CINCINNATI and DURHAM, N.C., Dec. 19, 2016 /PRNewswire/ -- Schulman IRB, an industry-leading central IRB for customer service and technology, is pleased to announce that it has joined SMART IRB, a platform to ease common challenges and burdens associated with initiating multisite research.
SMART IRB is a collaborative initiative supported by the National Center for Advancing Translational Sciences (NCATS) and led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across a national consortium of institutions and IRBs.
The goal of SMART IRB is to streamline the IRB review process in multisite research, helping investigators obtain trial results faster and, ultimately, advance the development of new diagnostics, treatments, and preventative measures for patients, while maintaining strong human research protections, oversight, and regulatory compliance.
"The SMART IRB model makes it easy for institutions to rely on a single IRB for multisite studies, simplifying the process for industry sponsored and federally funded research," said Michael Woods, President and CEO of Schulman IRB. "Given the ongoing regulatory movements toward single IRB review, this kind of collaboration makes a lot of sense. We look forward to working with and learning from SMART IRB members."
"As the first independent IRB to join SMART IRB, Schulman IRB brings a unique perspective to the consortium," said Sabune Winkler, Chief Regulatory Operations Officer for Reliance at SMART IRB. "We are excited to work with Schulman to explore and expand the efficiencies SMART IRB offers member institutions."
Under the SMART IRB Agreement, investigators conducting multisite research may request that participating institutions rely on the review of a single IRB, and institutions may elect to do so on a study-by-study basis.
A full list of participating institutions may be found at smartirb.org.
About Schulman IRB
Schulman IRB has been a leader in the protection of human research participants in the U.S., Puerto Rico and Canada since 1983. Schulman offers thorough, timely IRB review services –including dedicated review capabilities for all phases of research across all therapeutic areas –to clinical trial sponsors, CROs, investigators and institutions. Schulman also provides global consulting services, offering comprehensive solutions to maximize the protection of human subjects and improve overall quality standards for clinical studies and data integrity. Fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), Schulman has an unparalleled clean audit history with the Food and Drug Administration (FDA).
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SOURCE Schulman IRB