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:
Confirm that the sites you are collaborating with have agreed to use a single IRB to serve as the IRB of record and that collaborating institutions have agreed to rely on the single IRB.
Confirm both the single IRB and the institutions that will rely on the single IRB are SMART IRB participating institutions. You can do this by reviewing the list of participating institutions on the SMART IRB website. (Both Tufts Medical Center and Tufts University Health Sciences are SMART IRB participating institutions.)
Submit a request to the Tufts Health Sciences IRB to obtain institutional approval for a proposal to use SMART IRB. (See detailed instructions below.)
The IRB will review the submission and might contact you to request additional information.
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.
The Overall PI for the multi-site study must submit a request online through the SMART IRB Online Reliance System. The Online Reliance System allows you to request, track, and document reliance arrangements on a study-by-study basis. The overall PI for the multi-site study (or that person’s designee) will enter the following information in the SMART IRB Online Reliance System:
Details about the study
The engaged sites
Identifying activities and personnel at each site
Upload research protocol and any consent templates
Submit the Tufts version of the Informed Consent Form (ICF) to the single IRB of record, if the Tufts site will enroll participants. The single IRB of record will provide a copy of the ICF that can be revised with required institutional template language.
Finalize your SMART IRB Request:
Submit Local Context Survey: To be completed by an institution that is ceding (giving up) oversight.
Complete Relying Investigator Checklist: Developed to help site investigators and study teams understand and fulfill their responsibilities when IRB oversight has been ceded to an external institution.
The lead institution protocol document (required for requests to give up oversight)
Informed Consent Form(s) (ICFs) for requests to give up oversight:
A copy of the sample template ICF from the lead institution.
The Tufts version of the ICF containing Tufts institutional required template language, if the Tufts site will enroll participants. The single IRB will provide you a consent form that they have reviewed and approved for use. Take this consent form then and insert Tufts-specific information (i.e. headers, HIPAA language, research related injury language, contact information, etc.).
Informed Consent Form(s) (ICFs) for requests to take on oversight:
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.
Studies that utilize an ICF also require submission of the following forms:
Research Conflict of Interest (COI) Forms:Research COI form for the Tufts PI as well as COI forms from research team members who have indicated a “YES” response in any field on the form.
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.