OTSS - SMART IRB SUPPORT

Axle Informatics, Llc, North Bethesda MD

Investigators

Abstract

The National Institute of Health (NIH) is the nation’s leading medical research agency and the primary federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability by supporting and making medical discoveries. NCATS is the only center at the NIH that focuses exclusively on all aspects of the translation of research with an innovative pipeline of treatment discoveries for all diseases. NCATS brings together a diverse group of scientists, including medicinal chemists, biologists, toxicologists, clinicians, and engineers to translate basic science conducted elsewhere into products and services that help improve people's health and lives. NCATS’s mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common. 45 C.F.R. Part 46, Protection of Human Subjects, also known as the Common Rule, requires review by an institutional review board (IRB) of any research involving human subjects that is conducted, supported, or regulated by any Federal department or agency. Historically, institutions establish their own IRBs, which for multi-site research could result in multiple IRBs reviewing the same research. However, multi-site research is required by NIH to designate a single IRB (sIRB). See NOT-OD- 16-094. NCATS established the SMART IRB program in 2016 to harmonize and streamline the IRB review process for multi-site studies. SMART IRB is administered by Harvard University and funded by the NIH Clinical and Translational Science Awards (CTSA) Program. See https://smartirb.org/. Utilization of a sIRB requires that institutions document the reliance on the sIRB. Although the SMART IRB Agreement eliminates the need to negotiate the terms of the reliance documentation, institutions and IRBs must still document the use of the agreement for specific research. Within the SMART IRB platform, institutions agree to the terms of the SMART IRB agreement by ‘joining’. The SMART IRB Joinder platform supports the documentation of which institutions have joined the SMART IRB agreement as well as complete and share an Institutional Profile documenting key information about their institution (and IRBs, where applicable). Institutions that have signed the SMART IRB Agreement through the Joinder platform have access to the SMART IRB Online Reliance System (ORS)to coordinate and document sIRB arrangements with other SMART IRB Participating Institutions. There are some barriers preventing some institutions from using the ORS. Making Joinder and ORS less cumbersome and more user friendly and responding to documented needs communicated by the existing user community, will lead to increased use of these applications and allow for more efficient implementation of sIRB and therefore facilitate collaborative research nationwide.