IRB Review-Reliance Process

Can a Study be Reviewed by a Single IRB?

What Is Review-Reliance?

  • A multi-site study can be reviewed by a single Institutional Review Board (IRB) when all participating institutions agree to rely on one IRB for ethical oversight. This approach, known as a single IRB (sIRB) review, is mandated by federal policy for most federally funded research involving multiple sites in the United States. Exceptions to this requirement may apply in cases of tribal sovereignty or when specifically justified and approved by the funding agency.
  • The goal is to streamline the review process, reduce duplication, and enhance consistency across study sites. The designated sIRB single assumes responsibility for reviewing all IRB submissions related to the multi-site study, including initial, continuing, any subsequent modifications, and any unanticipated problems or adverse events.
  • Federal regulations (45 CFR 46) encourage the use of a sIRB for many cooperative research studies to reduce duplicate reviews while maintaining participant protections.
  • Review-Reliance is documented by one of the processes outlined in the “IRB Review-Reliance Agreement Decision Tool” below

IRB Review-Reliance Agreement Decision Tool

SDSU is the
Reviewing IRB:		 Smart IRB ORS (Online Reliance System) Smart IRB LOA (Letter of Acknowledgment) Inter-Institutional Agreement Individual Investigator Agreement
Only UCSD and SDSU are engaged in HSR Not allowed Allowed Not allowed Not allowed
SDSU-UCSD JDP Students Not allowed Allowed Not allowed Not allowed
All collaborating institutions are registered on SMART 3.0 Allowed Not allowed Not allowed Not allowed
Some collaborating institutions are registered on SMART 3.0, but not all Allowed Not allowed Allowed Not allowed
Relying institution is not registered on SMART 3.0 Not allowed Not allowed Allowed Not allowed
Relying institution does not have FWA or IRB Not allowed Not allowed Not allowed Allowed

Please Note: SDSU only enters into review-reliance agreements for NON-EXEMPT (ie, Full Board, Expedited) Human Subjects Research studies.

If you are working with a collaborator(s) from another institution, and the IRB has determined your study meets Exempt criteria, you do not need a review reliance agreement.

SDSU IRB Inter-Institutional Authorization Agreement (PDF)

Processes when SDSU is the reviewing IRB

  1. The SDSU PI submits their IRB proposal for review using the IRB submission platform, iRIS.

  2. On the IRB Protocol (i.e., the Initial Review Application), the SDSU PI includes UCSD PI, Co-PI, Co-I or any other UCSD study team members on the protocol and describes their role(s) in the study. The SDSU study team should include a description of the UCSD collaborator’s study activities in the Research Methods section of the application.

  3. The SDSU IRB includes a completed “Letter of Acknowledgment SDSU Reviews for UCSD (DOC)” with the IRB submission.

  4. Once the SDSU IRB approves the proposed study, the SDSU PI forwards the IRB approval, IRB-approved documents, including the Initial Application (study protocol), and the “Letter of Acknowledgment SDSU Reviews for UCSD” to the study team at UCSD for submission. If the collaborator is faculty at UCSD, the submission must be submitted to the UCSD IRB via Kuali, the UCSD IRB online submission platform, for review. The SDSU PI should inform their faculty collaborator at UCSD of this requirement. Failure to submit to the UCSD IRB via Kuali will result in a delay in the execution of the review-reliance agreement and the commencement of the research.

    If the PI is a SDSU-UCSD JDP student, a UCSD member of the student’s thesis/doctoral committee must submit the study to the UCSD IRB via Kuali. Failure to do this will result in a delay in the execution of the Review-Reliance Agreement. 

    Questions regarding the process at UCSD should be directed to [email protected].

  5. Note: The UCSD IRB Reliance team will require a Local Context sheet to be completed by the SDSU PI. This is a UCSD-specific form. Once completed, the SDSU PI must provide the Local Context sheet to the study team at UCSD. Our office can assist with specific questions on the form; however, the SDSU PI/study team must complete this form given the specifics of the study. This form may be completed or required earlier in the review-reliance process depending on UCSD requirements.

  6. A Communication Plan for when SDSU is the reviewing IRB (PDF) must be provided to the study team at UCSD. 

  7. Remember all future submissions (Amendments, Continuing/Annual Review, Adverse and Other Reportable Events) will be reviewed by the SDSU IRB, however, upon review of future submissions, the SDSU study team must forward all IRB approvals and IRB-approved documents to their collaborators at UCSD.

Please view this first to see if a collaborators institution participates in the SMART IRB agreement and to see an overview of the review-reliance process.

  1. The SDSU PI requests investigator access.
  2. The SDSU PI creates a reliance request on the SMART Platform and adds the institution(s) that is/are proposed as institution(s) relying on the SDSU IRB for review.
  3. Within the Reliance Request on the SMART platform, the SDSU PI uploads the study documents so that the institution(s) proposed as institutions to rely on SDSU IRB for review can determine if the study qualifies for reliance. The Point-of-Contact (POC) from each institution indicates whether or not they agree to rely on the SDSU IRB for review. Note: POC’s can also propose that another IRB serve as the reviewing IRB. 
  4. The SDSU PI submits the proposal via iRIS for IRB review and approval. The SDSU PI should note that the study number assigned in iRIS will have –SMT appended to the study number (e.g. IRB-26-001-SMT)
  5. Once the SDSU IRB approves the study, the SDSU IRB provides the IRB approval and ALL of the SDSU IRB approved documents to their collaborator(s) at the relying institution(s).
  6. Remember all future submissions (Amendments, Continuing Review/ Study Follow-ups, Adverse and Other Reportable Events) will be reviewed by the SDSU IRB, however, upon review of future submissions, the SDSU PI must forward all IRB approvals and IRB-approved documents to their collaborators at the institution(s) relying on SDSU IRB.

This form can be used by Reviewing IRBs and others to identify and document key communication roles for a study. It is recommended that the form be used to document the various responsibilities. However, the form also could be used less formally to guide conversations among the Reviewing IRB, Relying Institutions, and Lead Study Team. 

Communication Plan When the SDSU IRB Reviews (PDF)

Process when the SDSU IRB Relies on Another IRB (SDSU is not the Reviewing IRB)

 *In instances where the SDSU IRB relies on another IRB for review, the process will differ depending on the reviewing institution's policies and processes. SDSU investigators should work with their collaborators at the proposed reviewing institution to determine what the process and what their responsibilities are when the SDSU IRB is relying on another IRB for review.*

SDSU/UCSD Joint Student Review-Reliance Agreements

A brief description of how to initiate review-reliance

  1. Determine if the study meets the eligibility to be reviewed under a review-reliance agreement. Only studies that are eligible for expedited review or are determined to be minimal risk at a fully-convened IRB meeting are eligible for review-reliance.
    See SDSU-UCSD JDP Eligibility Facts (PDF) for more information.
  2. Determine whether SDSU or UCSD is the reviewing IRB. The Reviewing IRB is determined by the primary institutional affiliation of the faculty mentor responsible for oversight of the proposed research.
  3. Submit the research proposal to the reviewing IRB using the IRB e-submission platform. Include the SMART LOA with the IRB submission as a supporting document.
  4. The review process if SDSU is the reviewing IRB is the same as the process for SDSU faculty PIs. Questions regarding the process at UCSD can be directed to [email protected].
  5. At SDSU, once the IRB has reviewed and approved the submission, the SMART LOA will be routed for signature by both SDSU and UCSD. Once signed by both UCSD and SDSU, the research can commence. Note: If UCSD is the reviewing IRB the student PI should contact the UCSD IRB for detailed information regarding UCSD's reliance process.

*Failure to follow the steps outlined above, may result in delayed IRB approval.*

SDSU–CGU Joint Doctoral Programs

If you are a student in an SDSU–Claremont Graduate University Joint Doctoral Program (JDP), your dissertation research may follow a separate cooperative IRB review process. The SDSU and CGU have an agreement that allows qualifying dissertation research to undergo a single IRB review for both institutions. The Reviewing IRB is assigned by the JDP Program Directors, and the Reviewing IRB communicates with the Relying IRB throughout the review process.

What is SMART IRB?

SMART IRB

The process will differ depending on each stakeholder's role in the process. Watch the video of the SMART IRB Review-Reliance process below for more information. Investigators can sign up for SMART IRB to gain access for cooperative, multi-site studies to be reviewed under the agreement where SDSU is the reviewing IRB or is relying on another participating IRB for review.

SMART IRB Review-Reliance Process (Video)Sign up for SMART IRB

Smart IRB Standard Operating Procedures

Standard operating procedures (SOP) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement. The SOP contains a search-able index for locating relevant information quickly. It outlines the responsibilities investigators and study teams, of the Reviewing IRB, the Relying IRB, and Points of Contact (POC) for the Reviewing and the Relying IRBs.

Note: The SMART IRB platform is for documenting review-reliance when multiple institutions are engaged in human subjects research. The SMART IRB platform is not the SDSU IRB submission platform.  SDSU IRB submissions should be submitted for review via iRIS. See the Guidance page for more information on the process for submitting to proposals to the SDSU IRB for review.

Review-Reliance FAQs

IRB review reliance is an arrangement where one Institutional Review Board (IRB) reviews a research study for multiple institutions or sites. Instead of each participating site having its own IRB review the same study, one designated IRB (the Reviewing IRB) handles the ethical review for all sites involved.

The Reviewing IRB reviews and oversees the research, while the Relying IRB cedes its review to the Reviewing IRB. When SDSU IRB relies on another IRB for review, the process varies based on the reviewing institution’s policies. SDSU investigators should coordinate with their collaborators to understand the process and their responsibilities.

A document used to formalize reliance agreements under the SMART IRB master agreement, allowing one institution's IRB to cede review to another's.

This agreement is initiated when an institution engaged in human subjects research has an FWA #, but does not participate in SMART IRB. An inter-institutional agreement is a formal, written document that authorizes one of the institutions to serve as the reviewing IRB, or the IRB of Record.

An agreement used when an investigator on the protocol works for an agency that does not have an FWA # OR its own IRB and SDSU will be serving as the IRB.

Check with an IRB analyst or wait for your determination letter.

Contact the HRPP Office for more information.