NIH’s National Center for Advancing Translational Sciences (NCATS) announced that all Clinical and Translational Science Awards (CTSA) Program sites have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement.
“The NCATS SMART IRB authorization agreement was developed to establish a harmonized approach for roles and responsibilities of the single IRB and the participating sites,” Michelle Culp, M.P.H., Director of Clinical Operations, Division of Clinical Innovation, National Center for Advancing Translational Sciences, National Institutes of Health, told Outsourcing-Pharma.com.
“Enabling all participating sites in a clinical study to rely on the ethics review of a single IRB will streamline the ethics review process, making it possible to initiate multisite studies faster,” she added.
Moving forward, Culp said the next steps include collaborating with lead institutions on training, policies and procedures for implementing the SMART IRB Reliance Platform that can be used to support ethical review of multisite studies.
“Addressing long-standing systemic challenges in multisite clinical trials, such as approval of a single protocol by multiple institutional review boards, will dramatically accelerate the delivery of new treatments to patients,” said Culp.
“Obtaining all CTSA Program hubs’ support for the SMART IRB authorization agreement is the first milestone in a multi-step transformative initiative to provide a flexible platform that investigators can access nationwide to coordinate and streamline the ethics review process for their own multisite studies.”