Nationwide IRB Reliance Agreement Aimed at Speeding Research Reaches 1,000 Signatories
The NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) Institutional Review Board (IRB) agreement has achieved 1,000 participating sites. This milestone makes SMART IRB’s medical research study reliance agreement one of the largest in the United States.
“This is an incredible milestone for translational science and offers the ability to initiate medical trials faster,” said Michael Kurilla, M.D., Ph.D., director of NCATS’ Division of Clinical Innovation. “SMART IRB is a solution and resource for medical institutions across the country to conduct research and bring more treatments to all people more quickly.”
To test the safety and effectiveness of new treatments, medical trials need to enroll many participants at multiple locations. An IRB is selected to review and monitor each study to make sure the rights and welfare of the research participants are protected.
The SMART IRB provides a master IRB reliance agreement, enabling multisite studies to begin within weeks — instead of months — while ensuring appropriate oversight and protections for research participants. It also provides an easy-to-use platform to help research institutions involved in a multisite study agree on the IRB that provides the ethical review for all the sites.
The SMART IRB reliance agreement, developed at Harvard Medical School and implemented collaboratively with NCATS, was launched in 2016 and continues to grow. It supports and simplifies adherence to U.S Department of Health and Human Services regulatory requirements and the NIH policy requiring all NIH-funded multisite studies to use a single IRB.
The SMART IRB team unites members from across the Clinical and Translational Science Award (CTSA) Program and NCATS Technology Resources Branch to provide expert consultation, technical support and resources for its users.
For more information about the SMART IRB Platform or to join the agreement, please visit https://ncats.nih.gov/ctsa/projects/smartirb.