Background

Over the past several years, SMART IRB leadership worked with the SMART IRB Harmonization Steering Committee, the National Center for Advancing Translational Sciences (NCATS) and other federal agency representatives, and members of the SMART IRB community to discuss changes to Version 2.0 of the SMART IRB Agreement. The SMART IRB Reliance Agreement Version 3.0 changes are intended to: 

• address feedback from current and potential Participating Institutions
• fully reflect changes to IRB review requirements in the 2018 Common Rule; and 
• allow additional federal agencies to participate in the agreement.
• provide an optional Indemnification Addendum

You can learn more information about the development of SMART IRB Agreement V3.0 and the revisions to the SMART IRB Agreement in the Agreement section of the SMART IRB website.