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.
- Review-Reliance is documented by one of the processes outlined in the “IRB Review-Reliance Agreement Decision Tool” below
Additional Guidance
When SDSU IRB is the Reviewing IRB for Studies Where UCSD Relies on SDSU for IRB Review Process
Process when the SDSU IRB Relies on Another IRB (SDSU is not the Reviewing IRB)
SDSU/UCSD Joint Student Review-Reliance Agreements
A brief description of how to initiate review-reliance
- 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. - 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.
- 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.
- 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].
- 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.*
What is SMART IRB?
- SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is designed to streamline the IRB review process for multisite studies, ensuring a high level of protection for research participants.
- SMART IRB is not an IRB; it is a platform encompassing a common IRB reliance agreement (the SMART IRB Agreement) and a suite of web-based resources to facilitate single IRB arrangements. Through smartirb.org, institutions can join the SMART IRB Agreement and manage their profiles, and investigators, study team members, and IRB/HRPP staff and administrators can request, track, and document single IRB (sIRB) arrangements for their studies. SMART IRB also provides essential education and flexible tools and resources to support the implementation of single IRB oversight, with a team of ambassadors available to assist in onboarding and implementation.
- Please review the list of Participating Institutions to see if your collaborator’s institution has joined version 3.0 of the SMART IRB agreement. Additional resources are available on the SMART IRB Learning Center webpage.
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 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.