SMART IRB (Streamlined Multisite Accelerated Reliance for Trials)
This guidance reviews the process for use of the SMART IRB for setting up single IRB (sIRB) or reliance agreements for IRB review and oversight of multi-site research involving University of Massachusetts-Worcester (UMass) investigators. The SMART IRB is a platform for the over 300 participating research institutions to track and document reliance decisions on a study-by-study basis.
Use of the SMART IRB to set up reliance agreement is appropriate when:
- The research is for a study funded by the National Institute of Health (NIH) where UMass and at least one more unaffiliated site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.
- The research is for investigator-initiated collaboration between UMass and at least one more unaffiliated site or investigator conducting the same protocol involving non-exempt human subjects research.
- Each unaffiliated site maintains a master agreement with the SMART IRB. (check here)
Use of the SMART IRB to set up reliance agreement is NOT appropriate when:
- Collaboration is between investigators affiliated with UMass
- Collaboration involves international research sites
- The research protocol differs between sites
- Collaboration is for exempt or not human subjects research
If there are special circumstances or you are unclear about whether your study can utilize the SMART IRB platform to enter into a reliance agreement, contact the UMass IRB before preparing the submission to SMART IRB.
Although UMASS may rely upon an external IRB for review and approval of certain research studies, UMASS is still responsible for the conduct of that research. As shown in the graphic below, the IRB is only a subset of the functions of the Human Research Protection Program (HRPP) responsibilities.
Therefore, the UMASS IRB must be aware and approve of any submission to the SMART IRB through an administrative pre-review. UMASS Investigators considering external IRB review or the single IRB process should e-mail a copy of the protocol, consent form template, and completed HRP270 external IRB review application. The administrative pre-review confirms that:
- Research personnel have completed required trainings (including conflict of interest)
- Necessary ancillary reviews (Conflict of Interest, Radiation Safety, etc.) are complete
- Research injury compensation language is consistent with UMASS requirements
- There is a stand-alone HIPAA authorization
and identifies whether:
- Special populations will be consented
- Research involves an investigational new drug (IND) or investigational device exemption (IDE)
Basic Process as Lead PI:
- Email a copy of the protocol and consent form template to the UMASS IRB SMART IRB Liaisons and confirm that the submission meets the criteria above.
- Complete and submit the HRP270 external IRB review application.
- Upon receiving approval of the external IRB review application, request investigator access for the SMART IRB (if you haven’t already).
- Log in as an investigator to the SMART IRB and enter or upload:
- Basic information about the research (title of study, a brief description)
- Name of the Principal Investigator
- The institution that the lead PI would like to serve as the Reviewing IRB
- Funding sources (optional)
- List of the sites that will be engaged in human subjects research for the study and for each site detail:
- The site investigator’s name and contact information
- Research personnel names and contact information (optional)
- Research participants and activities
- Supporting documents (PDFs only) of:
- Research protocol
- Consent templates (optional)
- Other documentation (optional)
Additional details, including FAQs and SOPs, can be found on the SMART IRB website: https://smartirb.org/go/
Once the request for a reliance agreement has been submitted, the Point of Contact (POC) for each identified institution IRB is contacted. Importantly, the flow of information for the SMART IRB should follow the diagram below. The Lead PI should never be contacting the relying/ceding IRB directly, nor should a Co-PI be contacting the reviewing IRB directly.
The IRB POCs evaluate the request and identify the reviewing IRB. The decision on which site will be the reviewing site (s-site) and which sites will rely on, or cede to the reviewing IRB (p-sites) may be based on the institute of the lead PI, or the relative expertise of the IRBs with a particular research method or population, or which site will be conducting the majority of recruitment activities, or how the funding is structured, or other rationale.
After the s-site is decided, the p-site institutions express their willingness to rely and communicate local context information and the s-site IRB reviews each institution’s decision and issues a determination on the reliance agreement.
Enrollment can begin once the determination letter and IRB approval have been issued.