite Research Activities policy for detailed information.

 

Single IRB 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.

Relying on Other IRBs

Dictionary

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 IRB Serve as the IRB of Record for non-UC entity?

The UCI IRB primarily serves as the IRB for UCI. In general, UCI cannot be considered the IRB of record for non-affiliated institutions or investigators. However, there are a few exceptions and the conditions where the UCI IRB can as the IRB for institutions not affiliated with the University.

Sirbflowchart

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

  • 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.

UCI is the prime awardee on the award/contract: The IRB will agree to be the IRB of record if the scope of human research activities conducted at the collaborating site are considered minimal risk and discussed in the UCI IRB Application. If the risk is greater than minimal, the site engaged in human subject research must obtain its own Federalwide Assurance (FWA) and designate a registered IRB, or register its own IRB. For more information on securing a FWA go to OHRP Federalwide Assurance web page.

Research does not involve an award/contract: The IRB may agree to be the IRB of record if the human research activities conducted at the collaborating site are considered minimal risk and discussed in the UCI IRB Application. Because this type of research is handled on a protocol-by-protocol basis, contact the HRP Staff to discuss the details of the proposed study. See above for preclusions relating to international research.

sIRB Agreements

Non-Affiliated Institutions: UCI IRB can be the IRB of record if the institutions complete an IRB Authorization Agreement (IAA). The research may begin only after the Institutional Officials at the respective organizations have signed the IRB Authorization Agreement. Because these agreements are handled on a protocol-by-protocol basis, contact the HRP Staff to discuss the details of the proposed study.

Note: Generally, IAAs are executed with another institution where research procedures will occur within the United States only and as part of engagement with an United States academic institution. If research procedures occur in an international site, there is no engagement with an international academic institution or location (i.e., survey questions asked in Mexico but Mexico is not an engaged site via a formal academic institution). Researchers will still be required to address cultural appropriateness, as necessary.

Non-Affiliated Individual Investigators: UCI can be the IRB of record if the individual investigator signs an Individual Investigator Agreement (IIA). This document requires various assurances of the individual investigator, as well as the signature of the FWA Institutional Official. Because these agreements are handled on a protocol-by-protocol basis, contact the HRP Staff to discuss the details of the proposed study.

Note: Generally, IIAs are executed with another investigator where research procedures will occur within the United States only and, at times, as part of a formal affiliation with an United States academic institution. If research procedures occur in an international site, the investigator has no formal affiliation with an international academic institution  (i.e., survey questions asked in Mexico but Mexico is not an engaged site via a formal academic institution). Researchers will still be required to address cultural appropriateness, as necessary.

 

Requests for collaborating sites to rely on the UCI IRB must be made via a formal amendment to the UCI IRB approved study.  Reliance agreements where UCI serves as the IRB of record will not be considered at initial review due to the amount of time involved as this often protracts the initial IRB approval timeframe for the UCI site.  Note: Where the relying institution has an IRB, the use of the SMART IRB agreement is required.

UCI Documentation:

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: