NIH achieves milestone to accelerate multisite clinical studies

CTSA Program paves way for nationwide single IRB model.

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review...”

—Christopher P. Austin, M.D., Director, NCATS

The National Institutes of Health is leading policy and programmatic initiatives to streamline this overly cumbersome process. 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 multisite 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.”

In addition, the SMART IRB authorization agreement will provide the foundation for NCATS’ Trial Innovation Network central IRBs. The Trial Innovation Network is a collaborative CTSA Program initiative designed to address critical roadblocks in clinical research, and to optimize and streamline the clinical trial and studies process.

Next steps for the NCATS SMART IRB Platform include the development of education, training and harmonization of best practices for a single IRB review. Learn more at https://ncats.nih.gov/expertise/clinical/smartirb and https://smartirb.org(link is external).

About the National Center for Advancing Translational Sciences (NCATS): To get more treatments to more patients more quickly, NCATS incorporates the power of data, new technologies and strategic collaborations to develop, demonstrate and disseminate innovations in translational science. Rather than targeting a particular disease or fundamental science, NCATS focuses on what is common across all diseases and the translational process. Learn more at https://ncats.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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