How Smart IRB Works
for IRB and HRPP Administrators
By opting for IRB reliance with SMART IRB, institutions minimize duplicative IRB reviews while maintaining appropriate oversight.
Eligibility Criteria
Eligible and interested institutions may initiate the process of joining SMART IRB through the SMART IRB Joinder Platform
FWA or IRB Organization
Unless it is an IRB organization, your institution must maintain a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP).
Quality Assessment
If your institution has an IRB or is an IRB organization, it must have undergone or initiated an assessment of the quality of its human research protection program (HRPP) within five years prior to joining SMART IRB (through accreditation from an external organization, participation in OHRP’s Quality Assessment Program, or equivalent approach).
Point of Contact
Your institution must establish a Point of Contact (POC) who will be responsible for, and communicate on behalf of, your institution regarding the initial and ongoing implementation of the SMART IRB Agreement.
Enabling Single IRB Review
As part of SMART IRB, institutions may choose to rely on another IRB to review, approve, and oversee a research study.
The Reviewing IRB takes on IRB oversight responsibilities associated with that study throughout its duration. Relying Institutions provide key local context information about state law, study team member training and qualifications, and any applicable conflict of interests. Investigators and institutions retain their respective responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms of the institution’s FWA.
More Information?
For more information, view the SMART IRB Agreement and Standard Operating Procedures (SOPs), visit the Resources page, or contact us below
Resources
SMART IRB Agreement V2
Review the Master Common Reciprocal Institutional Review Board Authorization Agreement. As of October 1, 2020, any new signatory institution will sign SMART IRB Agreement v2.0.
SMART IRB SOP Manual
Standard operating procedures (SOPs) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement.
Join SMART IRB
Join the platform to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.
