NIH achieves milestone to accelerate multisite clinical studies
BU CTSI is among the 64 CTSA hubs utilizing SMART IRB, the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform. SMART IRB is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS) and intended to serve as a roadmap for institutions to implement The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multisite Research. Watch the video to learn more!
NIH News Release March 23, 2017
CTSA Program paves way for nationwide single IRB model
NIH’s National Center for Advancing Translational Sciences (NCATS) announced today 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. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multi-site studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.
The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously
The authorization agreement effort was led by Harvard Catalyst, University of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.
“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”
Visit NIH and SMART IRB to learn more!