SMART IRB (the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is a Reliance Agreement that streamlines IRB review and oversight of multi-site studies.
The goal of the SMART IRB agreement is to reduce duplicative IRB review by naming a single IRB of record for a research project and the institutions that will rely on that single IRB. The SMART IRB agreement eliminates the time and effort typically required to negotiate an IRB authorization agreement for each new study; a reviewing IRB as well as relying institutions can then be designated on a study-by-study basis via the SMART IRB Online Reliance System. The SMART IRB model can be used for a range of research, from large clinical trials to two-site collaborations.
Trial Innovation Network (TIN) Studies: TIN studies use SMART IRB, but have already identified an IRB of record, so would not require use of the SMART IRB Online Reliance System. TIN studies use IRB Reliance Exchange (IREx) to support single IRB review (to facilitate central IRB (CIRB) documentation, communication, and the exchange of information for all TIN studies). IRBs, coordinating centers, and study teams use IREx for the life of a TIN study. Johns Hopkins University, University of Utah, and Vanderbilt University Medical Center serve as single IRBs for TIN studies. If you are submitting a TIN study, please note this in your cover letter to the IRB. The IRB will help you complete the local context information to be entered into IREx.
Understanding the SMART IRB Process
In order for a single IRB to assume oversight for relying institutions through SMART IRB, you need to:
Please note that each request for the institution to take on or give up IRB oversight for a study is carefully considered on a case-by-case basis by a group that includes the IRB Chair and Institutional Official.
Submitting a request to the Tufts Health Sciences IRB to obtain institutional approval for a proposal to utilize the SMART IRB
Submit the following to the Tufts Health Sciences IRB (paper copy with original ink signatures):
Tufts Health Sciences IRB will provide a copy of the approved for use consent form with customizable sections highlighted in yellow. Only customizable sections can be revised.
New Study: If this is a new study, in addition to above-referenced documents, submit all other required new study submission documents. Refer to the IRB website for information about what to submit for a new study.
Existing Study: If this is an existing approved study, submit an Amendment to add relying sites. Revise the protocol or Site Specific Appendix, and any other study documents that require revisions to reflect the addition of relying sites, specifying the research activity that will occur at each new relying site.